AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CATHETER AND GUIDEWIRE WITH SENSORS AND METHODS OF USING THE SAME

Abstract

The present disclosure provides endoscopic retrograde cholangiopancreatography (ERCP) catheter systems having multiple ports and sensors configured to determine the location of the catheter's and/or guidewire's distal end as well as optional one or more magnetic bending aids, configured to aim a guidewire to the desired duct location. Further provided is a guidewire having a magnetic end and optional sensing elements. Also provided are methods of using the catheters and/or guidewires in ERCP procedures.

Claims

1.-66. (canceled)

67. An endoscopic retrograde cholangiopancreatography (ERCP) catheter comprising: an elongated catheter body comprising a multiplicity of internal lumens, said lumens extending from a proximal end of the elongated catheter body to a distal end of the elongated catheter body opposite thereto, said distal end is configured to be positioned within the common bile duct (CBD) or the pancreatic duct of a subject, said lumens comprising: at least one sensor configured to sense or measure one or more of: electrical impedance, resistance, conductance and/or electrical signal, at the distal end of the catheter; and a first lumen having an opening at a tip on the distal end of the catheter, said first lumen is configured to allow passage therethrough of a guidewire.

68. The catheter according to claim 67, additionally comprising a second lumen configured to allow passage of a guidewire therethrough, wherein the opening of the distal end of said second lumen is located at a proximal position relative to the opening of the first lumen, thereby allowing a guidewire passing through the second lumen to be positioned at a different internal body location compared to a guidewire passing through the first lumen.

69. The catheter according to claim 67, wherein said catheter further comprising a sensor lumen; further wherein said at least one sensor is at least one sensing probe; said sensor lumen having within said lumen said at least one sensing probe extending from a proximal end of the lumen to a distal end of the lumen, such that said one or more probes are configured to sense or measure one or more of: electrical impedance, resistance, conductance and/or electrical signal, at the distal end of the catheter.

70. The catheter according to claim 67, wherein said at least one sensor is provided as one or more sensing probes positioned on and/or in the elongated catheter body, the one or more sensing probes being configured to sense or measure one or more of: electrical impedance, resistance, conductance and/or electrical signal, at the distal end of the catheter.

71. The catheter according to claim 70, wherein the one or more sensing probes comprise a conductive material configured to pass electrical current therethrough.

72. The catheter according to claim 67, wherein a sensor system located at the proximal end of the catheter is configured to determine the resistance and/or impedance and/or conductance in the body cavity in which the distal end of the catheter is located, via said probes, and to assess the conductivity in said body region.

73. The catheter according to claim 67, wherein at least one of the following is being held true (a) the electrical impedance and/or resistance and/or conductance values determined at the distal end of the catheter are indicative of the location of the distal end of the catheter in the common bile duct or in the pancreatic duct of the subject; (b) the higher the resistivity and/or impedance values and/or the lower the conductivity value that are measured at the distal end of the catheter, is indicative that the distal end of the catheter is located in the common bile duct; (c) the electrical impedance and/or resistance and/or conductance and/or electrical signal values determined at the distal end of the catheter are indicative of the inflammatory condition in the bile duct or in the pancreatic duct; (d) the electrical signal is indicative of muscle or nerve activity; (e) the electrical signal is configured to allow Electromyography measurements; and any combination thereof.

74. The catheter according to claim 67, wherein the catheter is configured to be passed through an endoscope.

75. The catheter according to claim 67, wherein the catheter is sized to be passed through the duodenal endoscope, through the major duodenal papilla and/or Sphincter of Oddi and/or into the ampulla of Vater of the subject.

76. The catheter according to claim 67, wherein the endoscope comprises a magnetic cuff or a magnetic region at the external circumference or internal cavity of said endoscope, at a distal end thereof.

77. The catheter according claim 67, wherein at least one of the following is being held true (a) the catheter comprises a magnetic region on the body of the catheter; further wherein the magnetic region comprises an electromagnet; (b) the catheter is made of a biocompatible and flexible material.

78. The catheter according to claim 77, wherein the activation of the electromagnet is controlled by a user, during the procedure.

79. The catheter according to claim 68, wherein at least one of the following is being held true (a) the distal end of the second lumen is positioned at a proximal side region of the distal end of the catheter; (b) the location of the opening of the distal end of the second lumen within the subject body is controlled by rotating the catheter or at least a portion of the distal end of the catheter; (c) the second lumen comprises an obstacle, selected from a bump, a distortion in shape of the lumen, a bridge or combinations thereof, located in proximity with the distal opening of said second lumen, configured to aid in directing a guidewire passing through the second lumen, to a desired location; (d) the ERCP catheter is a sphincterotomy catheter; (e) the first and/or second lumens are configured to allow passage of one or more suitable medical instruments and/or substances; wherein the one or more suitable medical instruments and/or substances selected from: stent systems, cytology sheaths, dilators balloons, stent extractors, miniscopes, contrast dye, medication, or any combination thereof; (f) the proximal region thereof comprises one or more handles or ports for operating, inserting and/or maneuvering the guidewire, the medical instruments and/or substances; (g) any combination thereof.

80. The catheter according to claim 79, wherein at least one of the following is being held true (a) the guidewire comprises a flexible, biocompatible material; (b) the guidewire further comprises a magnetic tip at the distal end thereof; wherein the magnetic tip of the guidewire is configured to allow bending or deforming the distal end of the guidewire, to aid in directing or navigating the guidewire to the common bile duct.

81. A method for positioning a catheter, for preforming ERCP in a subject in need thereof, the method comprising: inserting a guidewire through a first lumen of the catheter, to protrude from the distal end of the catheter, wherein the catheter is inserted through an endoscope, through the major duodenal papilla, Sphincter of Oddi and into the ampulla of Vater of the subject; sensing, measuring and/or determining one or more of: conductivity, resistivity, impedance and/or electrical signal at the body cavity in which the external end of the catheter is located; determining based on the conductivity and/or resistivity and/or impedance if the catheter end is in the pancreatic duct or the common bile duct.

82. The method of claim 81, further comprising step of, if the catheter end is in the pancreatic duct, inserting a guidewire through the second lumen of the catheter, such that the distal end of the guidewire inserted through the second lumen is positioned within the common bile duct.

83. The method of claim 81, further comprising passing an electrical current through the probes of the catheter.

84. The method according to claim 81, additionally comprising at least one step selected from (a) determining the resistance and/or impedance and/or conductivity in the body cavity in which the distal end of the catheter is located is performed using a sensor system located at the proximal end of the catheter, or an external control unit to which the catheter and/or guidewire are connected; (b) determining that the distal end of the catheter is located in the bile duct when the higher the resistivity and/or impedance values and/or the lower the conductivity value that are measured at the distal end of the catheter; (c) inserting one or more medical instruments or substances through a lumen of the catheter into the internal body cavity; (d) operating and/or maneuvering the guidewire, one or more medical instruments and/or substances within the bile duct; (e) applying an external magnetic force to cause the distal end of a guidewire comprising a magnetic tip to bend towards the common bile duct; and any combination thereof.

85. A guidewire for use in endoscopic retrograde cholangiopancreatography (ERCP) procedure, said guidewire is made of or coated with a non-magnetic material and having a magnetic region at the distal end of the guidewire, said distal end is flexible, wherein said guidewire is configured to advance through a duodenal endoscope through the major duodenal papilla and/or Sphincter of Oddi and/or into the ampulla of Vater of the subject, wherein the magnetic tip of the guidewire is capable of mediating the distal end of the guidewire to bend in the direction of the common bile duct of the subject, wherein the bending of the distal end of the guidewire is affected by an external magnetic force.

86. The guidewire of claim 85, wherein at least one of the following is being held true (a) the magnetic region at the distal end is made of a magnetic or ferromagnetic material or is coated with magnetic or ferromagnetic material; (b) the guidewire is configured to pass through the endoscope within a lumen of a catheter, said catheter is passed within the lumen of the endoscope; (c) the external magnetic force is exerted by an electromagnet placed externally to the subject's body, or placed internally on the catheter and/or on the endoscope and/or within the endoscope.

87. The guidewire of claim 85, wherein the position and/or direction and/or intensity of the electromagnet is controlled such as to the direct the magnetic force in the direction of the common bile duct to thereby cause the bending of the distal end of the guidewire located within the subject body in the direction of the common bile duct.

88. The guidewire of claim 86, wherein the external magnetic force is exerted by a magnetic region/magnetic cuff positioned at the external circumference or in the internal lumen of the endoscope, at a distal end thereof.

89. The guidewire of claim 88, further comprising one or more sensing elements/probes, configured to sense, measure and/or detect electrical resistivity and/or impedance and/or conductivity and/or an electrical signal at a body region in which the distal end of the guidewire is located.

90. The guidewire of claim 85, wherein at least one of the following is being held true (a) the sensing elements comprise a conductive material, configured to pass electric current; (b) the sensing elements are positioned at the distal end of the guidewire or on the sides of the distal end of the guidewire; (c) the sensing elements are positioned coaxially, or in parallel to each other, along external or internal length of the guidewire; and any combination thereof.

91. The catheter according to claim 68, wherein at least one of the following is being held true (a) one or more of the sensing probes is positioned on an external circumference of the catheter body; (b) one or more of the sensing probes is positioned on the distal end of the catheter; (c) one or more of the sensing probes is positioned on the tip of the distal end of the catheter.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0049] Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the disclosure. For the sake of clarity, some objects depicted in the figures are not to scale. In the Figures:

[0050] FIG. 1 schematically depicts a perspective view of a catheter, according to some exemplary embodiments;

[0051] FIG. 2A schematically depicts a perspective side view of a distal end of a catheter, according to some exemplary embodiments;

[0052] FIG. 2B schematically depicts a perspective close up view of a distal end of a catheter, according to some exemplary embodiments;

[0053] FIG. 2C schematically depicts a perspective top view of a cross section of the distal end of a catheter, according to some exemplary embodiments;

[0054] FIG. 3A schematically depicts a perspective side view of a catheter, according to some exemplary embodiments;

[0055] FIG. 3B schematically depicts a perspective close up view of a distal end of a catheter and a guidewire, according to some exemplary embodiments;

[0056] FIG. 3C schematically depicts a perspective view of a distal end of a catheter, with and guidewires, according to some exemplary embodiments;

[0057] FIG. 4A schematically depicts a perspective close up view of a distal end of a catheter and lumen switching mechanism, according to some exemplary embodiments;

[0058] FIG. 4B schematically depicts a perspective close up view of a distal end of a catheter and lumen switching mechanism, according to some exemplary embodiments;

[0059] FIG. 5A schematically depicts a perspective view of a guidewire having a magnetic end, according to some exemplary embodiments;

[0060] FIG. 5B schematically depicts a perspective close up view of a distal end of an endoscope and a guidewire having a magnetic end, according to some exemplary embodiments;

[0061] FIG. 6A schematically illustrates a distal end of a catheter and guidewire within the bile duct region of a subject, according to some exemplary embodiments;

[0062] FIG. 6B schematically illustrates a distal end of a catheter and guidewire within the pancreatic duct region of a subject, according to some exemplary embodiments;

[0063] FIG. 6C schematically illustrates a distal end of a catheter and guidewire inserted via the second lumen of the catheter, within the bile duct region of a subject, according to some exemplary embodiments;

[0064] FIGS. 7A-E—schematically illustrate a perspective view of the distal end of guidewires, having sensors arrangements; according to some embodiments; and

[0065] FIG. 8—bar graphs showing resistivity values of various fluids, as determined by using electrical sensors.

DETAILED DESCRIPTION

[0066] The principles, uses and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout.

[0067] Reference is now made to FIG. 1 which schematically depicts a perspective view of a catheter, according to some exemplary embodiments. As shown in FIG. 1, catheter 2, has a distal end (configured to be placed within a body cavity) and a proximal end (located externally to the subject body). The catheter can include several lumens that run along internal body of the catheter, from the proximal end to the distal end. The lumens include sensor lumens, extending from the proximal end (lumens 8A-8B) to the distal end (end of lumen 8B is shown as opening 18B), having probes/sensors running therethrough, which can detect/measure/sense the conductivity and/or resistivity and/or impedance at the region in which the proximal end of the catheter is located. The catheter may further include a first lumen (12), having an opening (14) at the tip (15) of the distal end of the catheter. The catheter may include a second lumen (10, having an opening (16) at a side region of the distal end of the catheter.

[0068] Reference is now made to FIG. 2A, which schematically depicts a perspective side view of a distal end of a catheter, according to some embodiments. As shown in FIG. 2A, distal end (21) of the catheter (20), has an opening (26) at the tip (24) of a first lumen. On a side region of the distal end, an opening (22) of a second lumen is located. Further shown are the tips (ends) of sensors 29A-B, which protrude through the openings (28A-B) of their respective lumens.

[0069] Reference is now made to FIG. 2B, which schematically depicts a perspective close up view of a distal end of a catheter, according to some embodiments. Shown in the close up view of FIG. 2B, is the distal end (30) of catheter, and the openings of the first lumen (36), located at the tip (34) of the distal end of the catheter. Further shown is the opening (32) of the second lumen and the ends of probes/sensors (39A-B). In some embodiments, the end of the second lumen has a bridge, a bump, a distortion, or an obstacle configured to allow bending of the tip of a guidewire passing through the second lumen.

[0070] Reference is now made to FIG. 2C which schematically depicts a perspective top view of a cross section of the distal end of a catheter, according to some embodiments. The top view of the distal end (40) of the catheter shows the opening of the first, central lumen (44), the openings of the sensor lumens (48A-48B) and the opening of the second, side lumen.

[0071] Reference is now made to FIG. 3A, which schematically depicts a perspective side view of a catheter and a guidewire protruding from the distal end of the first lumen of the catheter, according to some embodiments. As shown in FIG. 3A, catheter 100, has an elongated body, having a proximal end (104) and a distal end (102), configured to be placed within the subject body. The catheter includes several lumens extending from the proximal end to the distal end of the catheter. At the proximal end of the catheter, a proximal end of guidewire (110′) is shown, the distal end of which (110) protrudes from the distal end of the first lumen of the catheter. Further, at the proximal end of the catheter, a proximal end of probes/sensors (106A′-B′) is shown, the distal end of which (106A-B) protrudes from the distal end of the sensor lumens of the catheter. Further shown is the end (108) of the second lumen of the catheter, which is located at the side of the catheter distal end and is preferentially proximal to the tip of the catheter. The end of the second lumen may include a bump or distortion, to allow bending or guiding a guidewire or other suitable medical instrument protruding therethrough.

[0072] Reference is now made to FIG. 3B, which schematically depicts a perspective close up view of a distal end of a catheter and a guidewire protruding from the distal end of the second lumen, according to some embodiments. As shown in FIG. 3B, the distal end of catheter (150), has an opening (156) of a first lumen, located at the tip (154) of the distal end. The first lumen is shown empty (i.e., not having a guidewire protruding therethrough). The second lumen has a guidewire inserted therethrough, such that the distal end of the guidewire (152) protrudes from the opening (160) of the second lumen. Further shown at the distal end are the ends (tips) of sensors/probes (158A-B).

[0073] Reference is now made to FIG. 3C, which schematically depicts a perspective side view of a catheter having a first guidewire protruding from the distal end of the first lumen of the catheter and a second guidewire protruding from the distal end of the second lumen of the catheter, according to some embodiments. As shown in FIG. 3C, at the distal end (202) of catheter (200) shown is the distal end of guidewire (210) protruding from the distal end of the first lumen of the catheter. Further shown is the distal end of a second guidewire (212) protruding from the second lumen of the catheter. As shown in FIG. 3C, the second guidewire (212) is directed/aimed in a different direction as compared to the first guidewire. In some embodiments, the aiming/bending of the second guidewire may be achieved by an obstacle, a bent, a bump, a bridge or any other obstructing element (shown as element 214). The obstructing element may be made of any suitable biocompatible material, magnetic material, or be coated with a magnetic or ferromagnetic material. In some embodiments, the obstructing element may be integrally formed with the catheter body, or may be attached, placed, or mounted thereto. In some embodiments, the aiming/bending of the first and/or second guidewire may be achieved by a magnetic tip placed or formed with the distal end of the guidewire, as further detailed below. Further shown in FIG. 3C are the distal ends of sensors 206A-B.

[0074] Reference is now made to FIG. 4A, which schematically depicts a perspective close up view of a distal end of a catheter and lumen switching mechanism, according to some embodiments. As shown in FIG. 4A, distal end of catheter 250 includes an opening of the first lumen (254), having a guidewire protruding therefrom (252). Further shown is the opening of the second lumen (256). On the right hand panel of FIG. 4A—a close up view of a cross section of the distal end is shown. Reference is made to FIG. 4B, which shows the distal end of catheter (250) which includes an opening of the first lumen (254). Further shown is the opening of the second lumen (256) having a guidewire (260) protruding therethrough.

[0075] According to some embodiments, the catheter may be made of any suitable biocompatible material. In some embodiments, the catheter may be at least partially flexible.

[0076] In some embodiments, the catheter may be a catheter that may function as a sphincterotome. In some embodiments, the catheter is a sphincterotomy catheter.

[0077] In some embodiments, the probes/sensors may include a conductive material configure to pass electrical current. In some embodiments, the probes may be made of any suitable metal.

[0078] According to some embodiments, a sensor system located at the proximal end of the catheter is configured to determine the resistance and/or conductance and/or impedance in the body cavity in which the distal end of the catheter is located, via the probes, and to assess the conductivity in said body region. In some embodiments, the electrical resistance and/or conductance and/or impedance values determined at the distal end of the catheter are indicative of the location of the distal end of the catheter in the common bile duct or in the pancreatic duct. In some exemplary embodiments, as exemplified below herein, the higher the resistivity and/or impedance value and/or the lower the conductivity value that are measured at the distal end of the catheter, it is indicative that the distal end of the catheter is located in the bile duct. In some exemplary embodiments, a resistivity value of over about 400 ohm-metre (Ωm), over about 500 (Ωm), over about 550 (Ωm), over about 600 (Ωm), over about 700 (Ωm), is indicative of a bile duct region.

[0079] According to some embodiments, a sensor system located at the proximal end of the catheter is configured to determine electrical signal or electrical activity, for example, of muscle fibers. In some embodiments, the sensor system may be configured to determine EMG activity in the body cavity in which the distal end of the catheter is located, via the probes.

[0080] According to some embodiments, the catheter system may be configured to detect or identify or recognize an inflammation or inflammatory condition in the ducts. In some embodiments, the identification of the inflammatory condition may be based at least in part on the electrical resistance and/or conductance and/or impedance and/or electrical activity measurements.

[0081] According to some embodiments, the lumen probes (sensors) disclosed herein may be configured to detect/measure/sense/determine one or more of: conductivity, resistivity, impedance and/or an electrical signal. Each possibility is a separate embodiment.

[0082] According to some embodiments, the lumen probes (sensors) disclosed herein may be configured to detect/measure/sense/determine one or more of: conductivity and/or resistivity and/or impedance and/or an electrical signal at an internal body cavity. Each possibility is a separate embodiment.

[0083] According to some embodiments, the catheter is configured to be passed through an endoscope, such as, a duodenal endoscope. In some embodiments, the catheter sis sized/constructed to be passed through the duodenal endoscope, through the major duodenal papilla and/or Sphincter of Oddi and/or into the ampulla of Vater of the subject. Each possibility is a separate embodiment.

[0084] According to some embodiments, the catheter may further include one or more additional internal lumens.

[0085] According to some embodiments, the catheter may include a magnetic portion or region along the body length of the catheter. In some embodiments, the magnetic portion of the catheter may be made of, or coated with a magnetic or ferromagnetic material. In some embodiments, the magnetic portion may be or include an electromagnet. In some embodiments the electromagnet may operate intermittingly (i.e., be turned on or off at will). In some embodiments, the operation of the electromagnet may be controlled externally, for example, by a health care provider operating the catheter system.

[0086] According to some embodiments, any of the lumens of the catheter (including the first/second and/or any additional lumens) are configured to allow passage of one or more suitable medical instruments and/or substances. In some embodiments, the one or more suitable medical instruments and/or substances selected from: stent systems, sphincterotomes, cytology sheaths, dilators balloons, stent extraction devices miniscopes, contrast dye, medication, or any combination thereof. Each possibility is a separate embodiment.

[0087] According to some embodiments, the proximal region of the catheter may include one or more handles or ports for operating, inserting and/or maneuvering the guidewire, the medical instruments and/or substances.

[0088] Reference is now made to FIG. 5A, which schematically depicts a perspective view of a guidewire having a magnetic end, according to some exemplary embodiments. As shown in FIG. 5A, the guidewire (300) has an elongated body having a proximal end (3026) and a distal end (302). The guidewire may include the distal end thereof, a magnetic tip/magnetic region (304). The magnetic tip of the guidewire is configured to allow mediating the distal end of the guidewire to bend in the direction of the common bile duct of a subject.

[0089] Reference is now made to FIG. 5B, which schematically depicts a perspective close up view of a distal end of an endoscope and a guidewire having a magnetic end, according to some embodiments. Shown in FIG. 5B, a distal end of an endoscope (36), having opening 364, through which guidewire (350) protrudes. The guidewire has a magnetic tip/region (354) at the distal end (352) thereof. Further shown is magnetic cuff 263, located on the circumference of the endoscope. The magnetic cuff can exert a magnetic force, capable of attracting the magnetic end of the guidewire and causing the distal end of the guidewire to bend, as illustrated in FIG. 5B.

[0090] According to some embodiments, the guidewire may be made of or coated with a non-magnetic material and having a magnetic region at the distal end of the guidewire. In some embodiments, the distal end of the guidewire may be flexible. In some embodiments, the body of the guidewire is substantially rigid or stiff. In some embodiments, the body of the guidewire is substantially flexible. In some embodiments, the guidewire is configured to advance through a duodenal endoscope. In some embodiments, the guidewire is configured to advance through a catheter lumen (wherein the catheter may be passed through an endoscope). In some embodiments, the guidewire is configured to be passed through an endoscope through the major duodenal papilla and/or Sphincter of Oddi and/or into the ampulla of Vater of a subject. In some embodiments, the magnetic region at the distal end of the guidewire may be made of a magnetic or ferromagnetic material or is coated with magnetic or ferromagnetic material. In some embodiments, the external magnetic force may be exerted by an electromagnet placed externally to the subject's body or placed internally on a catheter and/or on the endoscope and/or within the endoscope. According to some embodiments, the position direction and/or intensity of the electromagnet may be controlled such as to the direct the magnetic force in the direction of the bile duct of the subject, to thereby cause the bending of the distal end of the guidewire located within the subject body in the direction of the bile duct.

[0091] According to some embodiments, the guidewire may include one or more sensors/probes configured to sense/detect/measure electrical conductivity and/or resistivity and/or impedance and/or electrical signal/electrical activity. In some embodiments, the sensors are electrical sensors. In some embodiments, the electrical sensors may be positioned at the tip of the guidewire or on the sides of the distal end of the wire. In some embodiments, the electrical conducting probes/sensors/wires/cables/electrodes may be positioned coaxially (one around the other with insulation between them) or in parallel to each other, along the guidewire. In some embodiments, the guidewire may further be at least partially coated with different materials which provide desired properties such as, a hydrophilic coating.

[0092] Reference is now made to FIG. 6A which schematically illustrates a distal end of a catheter and guidewire within the bile duct region of a subject, according to some embodiments. As shown in FIG. 6A, via endoscope 420, catheter 402 protrudes and guided into the bile duct (406), with the guidance of guidewire (404), protruding from the first lumen of the catheter. Further shown is pancreatic duct (400). The endoscope may include at a distal region thereof a magnetic cuff (412), which can aid is aiming/attracting a magnetic end of the guidewire towards the bile duct.

[0093] Reference is now made to FIG. 6B which schematically illustrates a distal end of a catheter and guidewire within the pancreatic duct region of a subject, according to some embodiments. As shown in FIG. 6B, via endoscope (420), catheter (402′) protrudes and guided into the pancreatic duct (400), with the guidance of guidewire (404′), protruding from the first lumen of the catheter. Further shown is bile duct (406). The endoscope may include at a distal region thereof a magnetic cuff (412), which when exerting a magnetic force can aid is aiming/attracting a magnetic end of the guidewire.

[0094] Reference is now made to FIG. 6C which schematically illustrates a distal end of a catheter and guidewire inserted via the second lumen of the catheter, within the bile duct region of a subject, according to some embodiments. As shown in FIG. 6C, via endoscope (420), catheter (402″) protrudes. The catheter has a guidewire (416) protruding through the second lumen of the catheter, such the guidewire distal end is located in the bile duct (406). Further shown is pancreatic duct (400). The endoscope may include at a distal region thereof a magnetic cuff (412), which when exerting a magnetic force can aid is aiming/attracting a magnetic end of the guidewire towards the bile duct.

[0095] In some embodiments, when the catheter (and guidewire) are inserted into the body cavity (for example, by being passed through an endoscope, via the major duodenal papilla and/or Sphincter of Oddi and/or into the ampulla of Vater of a subject), the probes at the distal end of the catheter (or in some embodiments, located on the guidewire), can be used to sense/measure/detect/determine the electrical conductivity/resistivity/impedance/activity at the distal region. If, based on the measurements it is determined that the distal end of the catheter (and/or guidewire) are placed in the bile duct (as illustrated in FIG. 6A), further procedures in the bile duct can be continued. If, based on the measurements it is determined that the distal end of the catheter (and/or guidewire) is rather placed in the pancreatic duct (as illustrated in FIG. 6B), further procedures are not commenced, until the catheter (or a guidewire) is redirected to common bile duct (CBD). This can be done by inserting a second guidewire, through a second lumen of the catheter, such that the second guidewire is biased to be placed in the bile duct (as illustrated in FIG. 6C). Alternatively, in some embodiments, the first guidewire is retracted and positioned in the second lumen of the catheter, such that is biased to be placed in the bile duct.

[0096] Reference is now made to FIGS. 7A-E, which schematically illustrate perspective views of the distal end of guidewires, having sensors arrangements, according to some embodiments. FIG. 7A shows the end of guidewire, 500, having sensors (502A-B), arranged in parallel to each other and each passing along a different region of the guidewire. The sensors (502A and 502B) are arranged in parallel, and are insulated, so as to allow passage of electrical current. The sensors may run along the external or internal circumference of the guidewire. The insulation (504) is of and/or between the sensors. In some embodiments, the sensors are electrodes. Further shown is magnet (506), configured in aiding bending the tip of the guidewire (as detailed above). The guidewire may be further externally coated (coating 508), to aid operating the guidewire. FIG. 7B shows the end of guidewire, 520, having sensors (522A-B), arranged in parallel to each other and each passing along a different region of the guidewire. The sensors (522A and 522B) are arranged in parallel, and are insulated, so as to allow passage of electrical current. The insulation (524) is of and/or between the sensors. In some embodiments, the sensors are electrodes. Further shown is magnet (526), configured in aiding bending the tip of the guidewire (as detailed above). The guidewire may be further externally coated (coating 528), to aid operating the guidewire. FIG. 7C shows the end of guidewire, 520, having sensors (522A-B), arranged co-axially to each other and each passing along a different region of the guidewire. The sensors (532A and 532B) are arranged in coaxial design, and are insulated, so as to allow passage of electrical current. The insulation (534) is of and/or between the sensors. In some embodiments, the sensors are electrodes. Further shown is magnet (536), configured in aiding bending the tip of the guidewire (as detailed above). The guidewire may be further externally coated (coating 538), to aid operating the guidewire. FIG. 7D shows a top view of the end of guidewire, 540, having sensors (542A-B), arranged in parallel to each other and each passing along a different region of the guidewire. The sensors (542A and 542B) are arranged in parallel, and are insulated, so as to allow passage of electrical current. The insulation (544) is of and/or between the sensors. In some embodiments, the sensors are electrodes. Further shown is magnet (546) at the tip of the distal end of the guidewire, configured in aiding bending the tip of the guidewire (as detailed above). FIG. 7E shows a perspective side view of a guidewire, 550, having sensors (552A-B), arranged in parallel to each other and each passing along a different region of the guidewire. The sensors (542A and 542B) are arranged in parallel, and are insulated, so as to allow passage of electrical current. The insulation (544) is of and/or between the sensors. In some embodiments, the sensors are electrodes. Further shown is magnet (546) at the tip of the distal end (560) of the guidewire, configured in aiding bending the tip of the guidewire (as detailed above). The guidewire may be further externally coated (coating 528).

[0097] According to some embodiments, there is provide a method for determining and/or positioning the location of a distal end of the catheter, for preforming ERCP in a subject in need thereof, the method includes one or more of the steps of: [0098] inserting a guidewire through the first lumen of the catheter of, such that the distal end of the guidewire protrudes from the distal end of the catheter, wherein the catheter is inserted through an endoscope, through the major duodenal papilla and/or Sphincter of Oddi and/or into the ampulla of Vater of a subject of a subject; [0099] sensing, measuring and/or determining the conductivity and/or resistivity and/or impedance and/or electrical activity at the body cavity in which the external end of the catheter is located; [0100] determining, based on the conductivity or resistivity if the catheter end is in the pancreatic duct or the bile duct; and [0101] if the catheter end is in the pancreatic duct, insert a guidewire (a second guidewire or the same guidewire) through a second lumen of the catheter, such that the distal end of the guidewire inserted through the second lumen is positioned within the bile duct.

[0102] According to some embodiments, the methods may further include one or more of: [0103] passing an electrical current through the probes of the catheter. [0104] inserting one or more medical instruments or substances through a lumen of the catheter into the internal body cavity. [0105] operating and/or maneuvering the guidewire, one or more medical instruments and/or substances within the bile duct. [0106] optionally applying an external magnetic force to cause the distal end of a guidewire comprising a magnetic tip to bend towards the bile duct.

[0107] In some embodiments, the guidewire passing through the first lumen and/or the second lumen of the catheter is the same guidewire (for example, the guidewire may be retracted from the first lumen and re-inserted through the second lumen). In some embodiments, a first guidewire is configured to be inserted into the first lumen and a second guidewire may be inserted into the second lumen. In some embodiments, the first guidewire and the second guidewire may be identical, similar or different with respect of size (diameter, length), type, composition and/or shape. Each possibility is a separate embodiment.

[0108] According some embodiments, there is provided an ERCP catheter configured for determining the location and/or positioning of a distal end of the catheter within the CBD or the pancreatic duct (PD) of a subject, said catheter includes an elongated catheter body comprising a multiplicity of internal lumens, said lumens extend from a proximal end to the distal end opposite thereto, said distal end is configured to be positioned within the biliary tract; said lumens include:

at least two sensor lumens each having within the lumen a sensing probe extending from the proximal end of the lumen to the distal end of the lumen, said probes are configured to sense or measure electrical impedance and/or resistance and/or conductance at the distal end of the catheter; and
a first lumen having an opening at a tip on the distal end of the catheter, said first lumen is configured to allow passage therethrough of a guidewire; and
a second lumen configured to allow passage of a guidewire therethrough, wherein the opening of the distal end of said second lumen is located at a proximal position relative to the opening of the first lumen, thereby allowing a guidewire passing through the second lumen to be positioned at a different internal body location compared to the guidewire passing through the first lumen.

[0109] According to some embodiments, there is provided an endoscopic retrograde cholangiopancreatography (ERCP) catheter which includes:

an elongated catheter body having a multiplicity of internal lumens, the lumens extending through at least part of the length from a proximal end of the elongated catheter body to a distal end of the elongated catheter body opposite thereto, the distal end is configured to be positioned within the common bile duct (CBD) or the pancreatic duct of a subject, the lumens include:
a first lumen having an opening at a tip on the distal end of the catheter, said first lumen is configured to allow passage therethrough of a guidewire; and
a second lumen configured to allow passage of a guidewire therethrough, wherein the opening of the distal end of said second lumen is located at a proximal position relative to the opening of the first lumen, thereby allowing a guidewire passing through the second lumen to be positioned at a different internal body location compared to a guidewire passing through the first lumen.

[0110] In some embodiments, the ERCP catheter may further include one or more sensor lumens each having within the lumen a sensing probe at least partially extending from a proximal end of the lumen to a distal end of the lumen, the probes are configured to sense or measure one or more of: electrical impedance, resistance, conductance and/or electrical signal, at the distal end of the catheter.

[0111] According to some embodiments, there is provided a catheter with a magnet (such as, an electromagnet) that is placed more distal than the end of the catheter entering the duct. The magnet allows bending the tip of the guidewire to a sharp degree (in the range of for example, up to 90 degrees), thereby assisting the tip to fold backwards to a U shape and aids its navigation to the correct duct. According to some embodiments, once the tip is placed inside a duct a second verification step may be executed, to verify that it is in the correct duct (and not in the pancreatic duct, as undesired injection of contrast agent to this duct can lead to severe pancreatitis). This may be done by conductivity/resistivity and/or by impedance measurements using an electrode probe/sensor. Pancreatic juice contains bicarbonate buffer and thus it is more conductive. Bile salt are hydrophobic and are thus less conductive. Based on the conductivity difference, it is possible to measure the placement in the correct duct. In some embodiments, if identified to be in the correct duct-procedure may be continued. If the conductivity measurements indicate the catheter tip is in the incorrect pancreatic duct, then there is a second port (lumen) in the catheter, for inserting a second guidewire. As the incorrect pancreatic duct is already plugged by the misguided first guidewire, the second guidewire inserted can enter the bile duct.

[0112] As used herein, the terms “bile duct”, “common bile duct”, “CBD” and “biliary duct” may interchangeably be used.

[0113] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0114] Although steps of methods according to some embodiments may be described in a specific sequence, methods of the disclosure may include some or all of the described steps carried out in a different order. A method of the disclosure may include a few of the steps described or all of the steps described. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such.

[0115] Although the disclosure is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the disclosure embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.

[0116] The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

[0117] As used herein, the term “about” may be used to specify a value of a quantity or parameter (e.g. the length of an element) to within a continuous range of values in the neighborhood of (and including) a given (stated) value. According to some embodiments, “about” may specify the value of a parameter to be between 80% and 120% of the given value. For example, the statement “the length of the element is equal to about 1 m” is equivalent to the statement “the length of the element is between 0.8 m and 1.2 m”. According to some embodiments, “about” may specify the value of a parameter to be between 90% and 110% of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 95% and 105% of the given value.

[0118] In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

EXAMPLES

Example 1: Determining Resistivity Values of Physiological and Other Fluids

[0119] In order to determine the differences in electrical properties of various physiological and other fluids, the resistivity of different fluids, including bile juice, and compositions mimicking pancreatic environment (such as trypsin) was determined, using an electrical sensor.

[0120] The sensor uses two probes to pass current through the tested liquids, and then measures the resistance or impedance, from which conductivity can be calculated. This type of measurement assesses the concentration of ions in the solution, whereby the more ions that are in the solution, the higher the conductivity.

[0121] The results are presented in FIG. 8, which clearly demonstrate a difference in resistivity and conductivity between Ovis aries (sheep) bile juice and Trypsin solution which represents the pancreatic juice.

[0122] While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced be interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.