Endoscopic retrograde cholangiopancreatography (ERCP) catheter and guidewire with sensors and methods of using the same

Abstract

To provide improved endoscopic retrograde cholangiopancreatography (ERCP) catheter systems having multiple ports and sensing elements.SOLUTION: 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.SELECTED DRAWING: Figure 3C

Description

Technical Field

[0001] The present disclosure generally relates to improved catheter systems, and more particularly to improved endoscopic retrograde cholangiopancreatography (ERCP) catheters and guidewires having multiple ports and sensor elements, and methods of using the same.

Background Art

[0002] Endoscopic retrograde cholangiopancreatography (ERCP) is a diagnostic and therapeutic procedure for various pathologies of the biliary and pancreatic systems.

[0003] ERCP is performed when the bile duct or pancreatic duct is stenosed or occluded due to gallstones formed in the gallbladder and blocking the common bile duct, infections, acute pancreatitis, chronic pancreatitis, complications of trauma or surgery to the bile duct or pancreatic duct, pancreatic pseudocysts, tumors or cancers of the bile duct, tumors or cancers of the pancreas, and other symptoms.

[0004] In this procedure, an endoscope is inserted from the upper gastrointestinal tract to the second part of the duodenum (proximal part of the small intestine). When the endoscope enters the duodenum, the catheter passes through the working channel of the endoscope and extends through it. The guidewire is passed through the catheter, through the sphincter of Oddi, and into the common bile duct (CBD). Sometimes, a sphincterotomy of the sphincter of Oddi may be performed. The catheter is passed into the CBD above the guidewire, the guidewire is removed, and a radiopaque dye is injected through the catheter to visualize the bile duct.

[0005] ERCP is considered more beneficial than surgical treatment, but various serious complications, including pancreatitis, can occur as a result of the procedure. Some of these complications can be attributed, inter alia, to the injection of contrast agent into the pancreatic duct, the insertion of a guidewire into the pancreatic duct or other mechanical operations, resulting in damage to the pancreatic duct, and post-treatment occlusion of the pancreatic duct by stones.

[0006] Accordingly, there is a need in the art for improved devices and methods to enable safer ERCP procedures by reducing mechanical manipulation near the pancreas and avoiding, to the extent possible, injecting large amounts of contrast agent into the pancreas. This can be achieved by providing a method for confirming the exact position of a catheter and / or guidewire within the CBD prior to contrast agent injection and reducing the mechanical manipulation to achieve accurate cannula insertion.

SUMMARY OF THE INVENTION

[0007] Aspects of the present disclosure relate, according to some of its embodiments, to improved catheters and guidewires for performing endoscopic retrograde cholangiopancreatography (ERCP). More specifically, without limitation, according to some embodiments of the present disclosure, aspects of the present disclosure are based on differences in conductivity and resistivity between the contents of lumens to detect or determine whether the distal end of a catheter is located in a bile duct or a pancreatic duct, and include a lumen probe (sensor) configured to detect / measure / sense conductivity and / or resistivity and / or impedance and / or electrical signals in an internal body cavity, and relate to a catheter having a plurality of lumens.

[0008] Aspects of the present disclosure relate, according to some of its embodiments, further to a guidewire having a magnetic and / or ferromagnetic tip (tip) that can assist in directing the distal end (tip) of the guidewire into the common bile duct (CBD). In some embodiments, a magnetic force (by an electromagnet disposed outside the subject's body, and / or by an electromagnet disposed at the distal portion of the endoscope through which the guidewire passes, and / or by the guidewire passing The magnetic force exerted by an electromagnet disposed at the distal portion of the catheter being used helps bend the tip of the guide wire so that it is directed towards the CBD rather than the pancreatic duct. In some embodiments, the guide wire can further include one or more sensor elements configured to detect / measure / sense the conductivity and / or resistivity and / or impedance in the internal body cavity and detect or determine whether the distal end of the guide wire is located within the bile duct or the pancreatic duct based on the difference in conductivity and / or resistivity and / or impedance between the two ducts, and optionally identify an inflammatory condition within the duct.

[0009] According to some embodiments, the improved endoscopic retrograde cholangiopancreatography (ERCP) catheter system and / or guide wire provided herein, and methods of using the same, advantageously minimize the risks associated with an ERCP procedure and reduce its complications and side effects (e.g., post-ERCP pancreatitis (PEP), and optionally, bleeding, bowel perforation, and infection). In some embodiments, the improved apparatus and methods enable the performance of an ERCP procedure, preferably without the inadvertent injection of contrast agent into the pancreatic duct.

[0010] According to some embodiments, the apparatus (catheter and / or guide wire) and methods provided herein can avoid mechanical manipulation and unwanted dye injection into the pancreatic duct by enabling the guide wire to be advantageously directed into the bile duct when an incorrect placement is detected.

[0011] According to some embodiments, the apparatus and methods provided herein are advantageous in one or more of being able to provide a magnetically biased guide wire that is more likely to be inserted into the CBD (rather than the pancreatic duct), a catheter and / or guide wire that can detect correct / incorrect insertion into the duct, and / or the same catheter being able to direct the guide wire into the correct duct (i.e., the CBD) if a change in position is required.

[0012] Accordingly, according to one aspect of some embodiments, an endoscopic retrograde cholangiopancreatography (ERCP) catheter is provided. The ERCP catheter includes an elongated catheter body having a number of internal lumens. The lumens extend from the proximal end of the elongated catheter body to the distal end of the elongated catheter body on the opposite side. The distal end is configured to be disposed within the common bile duct (CBD) or pancreatic duct of a subject. The lumens include one or more sensor lumens having (or configured to have) one or more sensing probes extending from the proximal end of the lumen to the distal end of the lumen within the lumen. The one or more probes are configured to sense or measure one or more of electrical impedance, resistance, conductivity, and / or electrical signals at the distal end of the catheter. The lumens further include a first lumen having an opening at the tip on the distal end of the catheter. The first lumen is configured to allow the passage of a guidewire. The lumens further include a second lumen configured to allow the passage of a guidewire. The opening at the distal end of the second lumen is disposed at a proximal position relative to the opening of the first lumen, thereby allowing the guidewire passing through the second lumen to be disposed at a different body position compared to the guidewire passing through the first lumen.

[0013] In some embodiments, the sensing probe may include a conductive material configured to pass an electric current. In some embodiments, a sensor system disposed at the proximal end of the catheter or connected to the catheter is configured to determine the resistance and / or conductivity and / or impedance within the body cavity where the distal end of the catheter is disposed via the probe and to evaluate the conductivity within the body region. In some embodiments, the electrical impedance and / or resistance and / or conductivity values determined at the distal end of the catheter indicate the position of the distal end of the catheter within the bile duct or pancreatic duct. In some embodiments, the higher the resistivity and / or impedance value and / or the lower the conductivity value measured at the distal end of the catheter, the more it indicates that the distal end of the catheter is located within the bile duct.

[0014] In some embodiments, the electrical impedance and / or resistance and / or conductivity and / or electrical signal value determined at the distal end of the catheter indicates an inflammatory condition within the bile duct or pancreatic duct.

[0015] In some embodiments, the electrical signal indicates muscle or nerve activity. According to some embodiments, the electrical signal is configured to enable electromyogram measurement.

[0016] In some embodiments, the catheter may be configured to pass through an endoscope. In some embodiments, the endoscope may be a duodenoscope.

[0017] In some embodiments, the catheter may be sized to pass through the duodenoscope, through the papilla of Vater and the sphincter of Oddi, and into the Vater dilatation of the subject.

[0018] In some embodiments, the endoscope can include an electromagnetic or magnetic cuff / region on the outer periphery or internal cavity of the endoscope, preferably at its distal end. In some embodiments, the magnetic region is located within the gastrointestinal tract. In some embodiments, the magnetic region includes an electromagnet that can be controlled by a healthcare provider, for example, remotely (i.e., outside the body). For example, the electromagnet may be turned off after entering a lumen such as the bile duct.

[0019] In some embodiments, the catheter may be made of a biocompatible and / or flexible material.

[0020] In some embodiments, the catheter can include at least two sensor lumens each having (configured to have) a sensing probe that extends within the lumen from the proximal end of the lumen to the distal end of the lumen.

[0021] In some embodiments, the distal end of the second lumen is disposed in the proximal region of the distal end of the catheter. In further embodiments, the position of the opening of the distal end of the second lumen within the subject's body is controlled by rotating at least a portion of the catheter or the distal end of the catheter. In some embodiments, the second lumen is selected from a bulge, a distortion of the lumen shape, a bridge, or a combination thereof, and is disposed proximate to the distal opening of the second lumen and includes an obstacle configured to assist in guiding a guidewire passing through the second lumen to a desired position.

[0022] In some embodiments, the catheter may be a sphincterotomy catheter (having a mechanism that enables sphincterotomy of the sphincter of Oddi).

[0023] In some embodiments, the catheter may further include a magnetic region on the body of the catheter.

[0024] In some embodiments, the first and / or second lumen is configured to allow the passage of one or more suitable medical instruments and / or substances. In some embodiments, the one or more suitable medical instruments and / or substances may be selected from a stent system, a cytology sheath, a dilator balloon, a stent extractor, a mini - scope, a contrast agent, a drug, or any combination thereof.

[0025] In some embodiments, the proximal region of the catheter includes one or more handles or ports for manipulating, inserting, and / or moving a guidewire, a medical instrument, and / or a substance.

[0026] In some embodiments, a guidewire for use with the catheter may include a flexible biocompatible material.

[0027] In some embodiments, the guidewire can further include a magnetic tip at its distal end.

[0028] In some embodiments, the magnetic chip of the guide wire may be configured to enable bending or deforming the distal end of the guide wire and assist in guiding or leading the guide wire into the bile duct.

[0029] According to some embodiments, an endoscopic retrograde cholangiopancreatography (ERCP) catheter is provided. The ERCP catheter includes an elongated catheter body having a distal end configured to be disposed within the common bile duct (CBD) or pancreatic duct of a subject, and a plurality of internal lumens extending from a proximal end of the elongated catheter body to a distal end of the elongated catheter body on the opposite side thereof. The lumen includes at least a first lumen having an opening at a tip on the distal end of the catheter and configured to allow passage of a guide wire, and a second lumen configured to allow passage of a guide wire. The opening of the distal end of the second lumen is disposed at a proximal position relative to the opening of the first lumen, thereby allowing the guide wire passing through the second lumen to be disposed at a different in-vivo position from the guide wire passing through the first lumen. The lumen further includes one or more sensing probes disposed on and / or within the elongated catheter body. The one or more sensing probes are configured to sense or measure one or more of electrical impedance, resistance, conductivity, and / or electrical signals at the distal end of the catheter.

[0030] According to some embodiments, one or more sensing probes extend from a proximal end of the catheter body to a distal end of the catheter body.

[0031] According to some embodiments, one or more of the sensing probes may be disposed within one or more internal sensor lumens, and the one or more internal sensor lumens extend from a proximal end of the elongated catheter body to a distal end of the elongated catheter body.

[0032] According to some embodiments, one or more of the sensing probes may be disposed on the outer periphery of the catheter body.

[0033] According to some embodiments, one or more sensing probes may be disposed on or at the distal end of the catheter. According to some embodiments, one or more sensing probes are disposed at the tip of the distal end of the catheter.

[0034] According to some embodiments, there is provided a method for performing ERCP in a subject in need of ERCP for determining and / or positioning the distal end of a catheter and / or a guide wire. The method includes: (i) inserting a guide wire through a first lumen of the catheter and protruding it from the distal end of the catheter, wherein the catheter is inserted through an endoscope, through the Vater papilla and / or the sphincter of Oddi, and / or into the Vater dilatation of the subject; (ii) sensing, measuring, and / or determining the conductivity and / or resistivity and / or impedance and / or electrical signal (electrical activity) in the body cavity where the outer end of the catheter and / or the guide wire is located; (iii) determining whether the catheter and / or guide wire end is within the pancreatic duct or the bile duct based on the conductivity and / or resistivity and / or impedance; and (iv) when the catheter and / or guide wire tip is within the pancreatic duct, inserting a guide wire through a second lumen of the catheter such that the distal end of the guide wire inserted through the second lumen is located within the bile duct.

[0035] In some embodiments, the method may further include passing an electric current through a catheter and / or a probe of a guidewire. In some embodiments, the method may include determining the resistance and / or impedance and / or conductivity within a body cavity where the distal end of the catheter and / or guidewire is located, and is performed using a sensor system located at the proximal end of the catheter and / or guidewire, or an external control unit to which the catheter and / or guidewire is connected. In some embodiments, the higher the resistivity and / or impedance value measured at the distal end of the catheter, and / or the lower the conductivity value, the more it indicates that the distal end of the catheter is located within the bile duct. In some embodiments, the method can include determining an inflammatory condition of the duct based on one or more measurement values.

[0036] In some embodiments, the method can further include inserting one or more medical devices or substances into an internal body cavity through the lumen of the catheter.

[0037] In some embodiments, the method can further include manipulating and / or moving a guidewire, one or more medical devices, and / or a substance within the bile duct.

[0038] In some embodiments, the method may further include applying an external magnetic force to bend the distal end of a guidewire provided with a magnetic and / or ferromagnetic chip towards the bile duct.

[0039] According to some embodiments, a guide wire for use in an ERCP procedure is provided. The guide wire is made of a non-magnetic material or coated with a non-magnetic material, has a magnetic region at the distal end of the guide wire, the distal end is flexible, and the guide wire is configured to pass through a duodenal endoscope, through the ampulla of Vater and / or the sphincter of Oddi, and / or into the ampulla of Vater of the subject. The magnetic chip of the guide wire can be bent in the direction of the bile duct of the subject through the distal end of the guide wire, and the bending of the distal end of the guide wire is affected by an external magnetic force.

[0040] In some embodiments, the magnetic region at the distal end is made of a magnetic or ferromagnetic material or coated with a magnetic or ferromagnetic material.

[0041] In some embodiments, the guide wire may be configured to pass through an endoscope within the lumen of a catheter, and the catheter passes through the lumen of the endoscope.

[0042] In some embodiments, the external magnetic force may be exerted by an electromagnet disposed outside the subject's body, or inside the catheter, and / or on the endoscope, and / or inside the endoscope. In some embodiments, the position and / or direction and / or intensity of the electromagnet is controlled, for example, to direct the magnetic force in the direction of the bile duct, thereby bending the distal end of the guide wire located within the subject's body in the direction of the bile duct. In some embodiments, the external magnetic force is exerted by a magnetic region / magnetic cuff disposed on the outer periphery or within the lumen of the endoscope at the distal end of the endoscope.

[0043] In some embodiments, the guidewire can further include one or more sensor elements / probes configured to sense, measure, and / or detect the electrical resistivity and / or impedance and / or conductivity in the body region where the distal end of the guidewire is located. In some embodiments, the sensor element includes a conductive material configured to pass an electric current. In some embodiments, the sensor element (sensor) may be disposed at the distal end of the guidewire or on the side of the distal end of the guidewire. In some embodiments, the sensor elements (sensors) may be arranged coaxially or parallel to each other along the outer length or inner length of the guidewire.

[0044] According to some embodiments, a method of directing a guidewire into a bile duct of a subject for performing an ERCP procedure is provided. The method includes inserting the guidewire through an endoscope and / or a catheter, through the sphincter of Oddi and / or the papilla of Vater, and / or into the ampulla of Vater of the subject, and applying a magnetic force to bend the flexible distal end of the guidewire in the direction of the bile duct.

[0045] In some embodiments, the external magnetic force may be exerted by an electromagnet disposed outside the subject's body. In some embodiments, the magnetic force may be exerted by a magnetic region of the catheter and / or the endoscope. In some embodiments, the magnetic region may be on the outer surface of the lumen of the endoscope and / or within the lumen of the endoscope. In some embodiments, the magnetic region of the endoscope may be made of or coated with a magnetic material or a ferromagnetic material. In some embodiments, the magnetic region of the catheter may be made of or coated with a magnetic material or a ferromagnetic material.

[0046] In some embodiments, the method can further include detecting, measuring, and / or determining the electrical resistivity and / or impedance and / or conductivity and / or electrical activity in the body region where the distal end of the guidewire is located.

[0047] Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more other technical advantages will be readily apparent to those skilled in the art from the drawings, description, and claims included herein. Further, although specific advantages are listed above, various embodiments may include all or some of the listed advantages, or none at all.

[0048] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In case of conflict, the patent specification, including definitions, will control. As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.

Brief Description of the Drawings

[0049] Some embodiments of the present disclosure are described herein with reference to the accompanying drawings. The description, together with the drawings, will make apparent to those skilled in the art how some embodiments may be implemented. The drawings are for illustrative purposes only and are not intended to show the structural details of the embodiments in more detail than is necessary for a basic understanding of the disclosure. For clarity, some of the objects shown in the figures are not to scale.

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 3C

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 6A

Figure 6B

Figure 6C

Figure 7A

Figure 7B

Figure 7C

Figure 7D

Figure 7E

Figure 8

[0050] The principles, use, and implementation of the disclosure herein may be better understood with reference to the accompanying description and drawings. Upon review of the description and drawings herein, one of ordinary skill in the art will be able to implement the teachings herein without undue effort or experimentation. In the drawings, like reference numerals refer to like parts throughout.

[0051] Now, refer to FIG. 1 which schematically shows a perspective view of a catheter, according to some exemplary embodiments. As shown in FIG. 1, the catheter 2 has a distal end (configured to be disposed within a body cavity) and a proximal end (located outside the subject). The catheter can include a number of lumens extending along the inner body of the catheter from the proximal end to the distal end. The lumens can include a sensor lumen extending from the proximal end (lumens 8A - 8B) to the distal end (the end of lumen 8B is shown as opening 18B), and having a probe / sensor extending therethrough. The probe / sensor can detect / measure / sense conductivity and / or resistivity and / or impedance in the region where the proximal end of the catheter is located. The catheter can further include a first lumen (12) having an opening (14) at the tip (15) of the distal end of the catheter. The catheter can include a second lumen (10) having an opening (16) in the side region of the distal end of the catheter.

[0052] Refer to FIG. 2A, which schematically shows a perspective side view of the distal end of a catheter according to some embodiments. As shown in FIG. 2A, the distal end (21) of the catheter (20) has an opening (26) at the tip (24) of the first lumen. An opening (22) of the second lumen is disposed in the side region of the distal end. Further, the tips (ends) of sensors 29A - B protruding through the openings (28A - B) of the respective lumens are shown. The tip of the first lumen (24) has an opening (26). In the side region of the distal end, an opening (22) of the second lumen is arranged. Further, the tips (ends) of sensors 29A - B protruding through the openings (28A - B) of the respective lumens are shown.

[0053] Refer to FIG. 2B, which schematically shows an enlarged perspective view of the distal end of a catheter according to some embodiments. Shown in the enlarged view of FIG. 2B are the distal end (30) of the catheter and the opening of the first lumen (36) located at the tip (34) of the distal end of the catheter. Further, the opening of the second lumen (32) and the ends of the probes / sensors (39A - B) are shown. In some embodiments, the end of the second lumen has a bridge, bump, distortion, or obstacle configured to allow the tip of a guide wire passing through the second lumen to bend.

[0054] Refer to FIG. 2C, which schematically shows 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.

[0055] Referring now to FIG. 3A, which schematically shows a perspective side view of a catheter and a guide wire protruding from the distal end of a first lumen of the catheter, according to some embodiments. As shown in FIG. 3A, catheter 100 has an elongated body with a proximal end (104) and a distal end (102), which is configured to be placed within a subject's body. The catheter includes a plurality of lumens extending from the proximal end to the distal end of the catheter. The proximal end of the catheter shows the proximal end of a guide wire (110'), and its distal end (110) protrudes from the distal end of the first lumen of the catheter. Further, the proximal end of the catheter shows the proximal end of a probe / sensor (106A'-B'), and its distal end (106A-B) protrudes from the distal end of the sensor lumen of the catheter. Further, an end (108) of the second lumen of the catheter is shown, which is preferably located on the side of the distal end of the catheter and proximal to the tip of the catheter. The end of the second lumen may include a bulge or deformation to enable bending or guiding a guide wire or other suitable medical instrument protruding therethrough.

[0056] Referring now to FIG. 3B, which schematically depicts a perspective close-up view of the distal end of a catheter and a guide wire protruding through the distal end of a 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 in an empty state (i.e., without a guide wire protruding therethrough). The second lumen has a guide wire inserted therethrough such that the distal end of the guide wire (152) protrudes from an opening (160) of the second lumen. Further, the end (tip) of a sensor / probe (158A~B) is shown at the distal end.

[0057] Referring now to FIG. 3C, a perspective side view of a catheter having a first guide wire protruding from the distal end of a first lumen of the catheter and a second guide wire protruding from the distal end of a second lumen of the catheter, according to some embodiments, is schematically shown. As shown in FIG. 3C, the distal end (202) of the catheter (200) shows the distal end of a guide wire (210) protruding from the distal end of the first lumen of the catheter. Further, the distal end of a second guide wire (212) protruding from the second lumen of the catheter is shown. As shown in FIG. 3C, the second guide wire (212) is oriented / directed in a different direction compared to the first guide wire. In some embodiments, the orientation / bending of the second guide wire can be achieved by an obstacle, bend, bulge, bridge, or any other obstructive member (shown as member 214). The obstructive member may be made of any suitable biocompatible material, magnetic material, or coated with a magnetic or ferromagnetic material. In some embodiments, the obstructive member may be integrally formed with the catheter body, or attached, positioned, or mounted on the catheter body. In some embodiments, the orientation / bending of the first and / or second guide wire may be achieved by a magnetic tip disposed or formed at the distal end of the guide wire, as will be described in more detail below. Also shown in FIG. 3C are the distal ends of sensors 206A - B. In some embodiments, the obstructive member may be made of any suitable biocompatible material, magnetic material, or coated with a magnetic or ferromagnetic material. In some embodiments, the obstructive member may be integrally formed with the catheter body, or attached, positioned, or mounted on the catheter body. In some embodiments, the orientation / bending of the first and / or second guide wire may be achieved by a magnetic tip disposed or formed at the distal end of the guide wire, as will be described in more detail below. Also shown in FIG. 3C are the distal ends of sensors 206A - B.

[0058] Now, referring to FIG. 4A, which schematically shows a perspective enlarged view of the distal end of a catheter and a lumen switching mechanism, according to some embodiments. As shown in FIG. 4A, the distal end of the catheter 250 includes an opening of a first lumen (254) having a guide wire (252) protruding therefrom. An opening of a second lumen (256) is also further shown. The right panel of FIG. 4A shows a close - up view of a cross - section of the tip. Referring to FIG. 4B, which shows the distal end of the catheter (250) including the opening of the first lumen (254). Also shown is an opening of a second lumen (256) having a guide wire (260) protruding therethrough.

[0059] 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.

[0060] In some embodiments, the catheter may be a catheter that can function as a sphincterotomy knife. In some embodiments, the catheter is a sphincterotomy catheter.

[0061] In some embodiments, the probe / sensor may include a conductive material configured to pass an electric current. In some embodiments, the probe may be made of any suitable metal.

[0062] According to some embodiments, a sensor system located at the proximal end of the catheter is configured to determine the resistance and / or conductivity and / or impedance in the body cavity where the distal end of the catheter is located via the probe, and to evaluate the conductivity in the body region. In some embodiments, the electrical resistance and / or conductivity and / or impedance value determined at the distal end of the catheter indicates the position of the distal end of the catheter in the common bile duct or pancreatic duct. In some exemplary embodiments, as illustrated hereinbelow, the higher the resistivity and / or impedance value measured at the distal end of the catheter, and / or the lower the conductivity value, the more it indicates that the distal end of the catheter is located within the bile duct. In some exemplary embodiments, resistance values exceeding about 400 ohm meters (Ωm), exceeding about 500 (Ωm), exceeding about 550 (Ωm), exceeding about 600 (Ωm), exceeding about 700 (Ωm) indicate the bile duct region.

[0063] According to some embodiments, a sensor system located at the proximal end of the catheter is configured to determine, for example, the electrical signal or electrical activity of muscle fibers. In some embodiments, the sensor system may be configured to determine the EMG activity in the body cavity where the distal end of the catheter is located via the probe.

[0064] According to some embodiments, the catheter system may be configured to detect or identify or recognize inflammation or an inflammatory condition within a lumen. In some embodiments, the identification of the inflammatory condition can be based at least in part on measurements of electrical resistance and / or conductivity and / or impedance and / or electrical activity.

[0065] According to some embodiments, the lumen probe (sensor) 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.

[0066] According to some embodiments, the lumen probe (sensor) 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 within an internal body cavity. Each possibility is a separate embodiment.

[0067] According to some embodiments, the catheter is configured to pass through an endoscope such as a duodenoscope. In some embodiments, the catheter is sized / configured to be inserted through the duodenoscope, through the ampulla of Vater and / or the sphincter of Oddi, and / or into the ampulla of Vater of the subject. Each possibility is a separate embodiment.

[0068] According to some embodiments, the catheter can further include one or more additional internal lumens.

[0069] 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 material or ferromagnetic material. In some embodiments, the magnetic portion may be or include an electromagnet. In some embodiments, the electromagnet may operate intermittently (i.e., may be optionally turned on or off). In some embodiments, the operation of the electromagnet may be controlled externally, for example, by a healthcare provider operating the catheter system.

[0070] According to some embodiments, any of the lumens of the catheter (including the first / second and / or any additional lumens) are configured to allow the passage of one or more suitable medical devices and / or substances. In some embodiments, the one or more suitable medical devices and / or substances are selected from a stent system, a sphincterotome, a cytology sheath, an inflation balloon, a stent extraction device, a mini - scope, a contrast agent, a drug, or any combination thereof. Each possibility is a separate embodiment.

[0071] According to some embodiments, the proximal region of the catheter can include one or more handles or ports for manipulating, inserting, and / or moving a guidewire, a medical device, and / or a substance.

[0072] Now, refer to FIG. 5A, which schematically shows a perspective view of a guidewire with a magnetic end according to some exemplary embodiments. As shown in FIG. 5A, the guidewire (300) has an elongated body with a proximal end (3026) and a distal end (302). The guidewire may include a magnetic tip / magnetic region (304) at its distal end. The magnetic tip of the guidewire is configured to allow the distal end of the guidewire to bend in the direction of the common bile duct of the subject.

[0073] Referring now to FIG. 5B, which schematically shows an enlarged perspective view of a guidewire having a distal end of an endoscope and a magnetic end portion according to some embodiments. FIG. 5B shows the distal end of an endoscope (36) having an opening (364) through which the guidewire (350) protrudes. The guidewire has a magnetic chip / region (354) at its distal end (352). Further shown is a magnetic cuff 263 disposed on the outer periphery of the endoscope. The magnetic cuff can exert a magnetic force that can attract the magnetic end portion of the guidewire and bend the distal end of the guidewire, as shown in FIG. 5B. can.

[0074] According to some embodiments, the guidewire may be made of a non-magnetic material, or may be coated with a non-magnetic material, and may have a magnetic region at its distal end. 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 (the catheter may be passed through the endoscope). In some embodiments, the guidewire is configured to pass through the endoscope, through the ampulla of Vater and / or the sphincter of Oddi, and / or into the ampulla of Vater of the subject. In some embodiments, the magnetic region at the distal end of the guidewire may be made of a magnetic material or a ferromagnetic material, or may be coated with a magnetic material or a ferromagnetic material. In some embodiments, an external magnetic force may be exerted by an electromagnet disposed outside the subject's body, or inside the catheter and / or endoscope, and / or inside the endoscope. According to some embodiments, the position, orientation, and / or intensity of the electromagnet may be controlled such that the magnetic force is directed towards the bile duct of the subject, thereby bending the distal end of the guidewire located within the subject's body in the direction of the bile duct.

[0075] According to some embodiments, the guidewire can include one or more sensors / probes configured to sense / detect / measure conductivity and / or resistivity and / or impedance and / or electrical signals / electrical activity. In some embodiments, the sensor is an electrical sensor. In some embodiments, the electrical sensor may be disposed at the tip of the guidewire or on the side of the distal end of the wire. In some embodiments, conductive probes / sensors / wires / cables / electrodes may be arranged coaxially (one around the other with insulation therebetween) or parallel to each other along the guidewire. In some embodiments, the guidewire may be at least partially coated with a different material that provides desired properties such as a hydrophilic coating.

[0076] Now, refer to FIG. 6A which schematically shows the distal ends of a catheter and a guidewire within the bile duct region of a subject according to some embodiments. As shown in FIG. 6A, the catheter 402 is guided through an endoscope 420 by a guidewire (404) protruding from a first lumen of the catheter and protrudes and is guided into the bile duct (406). The pancreatic duct (400) is also shown. The endoscope may include a magnetic cuff (412) in its distal region, which may assist in directing / attracting the magnetic end of the guidewire towards the bile duct.

[0077] Now, refer to FIG. 6B which schematically shows the distal ends of a catheter and a guidewire within the pancreatic duct region of a subject according to some embodiments. As shown in FIG. 6B, through an endoscope (420), the catheter (402’) is guided by a guidewire (404’) protruding from a first lumen of the catheter and protrudes and is guided into the pancreatic duct (400). The bile duct (406) is also shown. The endoscope can include a magnetic cuff (412) in its distal region, and when a magnetic force is applied, it assists in directing / attracting the magnetic end of the guidewire.

[0078] According to some embodiments, refer to FIG. 6C, which schematically shows the distal ends of a catheter and a guidewire inserted into the bile duct region of a subject through a second lumen of the catheter. As shown in FIG. 6C, a catheter (402”) projects through an endoscope (420). The catheter has a guidewire (416) that projects through the second lumen of the catheter such that the distal end of the guidewire is positioned within the bile duct (406). The pancreatic duct (400) is also shown. The endoscope can include a magnetic cuff (412) in its distal region, which, when a magnetic force is applied, assists in directing / pulling the magnetic end of the guidewire towards the bile duct.

[0079] In some embodiments, when the catheter (and guidewire) is inserted into the body cavity (e.g., through the sphincter of Oddi and / or the ampulla of Vater and / or within the ampulla of Vater of the subject by passing through the endoscope), a probe at the distal end of the catheter (or, in some embodiments, located on the guidewire) can be used to sense / measure / detect / determine the conductivity / resistivity / impedance / activity in the distal region. Based on the measurement, if it is determined that the distal end of the catheter (and / or guidewire) is positioned within the bile duct (as shown in FIG. 6A), further procedures within the bile duct can be continued. Based on the measurement values, if it is determined that the distal end of the catheter (and / or guidewire) is rather positioned within the pancreatic duct (as shown in FIG. 6B), no further treatment is initiated until the catheter (or guidewire) is redirected towards the common bile duct (CBD). This can be done by inserting a second guidewire through the second lumen of the catheter such that it is biased to be positioned within the bile duct (as shown in FIG. 6C). Alternatively, in some embodiments, the first guidewire is drawn into and positioned within the second lumen of the catheter such that it is biased to be positioned within the bile duct.

[0080] Refer now to FIGS. 7A - E, which schematically show perspective views of the distal ends of guidewires having sensor arrangements according to some embodiments. FIG. 7A shows an end of a guidewire 500 having sensors (502A - B) arranged parallel to each other and passing along different regions of the guidewire. The sensors (502A and 502B) are arranged in parallel and are insulated to allow current to pass through. The sensors can extend along the outer or inner circumference of the guidewire. The insulator (504) is part of the sensor and / or is between the sensors. In some embodiments, the sensors are electrodes. Also shown is a magnet (506), which is configured to assist in bending the tip of the guidewire (as detailed above). The guidewire may further be coated externally (coating 508) to assist in the manipulation of the guidewire. FIG. 7B shows an end of a guidewire 520 having sensors (522A - B) arranged parallel to each other and passing along different regions of the guidewire. The sensors (522A and 522B) are arranged in parallel and are insulated to allow current to pass through. The insulator (524) is part of the sensor and / or is between the sensors. In some embodiments, the sensors are electrodes. Also shown is a magnet (526), which is configured to assist in bending the tip of the guidewire (as described above). The guidewire may further be coated externally (coating 528) to assist in the manipulation of the guidewire. FIG. 7C shows an end of a guidewire 520 having sensors (522A - B) arranged coaxially with each other and passing through each other along different regions of the guidewire. The sensors (532A and 532B) are arranged in a coaxial design and are insulated to allow current to pass through. The insulator (534) is part of the sensor and / or is between the sensors. In some embodiments, the sensors are electrodes. Also shown is a magnet (536), which is configured to assist in bending the tip of the guidewire (as described above). The guidewire may further be coated externally (coating 538) to assist in the manipulation of the guidewire.Figure 7D shows a top view of the end portion of a guide wire 540 having sensors (542A - B) arranged parallel to each other and passing along different regions of the guide wire. The sensors (542A and 542B) are arranged in parallel and are insulated to allow the passage of current. The insulator (544) is part of the sensor and / or is between the sensors. In some embodiments, the sensors are electrodes. Further, a magnet (546) is shown at the tip of the distal end of the guide wire, which is configured to assist in bending the tip of the guide wire (as detailed above). Figure 7E shows a perspective side view of a guide wire 550 having sensors (552A - B) arranged parallel to each other and passing along different regions of the guide wire. The sensors (542A and 542B) are arranged in parallel and are insulated to allow the passage of current. The insulator (544) is part of the sensor and / or is between the sensors. In some embodiments, the sensors are electrodes. Further, a magnet (546) is shown at the tip of the tip portion (560) of the guide wire, which is configured to assist in the bending of the tip of the guide wire (as detailed above). The guide wire may further be coated from the outside (coating 528).

[0081] According to some embodiments, a method for determining and / or positioning the distal end of a catheter is provided, which is a method for performing ERCP in a subject in need of ERCP. This method includes one or more of the following steps: Inserting a guide wire through a first lumen of the catheter such that the distal end of the guide wire protrudes from the distal end of the catheter. The catheter is inserted through an endoscope, through the papilla of Vater and / or the sphincter of Oddi, and / or into the duodenal bulb of the subject. Detecting, measuring, and / or determining the conductivity and / or resistivity and / or impedance and / or electrical activity in the body cavity where the outer end of the catheter is located. Determining whether the catheter tip is within the pancreatic duct or bile duct based on conductivity or resistivity. When the catheter tip is within the pancreatic duct, inserting a guide wire (a second guide wire or the same guide wire) through a second lumen of the catheter such that the distal end of the guide wire inserted through the second lumen is disposed within the bile duct.

[0082] According to some embodiments, the method may further comprise one or more of the following: Passing an electric current through a probe of the catheter. Inserting one or more medical instruments or substances into the internal body cavity through the lumen of the catheter. Manipulating and / or moving a guide wire, one or more medical instruments, and / or a substance within the bile duct. Optionally, applying an external magnetic force to bend the distal end of a guide wire, optionally including a magnetic tip, towards the bile duct.

[0083] In some embodiments, the guide wire passing through the first lumen and / or the second lumen of the catheter is the same guide wire (e.g., the guide wire may be withdrawn from the first lumen and reinserted through the second lumen). In some embodiments, a first guide wire may be configured to be inserted into the first lumen and a second guide wire may be inserted into the second lumen. In some embodiments, the first guide wire and the second guide wire may be the same, similar, or different in terms of size (diameter, length), type, composition, and / or shape. Each possibility is a separate embodiment.

[0084] According to some embodiments, an ERCP catheter is provided that is configured to determine the position and / or location of the distal end of the catheter within the common bile duct (CBD) or pancreatic duct (PD) of a subject. The catheter includes an elongate catheter body having a plurality of internal lumens. The lumens extend from a proximal end to a distal end opposite thereto. The distal end is configured to be disposed within the biliary tract. The lumens include the following: At least two sensor lumens, each having within the lumen a sensing probe extending from a proximal end of the lumen to a distal end of the lumen, the probe configured to sense or measure the electrical impedance and / or resistance and / or conductivity at a distal end of the catheter and at least two sensor lumens so configured. A first lumen having an opening at a tip on a distal end of the catheter and configured to allow passage of a guide wire. A second lumen configured to allow passage of a guide wire therethrough, an opening at a distal end of the second lumen being located in a proximal position relative to the opening of the first lumen, whereby the guide wire passing through the second lumen can be positioned at a different body location from the guide wire passing through the first lumen.

[0085] According to some embodiments, an endoscopic retrograde cholangiopancreatography (ERCP) catheter is provided that includes an elongate catheter body. The elongate catheter body has a number of internal lumens. The lumens extend through at least a portion of the length from a proximal end of the elongate catheter body to the opposing distal end of the elongate catheter body. The distal end is configured to be disposed within a common bile duct (CBD) or pancreatic duct of a subject. The lumens include a first lumen and a second lumen. The first lumen has an opening at a tip on the distal end of the catheter and is configured to allow passage of a guide wire. The second lumen is configured to allow passage of a guide wire therethrough, an opening at a distal end of the second lumen being located in a proximal position relative to the opening of the first lumen and allowing the guide wire passing through the second lumen to be positioned at a different body location from the guide wire passing through the first lumen.

[0086] In some embodiments, the ERCP catheter can further include one or more sensor lumens each having a sensing probe that at least partially extends within the lumen from the proximal end to the distal end of the lumen. The probe is configured to sense or measure one or more of electrical impedance, resistance, conductivity, and / or electrical signals at the distal end of the catheter.

[0087] According to some embodiments, a catheter is provided having a magnet (such as an electromagnet) disposed distal to the end of the catheter entering the conduit. The magnet enables the tip of the guidewire to be bent at an acute angle (e.g., in the range of up to 90 degrees), whereby the tip is bent rearward in a U-shape to assist in proper navigation into the conduit. According to some embodiments, when the tip (chip) is disposed within the tube, a second confirmation step is performed to confirm that the chip is within the correct tube (and since an undesired injection of contrast agent into this tube can lead to severe pancreatitis, the chip is not within the pancreatic duct). This can be done by conductivity / resistivity and / or impedance measurements using an electrode probe / sensor. Since pancreatic juice contains bicarbonate buffer, it has a relatively high conductivity. Since bile salts are hydrophobic, they have a relatively low conductivity. Based on the difference in conductivity, it is possible to measure the correct placement within the tube. In some embodiments, if it is confirmed that the correct tube has been entered, the procedure can be continued. If the conductivity measurement indicates that the catheter tip is erroneously within the pancreatic duct, a second port (lumen) for inserting a second guidewire is within the catheter. Since the incorrect pancreatic duct has already been blocked by the erroneously guided first guidewire, the inserted second guidewire can enter the bile duct.

[0088] As used herein, the terms "bile duct", "common bile duct", "CBD" and "biliary duct" may be used interchangeably.

[0089] For clarity, it is understood that specific features of the present disclosure that are described in the context of separate embodiments may be provided in combination in a single embodiment. Conversely, for brevity, various features of the disclosure that are described in the context of a single embodiment may be provided separately, or in any suitable combination, or as appropriate, in any other described embodiment of the disclosure. Features described in the context of an embodiment should not be regarded as essential features of that embodiment unless so explicitly specified. Features described in the context of an embodiment should not be regarded as essential features of that embodiment unless so explicitly specified.

[0090] Although the steps of a method according to some embodiments can be described in a specific order, the methods of the present disclosure can include some or all of the described steps performed in a different order. The methods of the present disclosure can include some of the described steps, or all of the described steps. A particular step in the disclosed method should not be regarded as an essential step of that method unless so explicitly specified.

[0091] Although the present disclosure is described in relation to its specific embodiments, it is obvious that numerous alternatives, modifications, and variations may exist that are apparent to those skilled in the art. Accordingly, the present disclosure encompasses all such alternative forms, modifications, and variations that are within the scope of the appended claims. It should be understood that the present disclosure is not necessarily limited to the details of the construction and arrangement of the components and / or methods described herein in its application. Other embodiments may be implemented, and the embodiments may be practiced in various ways.

[0092] The syntax and terminology used herein are for the purpose of description and should not be regarded as limiting. Citations or identifications of citations in this application should not be construed as admitting that such citations are available as prior art to the disclosure. Section headings are used herein to facilitate understanding of the specification and should not necessarily be construed as limiting.

[0093] As used herein, the term "about" can be used to specify a value of an amount or parameter (e.g., the length of a member) within a continuous range of values near (and including) a given (stated) value. According to some embodiments, "about" can specify a value of a parameter such that it is between 80% and 120% of a given value. For example, the statement "the length of the member is equal to about 1 m" is equivalent to the statement "the length of the member is between 0.8 m and 1.2 m". According to some embodiments, "about" can specify a value of a parameter such that it is between 90% and 110% of a given value. According to some embodiments, "about" can specify a value of a parameter such that it is between 95% and 105% of a given value.

[0094] In the description and claims of this application, each of the words "comprise", "include" and "have", and their forms, are not necessarily limited to the members in the list that the word can be associated with.

Example

[0095] [Example 1: Determination of Resistance Values of Physiological Fluids and Other Fluids] To determine the differences in electrical properties of various physiological fluids and other fluids, the resistivity of various fluids including bile and compositions (such as trypsin) that mimic the pancreatic environment was determined using an electrical sensor.

[0096] The sensor uses two probes to pass an electric current through the liquid being tested, then measures the resistance or impedance, and then can calculate the conductivity. This type of measurement evaluates the concentration of ions in the solution. Thus, the higher the concentration of ions in the solution, the higher the conductivity.

[0097] In FIG. 8 showing the results, the differences in resistivity and conductivity between Ovis aries (sheep) bile and the trypsin solution used in place of pancreatic juice are clearly seen.

[0098] Although several exemplary aspects and embodiments have been discussed above, those skilled in the art will appreciate certain variations, substitutions, additions, and subcombinations thereof. Accordingly, the following appended claims and the claims introduced hereinafter are intended to be construed to include all such modifications, substitutions, additions, and combinations as fall within their true spirit and scope. Although several exemplary aspects and embodiments have been discussed above, those skilled in the art will appreciate certain variations, substitutions, additions, and subcombinations thereof. Accordingly, the following appended claims and the claims introduced hereinafter are intended to be construed to include all such modifications, substitutions, additions, and combinations as fall within their true spirit and scope.

Claims

1. 1. An endoscopic retrograde cholangiopancreatography (ERCP) catheter system, comprising: an elongate catheter and one or more sensing probes; The elongated catheter comprises: a distal end configured to be placed within a common bile duct (CBD) or pancreatic duct of a subject; and a plurality of internal lumens extending from a proximal end of the elongate catheter to a distal end of the elongate catheter; the internal lumen having at least a first lumen having an opening at a tip on a distal end of the catheter and configured to permit passage of a guidewire; the one or more sensing probes are configured to sense or measure one or more of electrical impedance, resistance, conductivity, and / or electrical signals at a distal end of the catheter; Catheter system.

2. The guidewire further comprises: The catheter system of claim 1 , wherein the one or more sensing probes are disposed on and / or within the elongate catheter and / or the guidewire.

3. The catheter system of claim 1 or 2, wherein the one or more sensing probes include a conductive material configured to pass an electric current therethrough.

4. The catheter system according to any one of claims 1 to 3, further comprising a sensor system located at a proximal end of the catheter, the sensor system configured to determine, via the sensing probe, resistance and / or impedance and / or conductivity within a body cavity in which the distal end of the catheter is located, and to evaluate the conductivity within the body cavity.

5. The electrical impedance and / or resistance determined at the distal end of the catheter The catheter system of claim 1 , wherein the electrical conductivity value and / or the electrical conductivity value indicate a position of the distal end of the catheter in the common bile duct or pancreatic duct of the subject.

6. (a) a higher resistivity and / or impedance value and / or a lower conductivity value measured at the distal end of the catheter indicates that the distal end of the catheter is located within the common bile duct; (b) electrical impedance and / or resistance and / or conductivity and / or electrical signal values ​​determined at the distal end of the catheter are indicative of an inflammatory condition within the bile duct or pancreatic duct; (c) the electrical signal is indicative of muscle or nerve activity, and (d) the electrical signal is configured to enable electromyography. The catheter system according to any one of claims 1 to 5, wherein at least one of the following holds true.

7. 7. The catheter system of claim 1, wherein the catheter is sized to be inserted through a duodenoscope, the papilla of Vater and / or the sphincter of Oddi, and / or into the ampulla of Vater of the subject.

8. The catheter system of any one of claims 1 to 7, wherein the multiple internal lumens are configured to allow the passage of one or more suitable medical instruments and / or substances.

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