Abstract
The present invention relates to a methodology of, and an apparatus for, performing multiple interventions within the biliary tree without requiring multiple catheter exchanges. The device consists of a flexible elongate tube, introduced through an endoscope, having a proximal end towards the operator and a distal end directed towards a body lumen. The exposed part of an electrosurgical cutting wire near the distal end is used to cut the sphincter of Oddi. Two lumens extend from the proximal to the distal end, one configured to accept a guidewire, and the other to allow contrast injection. In some renderings, a single lumen may serve both functions. Another lumen extends from the proximal end to a dilator balloon housed distally on the catheter to further widen the biliary orifice. An additional lumen extends from the proximal end to an extractor balloon near the distal end of the catheter for stone extraction.
Claims
1. A medical device intended for human or non-human use to be introduced over a guidewire or otherwise, through a duodenoscope or another videoscope, port, sheath or opening comprising: a flexible elongate tube/catheter comprising a plurality of lumens, a proximal end towards the operator and a distal end directed towards the ampulla of Vater or another body lumen, a longitudinal axis extending from said proximal end to said distal end, a wire assembly that is attached to the catheter near the distal tip that has cutting (conductive) part exposed to the outside near the distal tip for performing a sphincterotomy and a non-conductive part that extends proximally through a first lumen towards the proximal end to be attached to a heat source and a handle (with steerable or non-steerable, rotating or non-rotating, locking or non-locking mechanisms) that controls tip deflection/tip manipulation; a second lumen extending from the distal tip to the proximal end, configured to accept contrast injection through the proximal end for cholangiography or similar uses; a third lumen extending from the distal tip to the proximal end, configured to accept a guidewire (or another elongate member), the lumen may be constructed without a split for the catheter to operate as a long-wire catheter or alternatively may be configured to have a splitable channel in the form of C, U, O or other similar channels for use as a short-wire catheter; a low-compliance, high-pressure dilator balloon on the distal shaft, for dilation of the ampulla of Vater or a stricture, that is filled with the infusion of a fluid through a fourth lumen that extends proximally from the balloon entry ports to the proximal end of the catheter, with a luer lock or another compatible connector at the proximal end to be attached to a pressure gauge and an inflation device, configured to be dilated to one fixed diameter or several different predetermined diameters dependent on the pressure level achieved; a second low-pressure, high-compliance balloon located more distally on the shaft for extraction/retrieval of stones or other objects, that is filled through a fifth lumen that extends proximally from the balloon entry ports to the proximal end of the catheter with a connector for a syringe, configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced through a syringe; an additional side-hole (side-port), optionally incorporated near the distal end of the guidewire lumen for the catheter to have additional guidewire exchange capability as ultra-short wire exchange (intraductal exchange) catheter; one or more radiopaque markers, optionally incorporated to mark certain areas of the catheter, e.g. the proximal and distal end of the dilator balloon, the proximal end of the stone extractor balloon and the site of the distal side-port, with or without color coded visual markers at various locations as desired.
2. A medical device intended for human or non-human use to be introduced over a guidewire or otherwise, through a duodenoscope or another videoscope, port, sheath or opening comprising: a flexible elongate tube/catheter comprising a plurality of lumens, a proximal end towards the operator and a distal end directed towards the ampulla of Vater or another body lumen, a longitudinal axis extending from said proximal end to said distal end, a wire assembly that slides in and out of the distal tip that has cutting (conductive) part that slides out from the distal tip for cutting directly into tissues and a non-conductive part that extends proximally through a first lumen towards the proximal end to be attached to a heat source and a handle (with steerable or non-steerable, rotating or non-rotating, locking or non-locking mechanisms) that controls the wire tip movement in and out of the catheter; a second lumen extending from the distal tip to the proximal end, configured to accept contrast injection through the proximal end for cholangiography or similar uses; a third lumen extending from the distal tip to the proximal end, configured to accept a guidewire (or another elongate device), the lumen may be constructed without a split for the catheter to operate as a long-wire catheter or alternatively may be configured to have a splitable channel in the form of C, U, O or other similar channels for use as a short-wire catheter; a low-compliance, high-pressure dilator balloon on the distal shaft, for dilation of the ampulla of Vater or a stricture, that is filled with the infusion of a fluid through a fourth lumen that extends proximally from the balloon entry ports to the proximal end of the catheter, with a luer lock or another compatible connector at the proximal end to be attached to a pressure gauge and an inflation device, configured to be dilated to one fixed diameter or several different predetermined diameters dependent on the pressure level achieved; a second low-pressure, high-compliance balloon located more distally on the shaft for extraction/retrieval of stones or other objects, that is filled through a fifth lumen that extends proximally from the balloon entry ports to the proximal end of the catheter with a connector for a syringe, configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced through a syringe; an additional side-hole (side-port), optionally incorporated near the distal end of the guidewire lumen for the catheter to have additional guidewire exchange capability as ultra-short wire exchange (intraductal exchange) catheter; one or more radiopaque markers, optionally incorporated to mark certain areas of the catheter, e.g. the proximal and distal end of the dilator balloon, the proximal end of the stone extractor balloon and the site of the distal side-port, with or without color coded visual markers at various locations as desired.
3. A medical device intended for human or non-human use to be introduced over a guidewire or otherwise, through a duodenoscope or another videoscope, port, sheath or opening comprising: a flexible elongate tube/catheter comprising a plurality of lumens, a proximal end towards the operator and a distal end directed towards the ampulla of Vater or another body lumen, a longitudinal axis extending from said proximal end to said distal end, a wire assembly that is attached to the catheter near the distal tip that has cutting (conductive) part exposed to the outside near the distal tip for performing a sphincterotomy and a non-conductive part that extends proximally through a first lumen towards the proximal end to be attached to a heat source and a handle (with steerable or non-steerable, rotating or non-rotating, locking or non-locking mechanisms) that controls tip deflection/tip manipulation; a second lumen extending from the distal tip to the proximal end, end configured to accept contrast injection through the proximal end for cholangiography or similar uses and also configured to accept a guidewire, with a Tuohy-Borst adapter that may be built in or attached to the proximal end; a low-compliance, high-pressure dilator balloon on the distal shaft, for dilation of the ampulla of Vater or a stricture, that is filled with the infusion of a fluid through a third lumen that extends proximally from the balloon entry ports to the proximal end of the catheter, with a luer lock or another compatible connector at the proximal end to be attached to a pressure gauge and an inflation device, configured to be dilated to one fixed diameter or several different predetermined diameters dependent on the pressure level achieved; a second low-pressure, high-compliance balloon located more distally on the shaft for extraction/retrieval of stones or other objects, that is filled through a fourth lumen that extends proximally from the balloon entry ports to the proximal end of the catheter with a connector for a syringe, configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced through a syringe; an additional side-hole (side-port), optionally incorporated near the distal end of the guidewire lumen for the catheter to have additional guidewire exchange capability as ultra-short wire exchange (intraductal exchange) catheter; one or more radiopaque markers, optionally incorporated to mark certain areas of the catheter, e.g. the proximal and distal end of the dilator balloon, the proximal end of the stone extractor balloon and the site of the distal side-port, with or without color coded visual markers at various locations as desired.
4. A medical device intended for human or non-human use to be introduced over a guidewire or otherwise, through a duodenoscope or another videoscope, port, sheath or opening comprising: a flexible elongate tube/catheter comprising a plurality of lumens, a proximal end towards the operator and a distal end directed towards the ampulla of Vater or another body lumen, a longitudinal axis extending from said proximal end to said distal end, a wire assembly that is slides in and out of the distal tip that has a cutting (conductive) part that slides out from the distal tip for cutting directly into tissues and a non-conductive part that extends proximally through a first lumen towards the proximal end to be attached to a heat source and a handle (with steerable or non-steerable, rotating or non-rotating, locking or non-locking mechanisms) that controls the wire tip movement in and out of the catheter; a second lumen extending from the distal tip to the proximal end, end configured to accept contrast injection through the proximal end for cholangiography or similar uses and also configured to accept a guidewire, with a Tuohy-Borst adapter that may be built in or attached to the proximal end; a low-compliance, high-pressure dilator balloon on the distal shaft, for dilation of the ampulla of Vater or a stricture, that is filled with the infusion of a fluid through a third lumen that extends proximally from the balloon entry ports to the proximal end of the catheter, with a luer lock or another compatible connector at the proximal end to be attached to a pressure gauge and an inflation device, configured to be dilated to one fixed diameter or several different predetermined diameters dependent on the pressure level achieved; a second low-pressure, high-compliance balloon located more distally on the shaft for extraction/retrieval of stones or other objects, that is filled through a fourth lumen that extends proximally from the balloon entry ports to the proximal end of the catheter with a connector for a syringe, configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced through a syringe; an additional side-hole (side-port), optionally incorporated near the distal end of the guidewire lumen for the catheter to have additional guidewire exchange capability as ultra-short wire exchange (intraductal exchange) catheter; one or more radiopaque markers, optionally incorporated to mark certain areas of the catheter, e.g. the proximal and distal end of the dilator balloon, the proximal end of the stone extractor balloon and the site of the distal side-port, with or without color coded visual markers at various locations as desired.
5. (canceled)
6. (canceled)
7. (canceled)
8. (canceled)
9. (canceled)
10. A method of use of medical device described in claim 1 to be introduced through a duodenoscope or another videoscope, port, sheath or opening to cut the sphincter of Oddi/ampulla of Vater or another normal or abnormal body tissue with a heated wire, balloon dilation of the ampulla or another body part with a dilator balloon and extraction of bile duct stones or other objects from the biliary tree or another lumen with the use of an extraction balloon over a guidewire or otherwise without requiring any catheter exchanges or requiring fewer catheter exchanges to improve efficiency, improve patient safety, reduce healthcare costs and minimize medical waste.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The embodiments of the present disclosure are depicted in the figures, the features and advantages will be more apparent from a reading of the detailed description in the following section. The figures are schematic and not intended to be drawn to scale. The locations, shapes and sizes of each lumen can be modified. The transverse cross-sectional views are true cross-sectional views along the transverse axis of the catheter at the respective lines. The side sectional views are not true longitudinal section views along a particular plane but are modified drawings to facilitate visual comprehension of the catheter. These drawings can be imagined as longitudinal sections cut along the axis of the wire assembly, with the lumens 103 A and 103 B added-in to have all essential parts represented in one view. Otherwise, these two lumens being located more peripherally would not be visible in a true longitudinal sectional view at the level of the wire assembly.
[0031] FIG. 1A depicts a side sectional view of the distal part of the first embodiment of the catheter.
[0032] FIG. 1 B depicts a side sectional view of the proximal part of the same embodiment of the catheter shown in FIG. 1A.
[0033] FIG. 2 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 2-2.
[0034] FIG. 3 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 3-3.
[0035] FIG. 4 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 4-4.
[0036] FIG. 5 depicts a cross-sectional view of a portion of the catheter of FIG. 1 B taken along line 5-5.
[0037] FIG. 6 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 6-6 at the level of the dilator balloon.
[0038] FIG. 7 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 7-7 at the level of the stone extractor balloon.
[0039] FIG. 8 is a merged view of FIG. 1A and FIG. 1 B depicting the proximal and distal end of the first embodiment of the catheter aligned in one view.
[0040] FIG. 9A depicts a side sectional view of the distal part of the second embodiment of the catheter.
[0041] FIG. 9 B depicts a side sectional view of the proximal part of the same embodiment of the catheter shown in FIG. 9A.
[0042] FIG. 10 depicts a cross-sectional view of a portion of the catheter of FIG. 9A taken along line 10-10.
[0043] FIG. 11 depicts a cross-sectional view of a portion of the catheter of FIG. 9A taken along line 11-11.
[0044] FIG. 12 depicts a cross-sectional view of a portion of the catheter of FIG. 9A taken along line 12-12.
[0045] FIG. 13 depicts a cross-sectional view of a portion of the catheter of FIG. 9 B taken along line 13-13.
[0046] FIG. 14A depicts a side sectional view of the distal part of the third embodiment of the catheter.
[0047] FIG. 14 B depicts a side sectional view of the proximal part of the same embodiment of the catheter shown in FIG. 14A.
[0048] FIG. 15 depicts a cross-sectional view of a portion of the catheter of FIG. 14A taken along line 15-15.
[0049] FIG. 16 depicts a cross-sectional view of a portion of the catheter of FIG. 14A taken along line 16-16.
[0050] FIG. 17 depicts a cross-sectional view of a portion of the catheter of FIG. 14A taken along line 17-17.
[0051] FIG. 18 depicts a cross-sectional view of a portion of the catheter of FIG. 14 B taken along line 18-18.
[0052] FIG. 19A depicts a side sectional view of the distal part of the fourth embodiment of the catheter.
[0053] FIG. 19 B depicts a side sectional view of the proximal part of the same embodiment of the catheter shown in FIG. 19A.
[0054] FIG. 20 depicts a cross-sectional view of a portion of the catheter of FIG. 19A taken along line 20-20.
[0055] FIG. 21 depicts a cross-sectional view of a portion of the catheter of FIG. 19A taken along line 21-21.
[0056] FIG. 22 depicts a cross-sectional view of a portion of the catheter of FIG. 19A taken along line 22-22.
[0057] FIG. 23 depicts a cross-sectional view of a portion of the catheter of FIG. 19 B taken along line 23-23.
[0058] FIG. 24A depicts a side sectional view of the distal part of the first embodiment of the catheter demonstrating different ways a guidewire can be loaded.
[0059] FIG. 24 B depicts a side sectional view of the proximal part of first embodiment demonstrating that the catheter can be used as a part of a long-wire or short-wire system.
[0060] FIG. 25 demonstrates a view of a duodenoscope in position in the duodenum, a bile duct stone is noted in the bile duct.
[0061] FIG. 26 demonstrates a view of the first embodiment of the catheter in action with the catheter tip engaged in the ampullary orifice and the sphincter of Oddi being cut by the cutting wire.
[0062] FIG. 27 demonstrates a view of the second embodiment of the catheter in action with a needle-knife being used to cut into the papilla to gain bile duct access.
[0063] FIG. 28 demonstrates a view of the first embodiment of the catheter being introduced into the bile duct over a guidewire and the dilator balloon in position in the inflated state causing expansion of the ampullary orifice.
[0064] FIG. 29 demonstrates a view of the first embodiment of the catheter in the bile duct over a guidewire with the stone retrieval balloon in the inflated state positioned proximal to a bile duct stone, in the process of sweeping the stone out of the bile duct and into the duodenum.
[0065] FIG. 30 demonstrates a view of the first embodiment of the catheter in the bile duct over a guidewire with the stone retrieval balloon in the inflated state positioned proximal to a bile duct stone while the dilator balloon is also in an inflated state. This may be a useful option to keep the biliary outflow tract straight and optimally aligned during the stone retrieval process. This can be particularly helpful in situations when the bile duct is sharply angulated, or the stone has sharp edges.
DETAILED DESCRIPTION OF THE INVENTION
[0066] The various embodiments of the present disclosure are depicted in the figures. The figures are schematic and not intended to be drawn to scale. The cross-sectional views are true cross-sectional views along the transverse axis of the catheter at the respective lines. The side sectional views are not true longitudinal section views along a particular plane but are modified drawings to facilitate visual comprehension of the catheter. These drawings can be imagined as longitudinal sections cut along the axis of the wire assembly, with the lumens 103 A and 103 B added-in to have all essential parts represented in one view. Otherwise, these two lumens being located more peripherally would not be visible in a true longitudinal sectional view at the level of the wire assembly.
[0067] FIG. 1A depicts a side sectional view of the distal part of the first embodiment of the catheter. A wire assembly 101 is depicted that is attached to the catheter near the distal tip and has cutting (conductive) part exposed to the outside near the distal tip and a non-conductive part that extends proximally through lumen 102 towards the proximal end to be attached to a handle that controls tip deflection. Lumen 104 extends from the distal tip to the proximal end, configured to accept contrast injection through the proximal end. Contrast exits the lumen at the distal tip to fill the bile duct or the pancreatic duct for fluoroscopic imaging. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire, it extends from the distal tip to the proximal end. The catheter may be configured to be preloaded with a guidewire if desired. It may be configured to be part of a long-wire or a short-wire system. Additionally, it may have a side hole (side-port) near the distal tip depicted by dashed lines 111 for guidewire acceptance to be compatible with an ultra-short wire system for intraductal exchange. Lumens 103 A & B are two separate lumens for independent inflation and deflation of two separate balloons. These are not visible as separate lumens on side sectional view because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on subsequent cross-sectional views. The catheter houses a low-compliance, high-pressure dilator balloon 109 on the distal shaft. This balloon is filled under pressure with the infusion a fluid through lumen 103 B that extends proximally from the balloon to the proximal end of the catheter. It has side holes 107 to allow the entry and exit of fluid from the lumen into the dilator balloon. It is filled under pressure with a fluid e.g., diluted contrast material, to expand the balloon to a predetermined diameter to dilate the ampulla of Vater. It may be configured to be inflated to a single diameter or several different diameters (multi-diameter) based on the pressure level achieved with the amount of the fluid administered (staged inflation). The catheter also houses a second low-pressure, high-compliance balloon 108 located more distally on the shaft for stone extraction/retrieval. It is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter. It has side holes 106 to allow the entry and exit of air from the lumen into the extractor balloon. It can be configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced. Radiopaque markers 110 may be placed to mark the proximal and distal end of the dilator balloon for optimal positioning of the catheter under fluoroscopy. The catheter, however, can also be positioned at the ampullary orifice under visual endoscopic guidance. Additional fluoroscopic markers may be placed as desired, for example at the proximal end of the stone extractor balloon and at the site of the distal side hole (side-port) to facilitate intraductal exchange. Color coded visual markers may be placed on the catheter at various locations as desired for guidance under endoscopic view.
[0068] FIG. 1 B depicts a side sectional view of the proximal part of the same embodiment of the catheter shown in FIG. 1A. Wire assembly 101 extends through lumen 102 to be attached to the handle 112 that controls the movements of the wire and distal tip deflection. The wire connects to a RF heating source through a RF connector 113. Lumen 103 B from the dilator balloon extends to the proximal end of the catheter and it has a luer lock or another compatible connector 114 at the proximal end to be attached to a pressure gauge and a 60-cc inflation device/fluid filled syringe (not shown). It is used to fill the dilator balloon under pressure with a fluid e.g., diluted contrast material, normal saline or sterile water, configured to inflate the balloon to one fixed diameter or several different predetermined diameters based on the pressure level achieved with the amount of the fluid administered. Lumen 103 A extends proximally from the stone extraction balloon to the proximal end of the catheter. It has a connector 115 at the proximal end to be attached to a syringe filled with air (not shown). The stone extraction balloon can be configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced. Lumen 104 extends from the distal tip to the proximal end, configured to accept contrast injection through a connector 116 at the proximal end. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire through port 117. The catheter may be configured to be preloaded with a guidewire if desired. It may be configured to a be part of long-wire system or it may have splitable channel in the form of C, U, 0 or other potential channels for use as a short-wire system.
[0069] FIG. 2 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 2-2. A wire assembly 101 is depicted that is attached to the catheter near the distal tip and extends proximally through lumen 102 towards the proximal end of the catheter. Lumen 104 extends from the distal tip to the proximal end, configured to accept contrast injection through the proximal end. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire and extends from the distal tip to the proximal end. Lumens 103 A and 103 B are two separate lumens for independent inflation and deflation of two separate balloons. These were not visible as separate lumens on side sectional view because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on this cross-sectional view. The low-compliance, high-pressure dilator balloon on the distal shaft is filled under pressure with the infusion of fluid through lumen 103 B that extends proximally from the dilator balloon to the proximal end of the catheter. The low pressure, high compliance stone extraction/retrieval balloon located more distally on the shaft is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter.
[0070] FIG. 3 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 3-3. This cross-sectional view is distal to the dilator balloon and therefore lumen 103 B in not present. Otherwise, it is identical to FIG. 2.
[0071] FIG. 4 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 4-4. This cross-sectional view is distal to the stone extraction/retrieval balloon and therefore lumen 103 A in not present. Otherwise, it is identical to FIG. 3.
[0072] FIG. 5 depicts a cross-sectional view of a portion of the catheter of FIG. 1 B taken along line 5-5. It is identical to FIG. 2.
[0073] FIG. 6 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 6-6 through the middle of the low-compliance, high-pressure dilator balloon 109. Lumens 103 A and 103 B are two separate lumens for independent inflation and deflation of two separate balloons. These are not visible as separate lumens on side sectional views because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on this cross-sectional view. The low-compliance, high-pressure dilator balloon on the distal shaft is filled under pressure with the infusion of fluid through lumen 103 B that extends proximally from the dilator balloon 109 to the proximal end of the catheter. The arrows 601 depict the flow of fluid, typically diluted radiographic contrast material, from lumen 103 B into the lumen of the dilator balloon 109, to distend the balloon. Fluid exits the balloon 109 into lumen 103 B during balloon deflation. The low-pressure, high-compliance stone extraction/retrieval balloon located more distally on the shaft is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter. A wire assembly 101 is depicted that is attached to the catheter near the distal tip and extends proximally through lumen 102 towards the proximal end of the catheter. Lumen 104 extends from the distal tip to the proximal end, configured to accept contrast injection through the proximal end. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire and extends from the distal tip to the proximal end.
[0074] FIG. 7 depicts a cross-sectional view of a portion of the catheter of FIG. 1A taken along line 7-7 through the middle of the low-pressure, high-compliance, stone extraction/retrieval balloon 108 located more distally on the catheter than the dilator balloon shown in FIG. 6. Lumen 103 B is not present anymore as it ends at the level of the low-compliance, high-pressure dilator balloon, located more proximally. The arrows 701 depict the flow of air from lumen 103 A into low-pressure, high-compliance stone extraction/retrieval balloon 108 to inflate the balloon. Air exits the balloon 108 into lumen 103 A during balloon deflation. Balloon inflation and deflation is controlled by an air-filled syringe attached to the proximal end of lumen 103A. A wire assembly 101 is depicted that is attached to the catheter near the distal tip and extends proximally through lumen 102 towards the proximal end of the catheter. Lumen 104 extends from the distal tip to the proximal end, configured to accept contrast injection through the proximal end. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire and extends from the distal tip to the proximal end.
[0075] FIG. 8 is a merged view of FIG. 1A and FIG. 1 B depicting the proximal and distal end of the catheter aligned in one view.
[0076] FIG. 9A depicts a side sectional view of the distal part of the second embodiment of the catheter. The wire assembly 901 is in a needle-knife configuration. In this configuration the manipulation of the handle allows the tip of the electrosurgical wire to slide in and out to the distal tip of the catheter. This allows the catheter to cut into the bile duct directly when cannulation of the bile duct is not feasible because of difficult anatomy. The wire 901 has a cutting (conductive) part at the distal tip that slides in and out of the tip of the catheter and a non-conductive part that extends proximally through lumen 902 towards the proximal end to be attached to a handle that controls the movement of the wire. Lumen 104 extends from the distal tip to the proximal end, configured to accept contrast injection through the proximal end. Contrast exits the lumen at the distal tip to fill the bile duct or the pancreatic duct for fluoroscopic imaging. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire, it extends from the distal tip to the proximal end. The catheter may be configured to be preloaded with a guidewire if desired. It may be configured to be part of a long-wire or a short-wire system. Additionally, it may have a side hole (side-port) near the distal tip depicted by dashed lines 111 for guidewire acceptance to be compatible with an ultra-short wire system for intraductal exchange. Lumens 103 A & B are two separate lumens for independent inflation and deflation of two separate balloons. These are not visible as separate lumens on side sectional view because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on subsequent cross-sectional views. The catheter houses a low-compliance, high-pressure dilator balloon 109 on the distal shaft. This balloon is filled under pressure with the infusion a fluid through lumen 103 B that extends proximally from the balloon to the proximal end of the catheter. It has side holes 107 to allow the entry and exit of fluid from the lumen into the dilator balloon. It is filled under pressure with a fluid e.g., diluted contrast material, to expand the balloon to a predetermined diameter to dilate the ampulla of Vater. It may be configured to be inflated to a single diameter or several different diameters (multi-diameter) based on the pressure level achieved with the amount of the fluid administered (staged inflation). The catheter also houses a second low-pressure, high-compliance balloon 108 located more distally on the shaft for stone extraction/retrieval. It is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter. It has side holes 106 to allow the entry and exit of air from the lumen into the extractor balloon. It can be configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced. Radiopaque markers 110 may be placed to mark the proximal and distal end of the dilator balloon for optimal positioning of the catheter under fluoroscopy. The catheter, however, can also be positioned at the ampullary orifice under visual endoscopic guidance. Additional fluoroscopic markers may be placed as desired, for example at the proximal end of the stone extractor balloon and at the site of the distal side hole (side-port) to facilitate intraductal exchange. Color coded visual markers may be placed on the catheter at various locations as desired for guidance under endoscopic view.
[0077] FIG. 9 B depicts a side sectional view of the proximal part of the same embodiment of the catheter shown in FIG. 9A. Wire assembly 901 extends through lumen 902 to be attached to the handle 903 that controls the movements of the wire and the wire tip. The wire connects to a RF heating source through a RF connector 904. Lumen 103 B from the dilator balloon extends to the proximal end of the catheter and it has a luer lock or another compatible connector 114 at the proximal end to be attached to a pressure gauge and a 60-cc inflation device/fluid filled syringe (not shown). It is used to fill the dilator balloon under pressure with a fluid e.g., diluted contrast material, normal saline or sterile water, configured to inflate the balloon to one fixed diameter or several different predetermined diameters based on the pressure level achieved with the amount of the fluid administered. Lumen 103 A extends proximally from the stone extraction balloon to the proximal end of the catheter. It has a connector 115 at the proximal end to be attached to a syringe filled with air (not shown). The stone extraction balloon can be configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced. Lumen 104 extends from the distal tip to the proximal end, configured to accept contrast injection through a connector 116 at the proximal end. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire through port 117. The catheter may be configured to be preloaded with a guidewire if desired. It may be configured to a be part of long-wire system or it may have splitable channel in the form of C, U, 0 or other potential channels for use as a short-wire system.
[0078] FIG. 10 depicts a cross-sectional view of a portion of the catheter of FIG. 9A taken along line 10-10. A wire assembly 901 is depicted that has a cutting wire at the distal tip and a non-conductive part that extends proximally through lumen 902 towards the proximal end of the catheter. Lumen 104 extends from the distal tip to the proximal end, configured to accept contrast injection through the proximal end. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire and extends from the distal tip to the proximal end. Lumens 103 A and 103 B are two separate lumens for independent inflation and deflation of two separate balloons. These were not visible as separate lumens on side sectional view because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on this cross-sectional view. The low-compliance, high-pressure dilator balloon on the distal shaft is filled under pressure with the infusion of fluid through lumen 103 B that extends proximally from the dilator balloon to the proximal end of the catheter. The low pressure, high compliance stone extraction/retrieval balloon located more distally on the shaft for It is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter.
[0079] FIG. 11 depicts a cross-sectional view of a portion of the catheter of FIG. 9A taken along line 11-11. This cross-sectional view is distal to the dilator balloon and therefore lumen 103 B in not present. Otherwise, it is identical to FIG. 10.
[0080] FIG. 12 depicts a cross-sectional view of a portion of the catheter of FIG. 9A taken along line 12-12. This cross-sectional view is distal to the stone extraction/retrieval balloon and therefore lumen 103 A in not present. Otherwise, it is identical to FIG. 11.
[0081] FIG. 13 depicts a cross-sectional view of a portion of the catheter of FIG. 9 B taken along line 13-13. It is identical to FIG. 10.
[0082] FIG. 14A depicts a side sectional view of the distal part of the third embodiment of the catheter. A wire assembly 101 is depicted that is attached to the catheter near the distal tip and has cutting (conductive) part exposed to the outside near the distal tip and a non-conductive part that extends proximally through lumen 102 towards the proximal end to be attached to a handle that controls tip deflection. Lumen 105 extends from the proximal end of the catheter to the distal tip, configured for injection of contrast material into the biliary tree and to accept a guidewire. The embodiment eliminates one of the lumens to save space. A Tuohy-Borst adapter may be built in or attached to the proximal end of the lumen to prevent contrast leakage. The catheter may be configured to be preloaded with a guidewire if desired. Lumens 103 A & B are two separate lumens for independent inflation and deflation of two separate balloons. These are not visible as separate lumens on side sectional view because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on subsequent cross-sectional views. The catheter houses a low-compliance, high-pressure dilator balloon 109 on the distal shaft. This balloon is filled under pressure with the infusion a fluid through lumen 103 B that extends proximally from the balloon to the proximal end of the catheter. It has side holes 107 to allow the entry and exit of fluid from the lumen into the dilator balloon. It is filled under pressure with a fluid e.g., diluted contrast material, to expand the balloon to a predetermined diameter to dilate the ampulla of Vater. It may be configured to be inflated to a single diameter or several different diameters (multi-diameter) based on the pressure level achieved with the amount of the fluid administered (staged inflation). The catheter also houses a second low-pressure, high-compliance balloon 108 located more distally on the shaft for stone extraction/retrieval. It is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter. It has side holes 106 to allow the entry and exit of air from the lumen into the extractor balloon. It can be configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced. Radiopaque markers 110 may be placed to mark the proximal and distal ends of the dilator balloon for optimal positioning of the catheter under fluoroscopy. The catheter, however, can also be positioned at the ampullary orifice under visual endoscopic guidance. Additional fluoroscopic markers may be placed as desired, for example at the proximal end of the stone extractor balloon as desired. Color coded visual markers may be placed on the catheter at various locations as desired for guidance under endoscopic view.
[0083] FIG. 14 B depicts a side sectional view of the proximal part of the same embodiment of the catheter shown in FIG. 14A. Wire assembly 101 extends through lumen 102 to be attached to the handle 112 that controls the movements of the wire and distal tip deflection. The wire connects to a RF heating source through a RF connector 113. Lumen 103 B from the dilator balloon extends to the proximal end of the catheter and it has a luer lock or another compatible connector 114 at the proximal end to be attached to a pressure gauge and a 60-cc inflation device/fluid filled syringe (not shown). It is used to fill the dilator balloon under pressure with a fluid e.g., diluted contrast material, normal saline or sterile water, configured to inflate the balloon to one fixed diameter or several different predetermined diameters based on the pressure level achieved with the amount of the fluid administered. Lumen 103 A extends proximally from the stone extraction balloon to the proximal end of the catheter. It has a connector 115 at the proximal end to be attached to a syringe filled with air (not shown). The stone extraction balloon can be configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire and contrast injection. A Tuohy-Borst adapter 116 may be built-in or attached to the proximal end of the lumen to prevent backflow of contrast. The silicone valve and cap 117 of the Tuohy-Borst adapter torque around the guidewire while contrast is injected through the injection port 118.
[0084] FIG. 15 depicts a cross-sectional view of a portion of the catheter of FIG. 14A taken along line 15-15. A wire assembly 101 is depicted that is attached to the catheter near the distal tip and extends proximally through lumen 102 towards the proximal end of the catheter. Lumen 105 extends from the proximal end of the catheter to the distal tip, configured for injection of contrast material into the biliary tree and to accept a guidewire. The embodiment eliminates one of the lumens to save space. Lumens 103 A and 103 B are two separate lumens for independent inflation and deflation of two separate balloons. These were not visible as separate lumens on side sectional view because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on this cross-sectional view. The low-compliance, high-pressure dilator balloon on the distal shaft is filled under pressure with the infusion of fluid through lumen 103 B that extends proximally from the dilator balloon to the proximal end of the catheter. The low pressure, high compliance stone extraction/retrieval balloon located more distally on the shaft for It is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter.
[0085] FIG. 16 depicts a cross-sectional view of a portion of the catheter of FIG. 14A taken along line 16-16. This cross-sectional view is distal to the dilator balloon and therefore lumen 103 B in not present. Otherwise, it is identical to FIG. 15.
[0086] FIG. 17 depicts a cross-sectional view of a portion of the catheter of FIG. 14A taken along line 17-17. This cross-sectional view is distal to the stone extraction/retrieval balloon and therefore lumen 103 A in not present. Otherwise, it is identical to FIG. 16.
[0087] FIG. 18 depicts a cross-sectional view of a portion of the catheter of FIG. 14 B taken along line 18-18. It is identical to FIG. 15.
[0088] FIG. 19A depicts a side sectional view of the distal part of the fourth embodiment of the catheter. The wire assembly 901 is in a needle-knife configuration. In this configuration the manipulation of the handle allows the tip of the electrosurgical wire to slide in and out to the distal tip of the catheter. This allows the catheter to cut into the bile duct directly when cannulation of the bile duct is not feasible because of difficult anatomy. The wire assembly 901 has a cutting (conductive) part at the distal tip that slides in and out of the tip of the catheter and a non-conductive part that extends proximally through lumen 902 towards the proximal end to be attached to a handle that controls the movement of the wire. Lumen 105 extends from the proximal end of the catheter to the distal tip, configured for injection of contrast material into the biliary tree and to accept a guidewire. The embodiment eliminates one of the lumens to save space. A Tuohy-Borst adapter may be built in or attached to the proximal end of the lumen to backflow of contrast. The catheter may be configured to be preloaded with a guidewire if desired. Lumens 103 A & B are two separate lumens for independent inflation and deflation of two separate balloons. These are not visible as separate lumens on side sectional view because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on subsequent cross-sectional views. The catheter houses a low-compliance, high-pressure dilator balloon 109 on the distal shaft. This balloon is filled under pressure with the infusion a fluid through lumen 103 B that extends proximally from the balloon to the proximal end of the catheter. It has side holes 107 to allow the entry and exit of fluid from the lumen into the dilator balloon. It is filled under pressure with a fluid e.g., diluted contrast material, to expand the balloon to a predetermined diameter to dilate the ampulla of Vater. It may be configured to be inflated to a single diameter or several different diameters (multi-diameter) based on the pressure level achieved with the amount of the fluid administered (staged inflation). The catheter also houses a second low-pressure, high-compliance balloon 108 located more distally on the shaft for stone extraction/retrieval. It is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter. It has side holes 106 to allow the entry and exit of air from the lumen into the extractor balloon. It can be configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced. Radiopaque markers 110 may be placed to mark the proximal and distal ends of the dilator balloon for optimal positioning of the catheter under fluoroscopy. The catheter, however, can also be positioned at the ampullary orifice under visual endoscopic guidance. Additional fluoroscopic markers may be placed as desired, for example at the proximal end of the stone extractor balloon as desired. Color coded visual markers may be placed on the catheter at various locations as desired for guidance under endoscopic view.
[0089] FIG. 19 B depicts a side sectional view of the proximal part of the same embodiment of the catheter shown in FIG. 19A. Wire assembly 901 extends through lumen 902 to be attached to the handle 903 that controls the movements of the wire and the wire tip. The wire connects to a RF heating source through a RF connector 113. Lumen 103 B from the dilator balloon extends to the proximal end of the catheter and it has a luer lock or another compatible connector 114 at the proximal end to be attached to a pressure gauge and a 60-cc inflation device/fluid filled syringe (not shown). It is used to fill the dilator balloon under pressure with a fluid e.g., diluted contrast material, normal saline or sterile water, configured to inflate the balloon to one fixed diameter or several different predetermined diameters based on the pressure level achieved with the amount of the fluid administered. Lumen 103 A extends proximally from the stone extraction balloon to the proximal end of the catheter. It has a connector 115 at the proximal end to be attached to a syringe filled with air (not shown). The stone extraction balloon can be configured to be inflated to one fixed or several different predetermined diameters based on the volume of air introduced. Lumen 105 is the lumen with the largest diameter configured to accept a guidewire and contrast injection. A Tuohy-Borst adapter 116 may be built-in or attached to the proximal end of the lumen to prevent backflow of contrast. The silicone valve and cap 117 of the Tuohy-Borst adapter torque around the guidewire while contrast is injected through the injection port 118.
[0090] FIG. 20 depicts a cross-sectional view of a portion of the catheter of FIG. 19A taken along line 20-20. A wire assembly 901 is depicted that is attached to the catheter near the distal tip and extends proximally through lumen 902 towards the proximal end of the catheter. Lumen 105 extends from the proximal end of the catheter to the distal tip, configured for injection of contrast material into the biliary tree and to accept a guidewire. The embodiment eliminates one of the lumens to save space. Lumens 103 A and 103 B are two separate lumens for independent inflation and deflation of two separate balloons. These were not visible as separate lumens on side sectional view because of the limitations of a two-dimensional figure. These can be clearly appreciated as separate, parallel lumens on this cross-sectional view The low-compliance, high-pressure dilator balloon on the distal shaft is filled under pressure with the infusion of fluid through lumen 103 B that extends proximally from the dilator balloon to the proximal end of the catheter. The low pressure, high compliance stone extraction/retrieval balloon located more distally on the shaft for It is filled independently through a separate lumen 103 A that extends proximally from the balloon to the proximal end of the catheter.
[0091] FIG. 21 depicts a cross-sectional view of a portion of the catheter of FIG. 19A taken along line 21-21. This cross-sectional view is distal to the dilator balloon and therefore lumen 103 B in not present. Otherwise, it is identical to FIG. 20.
[0092] FIG. 22 depicts a cross-sectional view of a portion of the catheter of FIG. 19A taken along line 22-22. This cross-sectional view is distal to the stone extraction/retrieval balloon and therefore lumen 103 A in not present. Otherwise, it is identical to FIG. 21.
[0093] FIG. 23 depicts a cross-sectional view of a portion of the catheter of FIG. 19 B taken along line 23-23. It is identical to FIG. 20.
[0094] FIG. 24A depicts a side sectional view of the distal part of the first embodiment of the catheter demonstrating different ways a guidewire can be loaded. The guidewire may be loaded to extend through the entire length of the lumen 105, depicted by guidewire 2402, protruding from each end in a long-wire or short-wire configuration of the catheter as desired. Alternatively, and additionally a side-hole near the distal tip shown by dashed lines 111 can be used for guidewire acceptance as depicted by guidewire 2401, for the catheter to be used as an ultra-short wire system for intraductal exchange. A radiopaque marker may be placed at the level of the side hole to facilitate intraductal exchange. Multiple guidewires can be placed simultaneously without requiring a catheter exchange, to cannulate multiple ducts, place multiple stents or do other simultaneous interventions.
[0095] FIG. 24 B depicts a side sectional view of the proximal part of first embodiment demonstrating that the catheter can be used as a part of a long-wire or short-wire system. If the catheter is configured as a long-wire catheter, guidewire 2403 would run through the entire length of the lumen 105 from the wire port 117 to the distal tip. Alternatively, it may have splitable channel in the form of C, U, 0 or other potential channels for use as a short-wire system, as depicted by the guidewire 2404 shown as being separated away from lumen 105. Furthermore, the catheter in either of these configurations, long-wire or short-wire, would have additional ultra-short wire capability as demonstrated in if FIG. 24A.
[0096] FIG. 25 demonstrates a view of a duodenoscope 2502 in position in the duodenal lumen 2501 for an ERCP procedure. A bile duct stone 2505 is noted in the bile duct 2504. The pancreatic duct 2506 joins the bile duct at the ampullary orifice 2507, surrounded by the sphincter of Oddi 2508. Gallbladder 2503 containing stones is also seen.
[0097] FIG. 26 demonstrates a view of the first embodiment of the catheter 2601 in action over a guidewire 2602 with the catheter tip engaged in the ampullary orifice 2507 and contrast 2606 has been injected. The sphincter of Oddi 2508 is being cut by the cutting wire 2603 of the catheter. The stone extraction/retrieval balloon 2604 and the dilator balloon 2605 are both in a deflated state within the working channel of the duodenoscope 2502.
[0098] FIG. 27 demonstrates a view of the second embodiment of the catheter 2701 in action with a needle-knife 2702 being used to cut into the sphincter of Oddi 2508 to gain access into the bile duct 2504. The stone extraction/retrieval balloon 2604 and the dilator balloon 2605 are both in a deflated state within the working channel of the duodenoscope 2502.
[0099] FIG. 28 demonstrates a view of the first embodiment of the catheter 2601 being introduced into the bile duct 2504 over a guidewire 2602. The dilator balloon 2605 is in position in the inflated state causing expansion of the ampullary orifice 2507. The stone retrieval balloon 2604 in the deflated state.
[0100] FIG. 29 demonstrates a view of the first embodiment of the catheter 2601 in the bile duct 2504 over a guidewire 2602. The dilator balloon 2605 is in a deflated state. The stone extractor/retrieval balloon 2604 in the inflated state positioned proximal to a bile duct stone 2505, in the process of sweeping the stone out of the bile duct and into the duodenal lumen 2501.
[0101] FIG. 30 demonstrates a view of the first embodiment of the catheter in the bile duct over a guidewire with the stone retrieval balloon in the inflated state positioned proximal to a bile duct stone while the dilator balloon is also in an inflated state. This may be a useful option to keep the biliary outflow tract straight and optimally aligned during the stone retrieval process. This can be particularly helpful in situations when the bile duct is sharply angulated, or the stone has sharp edges.
[0102] One of the lumens may have a large enough diameter to allow the passage of a 0.035 inch or a 0.025 inch guidewire. With improvements in guidewire materials, design and maneuverability, 0.025 inch guidewire has become more useful may become the new standard guidewire. It is possible that even a smaller diameter guidewire lumen may have utility in the future with further improvements in guidewire design. The other lumens can be quite small, and some of the lumens can be arranged along the periphery and/or have non-circular cross-sectional shapes to optimally utilize the space within the catheter. The locations, shapes and sizes of each lumen may be modified. It may be configured to a be part of long-wire system or it may have splitable channel in the form of C, U, O or other potential channels for use as a short-wire system. Additionally, it may have a side hole (side-port) near the distal tip for guidewire acceptance, approximately 2 to 8 cm from the distal tip, to be compatible with an ultra-short wire system for intraductal exchange. For use as a primary access device for an ultra-short wire exchange, the guidewire may be loaded through the distal side-port to exit from the tip for a comfortable distance and the two advanced together through the working channel of the duodenoscope. If it is difficult to keep the two coupled together through the working channel, the guidewire may be advanced first until it exits the tip of the duodenoscope. The guidewire can then be locked with the elevator and the catheter advanced over it until the two can be seen to be aligned at the tip of the duodenoscope under endoscopic view. After deep cannulation of the biliary tree, the catheter can be advanced and/or the guidewire can be pulled back to uncouple the two for intraductal exchange. The catheter can then be removed for a second device to be introduced over the guidewire. Additionally, or alternatively, a second guidewire may be introduced through the proximal end of the guidewire lumen while the catheter is still in place, if two guidewires are needed for a double-guidewire technique or for multiple stent/device placements. If for some reason, a different catheter was used to gain bile duct access and place a guidewire, this catheter can also be used as a secondary ultra-short wire device with the guidewire entering through the tip and exiting through the distal side-port. It may also be used as a secondary device for a short-wire or long-wire exchange.
[0103] The distal side-hole (side port) in the guidewire lumen (or an opening in another lumen) may configured to be used for injection of contrast or fluid to be strategically administered between two inflated balloons, or proximally or distally to one of the inflated balloons for selective contrast injection or for infusion of a medicine, chemical, biologic agent or a vector for gene therapy within the biliary tree or another lumen.
[0104] The catheter of this device may be constructed from any of a wide variety of suitable materials or blend of materials that are currently available such as nylon, teflon, silicone, polyurethane, polyethylene or polyvinyl chloride (PVC), or other materials that may become available in the future. The cutting wire may be constructed from any of the currently available materials like stainless steel, nitinol, tungsten or any materials that may become available in the future. The low-compliance, high-pressure dilator balloon may be constructed from PET (polyethylene terephthalate), nylon, Pebax or other similar materials or blend of materials that have high hoop strength to achieve high dilating forces. The low-pressure, high-compliance stone may be constructed from silicone, latex, polyurethane and other similar materials or blend of materials. Materials suitable for recycling may be used as much as possible. It is not the purpose of this document to provide specific measurements, however some general guidance may be appropriate. The length of the dilating balloon in the range of 2 to 4 cm may be optimal for dilation of the ampulla of Vater, other lengths are also acceptable. Catheters are generally constructed with multiple balloon diameter choices for the dilator balloons, whether single diameter or multidiameter (staged inflation), to match the diameter of the bile duct lumen. The stone extraction/retrieval balloons typically range in length from 1 cm to 3 cm. For a catheter with multiple elements, a length towards the shorter end of the range would be optimal. Catheters are generally constructed with multiple balloon diameter choices for stone extraction/retrieval balloons to match or exceed the diameter of the bile duct lumen. The exposed part of the cutting wire can vary in length from 1 cm to 3 cm, again a length towards the shorter end of the range would be desirable. The nose of the sphincterotome (the distance from the distal end of the exposed cutting wire to the distal tip of the catheter) typically ranges from 0.5 to 1.5 cm. For a catheter like this with multiple elements, a length in the lower end of the range would be optimal. The distance between the exposed part of the cutting wire and the extraction/retrieval balloon and between the extraction/retrieval balloon and the dilator balloon may be in the range of 1 cm to 2.5 cm, although other distances may be acceptable.
[0105] The biliary system is used as an example. The device, however, is not limited in its scope to use in the biliary system/gastroenterology applications and can be utilized in any human or non-human body lumen, cavity or organ for a variety of applications including but limited to interventional radiological, robotic surgical, urological, gynecological, cardiovascular and neurovascular procedures. It may be used with or without a guidewire. The term guidewire used in this document would encompass not only the guidewire or wire guide in a traditional sense of the word but also include any elongate member that can perform a similar function e.g., a small diameter catheter, basket, stylet, needle, cable, string, laser fiber, EHL fiber, light source, fiberoptic or videoscope. The device maybe constructed using any of a variety of suitable materials that are currently available or may become available in the future. Although, the heat source for the cutting wire is typically radiofrequency (RF) electrical current, the term heat source would encompass any available source of heat or energy including but not limited to other forms of electric currents, laser, electrohydraulic, ultrasonic, gamma rays and microwaves.
