Patent Description:
The present disclosure pertains to medical devices, and example methods for manufacturing medical devices. More particularly, the present disclosure pertains to medical devices for treating strictures along the biliary and/or pancreatic tract.

A wide variety of medical devices have been developed for medical use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.

<CIT> discloses a system for treating a stricture having a handle mechanism with proximal, middle and distal slidable handle members, a sheath, a steerable catheter and a needle.

The invention is defined by claims <NUM> and <NUM>.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. A system for treating a stricture is disclosed. The system comprises: a handle having a base, a first carriage translatable relative to the base, and a second carriage translatable relative to the base; a sheath coupled to the first carriage; a catheter shaft having a proximal end region and a steerable distal end region, the proximal end region being coupled to the second carriage; a needle releasably coupled to the handle, the needle being configured to pass through tissue into a position along the biliary and/or pancreatic tract; and a steering member having a first end coupled to the steerable distal end region of the catheter shaft and a second end disposed adjacent to the handle.

Alternatively or additionally to any of the embodiments above, the handle includes a first locking member for securing the axial position of the first carriage relative to the base.

Alternatively or additionally to any of the embodiments above, the handle includes a second locking member for securing the axial position of the second carriage relative to the base, relative to the first carriage, or both.

Alternatively or additionally to any of the embodiments above, the handle includes a third locking member for securing the axial position of the steering member relative to the base, relative to the second carriage, or both.

Alternatively or additionally to any of the embodiments above, the base includes a proximal connector and wherein the needle is secured to the proximal connector.

Alternatively or additionally to any of the embodiments above, the steering member includes a ribbon wire.

Alternatively or additionally to any of the embodiments above, the catheter shaft has a lumen formed therein and wherein the steering member extends through the lumen.

Alternatively or additionally to any of the embodiments above, at least a portion of the steering member extends along an outer surface of the catheter shaft.

Alternatively or additionally to any of the embodiments above, further comprising a sleeve disposed along the portion of the steering member extending along the outer surface of the catheter shaft.

Alternatively or additionally to any of the embodiments above, further comprising an endoscope having a channel formed therein, wherein the catheter shaft is configured to extend within the channel.

A system for treating a stricture is disclosed. The system comprises: a handle having a base, a first telescoping portion coupled to the base, and a second telescoping portion coupled to the base; a sheath coupled to the first telescoping portion; a catheter shaft for non-papillary access to the biliary and/or pancreatic tract, the catheter shaft having a guidewire lumen, a proximal end region and a steerable distal end region; wherein the proximal end region is coupled to the second telescoping portion; a needle having a piercing distal end region and a proximal end region coupled to a connector disposed along the handle, the piercing distal end region needle being configured to pass through tissue into a position along the biliary and/or pancreatic tract; a steering wire having a distal end coupled to the steerable distal end region, an external portion disposed along an outer surface of the catheter shaft, and a proximal end disposed adjacent to the handle; and a sleeve disposed along the external portion of the steering wire.

Alternatively or additionally to any of the embodiments above, the handle includes a first locking member for securing the axial position of the first telescoping portion relative to the base.

Alternatively or additionally to any of the embodiments above, the handle includes a second locking member for securing the axial position of the second telescoping portion relative to the first telescoping portion.

Alternatively or additionally to any of the embodiments above, the handle includes a steering lock for securing the axial position of the steering wire relative to the base, relative to the second telescoping portion, or both.

Alternatively or additionally to any of the embodiments above, the steering wire includes a ribbon wire.

A method for crossing a stricture is disclosed. The method comprises: advancing a catheter system through a digestive tract of patient to a position adjacent to a wall surface along the digestive tract; wherein the catheter system includes catheter shaft and a needle; arranging the needle relative to the catheter shaft so that a distal end of the needle extends distally beyond a distal end of the catheter shaft; piercing through the wall surface and into a luminal position within the biliary and/or pancreatic tract adjacent to a stricture; removing the needle from the catheter system; and advancing a guidewire through the catheter shaft and past the stricture.

Alternatively or additionally to any of the embodiments above, the wall surface along the digestive tract includes a duodenum wall surface.

Alternatively or additionally to any of the embodiments above, the wall surface along the digestive tract includes a stomach wall surface.

Alternatively or additionally to any of the embodiments above, piercing through the wall surface and into a luminal position within the biliary and/or pancreatic tract adjacent to a stricture includes piercing tissue between the wall surface and the luminal position within the biliary and/or pancreatic tract adjacent.

Alternatively or additionally to any of the embodiments above, the catheter shaft includes a steering member and further comprising steering a distal end region of the catheter shaft relative to the stricture.

In endoscopy, a frequent medical condition arises when a patient presents with abdominal pain with or without associated jaundice. The etiology is usually some type of obstruction in the biliary tree which prevents bile from flowing naturally from the proximal tree into the duodenum. The blockage may be the result of biliary stones caught in the lumen of the ducts or a tumor which is either in the wall of the duct or impinging upon the wall from adjacent tissue. When such a stricture occurs the duct proximal to the stricture dilates and the duct distal to the stricture receives a reduced flow of bile. In order to relieve the patient's symptoms, gastroenterologists seek to find a method for resuming the flow of bile from the proximal dilated duct into the duodenum. Some interventions contemplated for reliving symptoms may include placing a stent across the stricture to drain the proximal duct, removing a stone, and/or the like.

The most common method of placing a stent across the stricture is to perform an endoscopic retrograde cholangio-pancreatography (ERCP) where a side-viewing endoscope is placed in the duodenum at the location of the biliary papilla and a guidewire is placed through the papilla and up the biliary duct, across the stricture, in a retrograde fashion. Such procedures may be challenging. For example, depending on the location, geometry, and mechanics of the stricture, deep cannulation of the proximal duct may be difficult if not be possible. Furthermore, when the physician attempts to access the biliary duct, they may inadvertently cannulate the pancreatic duct. Inadvertent cannulation of the pancreatic duct could lead to complications such as pancreatitis. Disclosed herein are devices and methods that address these and other issues, for example by utilizing antegrade (e.g., non-papillary) stricture crossing.

<FIG> illustrate an example system <NUM> for treating a stricture along the biliary and/or pancreatic tract. In at least some instances, the system <NUM> is configured to be used with an endoscope (e.g., an endoscopic ultrasound device) for antegrade stricture crossing along the biliary and/or pancreatic tract. The system <NUM> may be understood to be a cold (e.g., unelectrified) access device that can be used for non-papillary access to the biliary and/or pancreatic tract. As will be described in more detail herein, the system <NUM> may be advanced through at least a portion of the digestive tract of a patient, used to pierce/puncture through a wall of the digestive tract and into a lumen/duct along the biliary and/or pancreatic tract, steered to a desired orientation, and then be used to allow a suitable device to pass therethrough for an intervention.

The system <NUM> may include a catheter shaft <NUM> and a handle <NUM> coupled to the catheter shaft <NUM>. A sheath <NUM> may be coupled to the handle <NUM>. In at least some instances, the sheath <NUM> may be or function like an introducer sheath. The sheath <NUM> may be formed form a relatively stiff material such as polyetheretherketone. Other materials are contemplated including those disclosed herein. The handle <NUM> may include a first or proximal connector <NUM>. In at least some instances, the proximal connector <NUM> may be used to secure a device relative to the system <NUM>. For example, a needle or sharp <NUM> (depicted in <FIG>) may be releasably secured to the system <NUM>. The needle/sharp <NUM> may have a piercing and/or penetrating distal end that allows the needle/sharp <NUM> to pass through tissue. The handle <NUM> may include a second or distal connector <NUM>. In at least some instances, the distal connector <NUM>, which may take the form of a luer or other suitable connector, may be used to secure the system <NUM> to an endoscope.

The handle <NUM> may include a base <NUM>, a first telescoping member or carriage <NUM> translatable relative to the base <NUM>, and a second telescoping member or carriage <NUM> translatable relative to the base <NUM> (and/or translatable relative to the first carriage <NUM>). The base <NUM> and the carriages <NUM>, <NUM> may be used to manipulate different portions of the system <NUM> during an intervention. For example, the base <NUM> may be coupled/secured to endoscope (e.g., the distal connector <NUM> may be attached to an endoscope). It may be desirable to arrange the sheath <NUM> relative to the endoscope. For example, it may be desirable to arrange the sheath <NUM> so that the sheath <NUM> extends just beyond the elevator of the endoscope. To adjust the sheath <NUM>, the handle <NUM> may be manipulated. For example, a proximal end region <NUM> of the sheath <NUM> may be coupled to the first carriage <NUM> (see, for example, <FIG>). Thus, translation of the first carriage <NUM> relative to the base <NUM> adjusts the axial position of the sheath <NUM> relative to the base <NUM> (and/or the endoscope). In some instances, the first carriage <NUM> may be understood to be a "length adjustment" for adjusting the length of the sheath <NUM> (e.g., relative to the base <NUM> and/or the endoscope).

A proximal end region <NUM> of the catheter shaft <NUM> may be coupled to the second carriage <NUM>. Thus, translation of the second carriage <NUM> relative to the base <NUM> adjusts the axial position of the catheter shaft <NUM> relative to the base <NUM> (and/or the endoscope). In addition, when the needle/sharp <NUM> is coupled to the handle <NUM>, the needle/sharp <NUM> may be secured to the proximal connector <NUM>. In some instances, the proximal connector <NUM> may be coupled to the second carriage <NUM>. Thus, when the needle/sharp <NUM> is secured to the handle <NUM>, translation of the second carriage <NUM> relative to the base <NUM> adjusts the axial position of both the catheter shaft <NUM> and the needle/sharp <NUM> relative to the base <NUM> (and/or the endoscope). In some instances, the second carriage <NUM> may be understood to be a "sharp throw" for adjusting the throw or length of the needle/sharp <NUM> (e.g., relative to the base <NUM> and/or the endoscope).

The handle <NUM> may include a number of additional features. For example, a first stop member <NUM> may be disposed along the base <NUM>. The first stop member <NUM> may take the form of a collar that can slide along the base <NUM>. In at least some instances, the first stop member <NUM> functions as a stop or limiter that limits how far the first carriage <NUM> can translate along the base <NUM>. In use, a clinician can adjust the first stop member <NUM> to the desired position along the base <NUM>. The base <NUM> may include visual indicia or markings indicative of the relative length/position of the sheath <NUM> to aid the clinician in determining the suitable length/position for the first stop member <NUM>. The first stop member <NUM> may include a first set screw <NUM>. The set screw <NUM> may be used to secure the position of the first stop member <NUM> relative to the base <NUM>.

A second stop member <NUM> may be disposed along the first carriage <NUM>. The second stop member <NUM> may take the form of a collar that can slide along the first carriage <NUM>. In at least some instances, the second stop member <NUM> functions as a stop or limiter that limits how far the second carriage <NUM> can translate along the first carriage <NUM>. In use, a clinician can adjust the second stop member <NUM> to the desired position along the first carriage <NUM>. The first carriage <NUM> may include visual indicia or markings indicative of the relative length/position of the catheter shaft <NUM> to aid the clinician in determining the suitable length/position for the second stop member <NUM>. The second stop member <NUM> may include a second set screw <NUM>. The second set screw <NUM> may be used to secure the position of the second stop member <NUM> relative to the first carriage <NUM>.

The handle <NUM> may include a first locking member <NUM>. The first locking member <NUM> may secure the axial position of the first carriage <NUM> relative to the base <NUM>. In addition, the handle <NUM> may include a second locking member <NUM>. The second locking member <NUM> may secure the axial position of the second carriage <NUM> relative to the first carriage <NUM> (and/or relative to the base <NUM>).

The handle <NUM> may include a steering lock <NUM>. The steering lock <NUM> may take the form of a collar that is slidable translatable along a region <NUM> of the handle <NUM>. In at least some instances, the steering lock <NUM> may be coupled to a steering member or wire <NUM> coupled to the catheter shaft <NUM> (e.g., described in more detail herein). Translation of the steering lock <NUM> may actuate the steering wire <NUM> to cause the catheter shaft <NUM> to bend. When the catheter shaft <NUM> is in the desired shape, a set screw <NUM> may be actuated to secure the steering lock <NUM> to the handle <NUM> (e.g., to secure the steering lock <NUM> relative to the second carriage <NUM>, the base <NUM>, or both) and, thus secure the catheter shaft <NUM> in the desired shape.

<FIG> is a cross-sectional view of the catheter shaft <NUM>. Here, a number of structural features can be shown. For example, the catheter shaft <NUM> may include an inner layer <NUM>, a reinforcing layer <NUM> (e.g., such as braid, coil, mesh, and/or the like), and an outer layer <NUM>. The materials for the various components of the catheter shaft <NUM> may include those materials disclosed herein. For example, the inner layer may include a lubricious material such as polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), combinations thereof, and the like, and/or other materials disclosed herein. The reinforcing layer <NUM> may include a stainless steel braid. The outer layer may include a polyamide, a polyether-ester, a nylon, combinations thereof, and the like, and/or other materials disclosed herein. In some instances, the materials used for the catheter shaft <NUM> may vary along the length of the catheter shaft <NUM>. This may allow the catheter shaft <NUM> to be more flexible near the distal end thereof. In some instances, the catheter shaft <NUM> is formed from a single layer of material. In some instances, the catheter shaft <NUM> may include a tubular member with a plurality of slots formed therein. The slotted catheter shaft <NUM> may be formed from a nickel-titanium alloy, stainless steel, and/or the like. A sleeve of outer layer may be disposed along the slotted catheter shaft <NUM>.

A guidewire and/or sharp tube <NUM>, defining a lumen <NUM> therein, may be disposed within the catheter shaft <NUM>. The tube <NUM> may include an inner layer <NUM>, a reinforcing layer <NUM> (e.g., such as braid, coil, mesh, and/or the like), and an outer layer <NUM>. The construction may of the tube <NUM> may be similar to the catheter shaft <NUM> or be different. In some instances, the tube <NUM> is formed from a single layer of material. A steering wire assembly <NUM> may also be disposed within the catheter shaft <NUM>. The steering wire assembly <NUM> may include a tubular member <NUM> having a lumen <NUM> defined therein and a steering wire <NUM> disposed within the lumen <NUM>. In some instances, the steering wire <NUM> may be a ribbon-shaped wire. In other instances, the steering wire <NUM> may be a round wire or have a different shape.

As indicated herein, the steering wire <NUM> may be actuated (e.g., by sliding the steering lock <NUM>) to bend the catheter shaft <NUM>. In some instances, the steering wire <NUM> may be disposed internally within the catheter shaft <NUM> as depicted in <FIG>. Alternatively, a portion of the steering wire <NUM> may be disposed along the exterior of the catheter shaft <NUM>. For example, <FIG> depicts a catheter shaft <NUM> with a portion of the steering wire <NUM> disposed along the exterior of the catheter shaft <NUM>. In some instances, a sleeve <NUM> may disposed along the exterior, exposed portion of the steering wire <NUM>, which may help to protect tissues from being damaged/cut but the steering wire <NUM> during use.

<FIG> illustrates an overview of the biliary system or tree. A portion of the duodenum <NUM> is shown. The papilla of Vater <NUM> (e.g., also known as the ampulla of Vater or simply the papilla) is located at the illustrated portion of the duodenum <NUM>. The papilla <NUM> generally forms the opening where the pancreatic duct <NUM> and the common bile duct <NUM> can empty into the duodenum <NUM>. The hepatic ducts, denoted by the reference numeral <NUM>, are connected to the liver <NUM> and empty into the bile duct <NUM>. Similarly, the cystic duct <NUM>, being connected to the gall bladder <NUM>, also empties into the bile duct <NUM>. In general, an endoscopic or biliary procedure may include advancing a medical device to a suitable location along the biliary tree and then performing the appropriate intervention.

System <NUM> may be used to access a stricture along the pancreatic duct <NUM> and/or the common bile duct <NUM>. For example, <FIG> illustrates an example endoscope <NUM> disposed in the duodenum <NUM>. The disclosure is not intended to be limited to disposing the endoscope <NUM> in the duodenum <NUM> as other locations are contemplated including other portions of the digestive system including the stomach. The system <NUM> may be secured to the endoscope <NUM> with the catheter shaft <NUM> extending through a channel (e.g., a working channel) of the endoscope <NUM>, and the handle <NUM> may be manipulated to position the catheter shaft <NUM> and sheath <NUM> in the desired positions. The catheter shaft <NUM> (e.g., having the needle/sharp <NUM> extending therethrough) may be advanced out from the endoscope <NUM>. This may include the use of an elevator <NUM> of the endoscope <NUM> to direct the catheter shaft <NUM> toward the wall of the duodenum <NUM>. The catheter shaft <NUM> having the needle/sharp <NUM> protruding therefrom may then pierce through the wall of the duodenum <NUM> and advance through tissue toward the target location, for example, a luminal position such as within common bile duct <NUM>.

Once the catheter shaft <NUM> is suitably positioned, the catheter shaft <NUM> can be steered to the desired orientation using the steering wire <NUM> as schematically depicted in <FIG>. In at least some instances, it may be desirable to remove the needle/sharp <NUM> from the system <NUM> prior to steering. Once the catheter shaft <NUM> is suitably oriented, a device such as a guidewire <NUM> may be advanced through the catheter shaft <NUM> and past the stricture <NUM> as depicted in <FIG>.

<FIG> is a side view of a portion of a handle <NUM> that can be part of a system similar to system <NUM>. The handle <NUM> may be similar in form and function to handle <NUM>. Rather than having a steering lock that slide along the handle, the handle <NUM> may include a rotary steering apparatus/lock <NUM> that is coupled to the handle <NUM> and to the steering wire <NUM>. Rotation of the steering apparatus/lock <NUM> may actuate the steering wire <NUM> (e.g., and cause the catheter shaft <NUM> to curve/bend).

The materials that can be used for the various components of the system <NUM> may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the catheter shaft <NUM>. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar tubular members and/or components of tubular members or devices disclosed herein.

The catheter shaft <NUM> may be made from or otherwise includes a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high-density polyethylene, low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLART), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

Claim 1:
A system (<NUM>) for treating a stricture, the system comprising:
a handle (<NUM>; <NUM>) having a base (<NUM>), a first carriage (<NUM>) translatable relative to the base (<NUM>), and a second carriage (<NUM>) translatable relative to the base (<NUM>);
a sheath (<NUM>) coupled to the first carriage (<NUM>);
a catheter shaft (<NUM>; <NUM>) having a proximal end region (<NUM>) and a steerable distal end region, the proximal end region being coupled to the second carriage;
a needle (<NUM>) releasably coupled to the handle (<NUM>; <NUM>), the needle being configured to pass through tissue into a position along the biliary and/or pancreatic tract;
a steering member (<NUM>; <NUM>) having a first end coupled to the steerable distal end region of the catheter shaft (<NUM>; <NUM>) and a second end disposed adjacent to the handle (<NUM>; <NUM>);
wherein the handle (<NUM>; <NUM>) includes a steering lock member (<NUM>, <NUM>; <NUM>) for securing the axial position of the steering member (<NUM>; <NUM>) relative to the base (<NUM>), relative to the second carriage (<NUM>), or both.