Intubation device for endoscopic retrograde cholangiopancreatography (ERCP)

Abstract

A cannula device is adapted to access a common bile duct (14) of a patient. In some cases, the intubation device includes a first guidewire lumen (34) extending through the elongate shaft and terminating in a first angled guidewire port (36); and a second guidewire lumen (38) extending through the elongate shaft and terminating in a second angled guidewire port (40). In some cases, the intubation device includes an inflatable balloon (72, 80, 92) inflatable from a collapsed configuration to an expanded configuration in which the inflatable balloon is adapted to occlude a pancreatic duct (16) of a patient. In some cases, the cannula device includes an expandable element (118, 140) expandable from a collapsed configuration in which the expandable element is disposed within the guidewire lumen to an extended configuration in which a portion of the expandable element extends distally from a guidewire port.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 400,366, filed Aug. 23, 2022, the entire content of which is incorporated herein by reference. Technical Field

[0002] The present invention relates to medical devices and methods for making and using medical devices. More particularly, the present invention relates to an intubation device for ERCP. Background Art

[0003] A variety of in-vivo medical devices have been developed for medical use, e.g., for intravascular use. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Each of the known in-vivo medical devices and methods for making and using them has certain advantages and disadvantages. There is a current need to provide alternative in-vivo medical devices and alternative methods for making and using in-vivo medical devices. Summary of the Invention

[0004] The present invention provides alternative designs, materials, manufacturing methods, and uses for in-vivo medical devices. An example can be found in an intubation device that is adapted to be advanced through an endoscope to a position adjacent to the duodenum of a patient for entry into the common bile duct of the patient. The intubation device includes a slender shaft extending to a non-invasive distal tip; a first guidewire lumen extending through the slender shaft and terminating at a first angled guidewire port; and a second guidewire lumen extending through the slender shaft and terminating at a second angled guidewire port.

[0005] Alternatively or additionally, the first angled guidewire port can be adapted to direct a guidewire to extend through the first guidewire lumen relative to the non-invasive tip in a first direction.

[0006] Alternatively or additionally, the second angled guidewire port can be adapted to direct a guidewire to extend through the second guidewire lumen relative to the non-invasive tip in a second direction different from the first direction.

[0007] Alternatively or additionally, the non-invasive distal tip can include a tapered outer surface, wherein the first angled guidewire port is disposed on a first portion of the tapered outer surface and the second angled guidewire port is disposed on a second portion of the tapered outer surface circumferentially spaced from the first portion of the tapered outer surface.

[0008] Alternatively or additionally, the first guidewire lumen can be parallel to the second guidewire lumen within a proximal portion of the intubation device.

[0009] Alternatively or additionally, the first guidewire lumen can radially deviate from the second guidewire lumen within a distal portion of the intubation device.

[0010] Alternatively or additionally, the intubation device may further include a cutting wire extending through the elongate shaft.

[0011] Alternatively or additionally, the intubation device may be adapted to be advanced through an endoscope.

[0012] Alternatively or additionally, the intubation device may be adapted to enter the common bile duct of a patient from a position proximal to the ampulla of Vater of the patient.

[0013] Another example can be found in an intubation device that is adapted to be advanced through an endoscope to a position proximal to the duodenum of a patient in order to enter the common bile duct of the patient. The intubation device includes an elongate shaft extending to a non-invasive distal tip and a guide wire lumen extending through the elongate shaft, the guide wire lumen terminating at a guide wire port disposed within the non-invasive distal tip. A inflatable balloon is provided relative to the non-invasive distal tip, the inflatable balloon being inflatable from a collapsed configuration to an expanded configuration, in the expanded configuration, the inflatable balloon being adapted to occlude the pancreatic duct of the patient. An inflation lumen extends through the elongate shaft and is in fluid communication with the inflatable balloon.

[0014] Alternatively or additionally, the inflatable balloon may also be adapted to push the non-invasive distal tip away from the pancreatic duct of the patient and towards the common bile duct of the patient when inflated, thereby assisting in aligning the guide wire port with the common bile duct.

[0015] Alternatively or additionally, the inflatable balloon may be disposed along one side of the non-invasive distal tip.

[0016] Alternatively or additionally, the inflatable balloon may form part of the non-invasive distal tip when in its collapsed configuration.

[0017] Alternatively or additionally, the intubation device may be adapted to enter the common bile duct of a patient from a position proximal to the ampulla of Vater of the patient.

[0018] Another example can be found in an intubation device that is adapted to be advanced through an endoscope to a position proximal to the duodenum of a patient in order to enter the common bile duct of the patient. The intubation device includes an elongate shaft extending to a non-invasive distal tip and a guide wire lumen extending through the elongate shaft, the guide wire lumen terminating at a guide wire port disposed within the non-invasive distal tip. An expandable element is disposed within the guide wire lumen, the expandable element being expandable from a collapsed configuration to an extended configuration, in the collapsed configuration, the expandable element is disposed within the guide wire lumen, and in the extended configuration, a portion of the expandable element extends distally from the guide wire port, the expandable element being adapted to allow a guide wire to extend through the interior of the expandable element.

[0019] Alternatively or additionally, the expandable element may be adapted to occlude the pancreatic duct of the patient.

[0020] Alternatively or additionally, the intubation device may be adapted to enter the common bile duct of the patient from a position proximal to the ampulla of Vater of the patient.

[0021] Alternatively or additionally, the expandable element may include an everted soft robot.

[0022] Alternatively or additionally, the expandable element may include an inverted polymeric sheath.

[0023] Alternatively or additionally, the end of the expandable element may be fixed relative to the distal end of the intubation device.

[0024] The foregoing summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present invention. The following drawings and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The present invention can be more fully understood by considering the following detailed description of various embodiments of the invention in conjunction with the accompanying drawings, in which:

[0026] Figure 1 is a schematic view of a part of the anatomical structure proximal to the duodenum and the ampulla of Vater;

[0027] Figure 2 is a schematic view of a part of an illustrative intubation device;

[0028] Figure 3 is a perspective view of a part of an illustrative intubation device;

[0029] Figure 4 is Figure 3 a first end view of a part of the illustrative intubation device shown;

[0030] Figure 5 is Figure 3 a second end view of a part of the illustrative intubation device shown;

[0031] Figure 6 is a schematic view of an illustrative intubation device positioned proximal to the ampulla of Vater;

[0032] Figure 7 is a schematic view of an illustrative intubation device positioned proximal to the ampulla of Vater;

[0033] Figure 8 is a schematic view of an illustrative intubation device, wherein the inflatable balloon is shown in a deflated configuration;

[0034] Figure 9 is a schematic view of an illustrative intubation device, wherein the inflatable balloon is shown in an inflated configuration;

[0035] Figure 10is a side view of an illustrative intubation device including an inflatable balloon shown in a deflated configuration;

[0036] Figure 11 is Figure 10 a side view of an illustrative intubation device, wherein the inflatable balloon is shown in an inflated configuration;

[0037] Figure 12 is Figure 10 a schematic view of an illustrative intubation device shown in a proper position within an anatomical structure, wherein the inflatable balloon is in a deflated configuration;

[0038] Figure 13 is Figure 10 a schematic view of an illustrative intubation device shown in a proper position within an anatomical structure, wherein the inflatable balloon is in an inflated configuration;

[0039] Figure 14 is a schematic view of an illustrative intubation device having an expandable element shown in a collapsed configuration;

[0040] Figure 15 is Figure 14 a schematic view of a portion of an illustrative intubation device;

[0041] Figure 16 is Figure 14 a schematic view of an illustrative intubation device, wherein the expandable element is shown in an extended configuration;

[0042] Figure 17 is a perspective view of a portion of an illustrative intubation device;

[0043] Figure 18 is Figure 17 a schematic view of an illustrative intubation device shown in a proper position within an anatomical structure, wherein the expandable element is in a collapsed configuration; and

[0044] Figure 19 is Figure 17 a schematic view of an illustrative intubation device shown in a proper position within an anatomical structure, wherein the expandable element is in an extended configuration.

[0045] While the present invention is susceptible to various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in more detail. It should be understood, however, that the invention is not intended to limit the various aspects of the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. Detailed Description

[0046] For the terms defined below, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0047] All numerical values are herein assumed to be modified by the term "about" whether or not explicitly indicated. The term "about" generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent to the recited number (i.e., having the same function or result). In many instances, the term "about" may include numbers that round to the nearest significant figure.

[0048] Recitation of a numerical range by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0049] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0050] The following detailed description should be read with reference to the accompanying drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0051] ERCP (endoscopic retrograde cholangiopancreatography) is a procedure that uses an endoscope and fluoroscopy to diagnose and treat problems that occur in the common bile duct and pancreatic duct. To observe the ducts via endoscopy and fluoroscopy, access through the ampulla of Vater is required, and the proper positioning of the papilla is crucial for improving the success of intubation. It is desirable to limit or even prevent multiple intubations of the pancreatic duct because multiple intubations of the pancreatic duct can lead to pancreatitis. In some cases, the anatomical features, inflammation, and adenomas of the papilla or periduodenal diverticulum also further complicate the attempt to successfully intubate the common bile duct without stimulating the pancreatic duct.

[0052] Figure 1 is a schematic view of a general anatomical structure 10. As shown, the anatomical structure 10 includes a portion of the duodenum 12. The common bile duct (CBD) 14 and the pancreatic duct (PD) 16 join the duodenum 12 at the ampulla of Vater 18. As shown, one or more gallstones 20 are disposed within the CBD 14. To access the CBD 14 in order to remove or fragment one or more gallstones 20, ERCP (endoscopic retrograde cholangiopancreatography) can be performed. Performing ERCP includes accessing the CBD 14 through the ampulla of Vater 18. As Figure 1As can be seen, this may mean passing through a large angle relative to the position within the duodenum 12. Partly due to this large angle, it is difficult to access the CBD 14 rather than the PD 16. As previously mentioned, repeated intubation of the PD 16 can lead to potential complications.

[0053] The endoscope 22 is shown positioned within the duodenum 12. The guide wire 24 is shown exiting the endoscope 22, passing through the ampulla of Vater 18 and into the CBD 14. Figures 2 to 2 0 provides an example of an intubation device that can be advanced through the endoscope 22 and used to help properly guide the guide wire 24 into the CBD 14 without repeated intubation of the PD 16, as well as an example of the intubation device in use.

[0054] Figure 2 is a schematic diagram of an illustrative intubation device 26. The illustrative intubation device 26 includes an elongate shaft 28 extending from a proximal portion 30 of the intubation device 26 to a distal portion 32 of the intubation device 26. In some cases, the intubation device 26 includes a first guide wire lumen 34 that extends through the elongate shaft 28 and terminates at a first angled guide wire port 36. A second guide wire lumen 38 extends through the elongate shaft 28 and terminates at a second angled guide wire port 40. The intubation device 26 includes a non-invasive distal tip 42. In some cases, the first angled guide wire port 36 can be considered angled because, for example, the first guide wire port 36 is neither parallel to the first guide wire lumen 34 nor at a right angle relative to the first guide wire lumen 34. The second angled guide wire port 40 can be considered angled because the second guide wire port 40 is neither parallel to the second guide wire lumen 38 nor at a right angle to the second guide wire lumen 38. In some cases, the relative angle of the first angled guide wire port 36 and the second angled guide wire port 40 can be determined at least in part by the extension angle of the conical outer surface 44.

[0055] In some cases, both the first angled guide wire port 36 and the second angled guide wire port 40 are disposed within the non-invasive distal tip 42. The non-invasive distal tip 42 can be considered to have a conical outer surface 44, where the first angled guide wire port 36 is disposed on a first portion of the conical outer surface 44, and the second angled guide wire port 40 is disposed on a second portion of the conical outer surface 44 that is circumferentially spaced from the first portion of the conical outer surface 44. In some cases, at least a portion of the non-invasive distal tip 42 can be considered to have a frustoconical shape or even a conical shape.

[0056] The first guide wire 46 shown extends through the first guide wire lumen 34 and out of the first angled guide wire port 36, and the second guide wire 48 shown extends through the second guide wire lumen 38 and out of the second angled guide wire port 40. As can be seen, the first guide wire 46 extends out of the cannulation device 26 in a first direction indicated by arrow 50, while the second guide wire 48 extends out of the cannulation device 26 in a second direction indicated by arrow 52. It should be understood that depending on the particular orientation of the cannulation device 26 within the duodenum 12, one of the first angled guide wire port 36 and the second angled guide wire port 40 may be more closely aligned with the CBD 14, while the other of the first angled guide wire port 36 and the second angled guide wire port 40 may be more closely aligned with the PD 16.

[0057] In use, a physician or other professional will advance a guide wire through one of the guide wire lumens 34 and 38. As an example, let's assume that the physician or other professional advances the first guide wire 46 through the first guide wire lumen 34 and out of the first angled guide wire port 36. When observed under fluoroscopy, the physician or other professional will be able to see whether the first guide wire 46 has cannulated the CBD 14 or the PD 16. If they see that the first guide wire 46 has successfully cannulated the CBD 14, the second guide wire 48 will not be used, and the physician or other professional can then proceed with the ERCP procedure.

[0058] However, if the physician or other professional determines that the first guide wire 46 has cannulated the PD 16, they will leave the first guide wire 46 in place temporarily while they advance the second guide wire 48 through the second guide wire lumen 38 and out of the second angled guide wire port 40. Since the first guide wire 46 is positioned within the PD 16, this means that the second angled guide wire port 40 can be more closely aligned with the CBD 14. Moreover, having the first guide wire 46 positioned within the PD 16 means that it will be much more difficult to accidentally advance the second guide wire 48 into the PD 16 with the first guide wire 46 already present. Thus, advancing the second guide wire 48 through the second guide wire lumen 38 and out of the second angled guide wire port 40 should allow for successful cannulation of the CBD 14. Once the CBD 14 has been successfully cannulated, the first guide wire 48 can be withdrawn proximally from the PD 16, and the physician or other professional can then proceed with the ERCP procedure. In some cases, the cannulation device 26 can be formed from any of a variety of polymers, such as but not limited to nylon, HDPE (high density polyethylene), PEBAX, Arnitel, Vestamidx, Grilamid, or a combination of polymers. In some cases, the cannulation device 26 can be a cutting wire or an electrocautery wire 54. The composition of the wire can include, for example, SS316LVM, nitinol, platinum, or titanium.

[0059] Figure 3FIG. 56 is a perspective view of an illustrative cannulation device 56 that can be considered an example of the cannulation device 26. Figure 4 FIG. 57 is a first end view of the cannulation device 56, showing its proximal end; Figure 5 FIG. 58 is a second end view of the cannulation device 56, showing its distal end. The cannulation device 56 includes an elongate shaft 58 that extends to a non-invasive tip 60. The elongate shaft 58 includes a first guidewire lumen 62 and a second guidewire lumen 64. The first guidewire lumen 62 terminates at a first angled guidewire port 66, and the second guidewire lumen 64 terminates at a second angled guidewire port 68. In some cases, the first guidewire lumen 62 and the second guidewire lumen 64 can be considered parallel to each other as they extend through the elongate shaft 58, and the first guidewire lumen 62 and the second guidewire lumen 64 can be radially offset from each other within the non-invasive tip 60. In some cases, the non-invasive tip 60 can be considered to be disposed at the distal end of the cannulation device 56, from which the elongate shaft 58 extends proximally. In some cases, the cannulation device 56 can be formed from any of a variety of polymers, such as but not limited to nylon, HDPE (high density polyethylene), PEBAX, Arnitel, Vestamidx, Grilamid, or a combination of polymers. The composition of the wire can include, for example, SS316LVM, nitinol, platinum, or titanium.

[0060] In some cases, instead of being configured to accommodate guidewires extending through two different guidewire lumens, the cannulation device can alternatively employ an inflatable balloon to increase the likelihood that a single guidewire advanced through the cannulation device will successfully cannulate the CBD 14 rather than the PD 16. Figures 6 to 13 An example of a cannulation device employing an inflatable balloon is provided.

[0061] Figure 6 FIG. 70 is a schematic view of an illustrative cannulation device 70 shown positioned within the ampulla of Vater 18. The cannulation device 70 includes an inflatable balloon 72 (shown in an inflated configuration) that is positioned to close off the access to the PD 16. As a result, a guidewire 74 exiting the non-invasive tip 76 can easily cannulate the CBD 14. Avoiding cannulation of the PD 16, particularly multiple cannulations of the PD 16 when attempting to cannulate the CBD 14, provides improved results. In some cases, the cannulation device 70 can be formed from any of a variety of polymers, such as but not limited to nylon, HDPE (high density polyethylene), PEBAX, Arnitel, Vestamidx, Grilamid, or a combination of polymers. The composition of the wire can include, for example, SS316LVM, nitinol, platinum, or titanium.

[0062] Figure 7FIG. 0 is a schematic illustration of an illustrative cannulation device 78 shown positioned within the ampulla of Vater 18. The cannulation device 78 includes an inflatable balloon 80 (shown in its inflated configuration) that is positioned to occlude access to the PD 16. The inflatable balloon 80 is not adapted to extend within the PD 16 (as was the case with the inflatable balloon 72), but rather serves only to block access to the PD 16. As a result, a guidewire 74 exiting the cannulation device 78 can readily cannulate the CBD 14. Avoiding cannulation of the PD 16, particularly multiple cannulations of the PD 16 when attempting to cannulate the CBD 14, provides improved results. In some instances, the cannulation device 78 can be formed from any of a variety of polymers such as, but not limited to, nylon, HDPE (high density polyethylene), PEBAX, Arnitel, Vestamidx, Grilamid, or combinations of polymers. The inflatable balloon 80 can be formed from any medical grade elastomer such as, but not limited to, silicone or a thermoplastic elastomer. The composition of the wire can include, for example, SS316LVM, nitinol, platinum, or titanium.

[0063] Figure 8 FIG. 4 is a schematic illustration of an illustrative cannulation device 82 having an inflatable balloon shown in its deflated configuration, and Figure 9 FIG. 6 is a schematic illustration of an illustrative cannulation device 82 having an inflatable balloon shown in its inflated configuration. The cannulation device 82 includes an elongate shaft 84 that extends distally to a non-invasive distal tip 86. A guidewire lumen 88 extends through the elongate shaft 84 and through the non-invasive distal tip. In some instances, as Figure 9 shown, a guidewire 90 can extend through the guidewire lumen 88. The cannulation device 82 includes an inflatable balloon 92 and an inflation lumen 94 that extends through the elongate shaft 84 and is in fluid communication with the interior of the inflatable balloon 92.

[0064] In use, a physician or other professional positions the cannulation device 82 in the appropriate location and advances a guidewire 90 through the guidewire lumen 88. When viewed under fluoroscopy, the physician or other professional will be able to see whether the guidewire 90 has cannulated the CBD 14 or the PD 16. If they see that the guidewire 90 has successfully cannulated the CBD 14, the physician or other professional can then proceed with the ERCP procedure.

[0065] However, if a physician or other professional determines that they have instead cannulated the PD 16, they will withdraw the guide wire 90 and inflate the inflatable balloon 82. Since the inflatable balloon 82 (when inflated) blocks the access to the PD 16, the physician or other professional can then advance the guide wire 90 again, which will successfully cannulate the CBD 14. In some cases, the physician or other professional can instead start the procedure by inflating the inflatable balloon 92 to block the access to the PD 16 and thus protect the PD 16 from being cannulated. In some cases, the cannulation device 82 can be formed from any of a variety of polymers, such as but not limited to nylon, polyurethane, HDPE (high density polyethylene), PEBAX, Arnitel, Vestamidx, Grilamid, or a combination of polymers. The inflatable balloon 82 can be formed from any medical grade elastomer, such as but not limited to silicone or a thermoplastic elastomer.

[0066] Figure 10 is a side view of an illustrative cannulation device 96 that can be considered an example of the cannulation device 82. The illustrative cannulation device 96 includes an elongate shaft 98 that extends to a non-invasive distal tip 100. The non-invasive distal tip 100 includes an inflatable balloon 102. Figure 10 shows the inflatable balloon 102 in a deflated configuration. Also a side view of the cannulation device 96 Figure 11 shows the inflatable balloon 102 in an inflated configuration. It should be understood that when inflated, the inflatable balloon 102 helps to occlude the access to the PD 16. The inflatable balloon 102 also helps to deflect the guide wire port 104 away from the PD 16 and towards the CBD 14 when the cannulation device 96 is properly positioned, particularly when inflated.

[0067] Figure 12 is a schematic view of the cannulation device 96 positioned within the ampulla of Vater 18. As shown, the cannulation device 96 also includes an elongate member 106 that extends proximally from the elongate shaft 98. In some cases, for example, the elongate member 106 can be considered an extension of the elongate shaft 98. The elongate member 106 can be integrally formed with the elongate shaft 98. Figure 13 shows the cannulation device 96 positioned within the ampulla of Vater 18 but with the inflatable balloon 102 inflated. As a result, the PD 16 is occluded and a guide wire 108 extending through the cannulation device 96 can successfully reach the CBD 14. In some cases, the cannulation device 96 can be formed from any of a variety of polymers, such as but not limited to nylon, polyurethane, HDPE (high density polyethylene), PEBAX, Arnitel, Vestamidx, Grilamid, or a combination of polymers.

[0068] In some cases, the cannulation device can use an expandable element, such as, but not limited to, an everted soft robot, to increase the likelihood that a single guide wire advanced through the cannulation device will successfully cannulate the CBD 14 rather than the PD 16. Figures 14 to 19 An example of a cannulation device utilizing an expandable element is provided.

[0069] Figure 14 and Figure 15 is a schematic view of an illustrative cannulation device 110. The illustrative cannulation device 110 includes an elongate shaft 112 extending to a non-invasive distal tip 114. The cannulation device 110 includes a lumen 116 that extends through the elongate shaft 112 and the non-invasive distal tip 114. The lumen 116 is adapted to receive a guide wire (not shown). The lumen 116 is also adapted to receive an expandable element 118 positioned within the lumen 116. In some cases, the expandable element 118 itself is adapted to receive a guide wire extending through the expandable element 118.

[0070] In some cases, the expandable element 118 can be fixed relative to the lumen 116 at point 120. The expandable element 118 can move between a collapsed configuration (as shown, for example, in Figure 14 and an extended configuration (partially shown in Figure 15 ). In the collapsed configuration, the expandable element 118 extends proximally within the lumen 116 from the attachment point 120. To move the expandable element 118 from its collapsed configuration to its extended configuration, fluid can be advanced through the actuation lumen 122, causing the expandable element 118 to begin to evert and thus extend itself. Figure 16 An illustration of the cannulation device 110 with the expandable element 118 in its extended configuration is shown. As shown, the expandable element 118 defines a lumen 124 that extends through the expandable element 118. The lumen 124 is adapted to receive a guide wire 126. In some cases, the cannulation device 110 can be formed from any of a variety of polymers, such as, but not limited to, nylon, polyurethane, HDPE (high density polyethylene), PEBAX, Arnitel, Vestamidx, Grilamid, or a combination of polymers. The expandable element 118 can be formed from any medical grade elastomer, such as, but not limited to, silicone or a thermoplastic elastomer, nylon, Pebax, Grilamid, or a combination of suitable polymers.

[0071] Figure 17 is a perspective view of an illustrative cannulation device 128 that can be considered an example of the cannulation device 110. The cannulation device 128 includes an elongate shaft 130 extending distally to a non-invasive distal tip 132. A lumen 134 extends through the elongate shaft 130 and the non-invasive distal tip 132 and is adapted to receive a guide wire (not shown in Figure 17both a non - shown (not shown) and an expandable element 136 disposed within the lumen 134 (when in its collapsed configuration).

[0072] Figure 18 and Figure 19 is a schematic view of an intubation device 128 positioned within the ampulla of Vater 18. In Figure 18 , the expandable element 136 is shown in its collapsed configuration. In Figure 19 , the expandable element 136 is shown in its extended configuration. In use, a physician or other professional moves the intubation device 128 into a proper position (as shown, for example, in Figure 18 ), and advances a guide wire 138 through the lumen 134. When observed under fluoroscopy, the physician or other professional will be able to see whether the guide wire 138 has intubated the CBD 14 or the PD 16. If they see that the guide wire 138 has successfully intubated the CBD 14, the physician or other professional can then proceed with the ERCP procedure.

[0073] However, if the physician or other professional determines that they have instead intubated the PD 16, they will withdraw the guide wire 138 and expand the expandable element 136 to its extended configuration, in which the expandable element 136 extends into the CBD 14 (as shown in Figure 19 ), such as by adding inflation fluid. Then, they will extend the guide wire 138 through the intubation device 128 and through the expandable element 136. Since the expandable element 136 now includes an extension portion 140 that extends directly into the CBD 14, the guide wire 138 cannot miss the CBD 14 and accidentally intubate the PD 16. In some cases, the intubation device 128 can be formed of any of a variety of polymers, such as but not limited to nylon, polyurethane, HDPE (high - density polyethylene), PEBAX, Arnitel, Vestamidx, Grilamid, or a combination of polymers. The expandable element 136 can be formed of any medical - grade elastomer, such as but not limited to silicone or a thermoplastic elastomer, nylon, Pebax, Grilamid, or a combination of suitable polymers.

[0074] The materials for the various components of the intubation device can include those commonly associated with medical devices. The various components of the intubation device described herein can be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal - polymer composites, combinations thereof, etc., or any other suitable material. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels; low - carbon steel; nitinol alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel - chromium - molybdenum alloys (e.g., UNS:N06625, such as 625, UNS: N06022, such as UNS: N10276, such as others nickel - copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel - cobalt - chromium - molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel - molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), 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, etc.; cobalt - chromium alloys; cobalt - chromium - molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum - rich stainless steels; titanium; combinations thereof; etc.; or any other suitable materials.

[0075] As mentioned above, within the commercially available family of nickel - titanium or nitinol alloys, there is a class designated as "linear elastic" or "non - superelastic" which, although chemically may be similar to traditional shape - memory and superelastic varieties, can exhibit different and useful mechanical properties. Linear elastic and / or non - superelastic nitinol can be distinguished from superelastic nitinol because linear elastic and / or non - superelastic nitinol does not show a significant "superelastic plateau" or "flag region" in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non - superelastic nitinol, as the recoverable strain increases, the stress continues to increase in a substantially linear or somewhat but not necessarily completely linear relationship until plastic deformation begins or at least in a more linear relationship than the superelastic plateau and / or flag region that might be seen in superelastic nitinol. Thus, for the purposes of this invention, linear elastic and / or non - superelastic nitinol can also be referred to as "substantially" linear elastic and / or non - superelastic nitinol.

[0076] In some cases, linear elastic and / or non - superelastic nitinol can also be distinguished from superelastic nitinol because linear elastic and / or non - superelastic nitinol can accept strains up to about 2 - 5% while remaining substantially elastic (e.g., before plastic deformation), while superelastic nitinol can accept strains up to about 8% before plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel (which can also be distinguished based on its composition), which can accept only about 0.2 to 0.44% strain before plastic deformation.

[0077] In some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys are alloys that do not exhibit any martensite / austenite phase transitions detectable by DSC and DMTA analyses over a large temperature range. For example, in some embodiments, in linear elastic and / or non-superelastic nickel-titanium alloys, there may be no martensite / austenite phase transitions detectable by DSC and DMTA analyses in the range of about -60 °C to about 120 °C. Thus, the mechanical bending properties of such materials are generally inert to temperature effects over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nickel-titanium alloys at ambient temperature or room temperature are substantially the same as the mechanical properties at, for example, body temperature because they do not exhibit a superelastic plateau and / or a flag region. In other words, over a wide temperature range, linear elastic and / or non-superelastic nickel-titanium alloys maintain their linear elastic and / or non-superelastic characteristics and / or properties and have substantially no yield point.

[0078] In some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys can be in the range of about 50 to about 60 weight percent nickel, the balance being primarily titanium. In some embodiments, the composition contains nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa TechnoMaterial Co., Kanagawa, Japan. Some examples of nickel-titanium alloys are disclosed in U.S. Patent Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (available from Toyota). In some other embodiments, superelastic alloys, such as superelastic nitinol, can be used to achieve the desired properties.

[0079] In at least some embodiments, the various components of the cannula devices described herein include radiopaque materials, including those listed herein or other suitable radiopaque materials.

[0080] In some embodiments, a degree of MRI compatibility is imparted to the cannula devices described herein. For example, to enhance compatibility with a magnetic resonance imaging (MRI) machine, the various components of the cannula devices described herein may need to be fabricated in a manner that will impart a degree of MRI compatibility. For example, the various components or portions thereof of the cannula devices described herein may be made of materials that substantially do not distort the image and create a large number of artifacts (artifacts are gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in the MRI image. The various components or portions thereof of the cannula devices described herein may also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloy (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloy (e.g., UNS: R30035, such as etc.), nitinol, etc.

[0081] Some examples of suitable polymers that can be used to form the various components of the cannula devices described herein may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., commercially available from DuPont as ), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., commercially available from DSM Engineering Plastics as ), ether- or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers, such as commercially available from DuPont as ), polyamide (e.g., commercially available from Bayer as or commercially available from Elf Atochem as ), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name ), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ) Polysulfone, nylon, nylon - 12 (such as those commercially available from EMS American Grilon), ) perfluoro(propyl vinyl ether) (PFA), ethylene - vinyl alcohol, polyolefin, polystyrene, epoxy resin, polyvinylidene chloride (PVdC), poly(styrene - b - isobutylene - b - styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath can be mixed with liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0082] In some embodiments, the outer surface of the cannula device described herein can include a coating, such as a lubricious, hydrophilic, protective, or other type of coating. Hydrophobic coatings, such as fluoropolymers, provide dry lubricity, which improves the handling and exchange of the device. Lubricious coatings improve steerability and enhance lesion crossing ability. Suitable lubricious polymers can include silicone, polymers such as high - density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, algae, sugars, caprolactone, etc., and mixtures and combinations thereof. Hydrophilic polymers can be mixed with each other or with a formulation amount of water - insoluble compounds (including some polymers) to produce a coating with appropriate lubricity, adhesiveness, and solubility. Some other examples of such coatings and the materials and methods for creating such coatings can be found in U.S. Patent Nos. 6,139,510 and 5,772,609, the entire disclosures of which are incorporated herein by reference.

[0083] It should be understood that the invention is illustrative in many respects. Changes can be made in details, particularly in matters of the shape, size, and arrangement of steps, without exceeding the scope of the invention. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. An intubation device, the intubation device being adapted to be advanced through an endoscope to a position proximal to the duodenum of a patient so as to enter the common bile duct of the patient, the intubation device comprising: a slender shaft extending to a non-invasive distal tip; a first guide wire lumen extending through the slender shaft, the first guide wire lumen terminating at a first angled guide wire port; and a second guide wire lumen extending through the slender shaft, the second guide wire lumen terminating at a second angled guide wire port.

2. The intubation device according to claim 1, wherein the first angled guide wire port is adapted to guide a guide wire to extend through the first guide wire lumen relative to the non-invasive tip in a first direction.

3. The intubation device according to claim 2, wherein the second angled guide wire port is adapted to guide a guide wire to extend through the second guide wire lumen relative to the non-invasive tip in a second direction different from the first direction.

4. The intubation device according to any one of claims 1 to 3, wherein the non-invasive distal tip comprises a tapered outer surface, wherein the first angled guide wire port is provided on a first portion of the tapered outer surface, and the second angled guide wire port is provided on a second portion of the tapered outer surface circumferentially spaced from the first portion of the tapered outer surface.

5. The intubation device according to any one of claims 1 to 4, wherein the first guide wire lumen is parallel to the second guide wire lumen within the proximal portion of the intubation device.

6. The intubation device according to claim 5, wherein the first guide wire lumen radially deviates from the second guide wire lumen within the distal portion of the intubation device.

7. The intubation device according to any one of claims 1 to 6, further comprising a cutting wire extending through the slender shaft.

8. An intubation device, the intubation device being adapted to be advanced through an endoscope to a position proximal to the duodenum of a patient so as to enter the common bile duct of the patient, the intubation device comprising: a slender shaft extending to a non-invasive distal tip; a guide wire lumen extending through the slender shaft, the guide wire lumen terminating at a guide wire port provided within the non-invasive distal tip; an inflatable balloon disposed relative to the non-invasive distal tip, the inflatable balloon being capable of inflating from a collapsed configuration to an expanded configuration, in which the inflatable balloon is adapted to occlude the pancreatic duct of the patient; and an inflation lumen extending through the slender shaft and in fluid communication with the inflatable balloon.

9. The intubation device according to claim 8, wherein the inflatable balloon is further adapted to, when inflated, push the non-invasive distal tip away from the pancreatic duct of the patient and towards the common bile duct of the patient, thereby assisting in aligning the guide wire port with the common bile duct.

10. The intubation device according to any one of claims 8 or 9, wherein the inflatable balloon is disposed along one side of the non-invasive distal tip.

11. The intubation device according to any one of claims 8 or 10, wherein the inflatable balloon forms part of the non-invasive distal tip when in its collapsed configuration.

12. An intubation device, the intubation device being adapted to be advanced through an endoscope to a position adjacent to the duodenum of a patient so as to access the common bile duct of the patient, the intubation device comprising: a slender shaft extending to a non-invasive distal tip; a guide wire lumen extending through the slender shaft, the guide wire lumen terminating at a guide wire port disposed within the non-invasive distal tip; and an expandable element disposed within the guide wire lumen, the expandable element being capable of expanding from a collapsed configuration to an extended configuration, in the collapsed configuration, the expandable element is disposed within the guide wire lumen, and in the extended configuration, a portion of the expandable element extends distally from the guide wire port, the expandable element being adapted to permit a guide wire to extend through the interior of the expandable element.

13. The intubation device according to claim 12, wherein the expandable element is adapted to occlude the pancreatic duct of the patient.

14. The intubation device according to any one of claims 12 or 13, wherein the intubation device is adapted to access the common bile duct of the patient from a position proximal to the ampulla of Vater of the patient.

15. The intubation device according to any one of claims 12 to 14, wherein an end of the expandable element is fixed relative to the distal end of the intubation device.

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