Patent Description:
A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular 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.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. A sphincterotome is disclosed. The sphincterotome comprises: an elongate shaft having an outer surface and a distal end region; a sphincterotome wire assembly having a distal end coupled to the distal end region of the elongate shaft and a body portion extending along the outer surface of the elongate shaft; wherein the sphincterotome wire assembly is designed to shift the distal end region of the elongate shaft between a first configuration and a curved configuration; and wherein the body portion of the sphincterotome wire assembly includes a cutting region and a non-conductive region.

The cutting region of the sphincterotome wire assembly is defined by a conductive cutting wire.

The non-conductive region of the sphincterotome wire assembly includes a non-conductive wire coupled to the conductive cutting wire.

The non-conductive wire is coupled to the conductive cutting wire by a housing.

Alternatively or additionally to any of the embodiments above, the elongate shaft includes a distal anchor, wherein the distal end of the sphincterotome wire assembly is coupled to the distal end region of the elongate shaft at the distal anchor, and wherein the sphincterotome wire assembly includes a proximal region that extends through a port formed along the elongate shaft and into a lumen formed in the elongate shaft.

Alternatively or additionally to any of the embodiments above, the elongate shaft includes a proximal anchor, wherein the conductive cutting wire has a proximal end region coupled to the distal end region of the elongate shaft at the proximal anchor, and wherein the proximal anchor is disposed between the distal anchor and the port.

Alternatively or additionally to any of the embodiments above, the elongate shaft includes a distal port, and wherein the conductive cutting wire extends through the distal port and extends proximally within a lumen formed in the elongate shaft.

Alternatively or additionally to any of the embodiments above, the conductive cutting wire includes a conductive coating.

Alternatively or additionally to any of the embodiments above, the conductive cutting wire includes a cutting wire and a ground wire.

Alternatively or additionally to any of the embodiments above, the non-conductive region of the body portion of the sphincterotome wire assembly includes an insulating member coupled thereto.

Alternatively or additionally to any of the embodiments above, the elongate shaft includes an insulating projection and wherein the non-conductive region of the body portion of the sphincterotome wire assembly is coupled to the insulating projection.

Alternatively or additionally to any of the embodiments above, the insulating projection includes one or more of a flap, an opening, and a groove formed therein.

A sphincterotome is disclosed. The sphincterotome comprises: an elongate shaft having an outer surface, a distal end region, and a distal anchor disposed along the distal end region; a cutting wire coupled to the distal anchor and having a cutting region extending along the outer surface of the elongate shaft; a non-conductive cord coupled to the cutting region of the cutting wire and extending proximally therefrom; wherein the cutting wire, the non-conductive cord, or both are designed to shift the distal end region of the elongate shaft between a first configuration and a curved configuration.

Alternatively or additionally to any of the embodiments above, the non-conductive cord extends through a port formed in the elongate shaft and into a lumen formed in the elongate shaft.

Alternatively or additionally to any of the embodiments above, the cutting wire is coupled to the elongate shaft at a medial anchor, the medial anchor being disposed between the distal anchor and the port.

Alternatively or additionally to any of the embodiments above, the non-conductive cord is coupled to the cutting region of the cutting wire at a non-conductive housing.

Alternatively or additionally to any of the embodiments above, further comprising a ground wire coupled to the cutting wire.

A sphincterotome is disclosed. The sphincterotome comprises: an elongate shaft having a distal anchor, a projection formed in the elongate shaft and disposed proximally of the distal anchor; a cutting wire having a distal end coupled to the distal anchor and a proximal region coupled to the projection; wherein the cutting wire is designed to shift the elongate shaft between a first configuration and a curved configuration; and wherein when the elongate shaft is in the curved configuration, at least a portion of the projection is radially spaced from an outer surface of the elongate shaft.

Alternatively or additionally to any of the embodiments above, the projection includes an insulating material.

Alternatively or additionally to any of the embodiments above, the projection has a channel formed therein.

On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims.

Endoscopic retrograde cholangiopancreatography (ERCP) may be utilized to diagnose and treat various disorders of the pancreaticobiliary system. A clinician may use a sphincterotome to cannulate the papillary orifice. The sphincterotome may have a number of features including a cutting wire for performing a sphincterotomy. When performing sphincterotomy, the distal portion of the cutting wire may be used for cutting tissue. The proximal portion of the wire, in general, may not serve a cutting function. Additionally, while performing sphincterotomy, the folds of the duodenal wall may come in contact with the proximal portion of the cutting wire, which could result in an ancillary tissue burn. Disclosed herein are sphincterotomes where the proximal portion of the cutting wire is designed to be non-conductive, insulated, and/or otherwise non-cutting.

<FIG> illustrates an example sphincterotome <NUM>. The sphincterotome <NUM> may include an elongate shaft <NUM> having a proximal end region <NUM> and a distal end region <NUM>. The sphincterotome <NUM> may include a sphincterotome wire assembly <NUM>. The sphincterotome wire assembly <NUM> may be designed to shift the distal end region <NUM> of the elongate shaft <NUM> between a first configuration (e.g., as depicted in <FIG>) and a curved or bowed configuration (e.g., as depicted in <FIG>). For example, exerting a proximal force on one or more of the components of the sphincterotome wire assembly <NUM> may cause the elongate shaft <NUM> to shift between configurations.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration (e.g., as depicted in <FIG>).

The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> may be coupled to the second member <NUM> at a joint <NUM>. In this example, the first member <NUM> may take the form of a wire having a cutting region 20a and a proximally-extending region 20b. A distal end region of the first member <NUM> may be anchored to the distal end region <NUM> of the shaft <NUM> (e.g., using, for example, a metallic anchor). A portion of the cutting region 20a of the first member <NUM> may be secured to or otherwise extend through a loop or opening defined at the joint <NUM> and then the first member <NUM> may extend generally toward the outer surface of the shaft <NUM>. In some instances, the first member <NUM> may extend through a first port <NUM> formed in the shaft <NUM> and into a lumen of the shaft <NUM> (e.g., the second lumen <NUM> as shown, for example, in <FIG>). The second member <NUM> may take the form of a wire or non-conductive cord (e.g., formed form a non-conductive material such as aramid) having a non-conductive region 22a and a proximally-extending region 22b. In some instances, a distal end region of the second member <NUM> may be secured to the joint <NUM>. The second member <NUM> may extend through a second port <NUM> formed in the shaft <NUM> and into a lumen of the shaft <NUM> (e.g., the first lumen <NUM> as shown, for example, in <FIG>). In at least some instances, the first port <NUM> may be disposed along the shaft <NUM> at a position between the location where the distal end region of the first member <NUM> is anchored to the shaft <NUM> and the second port <NUM>. In other words, the first port <NUM> may be disposed between the distal anchor and the second port <NUM>.

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 20a of the first member <NUM> and the non-conductive region 22a of the second member <NUM>. In at least some instances, the first member <NUM> is a conductive wire (e.g., an RF conductive wire) that can be energized. When doing so, the cutting region 20a may be energized so as to facilitate cutting. In contrast, the second member <NUM> may be non-conductive. Accordingly, the non-conductive region 22a may generally be described as being non-energized, non-cutting, and/or otherwise designed so as to not facilitate cutting.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, a third lumen <NUM>, and a fourth lumen <NUM>. In this example, the proximally-extending region 22b of the second member <NUM> may extend through the first lumen <NUM>. The proximally-extending region 20b of the first member <NUM> may extend through the second lumen <NUM>. The third lumen <NUM> may be used for infusing a fluid such as a contrast media. The fourth lumen <NUM> may be a guidewire lumen.

<FIG> illustrates a sphincterotome <NUM> according to the invention, that may be similar in form and function to other sphincterotomes disclosed herein. The sphincterotome <NUM> includes a shaft <NUM> having a distal end region <NUM>. The sphincterotome <NUM> includes a sphincterotome wire assembly <NUM>. The sphincterotome wire assembly <NUM> is designed to shift the distal end region <NUM> of the elongate shaft <NUM> between a first configuration and a curved or bowed configuration.

The sphincterotome wire assembly <NUM> includes a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> includes a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> is coupled to the second member <NUM> at a joint <NUM>. In the invention, the joint <NUM> takes the form of a non-conductive housing designed to be secured to both the first member <NUM> and the second member <NUM>. This may include a mechanical or other type of connection. The first member <NUM> may take the form of a wire having a cutting region 120a and a proximally-extending region 120b. A distal end region of the first member <NUM> may extend through a first port <NUM> formed in the shaft <NUM> and into a lumen of the shaft <NUM> (e.g., the second lumen <NUM> as shown, for example, in <FIG>). The second member <NUM> may take the form of a wire or non-conductive cord having a non-conductive region 122a and a proximally-extending region 122b. The second member <NUM> may extend through a second port <NUM> formed in the shaft <NUM> and into a lumen of the shaft <NUM> (e.g., the first lumen <NUM> as shown, for example, in <FIG>).

The body portion B of the sphincterotome wire assembly <NUM> includes the cutting region 120a of the first member <NUM> and the non-conductive region 122a of the second member <NUM>. In at least some instances, the first member <NUM> is a conductive wire (e.g., an RF conductive wire) that can be energized. When doing so, the cutting region 120a may be energized so as to facilitate cutting. In contrast, the second member <NUM> is non-conductive. Accordingly, the non-conductive region 122a may generally be described as being non-energized, non-cutting, and/or otherwise designed so as to not facilitate cutting.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, a third lumen <NUM>, and a fourth lumen <NUM>. In this example, the proximally-extending region 122b of the second member <NUM> may extend through the first lumen <NUM>. The proximally-extending region 120b of the first member <NUM> may extend through the second lumen <NUM>. The third lumen <NUM> may be used for infusing a fluid such as a contrast media. The fourth lumen <NUM> may be a guidewire lumen.

<FIG> illustrates another example sphincterotome <NUM> that may be similar in form and function to other sphincterotomes disclosed herein. The sphincterotome <NUM> includes a shaft <NUM> having a distal end region <NUM>. The sphincterotome <NUM> may include a sphincterotome wire assembly <NUM>. The sphincterotome wire assembly <NUM> may be designed to shift the distal end region <NUM> of the elongate shaft <NUM> between a first configuration and a curved or bowed configuration.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> may be coupled to the second member <NUM> at a joint <NUM>. The first member <NUM> may take the form of a wire having a cutting region 220a and a proximally-extending region 220b. A distal end region of the first member <NUM> may extend through a first port <NUM> formed in the shaft <NUM> and into a lumen of the shaft <NUM> (e.g., the second lumen <NUM> as shown, for example, in <FIG>). The second member <NUM> may take the form of a wire or non-conductive cord having a non-conductive region 222a and a proximally-extending region 222b. The second member <NUM> may extend through a second port <NUM> formed in the shaft <NUM> and into a lumen of the shaft <NUM> (e.g., the first lumen <NUM> as shown, for example, in <FIG>).

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 220a of the first member <NUM> and the non-conductive region 222a of the second member <NUM>. In at least some instances, the first member <NUM> is a wire having a conductive member 220c that can be energized. In some instances, the conductive member 220c takes the form of a conductive coating, a conductive paint, a conductive coil (e.g., surrounding the cutting region 220a), and/or the like. The cutting region 220a may be energized so as to facilitate cutting. In contrast, the second member <NUM> may be non-conductive. Accordingly, the non-conductive region 222a may generally be described as being non-energized, non-cutting, and/or otherwise designed so as to not facilitate cutting.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, a third lumen <NUM>, and a fourth lumen <NUM>. In this example, the proximally-extending region 222b of the second member <NUM> may extend through the first lumen <NUM>. The proximally-extending region 220b of the first member <NUM> may extend through the second lumen <NUM>. The third lumen <NUM> may be used for infusing a fluid such as a contrast media. The fourth lumen <NUM> may be a guidewire lumen.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> may take the form of a wire having a cutting region 320a and a proximally-extending region 320b. A distal end region of the first member <NUM> may be anchored to the distal end region <NUM> of the shaft <NUM>. The second member <NUM> may take the form of a protective mesh or sheath designed to cover and/or insulate a portion of the first member <NUM>.

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 320a of the first member <NUM> and at least a portion of the second member <NUM>. The cutting region 320a may be energized so as to facilitate cutting. The second member <NUM> may be non-conductive and insulate a portion of the first member <NUM> in a manner so as to not facilitate cutting.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, and a third lumen <NUM>. In this example, the proximally-extending region 320b of the first member <NUM> may extend through the first lumen <NUM>. The second lumen <NUM> may be used for infusing a fluid such as a contrast media. The third lumen <NUM> may be a guidewire lumen.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> may take the form of a wire having a cutting region 420a and a proximally-extending region 420b. A distal end region of the first member <NUM> may be anchored to the distal end region <NUM> of the shaft <NUM>. The second member <NUM> may take the form of a projection extending from the shaft <NUM>. In general, the projection <NUM> is designed to cover and/or insulate a portion of the first member <NUM>.

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 420a of the first member <NUM> and at least a portion of the second member <NUM>. The cutting region 420a may be energized so as to facilitate cutting. The second member <NUM> may be non-conductive and may cover and/or insulate a portion of the first member <NUM> in a manner so as to not facilitate cutting.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, and a third lumen <NUM>. In this example, the proximally-extending region 420b of the first member <NUM> may extend through the first lumen <NUM>. The second lumen <NUM> may be used for infusing a fluid such as a contrast media. The third lumen <NUM> may be a guidewire lumen.

<FIG> is an alternative cross-sectional view of a portion of the shaft <NUM>. In this example, the projection <NUM>' is formed as a cutout from the shaft <NUM>. Thus, the shaft <NUM> includes a cutout region <NUM>. In some instances, the projection <NUM>' may have a shape that mirrors or resembles the shape of the cutout region <NUM>. In other instances, the projection <NUM>' may be formed as a cutout and then processed to have a generally smaller shape and/or thickness.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> may take the form of a wire having a cutting region 520a and a proximally-extending region 520b. A distal end region of the first member <NUM> may be anchored to the distal end region <NUM> of the shaft <NUM>. The second member <NUM> may take the form of a projection extending from the shaft <NUM>. The projection <NUM> may include an opening 522a through which the first member <NUM> may extend. In general, the projection <NUM> is designed to cover and/or insulate a portion of the first member <NUM>. In some instances, the projection <NUM> may include a slot or groove (not shown) through which the first member <NUM> may extend.

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 520a of the first member <NUM> and at least a portion of the second member <NUM>. The cutting region 520a may be energized so as to facilitate cutting. The second member <NUM> may be non-conductive and may cover and/or insulate a portion of the first member <NUM> in a manner so as to not facilitate cutting.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, and a third lumen <NUM>. In this example, the proximally-extending region 520b of the first member <NUM> may extend through the first lumen <NUM>. The second lumen <NUM> may be used for infusing a fluid such as a contrast media. The third lumen <NUM> may be a guidewire lumen.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> may take the form of a wire having a cutting region 620a and a proximally-extending region 620b. A distal end region of the first member <NUM> may be anchored to the distal end region <NUM> of the shaft <NUM>. The second member <NUM> may take the form of a projection formed by a cutout in the shaft <NUM>. The projection <NUM> may include a groove <NUM> through which the first member <NUM> may extend. The shaft <NUM> may include a notch <NUM> corresponding to where the projection <NUM> is cut out from the shaft <NUM>. In general, the projection <NUM> is designed to insulate a portion of the first member <NUM>.

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 620a of the first member <NUM> and at least a portion of the second member <NUM>. The cutting region 620a may be energized so as to facilitate cutting. The second member <NUM> may be non-conductive and may cover and/or insulate a portion of the first member <NUM> in a manner so as to not facilitate cutting.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, and a third lumen <NUM>. In this example, the proximally-extending region 620b of the first member <NUM> may extend through the first lumen <NUM>. The second lumen <NUM> may be used for infusing a fluid such as a contrast media. The third lumen <NUM> may be a guidewire lumen.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> and the second member <NUM> may be coupled to one another at a joint <NUM>. In this example, the joint <NUM> may take the form of an insulated housing or spacer. The first member <NUM> may take the form of a bipolar wire assembly having a cutting region 720a and a proximally-extending region that includes a first wire region 720b (e.g., a conductive wire) and a second wire region 720c (e.g., a ground wire). In insulating medium 720d may be disposed between the first wire region 720b and the second wire region 720c. The first wire region 720b and the second wire region 720c may extend through ports formed in the shaft <NUM> into lumens of the shaft <NUM> (e.g., a second lumen 726a and a third lumen 726b as shown in <FIG>). The second member <NUM> may take the form of a wire or non-conductive cord having a non-conductive region 722a and a proximally-extending region 722b. The second member <NUM> may extend through a second port <NUM> formed in the shaft <NUM> and into a lumen of the shaft <NUM> (e.g., the first lumen <NUM> as shown, for example, in <FIG>).

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 720a of the first member <NUM> and at least a portion of the second member <NUM>. The cutting region 720a may be energized so as to facilitate cutting. The second member <NUM> may be non-conductive and insulate a portion of the first member <NUM> in a manner so as to not facilitate cutting.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen 726a, a third lumen 726b, a fourth lumen <NUM>, and a fifth lumen <NUM>. In this example, the proximally-extending region 722b of the second member <NUM> may extend through the first lumen <NUM>. The first wire region 720b and the second wire region 720c of the first member <NUM> may extend through the second lumen 726a and the third lumen 726b, respectively. The fourth lumen <NUM> may be used for infusing a fluid such as a contrast media. The fifth lumen <NUM> may be a guidewire lumen.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> and the second member <NUM> may be coupled to one another at a joint <NUM>. In this example, the joint <NUM> may take the form of an insulated housing. The first member <NUM> may take the form of a wire for delivering bipolar energy having a cutting region 820a and a proximally-extending region 820b. The first member <NUM> may extend through a first port <NUM> formed in the shaft <NUM> into a lumen of the shaft <NUM> (e.g., a second lumen <NUM> as shown in <FIG>). The second member <NUM> may take the form of a wire or non-conductive cord having a non-conductive region 822a and a proximally-extending region 822b. The second member <NUM> may extend through a second port <NUM> formed in the shaft <NUM> and into a lumen of the shaft <NUM> (e.g., the first lumen <NUM> as shown, for example, in <FIG>).

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 820a of the first member <NUM> and at least a portion of the second member <NUM>. The cutting region 820a may be energized so as to facilitate cutting. In contrast, the second member <NUM> may be non-conductive. Accordingly, the non-conductive region 822a may generally be described as being non-energized, non-cutting, and/or otherwise designed so as to not facilitate cutting. A ground pad <NUM>, which may serve as the return for the cutting wire portion 820a, may be disposed along the distal end region <NUM> of the shaft <NUM>. A ground wire <NUM> may be coupled to the ground pad <NUM>.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, a third lumen <NUM>, a fourth lumen <NUM>, and a fifth lumen <NUM>. In this example, the proximally-extending region 820b of the first member <NUM> may extend through the second lumen <NUM>. The proximally-extending region 822b of the second member may extend through the first lumen <NUM>. The third lumen <NUM> may be used for infusing a fluid such as a contrast media. The fourth lumen <NUM> may be a guidewire lumen. The ground wire <NUM> may extend through the fifth lumen <NUM>.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or portion <NUM> and a second member or portion <NUM>. The first member <NUM> may take the form of a wire having a cutting region 920a and a proximally-extending region 920b. A distal end region of the first member <NUM> may be anchored to the distal end region <NUM> of the shaft <NUM>.

The second member <NUM> may take the form of an external flap coupled to the shaft <NUM> (e.g., coupled via an adhesive bond, thermal bond, and/or the like). The second member <NUM> may be formed of a suitable material such as a polymer (e.g., polyetheretherketone and/or any suitable disclosed herein). The flap <NUM> may include a body region <NUM> disposed along the outer surface of the shaft <NUM>, a projection region <NUM> extending from the body region <NUM>, and an end region <NUM>. The projection region <NUM> may have a suitable length such as about <NUM>-<NUM>, or about <NUM>-<NUM>, or about <NUM>-<NUM>. In some instances, the projection region <NUM> may include a groove <NUM> (not shown in <FIG>, can be seen in <FIG>) through which the first member <NUM> may extend. In some of these and in other instances, the end region <NUM> may include or otherwise take the form of a loop or opening through which the first member <NUM> may extend.

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 920a of the first member <NUM> and at least a portion of the second member <NUM> (e.g., the projection region <NUM>). The cutting region 920a may be energized so as to facilitate cutting. The second member <NUM> may be non-conductive and may cover and/or insulate a portion of the first member <NUM> in a manner so as to not facilitate cutting. More particularly, the projection region <NUM> (and/or the second member <NUM>) may be designed to insulate a portion of the first member <NUM>.

It can be appreciated that the length of the first member <NUM> that is exposed or otherwise not covered/insulated by the projection region <NUM> can vary depending on the extent to which the shaft <NUM> is curved. For example, a clinician may be able to curve the shaft <NUM> to a relative small extent. When doing so, only a relatively small proportion of the length of the first member <NUM> may be covered/insulated by the projection region <NUM>. Further curving the shaft <NUM> may shorten the overall length of the first member <NUM> along the body region B and increase the proportion of the length of the first member <NUM> that is covered/insulated by the projection region <NUM>. This allows a clinician to vary the length of the first member <NUM> available for cutting, which may be desirable in order to tailor the sphincterotome <NUM> for a number of different interventions.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, and a third lumen <NUM>. In this example, the proximally-extending region 920b of the first member <NUM> may extend through the first lumen <NUM>. The second lumen <NUM> may be used for infusing a fluid such as a contrast media. The third lumen <NUM> may be a guidewire lumen.

The sphincterotome wire assembly <NUM> may include a body portion B generally defined as the portion of the sphincterotome wire assembly <NUM> extending along the outer surface of the elongate shaft <NUM> and that may be described as extending diagonally akin to the string of a bow when the elongate shaft <NUM> is in the curved configuration. The sphincterotome wire assembly <NUM> may include a first member or wire <NUM> having a cutting region 1020a and a proximally-extending region 1020b. A distal end region of the wire <NUM> may be anchored to the distal end region <NUM> of the shaft <NUM>. A plurality of different coatings may be disposed along the wire <NUM>. For example, a first coating 1035a may be disposed along a first portion (e.g., a more distal portion) of the wire <NUM> and a second or coating 1035b may be disposed along a second portion (e.g., a more proximal portion) of the wire <NUM>. The first coating 1035a, the second coating 1035b, or both may be disposed along the wire <NUM> using a suitable process. Some example processes that may be suitable include electroplating, sputter coating, dip coating, spray coating, other coating processes, and/or the like.

In some instances, the first coating 1035a may be a conductive coating. For example, the first coating 1035a may have a relatively high conductivity (e.g., on the order of about <NUM> x <NUM><NUM> Siemens/m or greater) and a relatively low resistivity (e.g., on the order of about <NUM> x <NUM>-<NUM> Ohms/m or less). In some instances, the first coating 1035a may include a metallic coating such as a gold coating. Other coatings are contemplated.

In some instances, the second coating 1035b may be a non-conductive or insulating coating that, in general, is designed to insulate a second portion of the wire <NUM>. For example, the second coating 1035b may have a relatively low conductivity (e.g., on the order of about <NUM> x <NUM><NUM> Siemens/m or less) and a relatively high resistivity (e.g., on the order of about <NUM> x <NUM>-<NUM> Ohms/m or greater). For example, the second coating 1035b may include a ceramic coating, a polymeric coating, metal oxide (e.g., such as aluminum oxide), a metal nitride, and/or the like.

The body portion B of the sphincterotome wire assembly <NUM> may include the cutting region 1020a of the wire <NUM>. The cutting region 1020a may be energized so as to facilitate cutting. When doing so, the first coating 1035a can conduct energy to facilitate cutting. The second coating 1035b may be non-conductive and may cover and/or insulate the wire <NUM> in a manner so as to not facilitate cutting. It can be appreciated that variations in the difference in conductivity between the first coating 1035a and the second coating 1035b may alter the cutting characteristics of the sphincterotome wire assembly <NUM>. For example, relatively large differences in conductivity between the first coating 1035a and the second coating 1035b may generate more aggressive tissue burns at positions more adjacent to the first coating 1035a and less aggressive tissue burns (e.g., or no tissue burns) at positions more adjacent to the second coating 1035b. Relatively small differences in conductivity between the first coating 1035a and the second coating 1035b may result in more evenly distributed burns along the sphincterotome wire assembly <NUM>. In some instances, the first coating 1035a, the second coating 1035b, or both may terminate adjacent to the outer surface of the shaft <NUM>.

<FIG> are cross-sectional views taken at various locations along the shaft <NUM>. Here it can be seen that the shaft <NUM> may include a number of different lumens. For example, the shaft <NUM> may include a first lumen <NUM>, a second lumen <NUM>, and a third lumen <NUM>. In this example, the proximally-extending region 1020b of the first member <NUM> may extend through the first lumen <NUM>. The second lumen <NUM> may be used for infusing a fluid such as a contrast media. The third lumen <NUM> may be a guidewire lumen. In other instances, the first coating 1035a, the second coating 1035b, or both may extend through the outer surface of the shaft <NUM> and into a lumen of the shaft <NUM>. For example, the second coating 1035b may extend into the first lumen <NUM>.

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

The shaft <NUM> may be made from 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), perfluoroalkoxy alkane (PFA), 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, KEVLAR®), 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.

In at least some embodiments, portions or all of the sphincterotome <NUM> may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the sphincterotome <NUM> in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the sphincterotome <NUM> to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the sphincterotome <NUM>. For example, the sphincterotome <NUM>, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The sphincterotome <NUM>, or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

Claim 1:
A sphincterotome (<NUM>, <NUM>, <NUM>), comprising:
an elongate shaft (<NUM>, <NUM>, <NUM>) having an outer surface and a distal end region (<NUM>, <NUM>, <NUM>), the distal end region shiftable between a first configuration and a curved configuration;
a sphincterotome wire assembly (<NUM>, <NUM>, <NUM>) having a distal end coupled to the distal end region of the elongate shaft and a body portion (B) extending along the outer surface of the elongate shaft when the distal end region of the elongate shaft is in the first configuration;
wherein the sphincterotome wire assembly is designed to shift the distal end region of the elongate shaft between the first configuration and the curved configuration; and
wherein the body portion of the sphincterotome wire assembly includes a cutting region (120a, 720a, 820a) and a non-conductive region,
wherein the cutting region of the sphincterotome wire assembly is defined by a conductive cutting wire,
characterized in that the non-conductive region of the sphincterotome wire assembly includes a non-conductive wire coupled to the conductive cutting wire, and
wherein the non-conductive wire is coupled to the conductive cutting wire by a housing.