Positioning device for body lumen

Abstract

To provide medical devices, systems and methods for locating devices and / or anatomy during medical procedures, and more specifically, medical device and / or anatomy locating devices, access devices, and systems and methods thereof, for use during, e.g., gastrojejunostomy procedures.SOLUTION: In an aspect, a medical device locator includes an elongate member (such as a sheath or guidewire) having a proximal end, a distal end, a longitudinal axis, and a length extending along the longitudinal axis. The elongated member includes a location device at a distal end thereof. The location device includes at least one light emitting diode (LED). The at least one LED is configured to be actuated to emit light having wavelengths corresponding to green light and red light.SELECTED DRAWING: Figure 3A

Description

[Technical field]

[0001] This disclosure relates generally to medical devices, systems, and methods for positioning devices and / or anatomical structures during medical procedures. More specifically, in some embodiments, the disclosure relates to medical device and / or anatomical structure positioning devices, access devices, and systems and methods thereof for use during gastrojejunostomy. [Background technology]

[0002] Various health problems, such as obesity and diabetes, affect a growing population and can cause additional illnesses and increase health risks for patients. Surgical procedures, such as bariatric surgery, for example, restricting a portion of the stomach and / or bypassing a portion of the intestine and / or other parts of the gastrointestinal (GI) tract, may be an option for certain patients with these and / or other health problems. These types of procedures can result in significant side effects, such as changes in gut hormones, and can be invasive surgical procedures with associated complications, tissue trauma, anastomotic leakage, infection, and / or additional surgery to modify the initial surgery, such as changing the placement of the bypass device, which can potentially increase risks for the patient.

[0003] Thus, less invasive medical devices, systems, and related methods for treating the digestive tract and / or bypassing portions of the intestine may be desirable to reduce complications associated with the treatment of some of these and other health problems. This disclosure may solve one or more of these problems, or other problems in the art. Summary of the Invention [Means for solving the problem]

[0004] According to one aspect, the medical device locator may include an elongate member including a positioning device at a distal end thereof. The positioning device may include at least one light emitting diode (LED), the at least one LED configured to be operative to emit light having wavelengths corresponding to green light and red light.

[0005] The positioning device may include a sidewall, a proximal end wall at a proximal end of the sidewall, and a distal end wall at a distal end of the sidewall, the sidewall, the proximal end wall, and the distal end wall may define a cavity, and the at least one LED may be disposed within the cavity.

[0006] The side walls may comprise a transparent or translucent material, and at least one of the proximal or distal end walls may comprise one or more of an opaque or light attenuating material.

[0007] The elongate member may include a fluid lumen extending from the proximal end of the elongate member to the distal end of the elongate member. A plurality of holes may be disposed in a sidewall of the elongate member and fluidly connected to the fluid lumen. A vacuum device and a fluid containing device may be connected to the elongate member, and the vacuum device and the fluid containing device may each be in fluid communication with the fluid lumen at the proximal end of the elongate member, and the vacuum device may be configured to create suction within the fluid lumen such that fluid from the body may be configured to flow through the multiple holes and along the fluid lumen to the fluid containing device.

[0008] The elongate member may include a central lumen configured to receive a guidewire. The positioning device may include a balloon at a distal end of the elongate member, and the balloon may be configured to expand.

[0009] The balloon may comprise a transparent or translucent material, and the at least one LED may be disposed on a surface of the elongated member, and light emitted from the LED may be configured to transmit through the balloon.

[0010] The balloon may be disposed on a first side of the elongate member and the at least one LED may be disposed circumferentially on an opposite side of the elongate member from the balloon. The at least one LED may include a plurality of LEDs. The plurality of LEDs may be disposed around a periphery of the balloon.

[0011] The elongate member may include an elongate member body and an elongate member distal tip, a proximal end of the elongate member distal tip may be connected to the distal end of the elongate member body by a plurality of wires, and one LED of the at least one LED may be attached to each wire from the plurality of wires.

[0012] An actuation wire may be attached to a distal tip of the elongate member, the actuation wire may be configured to move proximally relative to the body of the elongate member, and the LEDs may be configured to move radially outward when the actuation wire moves the distal end of the elongate member proximally relative to the body of the elongate member.

[0013] At least one LED may be configured to emit alternating green and red light. The at least one LED may be configured to emit green and red light in a pulsed manner.

[0014] A system with a medical device locator may include an endoscope having an imaging device and an end effector that may extend from a distal end of the endoscope, and the imaging device may be configured to detect light from the locator having wavelengths corresponding to green and red light emitted from at least one LED.

[0015] According to another aspect, a method may include inserting an endoscope into the body and advancing the endoscope to a stomach of the body, where a distal end of the endoscope includes a camera; inserting an elongated member into the body, where a distal end of the elongated member includes at least one light emitting diode (LED); advancing the elongated member through the stomach and into a small intestine of the body; activating the at least one LED to emit a first light having a first wavelength; detecting the first light with the camera; activating the at least one LED to emit a second light having a second wavelength different from the first wavelength; and detecting the second light with the camera.

[0016] The method may further include creating one or more incisions in the stomach wall and the small intestine wall corresponding to the location of the at least one LED. The first light may have a wavelength corresponding to red light and the second light may have a wavelength corresponding to green light.

[0017] According to yet another aspect, a method may include inserting an endoscope into a body and advancing the endoscope to a stomach of the body, the distal end of the endoscope including a camera, inserting an elongated member into the body, the distal end of the elongated member including a positioning device including at least one light emitting diode (LED), advancing the elongated member through the stomach to a small intestine of the body, creating an incision in a wall of the stomach, advancing the endoscope through the incision in the wall of the stomach, activating at least one LED to a red light, detecting the red light with a camera, activating at least one LED to emit a green light, detecting the green light with a camera, creating an incision in a wall of the small intestine, and positioning a stent to connect the wall of the stomach and the wall of the small intestine based on at least one of the detection of the red light and the detection of the green light. The at least one LED may be activated to emit the red light and the green light in a pulsed manner.

[0018] In another aspect, the medical device locator may include an elongate member having a proximal end, a distal end, a longitudinal axis, and a length extending along the longitudinal axis. The positioning device may be disposed along the length of the elongate member.

[0019] In various embodiments described herein and otherwise within the scope of the present disclosure, the elongated member may be a tubular sheath extendable around the catheter. A plurality of illumination members may be disposed along the length of the elongated member. The positioning device may include an inflatable member disposed along a distal end of the elongated member. An inflation lumen may extend along the length of the elongated member in fluid communication with the inflatable member. The plurality of illumination members may include LEDs disposed along the length of the elongated member, the LEDs being operable to emit light having a wavelength corresponding to green or red light. The positioning device may include one or more LEDs of the plurality of illumination members at a distal end point of the illumination member along the elongated member identifiable for positioning the medical device. The positioning device may include one or more LEDs of the plurality of illumination members leading to the distal end point. A plurality of leads may be in electrical communication with the plurality of illumination members extending along the elongated member. A controller may be in electrical communication with the plurality of leads extending along the elongated member. The controller may be configured to selectively activate a portion of the plurality of illumination members distally along the length of the elongated member. The controller may be configured to activate selected one or more LEDs of the plurality of lighting members in a distal direction sequentially along the length of the elongated member. The controller may be configured to activate all of the plurality of lighting members except one lighting member of the plurality of lighting members, which is sequentially changed upon activation of each of the lighting members in the distal direction. The plurality of lighting members may include selected lighting members along a proximal portion of the elongated member having a first wavelength and selected lighting members along a distal portion of the elongated member having a second wavelength. The plurality of lighting members may be operable at decreasing frequency intervals in a distal direction along the length of the elongated member. The plurality of lighting members may be arranged along the length of the elongated member such that the density of the lighting members increases along the length of the elongated member extending from the proximal end toward the distal point along the elongated member. The plurality of lighting members may be individually selectable and controllable as single lighting members or as groups of multiple lighting members.The plurality of illumination members may extend along the length of the elongate member over a distance of approximately 50 centimeters.

[0020] In another aspect, a system for locating a medical device may include a medical device locator including an elongate member having a proximal end, a distal end, a longitudinal axis, and a length extending along the longitudinal axis. The locator may be disposed along the length of the elongate member. A plurality of illumination members may be disposed along the length of the elongate member. The elongate member may be extendable within a first body lumen. The medical device may be positionable within a second body lumen. The medical device may be positionable with the medical device locator at a target location in a second body lumen opposite the locator across a tissue wall of the first body lumen and a second tissue wall of the body lumen. The plurality of illumination members may include LEDs. A controller may be electrically coupled to the plurality of LEDs. The controller may be configured to selectively activate the plurality of LEDs distally along the length of the elongate member.

[0021] In another aspect, a method of positioning a medical device locator may include inserting an elongate member into a first body lumen. The elongate member may include a plurality of LEDs extending along a length of the elongate member. The positioning device may be disposed at a distal end of the elongate member. The controller may be configured to selectively activate the plurality of LEDs distally along a length of the elongate member. The activated plurality of LEDs may be viewable across a wall of the first body lumen to position the positioning device at a target location within the first body lumen. An opening may be cut across the wall of the second body lumen toward the first body lumen at the target location, and an opening may be cut across the wall of the first body lumen at the target location. The positioning device may include one or more of the plurality of LEDs. Viewing of the activated plurality of LEDs may be performed from within the abdominal cavity.

[0022] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Brief description of the drawings]

[0023] [Figure 1] 1 shows the human digestive system. [Figure 2A] 1 illustrates an exemplary embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. [Figure 2B] 1 illustrates an exemplary embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. [Figure 2C] 1 illustrates an exemplary embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. [Figure 2D] 1 illustrates an exemplary embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. [Figure 2E] 1 illustrates an exemplary embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. [Figure 2F] 1 illustrates an exemplary embodiment of a system and process for creating an anastomosis, according to an aspect of the present disclosure. [Figure 3A] FIG. 2C is a perspective view of an example of a catheter and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 3B] FIG. 2C is a perspective view of an example of a catheter and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 3C] FIG. 2C is a perspective view of an example of a catheter and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 3D] FIG. 2C is a perspective view of an example of a catheter and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 4A] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 4B] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Diagram 5] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 6] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 7] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 8A] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 8B] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 9] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 10A] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 10B] FIG. 2C is a perspective view of another example of an elongate member and positioning device for use in the system of FIGS. 2A-2F, according to one embodiment of the present disclosure. [Figure 11A] 1 illustrates an elongate member extending into the jejunum and an instrument extending toward the elongate member through the stomach wall and into the abdominal cavity, according to one aspect of the present disclosure. [Figure 11B] 11B shows the system of FIG. 11A with an instrument for manipulating the jejunum. [Figure 11C] 11A and 11B are shown with the device extending through the wall of the jejunum. [Figure 12] 1 illustrates an elongated member having multiple LEDs disposed along its length, according to one embodiment of the present disclosure. [Figure 13] 1 illustrates an elongated member having multiple LEDs disposed along its length, according to one embodiment of the present disclosure. [Figure 14] 1 illustrates an elongated member having multiple LEDs disposed along its length, according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] The present disclosure will be described with reference to an exemplary medical system that may be used in an endoscopic medical procedure. However, it should be noted that reference to this particular procedure is provided for convenience only and is not intended to limit the disclosure. Those skilled in the art will recognize that the concepts underlying the disclosed apparatus and associated methods of use may be utilized in any suitable medical or other procedure. The present disclosure can be understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals.

[0025] Whenever possible, the same or similar reference numbers are used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part of the device that is furthest from the user when introducing the device into the patient. In contrast, the term "proximal" refers to the part of the device that is closest to the user when placing the device into the patient. As used herein, the terms "comprises" and "comprising," or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or device that includes a list of elements does not necessarily include only those elements, but may include other elements not expressly listed, or other elements inherent to such process, method, article, or device. The term "exemplary" is used in the sense of "example" rather than "ideal." Additionally, as used herein, the terms "about," "approximately," and "substantially" indicate a range of values ​​within + / - 10% of the stated or implied value. Additionally, terms describing the geometry of components / surfaces refer to exact and approximate shapes.

[0026] Although embodiments of the present disclosure are described with particular reference to embodiments of medical device locators, systems, and methods for placing medical devices within particular portions of the digestive tract for particular purposes (e.g., to affect metabolism, affect weight loss), it should be understood that such embodiments may be used to place various configurations of such medical devices in various different body lumens and / or passageways for a variety of different purposes, including, for example, anal access to the transverse colon, ascending colon, or ileum, Roux-en-Y, jejunocolic bypass, jejunoileal bypass, gastrectomy, biliary pancreatic diversion with duodenal switch (BPD-DS), gastrojejunostomy, partial colectomy, and other procedures involving using a medical device locator with a beacon to locate a target portion of a body lumen such that the beacon is visible from outside the lumen to allow an instrument to access the lumen of the target portion.

[0027] Although the present disclosure includes a description of anastomoses, openings or fistulas formed in the digestive tract to affect body weight and absorption, the devices, systems and methods herein may be implemented for a variety of other drainage and / or conduit purposes along various other portions of the digestive tract or between lumens outside the digestive tract.

[0028] It should be noted that references in this specification to "an embodiment," "some embodiments," "other embodiments," and the like, refer to the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, if a particular feature, structure, or characteristic is described in relation to one embodiment, it will be within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in relation to other embodiments, unless expressly stated to the contrary, whether or not expressly. That is, it is contemplated that various individual elements described below, even if not explicitly shown in a particular combination, can be combined or arranged with each other to form other additional embodiments or to complement and / or enrich the described embodiments, as understood by one skilled in the art.

[0029] 1, a gastrointestinal system 100 is shown. The gastrointestinal system 100 may include a stomach 105, a small intestine 125, and a pylorus 110 connecting the stomach 105 to the small intestine 125. The small intestine 125 includes a duodenum 115 and a jejunum 120, the duodenum 115 being proximal to the jejunum 120, the junction of the duodenum 115 and the jejunum 120 being defined by the location of the ligament of Treitz 130 connecting to the small intestine 125. As described herein, an anastomosis can be created between the stomach 105 and the jejunum 120 to bypass a portion of the pylorus 110, the duodenum 115, and / or the jejunum 120. In this manner, gastric contents (e.g., food, liquids, and nutrients) may not be absorbed or absorption of the gastric contents may be limited and / or delayed as they move from the stomach 105 through the small intestine 125, which can promote weight loss in a patient and, in some instances, improve weight-related health conditions, such as resolving type 2 diabetes, as well as other health conditions.

[0030] 2A-2F, an example of an endoscopic procedure, such as a gastrojejunostomy, according to the present disclosure is shown. In a first step 200, a nasal catheter 230 may be inserted into a patient, for example, through the nose and esophagus, into the patient's stomach 105 and / or small intestine 125. A distal end 235 of the nasal catheter 230 may be positioned within the small intestine 125 a desired distance to the jejunum 120 as determined by a medical professional and / or based on the medical procedure. The nasal catheter 230 may be advanced by a medical professional by peristalsis and / or by pushing a handle associated with a proximal end of the nasal catheter 230, thereby moving the nasal catheter 230 distally. As described herein, the nasal catheter 230 may be configured to slide along a guidewire such that the nasal catheter 230 is positioned within the gastrointestinal system 100. As shown in FIG. 2B, in a second step 205, an endoscope 240 may be inserted into the stomach 105 such that a distal end 245 of the endoscope 240 is positioned in a region of the stomach 105 that is near the distal end 235 of the nasal catheter 230 located in the jejunum 120, such as the fundus and / or antrum portion of the stomach, which has a greater curvature.

[0031] Once the distal end 245 of the endoscope 240 is positioned in the appropriate location within the stomach 105, a puncture or other incision is made in the inner wall of the stomach 105 in step 210, as shown in FIG. 2C. A gripping mechanism, such as an end effector 250 at or extending from the distal end 245 of the endoscope 240, and the distal end 245 of the endoscope 240 are advanced to the outside of the stomach 105 after the incision is made in the wall of the stomach. The location of the distal end 245 relative to the stomach 105 is determined by a medical professional by placing a positioning device on the distal end 235 of the nasal catheter 230, as described in detail herein. Once the outer wall of the jejunum 120 is gripped by the gripping member, an incision or other opening can be created in the jejunum 120, as described herein.

[0032] In step 215, shown in Figure 2D, a piercing mechanism 250 may be pierced into the jejunum 120 while maintaining the position of the nasal catheter 230 within the jejunum 120, for example via a fixed guidewire 255. It will be appreciated that the location of the distal end 235 of the nasal catheter 230, and therefore the location of the incision in the small intestine 125, may depend on the patient and / or medical procedure. As shown in Figure 2E, an anastomotic stent 260 is deployed from the endoscope 240 in step 220 to join the opening created in the wall of the stomach 105 and the opening created in the wall of the jejunum 120, thereby creating a bypass between the pylorus 110 and the duodenum 115, for example a gastrojejunostomy.

[0033] In FIG. 2F, a pylorus obstructing device 265 may be placed at the pylorus to prevent the patient's stomach contents from migrating through the pylorus 110 and redirecting the stomach contents through the anastomotic stent 260. The pylorus obstructing device 265 may be of any configuration to prevent food, liquid, and / or nutrients from flowing from the stomach 105 to the duodenum 115. Rather, the stomach contents may flow directly from the stomach 105 to the jejunum 120 through the anastomotic stent 260, thereby limiting and / or preventing nutrients, food, and / or liquids from being taken up by the body in the duodenum 115 (which procedures may include, but are not limited to, gastrointestinal anastomosis procedures, gastrojejunostomy procedures, and / or gastroduodenal anastomosis procedures). This may limit and / or prevent certain medical conditions, such as weight gain and diabetes. It is understood that the medical professional may later remove the pylorus obstruction device 265 and / or anastomotic stent 260, thereby increasing absorption of food, liquids, and / or nutrients by the stomach 105 and / or duodenum 115. Although endoscopic procedures for placing anastomotic devices are described herein, features of pylorus obstruction devices and anastomotic stents, additional procedures and devices for stent placement that may be useful, can be found in the full disclosures of U.S. Patent Application Publication No. 2019 / 0298401, filed March 22, 2019 and published October 3, 2019, entitled "SYSTEMS AND METHODS FOR PERFORMING ENDOSCOPIC PROCEDURES," and U.S. Patent Application Publication No. 2019 / 0298559, filed March 22, 2019 and published October 3, 2019, entitled "Devices, Systems, and Methods for Pylorus Obstruction."

[0034] As mentioned above, the distal end 235 of the nasal catheter 230 may be positioned in the jejunum 120 to aid the medical practitioner in determining the appropriate location for deploying the anastomotic stent. An exemplary positioning device for positioning the distal end of the nasal catheter is shown in FIG. 3A. For example, the distal end may include a positioning device 300 attached at its proximal end to a sheath, guidewire, or catheter 305. As used herein, the term "elongated member" may include any member attached to any catheter (including nasal catheters, oral catheters, anal catheters, or other endoscopic catheters), sheath, shaft, guidewire, wire, endoscope, or positioning device (with or without a lumen extending therethrough), including the positioning device 300 thereon, unless otherwise indicated. It will be understood that the positioning device 300 may be positioned proximal to the distal-most end of the sheath, guidewire, or elongated member 305, as shown in FIG. 3B. For example, the elongated member 305 may include a guidewire or the like to provide structural support for moving the elongated member 305 proximally and / or distally or to allow a medical professional to place the guidewire in the small intestine 125 and slide the elongated member 305 along the guidewire. The positioning device 300 may be attached to the exterior surface of the elongated member 305 using an adhesive or the like and may be positioned a distance from the distal most end of the elongated member 305, for example, about 15 cm. The elongated member 305 may be about 4 meters or less in length, for example, about 3 meters, but is not limited to this length. The elongated member 305 may have a diameter of about 0.035 inches (about 0.0889 centimeters) or about 0.025 inches (about 0.0635 centimeters) for elongated members 305 without a lumen, or about 7F (about 2.3 millimeters) or about 5F (about 1.7 millimeters) for elongated members 305 including a lumen. The distance and diameter are not limited and may be varied depending on the size of the patient and / or the treatment procedure being performed by the medical practitioner.

[0035] The elongated member 305 may also include a loop 312, as shown in FIG. 3B, where the distal end of the elongated member 305 is bent or curved such that the most distal end of the elongated member 305 faces generally in a proximal direction. The loop 312 may be formed after the elongated member 305 is introduced into the body by pushing the elongated member 305 distally. For example, at least a portion of the elongated member 305 may be flexible or have variable stiffness such that the distal end of the elongated member 305 is folded back on itself during the medical procedure to form the loop 312 from a straight configuration. As the elongated member 305 is moved proximally, the loop 312 may approach a straight configuration. The loop 312 may provide a blunted end, which may reduce the possibility of intestinal perforation when manipulating the elongated member 305 and may increase the accuracy of positioning of the positioning device 300. Alternatively, the loop 312 may be formed in or around the guidewire, and the elongate member 305 may extend along the guidewire via a lumen, as described herein. It will be appreciated that a conductive wire for conducting electricity may be disposed within the lumen of the elongate member 305 and / or disposed on an exterior surface of the elongate member 305. Alternatively, the conductive wire may be encapsulated within the wall of the elongate member 305 and / or between multiple walls of the elongate member 305.

[0036] According to the example shown in FIG. 3A, the positioning device 300 may include one or more light emitting diodes (LEDs) 310. The positioning device 300 may include a side wall 302, a distal end wall 304, and a proximal end wall 306. The positioning device 300 may be, for example, a capsule and may take any shape, including but not limited to an ellipsoid, a rectangular prism, or a sphere. The side wall 302 may be a single wall having a cylindrical shape, as shown in FIG. 3A, or the side wall 302 may include multiple side walls forming, for example, a rectangular prism. An interior space 308 may be formed between the side wall 302, the distal end wall 304, and the proximal end wall 306. The space 308 may include a fluid, atmosphere, and / or an inert gas or other gas. For example, the positioning device 300 may include an alternative light emitting feature, in which electrodes are provided within the interior space 308 and at both ends of the interior space 308, and a gas, such as neon gas, is disposed within the interior space 308.

[0037] According to an example, LEDs 310 may be disposed within the interior space 308. Each of the LEDs 310 may be any shape, such as, but not limited to, a rectangle. Additionally or alternatively, some of the LEDs 310 may be disposed in any shape, including a triangle (e.g., three LEDs 310 angled at 120 degrees relative to each adjacent LED 310), a cube (e.g., four LEDs 310 angled at 90 degrees relative to each adjacent LED 310), and / or may form an in-line orientation such that each LED 310 faces a different direction. Light emitted from the LEDs 310 may be emitted from the interior space 308 of the positioning device 300 through a sidewall 302, which may be transparent or translucent. According to an example, one or both of the distal end wall 304 or the proximal end wall 306 may include or be formed of an opaque or otherwise light-attenuating material, such that light emitted from the LEDs 310 may be focused through the sidewall 302 to aid a medical professional in positioning the positioning device 300. As described in detail herein, each diode from the LEDs 310 can emit one or more wavelengths of visible light, as described herein. The number of LEDs 310 is not limited. As an example, a single red LED 310 and a single green LED 310 can be on a first side of the elongated member 305, and a single red LED 310 and a single green LED 310 can be disposed on opposing sides of the circumference of the sheath or guidewire 305. As another example, one or more red LEDs 310 can be on a first side of the elongated member 305, and one or more green LEDs 310 can be on opposing sides of the circumference of the elongated member 305. Alternatively, there can be one LED of each color, or, for example, 2-10 or more LEDs 310 of each color. Alternatively, or in addition, the LEDs 310, and any LEDs described herein, may be arranged in multiple rows, such as two or more rows parallel or substantially parallel to the longitudinal axis of the elongate member 305 and positioning device 300, and may be arranged around the entire circumference of the elongate member 305 or may extend only around a portion of the circumference of the elongate member 305.

[0038] Alternatively, the positioning device 300 may include one or more LEDs 310 disposed on the elongated member 305, as shown in FIG. 3B. FIG. 3B shows an array of two LEDs 310, each of which may be the same or different in color, such as one green LED 310 and one red LED 310. As a further example, the LEDs 310 may be arranged in an array of 1-20 LEDs, or 4-6 rows of LEDs, each row parallel to the longitudinal axis of the elongated member 305 and the positioning device 300. The rows may be arranged circumferentially around the elongated member 305. Alternatively, the LEDs 310 may be disposed on only one side of the elongated member 305, for example to focus light emitted from the LEDs 310 on only one side of the positioning device 300. The LEDs 310 may be flashed in a pattern, such as turned on and off. For example, the LED 310 may be flashed at about 1 Hertz, with a duty cycle of about 10-15% and a current of about 150 mA.

[0039] A coating, such as an electrically insulating heat shrink or curable substance such as an adhesive, may be disposed over the side wall 302, the distal end wall 304, and the proximal end wall 306, or may completely replace these walls such that the coating covers all or a portion of the LED 310. This coating is not limited to the location of only the LED 310, but may extend distally and / or proximally along the elongated member 305 to ensure sufficient adhesion of the LED 310 to the elongated member 305. The coating may be transparent or translucent so that light from the LED 310 may be transmitted therethrough.

[0040] Each LED 310 may emit red and / or green light. Red light is more easily visible from a distance than green light because it is more highly penetrative to human tissue, while being less absorbed by human tissue and therefore scattered. Green light is more easily absorbed by human tissue, resulting in a lower transmittance than red light. However, green light is more easily located than red light, as it is less scattered within the body. Furthermore, medical personnel's eyes and endoscope image sensors (e.g., CMOS image sensors, etc.) are generally more sensitive to wavelengths of green light than to wavelengths of red light, which may further improve the determination of the specific location of the LED 310. For example, the LED 310 (e.g., the first LED 310) may be controlled to emit red light to determine the approximate area in which the positioning device 300 is located, and the LED 310 (e.g., the second LED 310) may emit green light to more specifically pinpoint the exact location of the positioning device 300. Thus, the red light may be a coarse locator or first adjustment to identify and position the medical device toward the desired location, and the green light may be a fine adjustment or second adjustment to identify and position the medical device toward the desired location. In some embodiments, the red light may be manually (or automatically) switched to the green light when the user has generally positioned the medical device as desired. In some embodiments, the red and green lights may alternate at a preselected interval, allowing the user to orient the medical device toward the desired location as the red and green lights alternate. Additionally or alternatively, the LEDs 310 may generate red and green lights simultaneously, for example, a first LED 310 / light array may generate red light and a second LED 310 / light array may generate green light. It will be appreciated that the LEDs 310 are not limited to these colored lights and may include other lights, including but not limited to white light.

[0041] 3A, the sheath, guidewire, or distal end of the elongated member 305 may extend through an opening in the proximal end wall 306, which may then be sealed around the elongated member 305. The elongated member 305 may include multiple wires, such as two positive wires (one positive wire for the anode terminal of each LED 310) and a common cathode return terminal wire, to transfer electrical energy from a power source (e.g., a generator, battery pack, or equivalent energy source) at the proximal end of the elongated member 305 to the LEDs 310 and to provide independent control for each LED 310, thereby improving the efficiency of light transmission and reducing any adverse effects associated with heat from the LEDs 310 light and heat on the body. For example, the wires may be included in a lumen or layer of the elongated member 305 that extends from the proximal end to the distal end of the elongated member 305, and / or the wires may extend along the exterior surface of the elongated member 305 from the proximal end to the distal end. The wires may also be insulated with a biocompatible polymer and left uncovered or attached to a member with greater stiffness, in which case the wires form a "pill-on-a-string" and may be positioned in the desired location via peristalsis.

[0042] According to another example, the positioning device 300 may include a diffuser instead of the LEDs 310. The elongated member 305 may include a plastic or glass diffused light pipe (the elongated member 305 may be a diffused light pipe, or the light pipe may replace the wires conducting electricity to the LEDs 310). The elongated member 305 may include a reflective surface to advance light to the distal end of the elongated member 305. For example, light may be coupled at the proximal end of the elongated member 305 using a light source. Once the light reaches the positioning device 300, the diffuser may diffuse the light away from the positioning device 300 in one or more directions, thereby illuminating the positioning device 300. A medical professional may activate the light source in any manner described herein.

[0043] As shown in FIG. 3D, another example of a positioning device 300′ on a guidewire, sheath, or elongated member 305′ is shown. The positioning device 300′ including one or more LEDs 310′ may be positioned approximately 15 cm proximal to the distal tip 315′ of the guidewire 300′. The distal tip 315′ has a rounded or otherwise blunted end to minimize harm to the esophageal passage during insertion. As described herein, wires for transmitting electricity from a power source to the LEDs 310′ may be positioned on or within the guidewire 300′. The elongated member 305′ may have a diameter of approximately 0.035 inches, or approximately 0.025 inches. It will be appreciated that the positioning device 300′ may be positioned anywhere along the elongated member 305′. It will also be appreciated that guidewire 300' may be inserted into the patient's body and advanced to small intestine 125 in any manner described herein.

[0044] 3C, the sheath, guidewire, or elongate member 305 may include markers, such as pylorus markers 305a, 305b, and 305c, and teeth markers 305a', 305b', and 305c', to indicate the distance traveled by the positioning device 300 when inserted into a patient. For example, a first pylorus marker 305a may be positioned on the elongate member 305 approximately 155 cm proximal to the positioning device 300, a second pylorus marker 305b may be positioned on the elongate member 305 approximately 170 cm proximal to the positioning device 300, and a third pylorus marker 305c may be positioned approximately 185 cm proximal to the positioning device 300. Additionally or alternatively, the first tooth marker 305a' may be positioned on the elongated member 305 approximately 250 cm proximal from the positioning device 300, the second tooth marker 305b' may be positioned on the elongated member 305 approximately 265 cm proximal from the positioning device 300, and the third tooth marker 305c' may be positioned approximately 280 cm proximal from the positioning device 300. The markers may aid and / or indicate the approximate location of the positioning device 300 with respect to the patient's anatomy. For example, as described herein, the positioning device 300 may be introduced via the mouth, esophageal passage, and / or another percutaneous gastrointestinal access point such that a medical professional would understand that the positioning device 300 has been moved approximately 250 cm into the patient when the first tooth marker 305a' is aligned with the patient's tooth. Similarly, when the second tooth marker 305b' and the third tooth marker 305c' are aligned with the patient's teeth, the medical professional will understand that the positioning device 300 has been moved approximately 265 cm and 280 cm into the patient, respectively. However, in some cases, the elongated member 305 may loop within the stomach 105, and the tooth markers 305a', 305b', and 305c' may not provide accurate distance results. Thus, the medical professional can use the image sensor at the distal end of the endoscope 240 to determine the distance from the positioning device 300 to the small intestine 125 by the pylorus markers 305a, 305b, and 305c.For example, when the first pylorus marker 305a is aligned with the pylorus 110, as determined using the image sensor, a medical professional can determine that the positioning device 300 extends approximately 155 cm from the pylorus 110 into the small intestine 125. Similarly, when the second pylorus marker 305b and the third pylorus marker 305c are aligned with the pylorus 110, a medical professional can determine that the positioning device 300 extends approximately 170 cm and 185 cm, respectively, from the pylorus 110 into the small intestine 125.

[0045] Alternatively, or in addition, the elongated member 305 may be color coded in a similar manner for all position markers on the elongated member 305 such that the outer surface of the elongated member 305 may include a first color between the positioning device 300 and the first pylorus marker 305a (or at a position approximately 155 cm from the positioning device 300), a second color on the outer surface between the first pylorus marker 305a and the second pylorus marker 305b (or at a position approximately 170 cm from the positioning device 300), a third color on the outer surface between the second pylorus marker 305b and the third pylorus marker 305c (or at a position approximately 185 cm from the positioning device 300), and a fourth color on the outer surface from the third pylorus marker 305c to the first tooth marker 305a' (or at a position approximately 250 cm from the positioning device 300). It will be appreciated that non-adjacent regions, such as the region between the positioning device 300 and the first pylorus marker 305a and the region between the second pylorus marker 305b and the third pylorus marker 305c, may be the same color.

[0046] The placement of the markers (and / or color transitions) is not limited to the locations described herein. For example, the markers may be placed along the elongated member 305 based on the physical characteristics of the patient, e.g., the markers may be placed further apart along the elongated member 305 for use with a taller patient than a smaller patient, and / or based on the medical problem being treated, e.g., a morbidly obese patient may require markers placed further apart along the elongated member 305 to position the positioning device 300 more distally in the jejunum 120 than a patient with mild to moderate obesity.

[0047] It will be appreciated that the pylorus markers 305a-305c and the tooth markers 305a'-305c' may be any identifying element, such as a colored marking, a raised area on the elongated member 305, a decal, text identifying a distance from the positioning device 300, a series of circumferential stripes, etc. The pylorus markers 305a-305c and the tooth markers 305a'-305c' may each include multiple markings, for example the first pylorus marker 305a may include multiple identical color-coded markers in the same area of ​​the elongated member 305. In this manner, the elongated member 305 may be suitable for use with all sizes of patients and / or all medical procedures. The pylorus markers 305a-305c and the tooth markers 305a'-305c' may also include characteristics that are identified by various medical imaging modalities. For example, pylorus markers 305a-305c and / or tooth markers 305a'-305c' may be radiopaque so that the location of each marker can be determined during a medical procedure using known medical imaging techniques. Although elongated member 305 may have a strength suitable for pulling and / or pushing elongated member 305, for example to move elongated member 305 when elongated member 305 is positioned within a patient, a guidewire may be used to position positioning device 300 within the body, and the guidewire and / or elongated member 305 may include these markers.

[0048] A method for positioning and operating the positioning device 300 will now be described. An endoscopic procedure can be performed as discussed herein with reference to Figures 2A-2F. Prior to the procedure, the positioning device 300 may be orally administered to the patient and swallowed. The proximal end of the elongated member 305 may extend through the patient's nose. According to one example, the positioning device 300 may be advanced along the digestive tract via peristalsis. In such an example (positioning device 300 swallowed and moved via peristalsis), the positioning device 300 may be delivered through the nasal cavity several hours prior to the proposed procedure. Alternatively, for elongated members 305 with relatively high pushability, the elongated members 305 / positioning device 300 may be endoscopically positioned using an endoscope, e.g., endoscope 240.

[0049] To aid in proper placement, the proposed procedure may begin once the positioning device 300 is properly positioned within the digestive tract. For example, an imaging modality (e.g., imaging device and / or device for locating radiopaque devices) may be used to determine when the pylorus markers 305a-305c are properly positioned at the pylorus. Alternatively, or additionally, the procedure may begin when the tooth markers 305a'-305c' are properly positioned at the patient's mouth / teeth. Proper location of these markers may indicate to the medical professional that the positioning device 300 is properly positioned within the jejunum 120. Alternatively, in the case of an elongated member 305 having a higher pushability, the elongated member 305 may be pushed until these markers are properly positioned, e.g., until the pylorus markers 305a-305c are positioned at the pylorus and / or until the tooth markers 305a'-305c' are positioned at the mouth.

[0050] The elongated member 305 may be connected to a power source before, during, or after the positioning device 300 is introduced into the patient. The LEDs 310 may be activated at any time during the procedure. Alternatively, the LEDs 310 may be activated when the positioning device 300 has been advanced a certain distance into the patient, as indicated by one or more markers 305a-305c. The medical professional may create an incision in a wall of the stomach 105, such as in the antrum of the stomach 105, and advance the endoscope 240 through the incision. The medical professional may then use a camera or other imaging device at the distal end 245 of the endoscope 240 to visualize the abdominal cavity and determine the location of the positioning device 300 within the jejunum 120. For example, the medical professional viewing an image of the abdominal cavity, for example on a monitor associated with the camera of the endoscope 240, may determine the location of the positioning device 300 within the jejunum 120 based on the location of light from the LEDs 310 transmitted through the wall of the jejunum 120. The positioning device 300 can provide the medical professional with a proper location for creating a puncture or incision in the wall of the jejunum 120 in steps 215 and 220 described herein. In this manner, the anastomosis device can be properly positioned. Alternatively, the medical professional can view the positioning device 300 through both the wall of the jejunum 120 and the wall of the stomach 105, which can aid the medical professional in determining where to make the incision in both the wall of the stomach 105 and the incision in the wall of the stomach 105.

[0051] The LEDs 310 may be activated according to a pattern. For example, one or more red LEDs 310 may be activated before or after the positioning device 300 is administered orally and may be illuminated continuously or pulsed. The medical professional may determine when the red light is located by a camera at the distal end 245 of the endoscope 240. The medical professional may then deactivate the red light and activate the green light. It will be appreciated that the green light may be illuminated continuously or pulsed as well. Additionally, the activation of the green light and the deactivation of the red light may be performed automatically by a controller associated with the camera. After the green light is activated, the medical professional may further manipulate the distal end 245 of the endoscope 240 to position the end effector 250 in the proper position to create an incision in the jejunum 120. Alternative embodiments may include activating both the red and green lights at the start of a procedure and / or pulsing one or both lights during a procedure and / or deactivating the red light when the positioning device 300 is located by the camera. One or more white lights may also be activated throughout the procedure, which may assist the medical professional in better positioning the positioning device 300 once an incision is made in one or more of the stomach 105 and jejunum 120.

[0052] Another example of a nasal catheter 430 (wherein the nasal catheter may include any catheter, sheath, or wire described herein) is shown in FIGS. 4A and 4B. According to one example, the nasal catheter 430 may include a lumen 440 extending from a proximal end and may include a positioning device, such as the positioning device 300, attached to its distal end. For example, the outer sheath / tube 431 of the nasal catheter 430 may define the lumen 440. The lumen 440 may include the elongated member 305 described in connection with FIGS. 3A-3C. However, the sheath 431 may include markers for determining distance. The outer sheath 431 may include a material that is sufficiently rigid to be manipulated, e.g., pushed and pulled, within the patient's body without relying on bodily functions such as peristalsis to move the nasal catheter 430 to a target location within the jejunum 120. The outer sheath 431 may include holes 432 that can fluidly connect the lumen 440 with the interior of the GI tract passage when the nasal catheter 430 is inserted into the patient's body. Alternatively, the holes 432 may be formed directly in the wall of the elongated member 305 to allow fluid to pass through the central lumen of the elongated member 305 (e.g., the fluid may pass through an adjacent coated wire). The holes 432 may be provided only at the distal end of the sheath 431 and / or the holes 432 may also be located along the middle and / or proximal length of the nasal catheter 430. The holes 432 may be located along substantially the same circumferential side of the sheath 431 and / or may be located around the circumference of the sheath 431 at multiple locations along the length of the sheath 431. The holes have a diameter of about 0.020 inches to about 0.040 inches, or about 0.025 inches to about 0.030 inches. The holes 432 assist in ventilating the GI passages, such as the stomach 105 and / or small intestine 125, thereby allowing insufflated and / or naturally occurring gases to escape from the GI passages.These gases may cause the walls of the stomach 105 and / or small intestine 125 (including the jejunum 120) to distend, which may increase the distance that the light from the LED 310 must travel from the positioning device 300 to the side wall of the jejunum 120, reducing the amount of light that passes from the jejunum 120 to the abdominal cavity and thus becomes visible by the endoscopic camera. This increased distance may make it difficult to locate the positioning device 300 within the jejunum 120 from the abdominal cavity. The holes 432 may allow gas introduced into and / or generated from the stomach 105 and / or small intestine 125 to be evacuated, thereby reducing distension of the GI walls and improving visualization of the light within the abdominal cavity and / or stomach 105 from the positioning device 300 positioned within the jejunum 120. It will be appreciated that a vacuum device may be attached to the proximal end of the lumen 440 to actively remove gas and / or a containment device may be attached to the proximal end of the lumen to contain gas removed from the GI pathway.

[0053] Methods for positioning and manipulating the nasal catheter 430 will now be described. The nasal catheter 430 can be introduced into the body in any manner described herein. For example, the nasal catheter 430 may be introduced through the mouth or nose and advanced into the small intestine by manipulating and / or pushing the proximal end of the nasal catheter 430 or via peristalsis. As the nasal catheter 430 is moved along the GI tract path, gases may actively or passively enter the holes 432 and move proximally along the lumen 440 to reach the proximal outlet. For example, a vacuum or other pump may be connected to the lumen 440 at the proximal end of the nasal catheter 430, and the vacuum may actively aspirate gases from the GI tract path. Alternatively, these gases may be passively moved along the proximal outlet of the lumen 440. For example, accumulation of gases in the GI tract path may create a pressure rise greater than atmospheric pressure. Due to the pressure differential between the GI pathway and the atmosphere surrounding the outside of the patient's body, these gases can flow along lumen 440 into holes 432 and out the proximal opening of lumen 440. It will be appreciated that a containment device may be attached to the proximal opening of lumen 440 to prevent gases from the body from venting into the procedure chamber. It will also be appreciated that gas may be continuously removed during the anastomosis procedure.

[0054] According to another example, as shown in FIG. 5, the positioning device 500 may be attached to a catheter or sheath 502 (the sheath 502 may include any catheter or nasal catheter described herein). The sheath 502 may include a guidewire lumen 504 through which a guidewire 505 may extend, allowing the sheath 502 to move along the guidewire 505. The positioning device 500 may be disposed at a distal end of the sheath 502. For example, the positioning device 500 may be disposed on an outer surface of the sheath 502, may protrude from the outer surface of the sheath 502 as shown in FIG. 5, and / or may be provided in a separate tube attached to the sheath 502. Alternatively, the positioning device 500 may include a capsule, such as the positioning device 300, disposed at the distal end of the sheath 502, and the guidewire 505 may extend through a central lumen of the capsule, allowing the sheath 502 to slide along the guidewire 505. According to one example, the positioning device 500 may be removably attached to the sheath 502. In this manner, different positioning devices 500, for example positioning devices 500 including different numbers of LEDs 510 and / or different colors of LEDs 510, may be interchanged according to the procedure being performed and / or the size or anatomy of the patient. The increased stiffness of the sheath 502 and its trackability over the guidewire 505 may improve the movement and maneuverability of the positioning device 500, thereby improving the medical procedure. Alternatively, the positioning device 500 may be pulled into the small intestine 125 along the exterior of the endoscope or through the lumen of the endoscope by an end effector, for example a pair of forceps.

[0055] A method of introducing the positioning device 500 will now be described. A guidewire 505 may be introduced through a natural orifice, such as the mouth, and advanced along the GI system. A sheath 502 is then inserted through the natural orifice by placing the sheath 502 around the guidewire 505 via the guidewire lumen 504. The sheath 502 may be advanced along the GI system in any manner described herein. Additionally, the LED 510 may be activated in any manner described herein.

[0056] According to another example, the positioning device 600 may be attached to a distal end of a sheath 602 (the sheath may include any catheter or nasal catheter described herein) having a central lumen 604. The sheath 602 may be shorter than other catheters described herein and sized to support the LEDs 610, as shown in FIG. 6. For example, the sheath 602 may only have a length sufficient to support the LEDs 610 and may be about 20 cm, about 10 cm, or about 5 cm long. A push member 606 may be attached to a proximal end of the sheath 602 to move the sheath 602 along the guidewire 605. The reduced size of the sheath 602 improves maneuverability of the sheath 602, the push member 606, and the guidewire 605, thereby enabling the positioning device 600 to navigate tortuous paths within a patient and / or navigate blockages or strictures within a gastrointestinal pathway. Additionally, this may allow for quick exchange of the positioning device 600 from the guidewire 605, which may allow a single medical professional to operate the guidewire 605 and the positioning device 600. The pushing member 606 may be a wire suitable for use in a medical procedure and may comprise any material sufficient for such use. The pushing member 606 may have a suitable rigidity to receive and move the positioning device 600 along the guidewire 605. It will be appreciated that an electrical wire may be supported by the pushing member 606 so that the LED 610 may receive power.

[0057] The positioning device 600 may be deployed in any manner described herein. For example, the guidewire 605 may be introduced as described with respect to the guidewire 605. The sheath 602 may then be placed over the guidewire 605 via the guidewire lumen 604. The pushing member 606 may then advance the sheath 602 along the guidewire 605 (via a force applied to the proximal end of the pushing member 606). The LED 610 may be activated in any manner described herein to allow a medical professional to position the positioning device 600 using an endoscopic camera placed in the stomach 105.

[0058] According to another example, the positioning device 700 can be attached to and / or surround the distal end of the sheath 702 (the sheath can include any catheter or nasal catheter described herein). The positioning device 700 can include an expandable balloon 704 that can surround the LEDs 710, as shown in FIG. 7. The balloon 704 can include a transparent or translucent material (e.g., polyethylene terephthalate (PET), polyethylene, polyamide copolymer (PEBA) latex, etc.) so that light from the LEDs 710 can be transmitted through the balloon 704 to the wall of the jejunum 120. The LEDs 710 can be any number and / or color and can be arranged on the sheath 702 in any manner described in any of the embodiments herein. The sheath 702 can include a central lumen 706 that can receive a guidewire 705 and can allow the sheath 702 to slide proximally and distally over the guidewire 705 as described herein. A fluid lumen 708 (shown in solid lines) may extend through the sheath 702 from a proximal end of the sheath 702 to an outlet 712 such that the lumen 708 is in fluid communication with the interior of the balloon 704. The lumen 708 may allow fluid to be transmitted therethrough to inflate the balloon 704. For example, a fluid containing device may be attached to the proximal end of the fluid lumen 708, and fluid may be introduced to or removed from the balloon 704 via the fluid lumen 708.

[0059] A method of deploying the positioning device 700 will now be described. The positioning device 700, including the balloon 704, can be advanced to a target location according to any of the methods described herein. The balloon 704 is then inflated. Inflating the balloon 704 can bring the balloon 704 into contact with the wall of the jejunum 120, thereby fixing the position of the balloon 704 within the jejunum 120. The contact between the balloon 704 and the wall of the jejunum 120 can eliminate air and / or fluid gaps between the positioning device 700 and the wall of the jejunum 120, which can increase the transmission of light from the LED 710 to and / or through the wall of the jejunum 120, improving visualization of the positioning device 700. The LED 710 can include different colored lights, e.g., red and / or green lights, as described herein, and it is understood that the different colored lights can be activated in various patterns in any of the ways described herein. Once the positioning device 700 has been positioned by a medical professional and an incision has been made in the wall of the jejunum 120, the balloon 704 may be deflated and the sheath 702 removed from the body.

[0060] 8A and 8B show another example of a positioning device 800. The positioning device 800 may include a balloon 804 on a first side of a distal end of a sheath 802 (the sheath 802 may include any catheter or nasal catheter described herein) and may include an LED 810 on a circumferentially opposite side of the sheath 802 from the balloon 804. The balloon 804 may extend around only a portion of the circumference of the sheath 802. The location of the LED 810 is not limited thereto and may extend around the circumference of the sheath 802 to enhance visibility of the positioning device 800. The sheath 802 may include a central lumen 806 and may be advanced over a guidewire 805 (within the lumen 806) to position the positioning device 800 adjacent to the wall of the jejunum 120. The balloon 804 may be inflated using a fluid lumen 808 (shown in solid lines), such as the fluid lumen 708 of the sheath 702, as shown in FIG. 8B. For example, the fluid lumen 808 may be connected at the proximal end to a fluid containing device for introducing or removing inflation fluid. When the balloon 804 is inflated, the side of the balloon 804 opposite the sheath 802 may contact the entirety of the jejunum 120 and the distal end of the sheath 802 may be pressed against the opposing wall of the jejunum 120. This inflation may press or urge the LEDs 810 against the wall of the jejunum 120, eliminating any air and / or fluid gaps between the positioning device 800 and the wall of the jejunum 120. This in turn may increase the transmission of light from the LEDs 810 to and / or through the wall of the jejunum 120, improving visualization of the positioning device 800 by an imaging device within the stomach 105. The positioning device 800 may be deployed similarly to the positioning device 700.

[0061] Another example of a positioning device 900 is shown in FIG. 9. Similar to the positioning devices 700 and 800, the positioning device 900 may include a balloon 904 at the distal end of a sheath 902 (the sheath may include any catheter or nasal catheter described herein) that may be inflated to position the LEDs 910 against the wall of the jejunum 120. The balloon 904 may surround the entire distal end of the sheath 902. Similar to the positioning devices 700 and 800, the sheath 902 may include a central lumen 906. The configuration of the sheath 902 may allow the sheath 902 to be advanced along a guidewire 905 (located within the lumen 906) to a target site within the jejunum 120. Once the positioning device 900 is positioned at the target site, the balloon 904 may be inflated in any manner described herein, such as using a fluid lumen 908 attached to a containment device containing an inflation fluid at the proximal end. The LEDs 910 may be positioned on the outer surface of the balloon 904. Wires (not shown) providing electrical current / power to the LEDs 910 may extend through the sheath 902 into the balloon 904 or along the surface of the balloon 904 and be electrically connected to the LEDs 910. Inflation of the balloon 904 may press or urge the LEDs 910 against the wall of the jejunum 120. The LEDs 910 may be arranged in alternating red and green lights around the balloon 904, or the LEDs 910 may include an array of red lights arranged circumferentially around the balloon 904 adjacent to an array of green lights similarly arranged around the balloon 904. The LEDs 910 may be centrally located along the longitudinal axis of the balloon 904 or may be equally spaced around the circumference of the balloon 904. Alternatively, the LEDs 910 may be located on the outer surface of the balloon 904 on circumferentially opposite sides of the balloon 904, which may improve visualization of the LEDs 910. It will be appreciated that the red and green lights of LED 910 may be operated independently or together in any manner described herein.

[0062] Another example of a positioning device 1000 is shown in Figures 10A and 10B. Similar to the positioning devices described herein, the positioning device 1000 may be disposed at the distal end of a sheath 1002 (the sheath may include any catheter or nasal catheter described herein). The sheath 1002 may include a central lumen 1006 through which a guidewire 1005 may extend. The sheath 1002 may include a distal tip 1002a connected to a sheath body 1002b by multiple wires 1002c. The distal tip 1002a may be ring-shaped and may include a lumen (which may be an extension of the central lumen 1006 from the sheath body 1002b) for tracking over the guidewire 1005. The distal tip 1002a may have the same or different circumference as the sheath body 1002b. An LED 1010 may be disposed on each of the multiple wires 1002c. For example, each of the wires 1002c may include a green LED 1010 and a red LED 1010, or may include multiple green and red LEDs 1010. Alternatively, each of the wires 1002c may include only one LED 1010, and the colors of the LEDs 1010 may alternate around the circumference of the sheath 1002. Alternatively, each LED 1010 may connect the proximal end of each wire 1002c to its respective distal end. The wire 1002c may provide current / power to the LEDs 1010. The tension wire 1003 may be attached to the distal tip 1002a and extend therefrom to the proximal end of the sheath 1002. The wire 1003 may be translated within the lumen 1006 and actuated to move the distal tip 1002a in a proximal and distal direction. For example, as the tension wire 1003 is moved proximally, the distal tip 1002a is also moved proximally, causing the plurality of wires 1002c to bend radially outward from the guidewire 1005. In this manner, the LEDs 1010 disposed on the plurality of wires 1002c may be moved toward and pressed against the wall of the jejunum 120.

[0063] A method of deploying the positioning device 1000 will now be described. It will be understood that the positioning device 1000 may be advanced to a target location in any manner described herein. Once the positioning device 1000 is positioned within the jejunum 120, a medical professional may control the tension wire 1003 (e.g., pull the wire 1003 proximally) to move the distal tip 1002a proximally while maintaining a fixed position of the body 1002b. This movement moves the LED 1010 away from the longitudinal axis of the sheath 1002, pressing or biasing the LED 1010 against the wall of the jejunum 120. The positioning device 1000 may then be positioned to create an incision in the stomach 105 and the wall of the jejunum 120 in any manner described herein. After the incision is made, the medical professional may control the tension wire 1003 (e.g., push the wire 1003 distally) to move the distal tip 1002a distally while maintaining a fixed position of the body 1002b, and move the LEDs 1010 radially inwardly closer to the guidewire 1005. It will be appreciated that it is possible to maintain the position of the distal tip 1002a while moving the body 1002b proximally and / or distally. Once the LEDs 1010 are no longer deployed, the sheath 1002 may be removed from the patient.

[0064] In various procedures, medical professionals may have difficulty locating a portion of a body lumen that includes a medical device locator. FIGS. 11A-11C show a portion of a gastrojejunostomy procedure substantially similar to the procedure of FIGS. 2B-2D. For example, in FIGS. 2C and 2D, a portion of the jejunum 120 that includes the distal end 235 of the nasal catheter 230 may be difficult to locate after the distal end 245 of the endoscope 240 is extended through the wall of the stomach 105 to view the small intestine 125. Similar difficulties in other procedures are contemplated in connection with locating devices and / or anatomical structures. FIGS. 11A-11C show a portion of a procedure for placing a medical device locator at a target location in the jejunum. The medical device locator at the target location can be viewed by an instrument insertable through the stomach wall. Once viewed, the target location in the jejunum can be accessed by the instrument and a stent or other drainage conduit can be placed to bridge the stomach and jejunum.

[0065] 11A , a sheath, guidewire, or elongated member 1100 is shown inserted into the digestive tract through a stomach 1134 and extended into the duodenum 1136 and jejunum 1130. An endoscope 1124 is shown extended into the stomach 1134 with a piercing or cutting mechanism 1120 extending distally from a working channel of the endoscope 1124 toward the tissue wall of the stomach 1134. The piercing mechanism 1120 is shown making an incision through the wall of the stomach 1134 into the abdominal cavity 1138, generally toward a portion 1132 of the jejunum 1130 that includes the positioning device 1102 at the distal end of the elongated member 1100 extended into the jejunum 1130.

[0066] 11B, the endoscope 1124 of the system of FIG. 11A is shown extended into the abdominal cavity 1138 through an incision in the tissue wall of the stomach 1134. The endoscope 1124 is generally aimed at the jejunum 1130 within the abdominal cavity 1138. A medical professional can view the jejunum 1130 within the abdominal cavity 1138 via the endoscope 1124 and / or other viewing techniques, such as fluoroscopy. The medical professional can view the jejunum 1130 and identify a portion 1132 of the jejunum 1130 that correlates with the position of the elongated member 1100 and / or the positioning device 1102 included therein by any visual indicator described herein, such as an illuminated LED. An end effector 1122, such as a grasper, is shown grasping the portion 1132 of the jejunum 1130 so that the portion 1132 of the jejunum 1130 can be held in place, manipulated for dissection, and / or manipulated relative to the stomach 1134. In FIG. 11B, portion 1132 has been manipulated closer toward stomach 1134 compared to its position in FIG. 11A.

[0067] 11C, the portion 1132 of the jejunum 1130 is shown manipulated into a position toward the stomach 1134 from FIGS. 11A and 11B. The piercing mechanism 1122 is shown making an incision in the portion 1132 of the jejunum 1130, and the positioning device 1102 is translated proximally from the portion 1132 to avoid collision with and / or heat transfer from the piercing mechanism 1122. However, the positioning device 1102 may remain in the portion 1132 for treatment. By making an incision in the tissue wall of the stomach 1134 and the tissue wall of the portion 1132 of the jejunum 1130, additional devices may be delivered to the tissue wall of the stomach 1134, the tissue wall of the jejunum 1130, and / or may extend into the abdominal cavity 1138 as described herein.

[0068] In various embodiments, the elongate member may be a catheter (e.g., a nasal catheter, etc.), an endoscope, a guidewire, or a sheath extending around another medical device. The elongate member may have visual indicators along its length, and its length may extend distally to a positioning device, as described herein.

[0069] 12, an embodiment of a medical device locator is shown that includes a sheath, guidewire, or elongate member 1200 having a proximal end 1200p, a distal end 1200d, and a length extending along a longitudinal axis L therethrough. LEDs 1204 are disposed along the length of the elongate member 1200. The LEDs 1204 are helically disposed about the longitudinal axis L of the elongate member 1200. A positioning device 1202 is disposed at the distal end 1200d of the elongate member 1200.

[0070] In various embodiments, the illumination members, which may be LEDs, may extend along a portion of the length of the elongate member. The LEDs may extend to the distal end of the elongate member that includes the positioning device. The LEDs may be arranged in various patterns along the elongate member such that the LEDs are visible from one or more of the radial viewing angles from the longitudinal axis of the elongate member, such as helically, axially, radially, circumferentially, linearly, intermittently spaced apart, randomly, at various densities along the length, or combinations of such arrangements. The LEDs may be activated to emit light. An activated LED may be visible across a tissue wall, for example, from outside the body lumen that contains the LEDs. The LEDs may have a variable wavelength to emit a color, e.g., red, green, etc., as an indicator that is more easily visible across a tissue wall than other colors. The LEDs may be activated at various frequencies as an indicator. The indicator may specify a location, for example, the indicator may be a specific distance from the end of the elongate member, the positioning device, or the anatomical structure. The LEDs may be individually selectable and controllable as single LEDs or as groups of multiple LEDs. The LEDs may be controllable by one or more parameters, such as density, location of the LEDs relative to one another, the anatomy or medical device, size, shape, activation frequency (e.g., patterned to aid in location or notification, such as a double blink followed by a pause), activation intensity (e.g., using a current source with pulse width modulation (PWM) operating at a desired frequency and / or duty cycle to affect the intensity of the LEDs), activation duration, color, or any combination of two or more of the foregoing.

[0071] In various embodiments, a controller may be electrically coupled to the LEDs along the elongated member. The electrical leads may be interleaved in electrical communication with the LEDs such that the LEDs may be independently activated. The controller may be configured to sequentially activate one or more LEDs at a time. The controller may sequentially activate the LEDs in a distal direction along the length of the elongated member, e.g., pointing in a direction toward the distal end of the elongated member toward the positioning device. The controller may be configured to sequentially activate the LEDs such that a single LED or multiple LEDs are activated at a time, e.g., in an activation pattern of an illumination wave traveling distally along the elongated member. The controller may be configured to activate all but one LED in a distally sequential pattern such that a majority of the LEDs (e.g., 90% or more of all LEDs) are activated for location verification, e.g., pointing in a direction such as an activation pattern of an extinction wave traveling distally along the elongated member. The controller may be configured to operate the LEDs at a higher frequency (e.g., a lower duty cycle with a lower percentage of time the LEDs are illuminated) with a shorter illumination time to reduce heat compared to LEDs operated at a lower frequency (e.g., a higher duty cycle with a higher percentage of time the LEDs are illuminated) with a longer illumination time. The controller may be configured to operate a portion of the LEDs at a first frequency and another portion of the LEDs at a second frequency, e.g., a distal portion of the LEDs may be operated at a higher frequency than a proximal portion of the LEDs. The LEDs may extend along the length of the elongated member for a distance substantially along the patient's anatomy. For example, the LEDs may extend along a length between the pylorus and a treatment target location of a portion of the jejunum. This may be any desired length, e.g., about 50 centimeters distal to the pylorus, about 150 centimeters distal to the pylorus, etc. The controller may be operated manually or automatically to activate one or more LEDs or to switch between various operation patterns. Such activation of the LEDs may be curtailed to reduce heat.

[0072] 13, an embodiment of a medical device locator is shown that includes a sheath, guidewire, or elongated member 1300 having a proximal end 1300p, a distal end 1300d, and a length extending along a longitudinal axis L therethrough. LEDs 1304 are disposed along the length of the elongated member 1300. The LEDs 1304 are linearly disposed around and along the longitudinal axis L of the elongated member 1300. A positioning device 1302 is disposed at the distal end 1300d of the elongated member 1300. The LEDs are configured to emit variable wavelengths. A proximal portion 1305 of the LED 1304 is configured to emit light of a red wavelength, a central portion 1306 of the LED 1304 is configured to emit light of a white wavelength, and a distal portion 1307 of the LED 1304 is configured to emit light of a green wavelength. The portions 1305, 1306, 1307 indicate positions along the elongated member 1300. Proximal portion 1305 indicates a location along elongate member 1300 proximal to central portion 1306, which indicates a location along elongate member 1300 proximal to distal portion 1307, which indicates a location along elongate member 1300 proximal to distal end 1300d or positioning device 1302. Each of portions 1305, 1306, 1307 may be located at various distances from distal end 1300d of elongate member 1300, for example proximal portion 1305 may be located, for example, about 50 centimeters from distal end 1300d, central portion 1306 may be located, for example, about 15 centimeters from distal end 1300d, and distal portion 1307 may be located substantially at distal end 1300d. Although three segments 1305, 1306, 1307 and three colors of LED 1304 are shown, any number and / or location of these segments and / or colors may be employed.

[0073] 14, an embodiment of a medical device locator is shown that includes an elongated member 1400, which may be a sheath, guidewire, or guidewire, for example. The elongated member 1400 includes LEDs 1410, 1412 disposed along its length. A support member 1402 extends longitudinally within the elongated member 1400. A board 1404 is disposed along the support member 1402 such that the board 1404 extends radially away from the support member 1402. The LEDs 1410, 1412 are disposed on opposite sides of the board 1404 such that a first pair of LEDs 1410 are disposed on a first side of the board 1404 and a second pair of LEDs 1412 are disposed on a second side of the board 1404. The LEDs 1410, 1412 are disposed on opposite sides of the board 1404 such that at least one pair of LEDs 1410, 1412 are viewed as a 180° arc 1418 around the elongated member 1400. Each pair of LEDs 1410, 1412 may include variable color LEDs, for example green and red, which may be both illuminated, selectively illuminated, alternating, or sequentially illuminated to enhance visibility (e.g., across tissue) and / or to indicate direction (e.g., green indicates a distal direction of the elongate member 1400 and red indicates a proximal direction of the elongate member 1400). Although the pair of LEDs 1410, 1412 is shown as four LEDs 1410, 1412 total, the LEDs may be grouped into sections larger than the pair or not grouped at all and any number of LEDs may be employed, for example 1, 2, 3, 5, 6, 8, 10, 15, 20, 50, 100, etc. The LEDs 1410, 1412 may be illuminated and controlled by a wire conduit 1416 that is electrically coupled to the LEDs 1410, 1412 and extends proximally along the elongate member 1400 within the elongate member 1400. The wire 1416 may extend proximally along the elongate member 1400 to a connector 1420. The connector 1420 may be reversibly coupled to a controller and may be sized to fit into the working channel of the endoscope. The controller may include a power source, circuitry, instructions, and / or switches for powering and controlling the lights, such as the LEDs 1410, 1412.The connector 1420 includes contacts 1422 in electrical communication with the wires 1416, which may be reversibly coupled to leads of a controller. The portions of the wires 1416 and LEDs exposed externally from the elongate member 1400 are covered by a transparent / translucent coating 1424 (e.g., silicone, etc.) that protects the electrical connections between the LEDs 1410, 1412, board 1404, wires 1416, and external fluids / debris (e.g., bodily fluids), and damage, while allowing visibility of the illuminated LEDs 1410, 1412.

[0074] In use, an endoscope having a working channel may be inserted into the duodenum of a patient, and the elongated member 1400 may be extended through the working channel into the duodenum. The elongated member 1400 may be further advanced along the small intestine to a desired location that may be observed and measured by markings (e.g., radiopaque and / or colored markings) on the elongated member 1400, which may indicate that the elongated member 1400 and / or LEDs 1410, 1412 are a desired distance (e.g., approximately 150 cm) beyond the pylorus. The endoscope may then be withdrawn proximally along the elongated member 1400, leaving the elongated member 1400 in the small intestine. As the distal end of the endoscope is withdrawn into the pylorus, the elongated member 1400 may be adjusted proximally or distally, for example, to position the markings of the elongated member 1400 at the pylorus. The endoscope may then be fully withdrawn from the patient along with the elongated member 1400 and the connector 1420. The connector 1420 may then be coupled to a controller that enables operation of the LEDs 1410,1412.

[0075] Generally, as applicable to any of the locator devices and systems described above or included in this disclosure, an embodiment of a method for positioning a medical device across a body lumen may include extending an elongate member including a plurality of LEDs along a length of the elongate member in a first body lumen, e.g., the jejunum, such as a step for positioning the locator device of FIG. 14, as described in the previous paragraph. The plurality of LEDs may be sequentially activated in a distal direction along the length of the elongate member. The sequentially activated LEDs may indicate the orientation of a device or anatomical structure, such as the positioning device and / or a portion of the first body lumen. The activated LEDs may be visible, e.g., from within the abdominal cavity, across the tissue wall of the first body lumen. A piercing mechanism, e.g., a cutting tool, may be extended across the tissue wall of a second body lumen, e.g., the stomach, toward the first body lumen to make a cut against the tissue wall of the first body lumen.

[0076] It will be apparent to one skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the present disclosure. For example, the configuration of the positioning device and catheter can be modified to accommodate any medical device or procedure. It will be understood that the number and / or location of LEDs is not limited to the examples set forth herein. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

1. an elongated member including a positioning device attached to an exterior surface of the elongated member, the positioning device including at least one light emitting diode (LED) emitting green light and at least one separate LED emitting red light, the LEDs being controllable to emit red light separately from the green light or separately from the red light to facilitate positioning of the positioning device; 1. A system comprising: a medical device comprising an endoscope, the endoscope including an imaging device and an end effector configured to extend from a distal end of the endoscope, the imaging device configured to detect green and red light emitted from the LED.

2. 2. The system of claim 1, wherein the positioning device comprises: A side wall; a proximal end wall at a proximal end of the side wall; a distal end wall at a distal end of the side wall, wherein the side wall, the proximal end wall, and the distal end wall define a cavity, and one of the LEDs is disposed within the cavity.

3. 3. The system of claim 2, wherein the side walls comprise a transparent or translucent material and at least one of the proximal end wall or the distal end wall comprises one or more of an opaque material or a light attenuating material.

4. 4. The system of claim 1, wherein the elongated member includes a fluid lumen extending from a proximal end of the elongated member to a distal end of the elongated member, and a plurality of holes are disposed in a sidewall of the elongated member and are fluidly connected to the fluid lumen.

5. 5. The system of claim 4, further comprising a vacuum device and a fluid containing device, each of the vacuum device and the fluid containing device being in fluid communication with the fluid lumen at the proximal end of the elongate member, the vacuum device being configured to create suction within the fluid lumen such that fluid from the body is configured to flow through the plurality of holes, along the fluid lumen and into the fluid containing device.

6. The system of any one of claims 1 to 5, wherein the elongate member further comprises a central lumen configured to receive a guidewire.

7. The system of any one of claims 1 to 6, wherein the positioning device further comprises a balloon at the distal end of the elongate member, the balloon configured to inflate.

8. 8. The system of claim 7, wherein the balloon comprises a transparent or translucent material, one of the LEDs is disposed on a surface of the elongated member, and light emitted from the LED is configured to pass through the balloon.

9. 8. The system of claim 7, wherein the balloon is disposed on a first side of the elongate member and one of the LEDs is disposed circumferentially on an opposite side of the elongate member from the balloon.

10. 8. The system of claim 7, wherein a plurality of the LEDs are positioned around the balloon.

11. 2. The system of claim 1, wherein the elongated member includes an elongated member body and a distal tip of the elongated member, a proximal end of the distal tip of the elongated member connected to a distal end of the elongated member body by a plurality of wires, and each LED of the LEDs is attached to a respective wire from the plurality of wires.

12. 12. The system of claim 11, further comprising an actuation wire attached to a distal tip of the elongate member, the actuation wire configured to move proximally relative to a body of the elongate member, and the LEDs configured to be moved radially outward when the actuation wire moves the distal tip of the elongate member proximally relative to the body of the elongate member.

13. 13. The system of claim 1, wherein the LEDs are configured to alternately emit green light from the at least one LED that emits green light and red light from the at least one distinct LED that emits red light.

14. 14. The system of claim 1, wherein the LEDs are configured to emit green light from the at least one LED emitting green light in a pulsed manner and red light from the at least one separate LED emitting red light.

15. 15. A system according to any one of claims 1 to 14, wherein the endoscope is configured to be inserted into a body and advanced to a stomach within the body, the endoscope having a working channel, and the elongated member configured to extend through the working channel.

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