Devices, systems and methods for locating body cavities

Abstract

The present invention generally relates to medical devices, systems and methods for positioning devices and / or anatomical structures during medical procedures. More particularly, in some embodiments, the present invention relates to medical device and / or anatomical structure positioning devices, access devices and systems and methods thereof for use, for example, during a gastrojejunostomy. In one aspect, a medical device positioner can include an elongated 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. A positioning device can be disposed along the length of the elongated member.

Description

[0001] priority

[0002] This application claims the benefit of priority under 35 USC §119 to U.S. Provisional Patent Application Serial No. 62 / 954,875, filed on December 30, 2019, the entire contents of which are incorporated herein by reference and for all purposes. Technical Field

[0003] The present invention generally relates to medical devices, systems and methods for positioning devices and / or anatomical structures during medical procedures. More particularly, in some embodiments, the present invention relates to medical device and / or anatomical structure positioning devices, access devices and systems and methods thereof for use during gastrojejunostomy. Background Art

[0004] Various health problems, such as obesity and diabetes, affect a growing population and may lead to additional diseases, thereby increasing the risk to the patient's health. Surgical procedures, such as bariatric surgery, for example, to restrict a portion of the stomach and / or bypass portions of the intestines and / or other portions of the gastrointestinal (GI) tract, may be an option for certain patients with these and / or other health problems. These types of surgeries may have significant side effects, such as, for example, intestinal hormone changes, and may be invasive surgical procedures with associated complications, tissue trauma, anastomotic leaks, infections, and / or additional surgery to modify the initial surgery, for example, to redirect the placement of a bypass device, which in some cases may place the patient at increased risk.

[0005] Therefore, there may be a need for less invasive medical devices, systems and related methods for treating the GI tract and / or bypassing portions of the intestine to reduce complications associated with treating these and other health problems. The present invention may address one or more of these or other problems in the art. Summary of the invention

[0006] According to one aspect, a medical device positioner may include an elongated member including a positioning device at a distal end of the elongated member. The positioning device may include at least one light emitting diode (LED), and wherein the at least one LED may be configured to be actuated to emit light having wavelengths corresponding to green light and red light.

[0007] The positioning device may include a side wall, a proximal wall at a proximal end of the side wall, and a distal wall at a distal end of the side wall, wherein the side wall, the proximal wall and the distal wall may define a cavity, and wherein at least one LED may be disposed within the cavity.

[0008] The side walls may include a transparent material or a translucent material, and at least one of the proximal wall or the distal wall may include one or more of an opaque material or a light attenuating material.

[0009] The elongated member may include a fluid cavity extending from a proximal end of the elongated member to a distal end of the elongated member.A plurality of apertures may be disposed in a sidewall of the elongated member and fluidly connected to the fluid cavity.

[0010] The vacuum device and the fluid containment device can be connected to the slender member, wherein each of the vacuum device and the fluid containment device can be in fluid communication with a fluid cavity at the proximal end of the slender member, and wherein the vacuum device can be configured to create suction within the fluid cavity so that fluid from the body can be configured to flow through the plurality of holes and along the fluid cavity to the fluid containment device.

[0011] The elongate member may include a central lumen configured to receive a guidewire.

[0012] The positioning device may include a balloon at the distal end of the slender member, and the balloon may be configured to be inflated.

[0013] The balloon may include a transparent or translucent material, at least one LED may be disposed on a surface of the elongated member, and light emitted from the LED may be configured to be transmitted through the balloon.

[0014] The balloon may be disposed on a first side of the elongated member, and at least one LED may be disposed on a side of the elongated member circumferentially opposite the balloon.

[0015] The at least one LED may include a plurality of LEDs. The plurality of LEDs may be arranged around the circumference of the balloon.

[0016] The slender member may include a slender member body and a slender member distal tip, wherein the proximal end of the slender member distal tip can be connected to the distal end of the slender member body by a plurality of wires, and wherein at least one LED can be attached to each wire originating from the plurality of wires.

[0017] The actuation wire can be attached to the distal tip of the slender member, wherein the actuation wire can be configured to move proximally relative to the slender member body, and wherein the LED can be configured to move radially outward when the actuation wire causes the distal end of the slender member to move proximally relative to the slender member body.

[0018] The at least one LED may be configured to emit green light and red light alternately.

[0019] The at least one LED may be configured to emit green light and red light in a pulsed manner.

[0020] A system with a medical device may include an endoscope having an imaging device and an end effector that may extend from a distal end of the endoscope, wherein the imaging device may be configured to detect light from a locator having wavelengths corresponding to green and red light emitted from at least one LED.

[0021] According to another aspect, a method may include inserting an endoscope into a body and advancing the endoscope to a stomach of the body, wherein a distal end of the endoscope includes a camera; inserting a slender member into the body, wherein the distal end of the slender member includes at least one light emitting diode (LED); advancing the slender member through the stomach and to the small intestine of the body; activating at least one LED to emit a first light having a first wavelength; detecting the first light with a camera; activating at least one LED to emit a second light having a second wavelength different from the first wavelength; and detecting the second light with a camera.

[0022] The method may also include creating one or more of the incisions in the stomach wall and the small intestine wall corresponding to the location of the at least one LED.

[0023] The first light may have a wavelength corresponding to red light, and the second light may have a wavelength corresponding to green light.

[0024] According to yet another aspect, a method may include inserting an endoscope into a body and advancing the endoscope to a stomach of a body, wherein a distal end of the endoscope includes a camera; inserting an elongated member into the body, wherein the distal end of the elongated member includes a positioning device, the positioning device including at least one light emitting diode (LED); advancing the elongated member through the stomach and into the small intestine of the body; creating an incision in the stomach wall; advancing the endoscope through the incision in the stomach wall; activating at least one LED to emit red light; detecting the red light with a camera; activating at least one LED to emit green light; detecting the green light with a camera; creating an incision in the small intestine wall based on at least one of detecting the red light and detecting the green light; and placing a stent to connect the stomach wall and the small intestine wall. The at least one LED may be activated to emit red and green light in a pulsed manner.

[0025] In another aspect, a medical device positioner can include an elongated member having a proximal end, a distal end, a longitudinal axis, and a length extending along the longitudinal axis. A positioning device can be disposed along the length of the elongated member.

[0026] In various embodiments described herein and otherwise within the scope of the present invention, the elongated member may be a tubular sheath that can extend 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 the distal end of the elongated member. The inflation chamber may extend along the length of the elongated member in fluid communication with the inflatable member. A plurality of illumination members may include an LED disposed along the length of the elongated member, the LED being actuated to emit light having a wavelength corresponding to green light or red light. The positioning device may include one or more LEDs in the plurality of illumination members, which are located at a distal point of the illumination member along the elongated member that can be identified to locate the medical device. The positioning device may include one or more LEDs in the plurality of illumination members leading upward to the distal point of the terminal. A plurality of leads may be electrically connected to the plurality of illumination members extending along the elongated member. The controller may be electrically connected to the plurality of leads extending along the elongated member. The controller may be configured to selectively actuate a portion of the plurality of illumination members in a distal direction along the length of the elongated member. The controller may be configured to sequentially actuate one or more LEDs selected from a plurality of illumination members in a distal direction along the length of the elongated member. The controller may be configured to actuate all illumination members of a plurality of illumination members except one illumination member in the plurality of illumination members, wherein one illumination member sequentially changes each time an illumination member is activated in a distal direction. The plurality of illumination members may include a selected illumination member along the proximal portion of the elongated member having a first wavelength and a selected illumination member along the distal portion of the elongated member having a second wavelength. The plurality of illumination members may be actuated at shortened frequency intervals in a distal direction along the length of the elongated member. The plurality of illumination members may be arranged along the length of the elongated member so that the density of the illumination members increases along the length of the elongated member extending from the proximal end toward the distal point along the end of the elongated member. The plurality of illumination members may be individually selected and controlled as a single illumination member or in a group of more than a single illumination member. The plurality of illumination members may extend a distance of about 50 centimeters along the length of the elongated member.

[0027] In another aspect, a system for positioning a medical device may include a medical device positioner, which includes a slender member having a proximal end, a distal end, a longitudinal axis, and a length extending along the longitudinal axis. The positioning device may be arranged along the length of the slender member. A plurality of lighting components may be arranged along the length of the slender member. The slender member may extend in a first body cavity. The medical device may be positioned in a second body cavity. The medical device may be positioned with the medical device positioner to a target position in the second body cavity opposite to the positioning device through a tissue wall of the first body cavity and a second tissue wall of the body cavity. The plurality of lighting components may include LEDs. The controller may be electrically coupled to the plurality of LEDs. The controller may be configured to selectively actuate the plurality of LEDs along the length of the slender member in a distal direction.

[0028] In another aspect, a method for positioning a medical device locator may include inserting an elongated member into a first body cavity. The elongated member may include a plurality of LEDs extending along the length of the elongated member. A positioning device may be disposed at the distal end of the elongated member. A controller may be configured to selectively actuate a plurality of LEDs along the length of the elongated member in a distal direction. The actuated plurality of LEDs may be viewed through the first body cavity wall to position the positioning device at a target location within the first body cavity. An opening may be cut through the second body cavity wall toward the first body cavity at the target location, and through the first body cavity wall at the target location. The positioning device may include one or more of the plurality of LEDs. Observation of the actuated plurality of LEDs may be performed from within the peritoneal cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] 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.

[0030] Figure 1 The human gastrointestinal system is shown;

[0031] Figures 2A to 2F An exemplary embodiment of a system and process for creating a stoma according to an aspect of the present invention is shown;

[0032] Figures 3A to 3D According to one aspect of the present invention Figures 2A to 2F A perspective view of a catheter and a positioning device used with a system;

[0033] Figure 4A and 4B According to one aspect of the present invention Figures 2A to 2F A perspective view of another example of an elongated member and a positioning device for use with a system;

[0034] Figure 5 According to one aspect of the present invention Figures 2A to 2F A perspective view of another example of an elongated member and a positioning device for use with a system;

[0035] Figure 6 According to one aspect of the present invention Figures 2A to 2F A perspective view of another example of an elongated member and a positioning device for use with a system;

[0036] Figure 7 According to one aspect of the present invention Figures 2A to 2F A perspective view of another example of an elongated member and a positioning device for use with a system;

[0037] Fig. 8A and 8B According to one aspect of the present invention Figures 2A to 2F A perspective view of another example of an elongated member and a positioning device for use with a system;

[0038] Fig. 9 According to one aspect of the present invention Figures 2A to 2F A perspective view of another example of an elongated member tube and a positioning device for use with a system;

[0039] Fig. 10A and 10B According to one aspect of the present invention Figures 2A to 2F A perspective view of another example of an elongated member and a positioning device for use with a system;

[0040] Fig.11A An elongated member extending into the jejunum and an instrument extending toward the elongated member through the stomach wall into the peritoneal cavity are shown according to one aspect of the present invention;

[0041] Fig. 11B A device for manipulating the jejunum is shown. Fig.11A system;

[0042] Fig. 11C A device with a device extending through the jejunal wall is shown. Fig.11A and 11B system;

[0043] Fig.12 An elongated member having a plurality of LEDs disposed along its length is shown according to one aspect of the present invention;

[0044] Fig.13 An elongated member having a plurality of LEDs disposed along its length is shown according to one aspect of the present invention; and

[0045] Fig.14 An elongated member having a plurality of LEDs disposed along its length is shown in accordance with one aspect of the present invention. DETAILED DESCRIPTION

[0046] The present invention will now be described with reference to an exemplary medical system that can be used in an endoscopic medical procedure. However, it should be noted that reference to this particular procedure is provided only for convenience and is not intended to limit the present invention. One of ordinary skill in the art will recognize that the concepts underlying the disclosed apparatus and associated methods of use can be used in any suitable surgical, medical or other context. The present invention may be understood with reference to the following description and accompanying drawings, in which like elements are designated by like reference numerals.

[0047] Whenever possible, the same or similar reference numerals will be used in all drawings to refer to the same or similar parts. The term "distal" refers to the part farthest from the user when the device is introduced into the patient's body. Conversely, the term "proximal" refers to the part closest to the user when the device is placed in the patient's body. As used herein, the terms "include", "comprise" or any other variation thereof are intended to cover non-exclusive contents, so that the process, method, article or device including a list of elements does not necessarily include only those elements, but may include other elements that are not explicitly listed or are not inherent to such process, method, article or device. The term "exemplary" is used in the sense of "example" rather than "exemplary". In addition, as used herein, the terms "approximately", "about" and "substantially" indicate a range of values ​​within + / -10% of the value or implied value. Additionally, the terms indicating the geometric shape of the component / surface refer to precise and approximate shapes.

[0048] Although embodiments of the present invention are described with specific reference to medical device positioners and systems and methods for positioning medical devices within specific portions of the GI tract for specific purposes (e.g., affecting metabolism and affecting weight loss), it will be understood that such embodiments can be used to position various forms of such medical devices into a variety of different body cavities and / or passages for a variety of different purposes, including, for example, transanal access to the transverse colon, ascending colon, or ileum, choledochojejunostomy, jejunocolic bypass, jejunoileal bypass, gastrectomy, biliopancreatic diversion with duodenal switch (BPD-DS), gastrojejunostomy, segmental colectomy, and other procedures involving the use of a medical device positioner having a beacon for locating a target portion of a body cavity such that an instrument can enter the cavity at the target portion by viewing the beacon from outside the cavity, and the like.

[0049] Although the present invention includes descriptions of stomas, openings, or fistulas formed in the GI tract for affecting weight and absorption, the devices, systems, and methods herein may be implemented along various other portions of the GI tract, or between lumens outside the GI tract, and for various other drainage and / or catheter purposes.

[0050] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. In addition, such phrases do not necessarily refer to the same embodiment. In addition, when a particular feature, structure, or characteristic is described in conjunction with one embodiment, whether or not explicitly described, it is within the knowledge of those skilled in the art to implement such feature, structure, or characteristic in conjunction with other embodiments, unless explicitly stated to the contrary. That is, even if not explicitly shown in a particular combination, the various individual elements described below are still considered to be combinable or arranged with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as will be understood by those of ordinary skill in the art.

[0051] refer to Figure 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, wherein the duodenum 115 is proximal to the jejunum 120, and the junction of the duodenum 115 and the jejunum 120 is defined by the location of the ligament of Treitz 130 connected to the small intestine 125. As will be explained herein, an anastomosis may 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 travel from the stomach 105 through the small intestine 125, which may promote weight loss in the patient and, in some examples, improve weight-related and other health conditions, such as addressing type 2 diabetes.

[0052] refer to Figures 2A to 2F , shows an example of an endoscopic procedure according to the present invention, e.g., a gastrojejunostomy. In a first step 200, a nasal catheter 230 can be inserted into a patient's body, e.g., through the nose and esophagus into the patient's stomach 105 and / or small intestine 125. The distal end 235 of the nasal catheter 230 can be positioned at a desired distance in the small intestine 125 to the jejunum 120, as determined by a medical professional and / or based on the medical procedure. The nasal catheter 230 can be advanced by peristaltic motion and / or by a medical professional by pushing a handle associated with the proximal end of the nasal catheter 230, which can cause the nasal catheter 230 to move distally. As will be described herein, the nasal catheter 230 can be configured to slide along a guide wire to position the nasal catheter 230 in the gastrointestinal system 100. In a second step 205, as Figure 2BAs shown, endoscope 240 can be inserted into stomach 105 so that distal end 245 of endoscope 240 is positioned in an area of ​​stomach 105 proximal to distal end 235 of nasal catheter 230 positioned in jejunum 120, for example, at the fundus of the stomach having a greater curvature and / or in the antrum of the stomach.

[0053] Once the distal end 245 of the endoscope 240 is in position in the stomach 105, a perforation or other incision is made in the mucosa of the stomach 105 at step 210, such as Figure 2C After making the incision in the stomach wall, a grasping 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 outside the stomach 105. The position of the distal end 245 relative to the stomach 105 is determined by a medical professional by positioning a positioning device at the distal end 235 of the nasal catheter 230, as will be described in detail herein. Once the outer wall of the jejunum 120 is grasped by the grasping mechanism, an incision or other opening can be made in the jejunum 120, as will be described herein.

[0054] exist Figure 2D In step 215 shown in FIG. 1 , the end effector 250 may pierce the jejunum 120 while maintaining the position of the nasal catheter 230 in the jejunum 120 via, for example, an anchoring guidewire 255. It should be understood that the position of the distal end 235 of the nasal catheter 230 and therefore the position of the incision in the small intestine 125 may depend on the patient and / or medical procedure. Figure 2E As shown, anastomotic stent 260 is deployed from endoscope 240 in step 220 to join the opening made in the wall of stomach 105 and the opening made in the wall of jejunum 120 to create a bypass of pylorus 110 and duodenum 115, eg, a gastrojejunostomy.

[0055] exist Figure 2FIn the embodiment of the present invention, the pyloric occlusion device 265 can be deployed at the pylorus to prevent the patient's gastric contents from traveling through the pylorus 110 and redirecting the gastric contents through the anastomotic stent 260. The pyloric occlusion device 265 can be any form for preventing food, liquid and / or nutrients from flowing from the stomach 105 into the duodenum 115. Instead, the gastric contents can be directly transferred from the stomach 105 to the jejunum 120 via the anastomotic stent 260, thereby limiting and / or preventing nutrients, food and / or liquid from being taken up by the body in the duodenum 115 (the surgery can include, but is not limited to, gastroenterostomy, gastrojejunostomy, and / or gastroduodenostomy). This can limit and / or prevent certain medical conditions, such as weight gain and diabetes. It should be understood that the medical professional can remove the pyloric occlusion device 265 and / or the anastomotic stent 260 later, thereby increasing the absorption of food, liquid and / or nutrients by the stomach 105 and / or duodenum 115. Although an endoscopic procedure for placing an anastomotic device is described herein, additional surgical and device features for pyloric occlusion devices and anastomotic stents and stenting that may be useful may also be found in the complete disclosures of U.S. Publication No. 2019 / 0298401, filed on March 22, 2019, published on October 3, 2019, and entitled “Systems and Methods for Performing Endoscopic Procedures,” and U.S. Publication No. 2019 / 0298559, filed on March 22, 2019, published on October 3, 2019, and entitled “Device, System, and Method for Pyloric Occlusion,” the entire disclosures of each of which are incorporated herein by reference.

[0056] As described above, the distal end 235 of the nasal catheter 230 can be positioned within the jejunum 120 to assist medical personnel in determining the proper location for deploying the anastomotic stent. Figure 3A An example positioning device for positioning the distal end of a nasal catheter is shown in . For example, the distal end may include a positioning device 300 that is attached at its proximal end to a sheath, guidewire, or elongated member 305. As used herein, unless otherwise specified, the term "elongated member" or "elongated member" may include any catheter (including a nasal catheter, oral catheter, anal catheter, or other endoscopic catheter), sheath, shaft, guidewire, wire, endoscope, or any member attached to a positioning device (with or without a lumen extending therethrough), including the positioning device 300 thereon. It should be understood that the positioning device 300 can be placed proximal to the distal-most end of the sheath, guidewire, or elongated member 305, such as Figure 3BAs shown. For example, the elongated member 305 may include a guide wire or the like to provide structural support to move the elongated member 305 proximally and / or distally, or to allow a medical professional to place a guide wire in the small intestine 125 and slide the elongated member 305 along the guide wire. The positioning device 300 may be attached to the outer surface of the elongated member 305 using an adhesive or the like, and may be positioned at a distance from the farthest end of the elongated member 305, such as a distance of about 15 cm. The length of the elongated member 305 may be about 4 meters or less, such as about 3 meters, but is not limited to this length. The elongated member 305 may have a diameter of about 0.035 inches, or an elongated member 305 without a cavity of about 0.025 inches in diameter, or a diameter of about 7F or about 5F for an elongated member 305 including a cavity. The distance and diameter are not limited and may vary depending on the size of the patient and / or the treatment procedure being performed by the medical staff.

[0057] The elongated member 305 may also include a ring 312, such as Figure 3B As shown, the distal end of the elongated member 305 is bent or curved, and the distal end of the elongated member 305 is facing in a generally proximal direction. The ring 312 can be formed by pushing the elongated member 305 distally and after the elongated member 305 is introduced into the body. For example, at least a portion of the elongated member 305 can be flexible, or have a variable stiffness, so that the distal end of the elongated member 305 folds back on itself during a medical procedure, thereby forming the ring 312 from a straight line. When the elongated member 305 is moved proximally, the ring 312 can approach a straight line. The ring 312 can provide a blunt end, which can reduce the chance of intestinal perforation when manipulating the elongated member 305 and can increase the positioning accuracy of the positioning device 300. The ring 312 can be alternatively formed in or around the guide wire, and the elongated member 305 can extend along the guide wire via a cavity, as will be described herein. It should be understood that the wire for conducting electricity can be arranged inside the cavity of the elongated member 305 and / or on the outer surface of the elongated member 305. Alternatively, the wires may be encapsulated within the walls of the elongated member 305 and / or between multiple layers of the walls of the elongated member 305 .

[0058] according to Figure 3A In the example shown in , 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 wall 304, and a proximal 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 cuboid, or a sphere. The side wall 302 may be a single wall having a cylindrical shape, such as Figure 3AAs shown, or the side wall 302 can include multiple side walls forming, for example, a rectangular prism. An internal space 308 can be formed between the side wall 302, the distal wall 304 and the proximal wall 306. The space 308 can include a fluid, an atmosphere and / or an inert gas or other gas. For example, the positioning device 300 can include an alternative light-emitting feature, wherein the electrodes are disposed within the internal space 308 and at opposite ends thereof, and a gas, such as neon, is disposed within the internal space 308.

[0059] According to one example, the LEDs 310 can be positioned within the interior space 308. Each of the LEDs 310 can be any shape, such as, but not limited to, a rectangle. Additionally or alternatively, the plurality of LEDs 310 can be arranged in any shape, including a triangle (e.g., three LEDs 310 at 120 degree angles relative to each adjacent LED 310), a cube (e.g., four LEDs 310 at 90 degree angles relative to each adjacent LED 310), and / or can form an in-line orientation, wherein each LED 310 faces a different direction. Light emitted from the LEDs 310 can be emitted from the interior space 308 of the positioning device 300 via the sidewalls 302, which can be transparent or translucent. According to one example, one or both of the distal wall 304 or the proximal wall 306 can include or be formed of an opaque or other light attenuating material that can focus light emitted from the LEDs 310 through the sidewalls 302 and can assist a medical professional in positioning the positioning device 300. As will be described in detail herein, each diode from the LED 310 can emit visible light of one or more wavelengths of light, as will be 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 located on a first side of the elongated member 305, and the single red LED 310 and the single green LED 310 can be located on circumferentially opposite sides of the elongated member 305. As another example, one or more red LEDs 310 can be located on a first side of the elongated member 305, and one or more green LEDs 310 can be located on circumferentially opposite sides of the elongated member 305. Alternatively, there can be one LED of each color, or, for example, two (2) to ten (10) or more LEDs 310 of each color. Alternatively or additionally, LED 310 and any LEDs described herein may be arranged in multiple rows, for example, two or more rows parallel to or substantially parallel to the longitudinal axis of the slender member 305 and the positioning device 300, and may be arranged around the entire circumference of the slender member 305, or may extend around only a portion of the circumference of the slender member 305.

[0060] Alternatively, the positioning device 300 may include one or more LEDs 310 disposed on the elongated member 305, such as Figure 3B shown. Figure 3B An array of two LEDs 310 is shown, and the color of each of these LEDs 310 can be the same or different, for example, one green LED 310 and one red LED 310. As a further example, the LEDs 310 can be located in an array of 1 to 20 LEDs or 4 to 6 rows of LEDs, wherein each row is parallel to the longitudinal axis of the elongated member 305 and the positioning device 300. The rows can be arranged circumferentially around the elongated member 305. Alternatively, the LEDs 310 can be arranged on only one side of the elongated member 305, for example, to focus the light emitted by the LEDs 310 only to one side of the positioning device 300. The LEDs 310 can flash, for example, can be turned on and off in a pattern. For example, the LEDs 310 can flash at about 1 Hz, with a duty cycle of about 10-15% and a current of about 150 mA.

[0061] A covering, such as an electrically insulating heat shrink tubing or a hardening substance, such as glue, may be placed over the side walls 302, distal wall 304, and proximal wall 306, or these walls may be replaced entirely, such that the covering covers all or a portion of the LEDs 310. The covering is not limited to a location only at the LEDs 310, and may extend along the elongated member 305 in a distal and / or proximal direction to ensure that the LEDs 310 are adequately adhered to the elongated member 305. The covering may be transparent or translucent such that light from the LEDs 310 may be transmitted therethrough.

[0062] Each LED 310 can emit red light and / or green light. Red light is relatively less absorbed by human tissue and is therefore scattered, but due to its higher transmission through human tissue, it can be seen more easily than green light from a distance. Green light is relatively more absorbed by human tissue, resulting in lower transmission than red light. However, due to the reduced scattering of green light in the body, green light is more easily located than red light. In addition, the eyes of medical personnel and the image sensors of endoscopes (e.g., CMOS image sensors, etc.) are generally more sensitive to the wavelength of green light than to the wavelength of red light, which can further improve the determination of the specific position of LED 310. For example, LED 310 (e.g., first LED 310) can be controlled to emit red light to determine the approximate area where the positioning device 300 is located, and LED 310 (e.g., second LED 310) can emit green light to more specifically locate the precise position of the positioning device 300. Thus, the red light can be a rough locator or first adjustment for identifying the medical device and positioning the medical device toward a desired location, and the green light can be a fine or second adjustment for identifying the medical device and positioning the medical device at a desired location. In some embodiments, the red light can be manually (or automatically) switched to green light when the user has roughly positioned the medical device as desired. In some embodiments, the red light and the green light can alternate at preselected intervals so that the user can direct the medical device toward a desired location as the red light and the green light alternate. Additionally or alternatively, the LED 310 can generate red light and green light simultaneously, for example, the first LED 310 / light array can generate red light, and the second LED 310 / light array can generate green light. It should be understood that the LED 310 is not limited to these colored lights, and can include other lights, including, but not limited to, white light.

[0063] refer to Figure 3A, the distal end of the sheath, guidewire or elongated member 305 can extend through the opening in the proximal wall 306, and the opening can then be sealed around the elongated member 305. The elongated member 305 can include multiple wires, for example, two positive wires (one positive wire for each LED 310 anode terminal) and a common cathode return terminal wire for delivering electrical energy from a power source (e.g., a generator, battery pack, or equivalent energy source) located at the proximal end of the elongated member 305 to the LEDs 310, and providing independent control of each LED 310, which can improve light transmission efficiency and can reduce the heat of the light from the LEDs 310 and any adverse effects on the body associated with the heat. For example, the wires can be contained in a cavity or layer of the elongated member 305 extending from the proximal end of the elongated member 305 to the distal end, and / or the wires can extend from the proximal end to the distal end along the outer surface of the elongated member 305. The wires can also be insulated with a biocompatible polymer and not covered, or can be attached to a member with greater rigidity. In this case, the wire will form a "pill on a string" and can be positioned at the desired location via peristalsis.

[0064] According to another example, the positioning device 300 can include a diffuser in place of the LED 310. The elongated member 305 can include a plastic or glass diffuse light pipe (the elongated member 305 can be a diffuse light pipe or the light pipe can replace the wires that conduct current to the LED 310). The elongated member 305 can include a reflective surface to push light to the distal end of the elongated member 305. For example, the light can be coupled to the proximal end of the elongated member 305 using a light source. Once the light reaches the positioning device 300, the diffuser can disperse the light from the positioning device 300 in one or more directions, thereby illuminating the positioning device 300. The medical professional can activate the light source in any manner described herein.

[0065] like Figure 3D As shown, another example of a positioning device 300' on a guidewire, sheath or elongated member 305' is shown. A positioning device 300' including one or more LEDs 310' can be positioned about 15 cm proximal to the distal tip 315' of the positioning device 300'. The distal tip 315' can be rounded or can otherwise have a blunt end, which can minimize damage to the esophageal passage during insertion. As described herein, a wire for transmitting power from a power source to the LED 310' can be set on or in the positioning device 300'. The elongated member 305' can have a diameter of about 0.035 inches or about 0.025 inches. It should be understood that the positioning device 300' can be set at any position along the elongated member 305'. It should also be understood that the positioning device 300' can be inserted into the patient's body and advanced to the small intestine 125 in any mode described herein.

[0066] like Figure 3C As shown, the sheath, guidewire or elongated member 305 may include markings, such as pyloric markings 305a, 305b and 305c and dental markings 305a', 305b' and 305c' to indicate the distance that the positioning device 300 has traveled when inserted into the patient. For example, the first pyloric marking 305a may be placed on the elongated member at about 155 cm proximal to the positioning device 300, the second pyloric marking 305b may be placed on the elongated member at about 170 cm proximal to the positioning device 300, and the third pyloric marking 305c may be placed at about 185 cm proximal to the positioning device 300. Additionally or alternatively, a first tooth marker 305a' can be placed on the elongated member about 250 cm proximally from the positioning device 300, a second tooth marker 305b' can be placed on the elongated member about 265 cm proximally from the positioning device 300, and a third tooth marker 305c' can be placed about 280 cm proximally from the positioning device 300. The markers can assist and / or indicate the approximate position of the positioning device 300 relative to the patient's anatomical structure. For example, as will be described herein, the positioning device 300 can be administered via the mouth, esophageal passage, and / or another percutaneous gastrointestinal access point so that when the first tooth marker 305a' is aligned with the patient's teeth, the medical professional will know that the positioning device 300 has traveled about 250 cm into the patient's body. Similarly, when the second tooth marker 305b' and the third tooth marker 305c' are aligned with the patient's teeth, the medical professional will know that the positioning device 300 has traveled 265 cm and 280 cm, respectively, into the patient's body. However, in some cases, the elongated member 305 may become looped in the stomach 105, and the tooth marks 305a', 305b', and 305c' may not provide accurate distance results. Therefore, the medical professional can use the pyloric marks 305a, 305b, and 305c using the image sensor on the distal end of the endoscope 240 to determine the distance of the positioning device 300 into the small intestine 125. For example, when the first pyloric mark 305a is aligned with the pylorus 110, as determined using the image sensor, the medical professional can determine that the positioning device 300 has extended from the pylorus 110 into the small intestine 125 by approximately 155 cm. Similarly, when the second pyloric mark 305b and the third pyloric mark 305c are aligned with the pylorus, the medical professional can determine that the positioning device 300 has extended from the pylorus 110 into the small intestine 125 by approximately 170 cm and 185 cm, respectively.

[0067] Alternatively or additionally, the slender member 305 can be color-coded such that the outer surface of the slender member 305 can include a first color located between the positioning device 300 and the first pyloric mark 305a (or a position approximately 155 cm from the positioning device 300), a second color on the outer surface between the first pyloric mark 305a and the second pyloric mark 305b (or a position approximately 170 cm from the positioning device 300), a third color on the outer surface between the second pyloric mark 305b and the third pyloric mark 305c (or a position approximately 185 cm from the positioning device 300), a fourth color on the outer surface from the third pyloric mark 305c to the first tooth mark 305a' (or a position approximately 250 cm from the positioning device 300), and so on for all position marks on the slender member 305. It should be understood that non-adjacent areas, for example, the area between the positioning device 300 and the first pyloric mark 305a and the area between the second pyloric mark 305b and the third pyloric mark 305c may have the same color.

[0068] The placement (and / or color conversion) of the markers is not limited to the positions described herein. For example, the markers may be placed along the elongated member 305 based on the patient's physical characteristics, for example, the markers may be further apart along the elongated member 305 for use in a taller patient than in a shorter patient, and / or based on the medical problem being treated, for example, a morbidly obese patient may require the markers to be further apart along the elongated member 305 to position the positioning device 300 in a more distal position in the jejunum 120 than for a patient with mild to moderate obesity.

[0069] It should be understood that the pyloric markers 305a to 305c and the tooth markers 305a' to 305c' can be any identification element, for example, a colored marker, a raised area of ​​the elongated member 305, a decal, text identifying the distance from the positioning device 300, a series of circumferential stripes, etc. Each of the pyloric markers 305a to 305c and the tooth markers 305a' to 305c' can include multiple markers, for example, the first pyloric marker 305a can include multiple markers of the same color coding in the same area of ​​the elongated member 305. In this way, the elongated member 305 can be suitable for patients of all sizes and / or all medical procedures. The pyloric markers 305a to 305c and the tooth markers 305a' to 305c' can also include characteristics to be recognized by various medical imaging modalities. For example, the pyloric markers 305a to 305c and / or the dental markers 305a' to 305c' can be radiopaque so that the position of each marker can be determined during a medical procedure using known medical imaging techniques. Although the elongated member 305 can have a strength suitable for pulling and / or pushing the elongated member 305, for example, to move the elongated member 305 when the elongated member 305 is positioned in a patient's body, a guidewire can be used to position the positioning device 300 in the body, and the guidewire and / or the elongated member 305 can include these markers.

[0070] A method for positioning and operating the positioning device 300 will now be described. Figures 2A to 2F Endoscopic surgery is performed as discussed above. Prior to surgery, positioning device 300 can be orally administered to the patient and swallowed. The proximal end of elongated member 305 can extend through the patient's nose. According to one example, positioning device 300 can be propelled along the gastrointestinal tract via peristalsis. In such an example (positioning device 300 is swallowed and moved via peristalsis), positioning device 300 can be fed through the nasal passage a few hours before the proposed surgery. Alternatively, for elongated member 305 with relatively high pushability, elongated member 305 / positioning device 300 can be positioned endoscopically using an endoscope, such as endoscope 240.

[0071] To assist in proper positioning, once the positioning device 300 is properly positioned within the gastrointestinal tract, the proposed surgery can be initiated. For example, an imaging modality (e.g., an imaging device and / or a device for positioning a radiopaque device) can be used to determine when the pyloric markers 305a to 305c are properly positioned at the pylorus. Alternatively or in addition, the surgery can be initiated when the dental markers 305a' to 305c' are properly positioned at the patient's mouth / teeth. The proper position of these markers can indicate to the medical professional that the positioning device 300 is positioned at the proper position within the jejunum 120. Alternatively, for an elongated member 305 having greater pushability, the elongated member 305 can be pushed until the markers are properly positioned, for example, the pyloric markers 305a to 305c are positioned at the pylorus and / or the dental markers 305a' to 305c' are positioned at the mouth, etc.

[0072] The elongated member 305 can be connected to a power source before, during, or after the positioning device 300 is applied to the patient. The LED 310 can be activated at any point during the operation. Alternatively, the LED 310 can be activated when the positioning device 300 has been advanced a distance into the patient's body, as indicated by one or more of the markings 305a to 305c. The medical professional can create an incision in the wall of the stomach 105, such as in the stomach 105 antrum, and advance the endoscope 240 through the incision. Subsequently, the medical professional can use a camera or other imaging device located at the distal end 245 of the endoscope 240 to visualize the peritoneal cavity to determine the position of the positioning device 300 in the jejunum 120. For example, a medical professional who observes an image of the peritoneal cavity on a monitor associated with the camera of the endoscope 240 can determine the position of the positioning device 300 in the jejunum 120 based on the position of the light from the LED 310 transmitted through the wall of the jejunum 120. The positioning device 300 can provide the medical professional with the appropriate location for creating a perforation or incision in the wall of the jejunum 120 in steps 215 and 220 described herein. In this way, the anastomotic device can be properly positioned. Alternatively, the medical professional can visualize the positioning device 300 through both the jejunum 120 wall and the stomach 105 wall, which can help the medical professional determine where to make both the incision in the stomach 105 wall and the incision in the stomach 105 wall.

[0073] The LED 310 can be activated according to a pattern. For example, one or more red LEDs 310 can be activated before or after the positioning device 300 is orally administered, and can be turned on continuously or can be pulsed. The medical professional can determine when the red light is located by the camera at the distal end 245 of the endoscope 240. Then, the medical professional can deactivate the red light and can activate the green light. It should be understood that the green light can also be turned on continuously or can be pulsed. In addition, the activation of the green light and the deactivation of the red light can be automatically performed by a controller associated with the camera. After the green light is activated, the medical professional can further manipulate the distal end 245 of the endoscope 240 to position the end effector 250 in the appropriate position to create an incision in the jejunum 120. Alternative embodiments can include activating both the red light and the green light at the beginning of the operation and / or pulsing one or both of the lights during the operation, and / or deactivating the red light once the positioning device 300 is located by the camera. One or more white lights may also be activated by the procedure, which may help the medical professional better position the positioning device 300 once the incision is made in one or more of the stomach 105 and the jejunum 120 .

[0074] exist Figure 4A and 4B 4 shows a nasal cannula 430 according to another example (the nasal cannula may include any of the cannulae, sheaths, or wires described herein). According to one example, the nasal cannula 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, an outer sheath / tube 431 of the nasal cannula 430 may define the lumen 440. The lumen 440 may include a combination of Figures 3A to 3CThe elongated member 305 described. However, the sheath 431 may include markings for determining the distance. The outer sheath 431 may include a material having sufficient rigidity to be manipulated within the patient's body, for example, to push and pull, without relying on body functions, such as peristalsis, to move the nasal catheter 430 to a target location in the jejunum 120. The outer sheath 431 may include a hole 432 that can fluidly connect the cavity 440 and the interior of the gastrointestinal passage when the nasal catheter 430 is inserted into the patient's body. Alternatively, the hole 432 can be formed directly in the wall of the elongated member 305, thereby allowing the fluid to pass through the central cavity of the elongated member 305 (for example, the fluid can pass through the adjacent coated wire). The hole 432 can be set only at the distal end of the sheath 431, and / or the hole 432 can also be placed along the middle and / or proximal length of the nasal catheter 430. The holes 432 may be placed along substantially the same circumferential side of the sheath 431 and / or may be placed around the circumference of the sheath 431 at multiple locations along the length of the sheath 431. The holes may have a diameter of about 0.020 inches to 0.040 inches or about 0.025 inches to 0.030 inches. The holes 432 may assist the gastrointestinal passage, for example, the stomach 105 and / or the small intestine 125 to vent, thereby releasing insufflation and / or naturally occurring gases from the gastrointestinal passage. These gases may cause the walls of the stomach 105 and / or the small intestine 125 (including the jejunum 120) to expand, which may increase the distance that the light from the LED 310 travels from the positioning device 300 to the side wall of the jejunum 120, and may reduce the amount of light that enters the peritoneal cavity from the jejunum 120 and is therefore visible to the endoscopic camera. This increased distance may create difficulty in locating the position of the positioning device 300 in the jejunum 120 from the peritoneal cavity. Because the holes 432 can vent gas introduced into and / or produced by the stomach 105 and / or small intestine 125, distension of the gastrointestinal wall can be reduced and visualization of light in the peritoneal cavity and / or stomach 105 can be improved from the positioning device 300 positioned in the jejunum 120. It should be understood that a vacuum device can be attached to the proximal end of the cavity 440 to actively remove gas and / or a containment device can be attached to the proximal end of the cavity to contain gas removed from the gastrointestinal passage.

[0075] A method for positioning and operating 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 can be introduced via the mouth or nose, and can be advanced into the small intestine by manipulating and / or pushing the proximal end of the nasal catheter 430 or via peristalsis. When the nasal catheter 430 moves along the gastrointestinal passage, the gas can actively or passively enter the hole 432 and move proximally along the cavity 440 to the proximal outlet. For example, a vacuum pump or other pump can be connected to the cavity 440 at the proximal end of the nasal catheter 430, and the vacuum can actively suck out the gas from the gastrointestinal passage. Alternatively, these gases can passively travel along the proximal outlet of the cavity 440. For example, the accumulation of gas in the gastrointestinal passage may cause a pressure increase greater than atmospheric pressure. The pressure difference between the gastrointestinal passage and the atmosphere surrounding the patient's body outside can allow these gases to flow into the hole 432, flow along the cavity 440 and flow out of the proximal opening of the cavity 440. It should be understood that a containment device can be attached to the proximal opening of cavity 440 to prevent gas from the body from being released into the operating room. It should also be understood that gas can be continuously removed during the anastomosis procedure.

[0076] According to another example, the positioning device 500 can be attached to a catheter or sheath 502 (the sheath 502 can include any catheter or nasal cannula described herein), such as Figure 5 As shown. The sheath 502 may include a guidewire lumen 504 through which a guidewire 505 may extend, thereby allowing the sheath 502 to travel along the guidewire 505. The positioning device 500 may be positioned at the distal end of the sheath 502. For example, the positioning device 500 may be disposed on the outer surface of the sheath 502, such as Figure 5 As shown, the positioning device 500 may protrude from the outer surface of the sheath 502, and / or may be disposed in a separate tube attached to the sheath 502. Alternatively, the positioning device 500 may include a capsule, such as the positioning device 300, which is disposed at the distal end of the sheath 502, and the guide wire 505 may extend through a cavity in the center of the capsule to allow the sheath 502 to slide along the guide wire 505. According to one example, the positioning device 500 may be removably attached to the sheath 502. In this way, different positioning devices 500, such as positioning devices 500 including different numbers of LEDs 510 and / or different colors of LEDs 510, may be interchangeable according to the surgery to be performed and / or the body size or anatomical structure of the patient. The increased rigidity of the sheath 502 and its trackability on the guide wire 505 may improve the movement and operability of the positioning device 500, thereby improving the medical surgery. Alternatively, the positioning device 500 can be pulled along the outer surface of the endoscope or through the lumen of the endoscope and into the small intestine 125 by an end effector, such as a pair of forceps.

[0077] A method for introducing positioning device 500 will now be described. Guidewire 505 can be introduced via a natural orifice, such as the mouth, and advanced along the gastrointestinal system. Subsequently, sheath 502 is inserted via the natural orifice by placing sheath 502 around guidewire 505 via guidewire lumen 504. Sheath 502 can be advanced along the gastrointestinal system in any manner as described herein. In addition, LED 510 can be activated in any manner as described herein.

[0078] According to another example, the positioning device 600 can be attached to the distal end of a sheath 602 having a central lumen (the sheath can include any catheter or nasal cannula described herein). Figure 6 As shown, the sheath 602 can be shorter than other catheters described herein, and its size can be set to support LED 610. For example, the sheath 602 can be only long enough to support LED 610 and can have a length of about 20 cm, a length of about 10 cm, or a length of about 5 cm. A pushing member 606 can be attached to the proximal end of the sheath 602 to move the sheath 602 along the guide wire 605. The reduced size of the sheath 602 can improve the maneuverability of the sheath 602, the pushing member 606, and the guide wire 605, thereby allowing the positioning device 600 to travel through the tortuous path in the patient's body and / or navigate through the obstruction or narrowing portion in the gastrointestinal passage. Additionally, this can allow the positioning device 600 to be quickly replaced from the guide wire 605, which can allow a single medical professional to manipulate the guide wire 605 and the positioning device 600. The pushing member 606 can be a wire suitable for medical surgery and can include any material sufficient for such use. The pushing member 606 may have a stiffness suitable for receiving the positioning device 600 and moving the positioning device 600 along the guide wire 605. It should be understood that electrical wires may be supported by the pushing member 606 so that the LED 610 may receive power.

[0079] The positioning device 600 can be deployed in any manner described herein. For example, the guidewire 605 can be introduced as described with respect to the guidewire 605. Subsequently, the sheath 602 can be placed over the guidewire 605 via the guidewire lumen 604. The pushing member 606 can then advance the sheath 602 along the guidewire 605 (via a force applied at the proximal end of the pushing member 606). The LED 610 can be activated in any manner described herein so that a medical professional can position the positioning device 600 using an endoscopic camera located in the stomach 105.

[0080] According to another example, the positioning device 700 can be attached to the distal end of the sheath 702 (the sheath can include any catheter or nasal catheter described herein) and / or can surround the distal end of the sheath 702. Figure 7As shown, the positioning device 700 may include an expandable balloon 704 that can surround an LED 710. The balloon 704 may include a transparent or translucent material (e.g., polyethylene terephthalate (PET), polyethylene, polyamide copolymer (PEBA) latex, etc.) so that light from the LED 710 can be transmitted through the balloon 704 to the wall of the jejunum 120. The LEDs 710 can be any number and / or any color and can be arranged on the sheath 702 in any manner described in any of the embodiments herein. The sheath 702 may include a central lumen 706 that can receive a guidewire 705 and can allow the sheath 702 to slide proximally and distally on the guidewire 705, as described herein. A fluid lumen 708 (shown in solid lines) may extend from the proximal end of the sheath 702 through the sheath 702 to an outlet 712 that 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 can be attached to the proximal end of fluid lumen 708 , and fluid can be introduced into or removed from balloon 704 via fluid lumen 708 .

[0081] A method for deploying the positioning device 700 will now be described. The positioning device 700 including the balloon 704 can be advanced to the target position according to any of the methods described herein. Then, the balloon 704 is inflated. The inflation of the balloon 704 can cause the balloon 704 to contact the wall of the jejunum 120, thereby fixing the position of the balloon 704 in the jejunum 120. The contact between the balloon 704 and the wall of the jejunum 120 can eliminate the air and / or fluid gap between the positioning device 700 and the wall of the jejunum 120, which can increase the light transmission from the LED 710 to and / or through the wall of the jejunum 120 and can improve the visualization of the positioning device 700. It should be understood that the LED 710 can include lights of different colors as described herein, for example, red and / or green lights, and can activate lights of different colors in various modes in any manner described herein. Once the positioning device 700 is positioned by a medical professional and an incision is made in the wall of the jejunum 120, the balloon 704 can be scaled and the positioning device 700 can be removed from the body.

[0082] Fig. 8A and 8BAnother example of a positioning device 800 is shown. 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 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 increase 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 used as described above. Figure 8B The fluid chamber 808 shown (shown in solid lines) is inflated like the fluid chamber 708 of the sheath 702. For example, the fluid chamber 808 can be connected to a fluid containing device at the proximal end to introduce or remove the inflation fluid. Inflating the balloon 804 can cause the side of the balloon 804 opposite to the sheath 802 to contact the entire jejunum 120 and force the distal end of the sheath 802 toward the opposite wall of the jejunum 120. Inflation causes the LED 810 to be pressed or pushed against the wall of the jejunum 800, which can eliminate air and / or fluid gaps between the positioning device 800 and the wall of the jejunum 120. This in turn can increase the light transmission from the LED 810 to and / or through the wall of the jejunum 120, and improve the visualization of the positioning device 800 by the imaging device in the stomach 105. The positioning device 800 can be deployed similarly to the positioning device 700.

[0083] exist Fig. 9Another example of a positioning device 900 is shown in FIG. Similar to positioning devices 700 and 800, positioning device 900 may include a balloon 904 on the distal end of a sheath 902 (the sheath may include any catheter or nasal catheter described herein) that may be inflated to position LED 910 against the wall of jejunum 120. Balloon 904 may surround the entirety of the distal end of sheath 902. As with positioning devices 700 and 800, sheath 902 may include a central lumen 906. The construction of sheath 902 may allow sheath 902 to be advanced along a guidewire 905 (positioned in lumen 906) to a target site within jejunum 120. Once positioning device 900 is positioned at the target site, balloon 904 may be inflated in any manner described herein, such as using a fluid lumen 908 attached at the proximal end to a containment device including an inflation fluid, etc. LED 910 may be disposed on the outer surface of balloon 904. A wire (not shown) that provides current / power to the LED 910 can extend through the sheath 902 and into the interior of the balloon 904, or extend along the surface of the balloon 904 to electrically connect to the LED 910. The inflation of the balloon 904 can press or push the LED 910 against the wall of the jejunum 120. The LED 910 can alternate between red and green lights around the circumference of the balloon 904, or the LED 910 can include an array of red lights disposed circumferentially around the balloon 904 adjacent to an array of green lights similarly disposed around the circumference of the balloon 904. The LED 910 can be centered along the longitudinal axis of the balloon 904 and can be equally spaced around the outer circumference of the balloon 904. Alternatively, the LED 910 can be positioned on the outer surface of the balloon 904 on circumferentially opposite sides of the balloon 904, which can improve the visualization of the LED 910. It should be understood that the red and green lights of LED 910 can be actuated independently or together in any manner described herein.

[0084] exist Fig. 10A and 10BAnother example of a positioning device 1000 is shown in FIG. Similar to the positioning devices described herein, the positioning device 1000 can be disposed at the distal end of a sheath 1002 (the sheath can include any catheter or nasal catheter described herein). The sheath 1002 can include a central lumen 1006 through which a guidewire 1005 can extend. The sheath 1002 can include a distal tip 1002a connected to a sheath body 1002b by a plurality of wires 1002c. The distal tip 1002a can be annular and can include a lumen (which can be an extension of the central lumen 1006 from the sheath body 1002b) to track on the guidewire 1005. The distal tip 1002a can have an outer circumference that is the same as or different from that of the sheath body 1002b. An LED 1010 can be disposed on each of the plurality of wires 1002c. For example, each of the plurality of wires 1002c may include a green LED 1010 and a red LED 1010, or a plurality of green and red LEDs 1010. Alternatively, each of the plurality of 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 tension wire 1003 may translate within the cavity 1006 and may be actuated to move the distal tip 1002a in a proximal direction and in a distal direction. For example, when the tension wire 1003 moves proximally, the distal tip 1002a also moves in the proximal direction, causing the plurality of wires 1002c to bend radially outward from the guidewire 1005. In this manner, the LED 1010 positioned on the plurality of wires 1002c can move toward and press against the wall of the jejunum 120.

[0085] A method of deploying the positioning device 1010 will now be described. It should be understood that the positioning device 1000 can be advanced to a target location in any manner described herein. Once the positioning device 1010 is positioned within the jejunum 120, a medical professional can control the tension wire 1003 (e.g., pull the tension wire 1003 proximally) to move the distal tip 1002a proximally while maintaining a fixed position of the body 1002b. This movement causes the LED 1010 to move away from the longitudinal axis of the sheath 1002 and press or push the LED 1010 against the wall of the jejunum 120. The positioning device 1000 can then be positioned and an incision can be made in the walls of the stomach 105 and the jejunum 120 in any manner described herein. After the incision is made, the medical professional can control the tension wire 1003 (e.g., push the tension wire 1003 distally) to move the distal tip 1002a distally while maintaining the fixed position of the body 1002b, thereby moving the LED 1010 radially inward and close to the guidewire 1005. It should be understood that the position of the distal tip 1002a can be maintained while moving the body 1002b in the proximal and / or distal directions. Once the LED 1010 is no longer deployed, the sheath 1002 can be removed from the patient.

[0086] During various procedures, a medical professional may have difficulty locating a portion of a body cavity that contains a medical device locator. Figures 11A to 11C Shown with Figures 2B to 2D Part of a gastrojejunostomy that is essentially similar. For example, Figure 2C and 2D In the present invention, after extending the distal end 245 of the endoscope 240 through the wall of the stomach 215 to view the small intestine 125, the portion of the jejunum 120 containing the distal end 235 of the nasal catheter 230 may be difficult to locate. Similar difficulties with other procedures related to positioning devices and / or anatomical structures can be envisioned. Figures 11A to 11C A portion of a procedure for positioning a medical device positioner at a target location within the jejunum is shown. The medical device positioner at the target location can be visualized by an instrument that can be inserted through the stomach wall. Once visualized, the target location in the jejunum can be accessed by the instrument, and a stent or other drainage catheter can be placed to bridge the stomach and jejunum.

[0087] refer to Fig.11A, a sheath, guidewire or elongated member 1100 is shown inserted into the GI tract through the stomach 1134 and extending into the duodenum 1136 and the jejunum 1130. An endoscope 1124 is shown extending within the stomach 1134 with a perforating or cutting mechanism 1120 extending distally out of a working channel of the endoscope 1124 toward the tissue wall of the stomach 1134. The perforating mechanism 1120 is shown making an incision 1132 into the wall of the stomach 1124, into the peritoneal cavity 1138 and generally toward the portion 1132 of the jejunum 1130 containing the positioning device 1102 at the distal end of the elongated member 1100 extending within the jejunum 1130.

[0088] refer to Fig. 11B , Fig.11A The endoscope 1124 of the system is shown extending through an incision in the tissue wall of the stomach 1134 into the peritoneal cavity 1138. The endoscope 1124 is oriented generally toward the jejunum 1130 in the peritoneal cavity 1138. The medical professional can observe the jejunum 1130 within the peritoneal cavity 1138 via the endoscope 1124 and / or through other observation techniques, such as, for example, fluoroscopy, etc. The medical professional can observe the jejunum 1130 and identify, via any visual indicators described herein, such as illuminated LEDs, portions 1132 of the jejunum 1130 associated with the position of the elongated member 1100 and / or the positioning device 1102 contained therein. A perforating mechanism 1122, such as a grasper, is shown grasping the portion 1132 of the jejunum 1130 so that the portion 1132 can be held in an appropriate position, manipulated to be incised and / or manipulated toward the stomach 1134. In Fig. 11B In, with Fig.11A Portion 1132 is manipulated closer to stomach 1134 than in the position in the.

[0089] refer to Fig. 11C , a portion 1132 of the jejunum 1130 is shown from Fig.11A and 11B 1134. The perforating mechanism 1122 is shown as making an incision into the portion 1132 of the jejunum 1130, and the positioning device 1102 has been translated proximally away from the portion 1132 to avoid collision and / or heat transfer from the perforating mechanism 1122. However, the positioning device 1102 can remain at the portion 1132 for the procedure. With the incisions in the tissue wall of the stomach 1134 and in the tissue wall of the portion 1132 of the jejunum 1130, additional devices can be delivered to the tissue wall of the stomach 1134, the tissue wall of the jejunum 1130, and / or extended within the peritoneal cavity 1138, as described herein.

[0090] In various embodiments, the elongated member can be a catheter (e.g., nasal cannula, etc.), an endoscope, a guidewire, or a sheath extending around another medical device. The elongated member can have a visual indicator along its length, and its length can extend distally to a positioning device as described herein.

[0091] refer to Fig.12 , shows an embodiment of a medical device positioner, which includes a sheath, guidewire or elongated member 1200 having a proximal end 1200p, a distal end 1200d and a length extending therethrough along a longitudinal axis l. LEDs 1204 are disposed along the length of the elongated member 1200. The LEDs 1204 are helically arranged around the longitudinal axis l of the elongated member 1200. A positioning device 1202 is disposed at the distal end 1200d of the elongated member 1200.

[0092] In various embodiments, the lighting member, which may be an LED, may extend along a portion of the length of the elongated member. The LED may extend to the distal end of the elongated member including the positioning device. The LED may be arranged in various patterns along the elongated member, for example, spirally, axially, radially, circumferentially, linearly, intermittently spaced, randomly, along the length with various densities or a combination of their arrangements, etc., so that the LED can be observed from one or more radial perspectives originating from the longitudinal axis of the elongated member. The LED may be actuated to emit light. The actuated LED may be visible through the tissue wall, for example, visible from the outside of the body cavity containing the LED. The LED may have a variable wavelength so that it emits a color that can be seen more easily through the tissue wall than other colors, for example, red, green, etc., and as an indicator that can be more visible than other colors. The LED may be actuated at different frequencies as an indicator. The indicator may specify a position, for example, the indicator may be at a distance from the end of the elongated member, the positioning device, or the anatomical structure. The LED may be individually selected and controlled as a single LED or in groups of more than a single LED. The LEDs can be controlled by one or more parameters, such as density, location of the LEDs relative to each other, the anatomical structure, or the medical device, size, shape, actuation frequency (e.g., patterning to aid positioning or notification, such as a double flash followed by a pause), actuation intensity (e.g., using a current source, e.g., with pulse width modulation (PWM) operating at a desired frequency and / or a duty cycle that affects LED intensity), actuation duration, color, or any combination of two or more of the foregoing.

[0093] In various embodiments, the controller can be electrically connected to the LED along the elongated member. The electrical leads can be electrically connected to the LED in an interlaced manner so that the LED can be independently actuated. The controller can be configured to sequentially actuate one or more of the LEDs at a time. The controller can sequentially actuate the LEDs in a distal direction along the length of the elongated member, for example, indicating a direction toward the distal end of the elongated member, which is toward the positioning device. The controller can be configured to sequentially actuate the LEDs so that only a single LED or multiple LEDs are actuated at a time, for example, an actuation mode of an illumination wave traveling distally along the elongated member. The controller can be configured to actuate all LEDs except one LED in a distally sequential mode, so that a large number (e.g., more than 90% of all LEDs, etc.) of LEDs are actuated for position identification while still indicating a direction, for example, an actuation mode of canceling an illumination wave traveling distally along the elongated member. The controller can be configured to actuate the LED at a higher frequency with reduced illumination time (e.g., a lower duty cycle, which has a smaller percentage of the time when the LED is illuminated) to reduce heat compared to an LED actuated at a lower frequency with a longer illumination time (e.g., a higher duty cycle, which has a larger percentage of the time when the LED is illuminated). The controller can be configured to actuate a portion of the LED at a first frequency and another portion of the LED at a second frequency, for example, actuating the distal portion of the LED at a higher frequency than the proximal portion of the LED. The LED can extend along the length of the elongated member for a distance that is substantially aligned with the patient's anatomical structure. For example, the LED can extend along the length between the pylorus and the portion of the jejunum having the target location for surgery. This can be any desired length amount, such as about 50 centimeters distal to the pylorus, about 150 centimeters distal to the pylorus, etc. The controller can be manually or automatically operated to actuate one or more LEDs or switch between various operating modes. This actuation of the LED can be shortened to reduce heat.

[0094] refer to Fig.13, shows an embodiment of a medical device locator, which includes a sheath, guidewire or elongated member 1300, the elongated member 1300 having a proximal end 1300p, a distal end 1300d and a length extending therethrough along a longitudinal axis l. LEDs 1304 are disposed along the length of the elongated member 1300. The LEDs 1304 are linearly arranged 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. The proximal portion 1305 of the LED 1304 is configured to emit light of a red wavelength, the middle portion 1306 of the LED 1304 is configured to emit light of a white wavelength, and the distal portion 1307 of the LED 1304 is configured to emit light of a green wavelength. The portions 1305, 1306, 1307 indicate the position along the elongated member 1300. The proximal portion 1305 indicates a location along the elongated member 1300 proximal to the middle portion 1306, the middle portion 1306 indicates a location along the elongated member 1300 proximal to the distal portion 1307, and the distal portion 1307 indicates a location along the elongated member 1300 proximal to the distal end 1300d or the positioning device 1302. The portions 1305, 1306, 1307 may each be located at a different distance from the distal end 1300d of the elongated member 1300, for example, the proximal portion 1305 may be located about, for example, 50 centimeters, etc., from the distal end 1300d, the middle portion 1306 may be located about, for example, 15 centimeters, etc., from the distal end 1300d, and the distal portion 1307 may be substantially located at the distal end 1300d. Although three segments 1305, 1306, 1307 and three colors of LED 1304 are shown, any number and / or location of segments and / or colors may be used.

[0095] refer to Fig.14, an embodiment of a medical device positioner is shown, which includes a sheath, guidewire or slender member 1400, which can be, for example, a guidewire. The slender member 1400 includes LEDs 1410, 1412 arranged along its length. The support member 1402 extends longitudinally within the slender member 1400. A plate 1404 is arranged along the support member 1402 so that the plate 1404 extends radially away from the support member 1402. The LEDs 1410, 1412 are arranged on opposite sides of the plate 1404 so that a first pair of LEDs 1410 are arranged on a first side of the plate 1404 and a second pair of LEDs 1412 are arranged on a second side of the plate 1404. The LEDs 1410, 1412 are arranged on opposite sides of the plate 1404 so that at least one pair of LEDs 1410, 1412 is visible in a 180° arc 1418 around the slender member 1400. The pairs of LEDs 1410, 1412 can each include a variable color LED, such as green and red, which can be illuminated, selectively illuminated, alternately illuminated, or sequentially illuminated to increase visibility (e.g., through tissue) and / or indicate orientation (e.g., green indicates a distal direction of the elongated member 1400, and red indicates a proximal direction of the elongated member 1400). Although multiple pairs of LEDs 1410, 1412 are shown, the total of four LEDs 1420, 1412 can be grouped in larger portions than pairs or not grouped at all, and any number of LEDs can be employed, such as 1, 2, 3, 5, 6, 8, 10, 15, 20, 50, 100, etc. The LEDs 1410, 1412 can be illuminated and controlled by a wire 1416 electrically coupled to the LEDs 1410, 1412 and extending proximally within the elongated member 1400 and along it. Wire 1416 can extend proximally along elongated member 1400 to connector 1420. Connector 1420 can be reversibly coupled to a controller and can be sized to fit through a working channel of an endoscope. The controller can include, for example, a power supply, circuitry, instructions, and / or switches for powering and controlling illumination of LEDs 1410, 1412, etc. Connector 1420 includes contacts 1422 in electrical communication with wire 1416, and contacts 1422 can be reversibly coupled to leads of the controller. The portions of the wires 1416 and LEDs exposed from the elongated member 1400 are covered by a transparent / translucent coating 1424 (e.g., silicone, etc.) that protects the electrical connections between the LEDs 1410, 1412, the board 1404, the wires 1416, and the connector 1420 from external fluids / debris (e.g., body fluids) and trauma while allowing visibility of the illuminated LEDs 1410, 1412.

[0096] In use, an endoscope with a working channel can be inserted into the duodenum of a patient, and the elongated member 1400 can extend through the working channel into the duodenum. The elongated member 1400 can be further advanced to a desired position along the small intestine, which can be observed and measured by a mark (e.g., radiopaque and / or color mark) on the elongated member 1400 to indicate that the elongated member 1400 and / or LEDs 1410, 1412 are at a desired distance (e.g., about 150 cm) beyond the pylorus. The endoscope can then be withdrawn proximally along the elongated member 1400, thereby leaving the elongated member 1400 in the small intestine. When the distal end of the endoscope is withdrawn to the pylorus, the elongated member 1400 can be adjusted proximally or distally, for example, to place the mark of the elongated member 1400 at the pylorus. The endoscope can then be completely withdrawn from the patient along the elongated member 1400 and the connector 1420. The connector 1420 may then be coupled to a controller, thereby allowing operation of the LEDs 1410 , 1412 .

[0097] Generally, as applicable to any of the locator devices and systems described above or elsewhere herein, embodiments of methods of locating a medical device through a body cavity may include extending an elongated member including a plurality of LEDs, such as for locating a medical device, along a length of the elongated member within a first body cavity, such as the jejunum. Fig.14 The steps of positioning a locator device are as described above in the previous paragraph. Multiple LEDs can be sequentially actuated in a distal direction along the length of the slender member. The sequentially actuated LEDs can indicate the direction of the device or anatomical structure, such as a portion of the locating device and / or the first body cavity. The tissue wall of the first body cavity can be penetrated, for example, the actuated LEDs can be observed from within the peritoneal cavity. A perforating mechanism, such as a cutting tool, can extend toward the first body cavity through the tissue wall of a second body cavity, such as a stomach, thereby incising the tissue wall of the first body cavity.

[0098] It will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed device without departing from the scope of the invention. For example, the configuration of the positioning device and the catheter may be altered to accommodate any medical device or medical treatment. It should be understood that the number and / or position of the LEDs are not limited to the examples described herein. Other embodiments of the invention 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 merely exemplary, and the true scope and spirit of the invention are indicated by the following claims.

Claims

1. A medical device, include: an elongated member comprising a positioning device at a distal end of the elongated member, the positioning device comprising at least one light emitting diode (LED), and wherein the at least one LED is configured to be actuated to emit light having wavelengths corresponding to green light and red light, wherein the positioning device comprises a balloon at the distal end of the elongated member, wherein the balloon is configured to be inflated, and wherein the balloon is disposed on a first side of the elongated member, and wherein the at least one LED is disposed on a side of the elongated member circumferentially opposite to the balloon.

2. The medical device according to claim 1, wherein the positioning device include: Sidewall, a proximal wall at a proximal end of the side wall, and A distal wall at a distal end of the side wall, wherein the side wall, the proximal wall, and the distal wall define a cavity, and wherein the at least one LED is disposed within the cavity.

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

4. The medical device of claim 1, wherein the elongated member comprises a fluid lumen extending from a proximal end of the elongated member to a distal end of the elongated member, and wherein a plurality of apertures are located in a sidewall of the elongated member and are fluidly connected to the fluid lumen.

5. The medical device of claim 4, further comprising a vacuum device and a fluid containment device, wherein each of the vacuum device and the fluid containment device is in fluid communication with the fluid cavity at the proximal end of the elongated member, and wherein the vacuum device is configured to create suction within the fluid cavity so that fluid from the body is configured to flow through the plurality of holes and along the fluid cavity to the fluid containment device.

6. The medical device of claim 1, wherein the elongated member further comprises a central lumen configured to receive a guide wire.

7. The medical device of claim 1, wherein the balloon comprises a transparent or translucent material, wherein the at least one LED is disposed on a surface of the elongated member, and wherein the light emitted from the LED is configured to be transmitted through the balloon.

8. The medical device of claim 1, wherein the at least one LED comprises a plurality of LEDs disposed around a circumference of the balloon.

9. The medical device of claim 1 , wherein the elongated member comprises an elongated member body and an elongated member distal tip, wherein a proximal end of the elongated member distal tip is connected to a distal end of the elongated member body by a plurality of wires, and wherein an LED of the at least one LED is attached to each wire originating from the plurality of wires.

10. The medical device of claim 9, further comprising an actuation wire attached to the distal tip of the elongated member, wherein the actuation wire is configured to move proximally relative to the elongated member body, and wherein the LED is configured to move radially outward when the actuation wire causes the distal end of the elongated member to move proximally relative to the elongated member body.

11. The medical device of claim 1, wherein the at least one LED is configured to emit the green light and the red light alternately.

12. The medical device of claim 1, wherein the at least one LED is configured to emit the green light and the red light in a pulsed manner.

13. The medical device according to claim 1, further comprising: include: An endoscope comprising an imaging device and an end effector configured to extend from a distal end of the endoscope, wherein the imaging device is configured to detect the light having wavelengths corresponding to the green light and the red light emitted from the at least one LED.

Images