Devices and methods for body cavity treatment

Abstract

A method for performing a medical procedure may include advancing a first device through a first body cavity. The distal portion of the first device may include a magnet. The method may also include advancing a second device through a second body lumen. The second device may include a magnetic field sensor. The method may also include receiving a signal from the magnetic field sensor. The signal may be indicative of the magnetic field measured by the magnetic field sensor. The method may also include confirming the position of the magnet if the received signal matches the magnetic field of the magnet.

Description

This application is a divisional application of 201980082977.3 CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 752,574, filed on October 30, 2018, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure generally relates to devices and methods for diagnosing and / or treating tissue using, for example, endoscopes, bronchoscopes, and ureteroscopes. More specifically, aspects of the present disclosure relate to devices and methods for positioning a medical device within a body cavity of a subject. Background Art

[0003] Endoscopic, bronchoscopic, or ureteroscopic techniques can be used to diagnose, treat, and / or monitor medical conditions by advancing tools and other devices through body cavities. Such techniques can provide treatment options without having to make incisions in the patient's skin. However, endoscopic devices can be limited in their ability to perform certain procedures due to, for example, difficulty visualizing the area of ​​interest.

[0004] For example, difficulties may arise in operations involving multiple body cavities or involving a portion of a single cavity separated by tissue walls. For example, in gastric bypass surgery, a portion of the gastric cavity may be connected to a portion of the intestinal cavity (such as the jejunum). It is desirable to construct an anastomosis between a specific portion of the jejunum and the stomach. Typical therapeutic and diagnostic endoscopes are limited in their ability to confirm the appropriate portion of the intestine that should be connected to the gastric pouch or other portion of the stomach. For example, an ultrasonic endoscope may have a too small range for effectively confirming the relevant portion of the intestine. For example, an endoscope may not be able to reach the target location and / or ultrasound may have a range that cannot visualize the target location (e.g., through the wall of the body cavity) because it is too far from ultrasound. Summary of the invention

[0005] In addition, examples of the present disclosure relate to devices and methods for identifying and / or detecting portions of a body cavity of a subject.Each example disclosed herein may include one or more features described in conjunction with any other disclosed example.

[0006] In one example, a method for performing a medical procedure may include advancing a first device through a first body cavity. A distal portion of the first device may include a magnet. The method may also include advancing a second device through a second body cavity. The second device may include a magnetic field sensor. The method may also include receiving a signal from the magnetic field sensor. The signal may be an indication of a magnetic field measured by the magnetic field sensor. The method may also include confirming the position of the magnet if the received signal matches the magnetic field of the magnet.

[0007] Any method described herein may include one or more of the following features or steps. The method may also include confirming the position of a tissue wall surrounding a first body cavity. The position may be close to a magnet. The first body cavity may be a small intestine cavity. The second body cavity may be a stomach cavity. The method may also include connecting the first cavity to the second cavity. The signal may include information related to at least one of the direction or amplitude of the magnetic field. The magnet may be a diametrical magnet. The first device may include at least one magnetic shield. The second device may also include an atraumatic grasper. The distal portion of the first device may also include a light emitting source. The method may also include detecting light emitted by the light emitting source. The method may also include forming a first hole in a first tissue wall defining the first body cavity. The method may also include forming a second hole in a second tissue wall defining the second body cavity. The method may also include connecting the first tissue wall to the second tissue wall. After connecting the first tissue wall to the second tissue wall, the first hole may be connected to the second hole. The magnetic field may have a direction perpendicular to the tissue wall defining the first body cavity.

[0008] In another example, a method for performing a medical procedure may include advancing a first device through a first body cavity to a portion of the first body cavity. The distal portion of the first device may include a magnet. The method may also include advancing a second device through a second body cavity. The second device may include a magnetic field sensor. The method may also include receiving a signal from the magnetic field sensor. The signal may be an indication of a magnetic field measured by the magnetic field sensor. Based on the received signal, the portion of the first body cavity may be connected to the second body cavity.

[0009] Any method described herein may include one or more of the following features or steps. The method may also include confirming the position of a tissue wall surrounding a first body cavity. The position may be in close proximity to a magnet. The first body cavity may be a small intestine cavity. The second body cavity may be a stomach cavity. The method may also include grasping a wall of the first body cavity surrounding the portion in close proximity to the first body cavity. The magnetic field may have a direction perpendicular to the tissue wall defining the first body cavity.

[0010] In yet another example, a method for performing a medical procedure may include advancing a first device through a first body cavity. A distal portion of the first device may include a magnet. The method may also include advancing a second device through a second body cavity. The second device may include a magnetic field sensor. The method may also include receiving a signal from the magnetic field sensor. The signal may be an indication of a magnetic field measured by the magnetic field sensor. Based on the received signal, a medical tool may be advanced from the second body cavity into the first body cavity.

[0011] Any method described herein may include one or more of the following features or steps. The method may also include confirming the location of a tissue wall surrounding a first body cavity. The location may be in close proximity to a magnet. The first body cavity may be a small intestine cavity. The second body cavity may be a stomach cavity. The magnetic field may have a direction perpendicular to the tissue wall defining the first body cavity.

[0012] In another example, a system for performing a medical procedure may include a first device. A distal portion of the first device may include a magnet having a magnetic field. The first device may be configured to travel into a first body cavity. The system may also include a second device. The second device may include a magnetic field sensor. The magnetic field sensor may be configured to send a signal that is an indication of a magnetic field measured by the magnetic field sensor. The signal may be compared to one or more parameters related to the magnetic field of the magnet to confirm the position of the magnet.

[0013] Any system described herein may include one or more of the following features. The signal may include information about at least one of the direction or magnitude of the magnetic field. The magnet may be an opposing magnet. The first device may include at least one magnetic shield. The first device may include at least one magnetic shield proximal to the magnet and at least one magnetic shield distal to the magnet. The second device may also include an atraumatic grasper. The distal portion of the first device may also include a light emitting source. The second device may include an optical device for detecting the light emitting source. The magnetic field may have a direction perpendicular to the wall of the tissue defining the first body cavity. The second device may be configured to be inserted into the working channel of the sheath. The first body cavity may be a small intestine cavity and the second body cavity may be a stomach cavity. The first device may include an articulated joint and a handheld controller. The confirmed position may be an indication of the location of the tissue wall in which the hole is formed. The first device may be configured to be positioned so that the magnet is located approximately 150 cm distal to the pylorus. The first device may be configured to be inserted into the first cavity while the second device is inserted into the second cavity. The magnetic field sensor may be at least one of a Hall effect sensor, a magnetoresistive sensor, a fluxgate, a flux coil, or a magnetic induction sensor.

[0014] It will be understood that both the foregoing overview and the following detailed description are exemplary and explanatory only and are not limiting of the claimed invention. As used herein, the terms "comprises," "comprising," or any other variants thereof are intended to encompass non-exclusive inclusions, whereby a process, method, article, or device comprising a series of elements may include not only these elements, but may also include other elements not expressly listed or peculiar to such process, method, article, or device. The term "exemplary" is used in the sense of "exemplary" rather than "ideal." The term "endoscope" may be used herein, but it is not limiting. References to endoscopes may also include other medical devices, including but not limited to bronchoscopes, ureteroscopes, colonoscopes, catheters, sheaths, and the like. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0016] Figure 1 An exemplary system for performing a medical procedure, such as a gastrointestinal anastomosis, is shown.

[0017] Figure 2 An exemplary distal portion of an endoscope for use with a system for performing a medical procedure, such as a gastrointestinal anastomosis, is shown.

[0018] Figure 3A to Figure 3C An exemplary magnetic component for use with a system for performing gastric bypass surgery is shown.

[0019] Figures 4 to 6 An exemplary system for performing gastric bypass surgery is shown.

[0020] Figure 7 A flow chart of an exemplary medical procedure is shown. DETAILED DESCRIPTION

[0020] The present disclosure relates to devices, systems and methods for diagnosing and / or treating tissues using, for example, endoscopes, bronchoscopes, ureteroscopes and other medical devices. More specifically, aspects of the present disclosure are about devices and methods for positioning medical devices in a subject's body cavity. In particular, at least in some aspects, the devices, systems and methods disclosed herein facilitate confirmation and / or detection of various parts of a subject's body cavity. Although gastrointestinal anatomical structures may be cited herein, the citation of gastrointestinal anatomical structures should not be understood as limiting the possible applications of the disclosed devices and methods. The disclosed devices and methods may be suitable for use in various parts of a subject's body, including, for example, urinary organs, respiratory systems, or other parts of the digestive system. Although gastric bypass surgery may be cited herein, the disclosed devices and methods may be used in a variety of medical surgeries, including any process requiring precise positioning inside a body cavity.

[0022] Figure 1 An exemplary system 10 for performing gastric bypass surgery is depicted. System 10 may include a first device 12 and a second device 14. Device 12 and / or device 14 may be, for example, an endoscopic device adapted for insertion into a body cavity of a subject. Figure 11 and 14 are illustrated as separate devices (e.g., endoscopic devices) that are directly inserted into a patient's body cavity, but it should be understood that the first device 12 and the second device 14 can be used together with other devices. For example, the first device 12 and / or the second device 14 can be inserted into a patient's body cavity through a sheath (e.g., an endoscope sheath). For example, the sheath can be inserted into the patient's body cavity, and then the first device 12 and / or the second device 14 can be inserted into the working channel of the sheath.

[0023] The first device 12 can be inserted into a subject and can include an elongated member or shaft 20. The member 20 can be made of a flexible material suitable for use inside a body cavity of a subject. The member 20 can be manipulated using, for example, a handheld controller outside the body and an articulated joint at the distal end of the member 20. Alternatively, the member 20 can be passively bent in the body cavity of the subject. The member 20 can have a distal portion 22. The distal portion 22 can include any suitable mechanism for visualizing the body cavity of the subject and / or navigating in the body cavity of the subject. For example, the distal portion 22 can include an illuminating portion, a camera, or any other suitable device. Alternatively, the first device 12 can be configured to be inserted together with another device including a steering mechanism and / or a guiding mechanism. For example, the first device 12 can be inserted into the working channel of a sheath (such as a sheath of an endoscope). After such an insertion device is removed from the body cavity, the first device 12 can remain in the body cavity of the subject. Alternatively, the first device 12 and the insertion device or mechanism for guiding the first device 12 can remain in the body cavity of the patient. The distal portion 22 of the first device 12 may include a distal tip 24. The distal tip 24 may have a non-traumatic feature (such as a rounded tip) to avoid damage to the body cavity tissue of the subject. In addition or alternatively, the distal tip 24 may have an opening for lighting and / or a video mechanism and / or an opening for flushing, suction, insufflation or other functions. For example, the distal tip 24 may include an opening for one or more light emitting diodes, cameras, lenses, optical fibers, etc.

[0024] The distal portion 22 (or another portion of the first device 12) may also include a magnetic device 26. The magnetic device 26 may be a permanent magnet, or may be activated by a wire current flowing through the shaft 20 and the magnetic device 26. The magnetic device 26 may have a known magnetic field, such as described below with respect to Figure 3A to Figure 3C In particular, when the first device 12 is inserted into a portion of the subject's small intestine, the field of the magnetic device 26 in the area between the magnetic device 26 and the subject's gastric cavity is known, such as Figure 1. For example, the magnetic field in the stomach cavity in the area near the greater curvature or pylorus of the subject's stomach may be known. For example, the general shape of the magnetic field, the general strength of the magnetic field, etc. may be known. For example, the strongest magnetic field is known to correspond to a specific location of the magnetic device 26. Although exemplary magnetic fields are discussed below, a variety of magnetic field configurations may be suitable for use with the devices, systems, and methods disclosed herein.

[0025] The second device 14 can be inserted into the subject and can include an elongated member 30. The member 30 can be made of a flexible material suitable for use inside the subject's body cavity. The member 30 can be manipulated, for example, via a handheld controller outside the body and an articulated joint at the distal end of the member 30. Alternatively, the elongated member can be passively bent in the subject's body cavity. The member 30 can have a distal portion 32. The distal portion 32 can include any suitable mechanism for visualizing the subject's body cavity and / or guiding through the subject's body cavity. For example, the distal portion 32 can include an illumination portion, a camera, or any other suitable device. Alternatively, the second device 14 can be configured to be inserted together with another device including a manipulation and / or guidance mechanism. For example, the second device 14 can be inserted into the working channel of a sheath (such as a sheath of an endoscope). After the insertion device is removed from the body cavity, the second device 14 can remain in the subject's body cavity. Alternatively, both the second device 14 and the insertion device or mechanism for guiding the second device 14 can remain in the patient's body cavity. The distal portion 32 of the second device 14 may include a distal tip 34. The distal tip 34 may have a non-traumatic feature (such as a rounded tip) to avoid damage to the body cavity tissue of the subject. In addition or alternatively, the distal tip 34 may have an opening for lighting and / or video mechanisms and / or an opening for flushing, suction, insufflation, or other functions. For example, the distal tip 34 may include an opening for one or more light emitting diodes, cameras, lenses, optical fibers, etc.

[0026] The distal portion 32 (or another part of the second device 14) may also include a magnetic field sensor 36. The magnetic field sensor 36 may be any suitable type of magnetic field sensor known in the art, such as a Hall effect sensor, a magnetoresistive sensor, a fluxgate or coil, or a magnetic induction sensor. The magnetic field sensor 36 may measure one or more of the magnitude or direction of the magnetic field. The above-mentioned types of magnetic field sensors are exemplary and not restrictive. The magnetic field sensor 36 may be any type of sensor for measuring a magnetic field. The magnetic field sensor 36 may measure the direction and / or magnitude of the magnetic field emitted by the magnetic device 26. The magnetic field sensor 36 may be configured to send a signal about the direction and / or magnitude of the measured magnetic field. The controller may be configured to compare the signal with one or more parameters related to the known characteristics (e.g., direction or strength) of the magnetic field of the magnet to confirm the position of the magnet. Alternatively, the signal measured by the magnetic field sensor 36 may be compared with one or more parameters related to the magnetic field of the magnetic device 26, such as by manual comparison performed by an operator or other means. The compared parameters may be used to confirm the position or location of magnet 26 as described herein (e.g., using the magnetic field direction of magnet 26 or the magnitude of the magnetic field direction of magnet 26). Additionally or alternatively, magnetic field sensor 36 may be configured to confirm when an area of ​​maximum measured magnetic field has been confirmed.

[0027] Second device 14 can be advanced into the stomach of a subject such that distal portion 32 (including magnetic field sensor 36) is located in a known or predetermined region of the stomach (e.g., near the stomach wall proximate to the greater curvature, antrum, and / or pylorus). For example, distal portion 32 can be advanced to a portion of the stomach where a bypass procedure is to be performed to connect a pouch of the stomach to the ileum or other portion of the small intestine.

[0028] The first device 12 may be advanced through the small intestine of the subject until a known or predetermined portion of the small intestine is reached. For example, it may be desirable to implement a gastric bypass between the stomach and a portion of the small intestine approximately 150 cm beyond the pylorus. The first device 12 may include markings or other features that enable a user to advance the first device 12 to a known location (e.g., approximately 150 cm beyond the pylorus). For example, a hash mark or ruler-type marking may be used on a portion of the first device 12 (e.g., a jacket or catheter) so that after the marked portion of the device 12 reaches the end of an endoscope for inserting the device 12, the distance that the device 12 extends into the jejunum may be measured using the markings. Additionally or alternatively, the shaft of the first device 12 may change color at a distance of 150 cm so that the distance to the pylorus is apparent by viewing the color of the shaft of the first device 12 at the pylorus.

[0029] The second device 14 may then be manipulated in the stomach cavity until a reading obtained by the magnetic field sensor 36 indicates that the magnetic field sensor 36 is adjacent to the magnetic device 26. In this way, the magnetic field sensor 36 may be determined to be adjacent to the magnetic device 26 even though two tissue walls (e.g., the stomach wall and the wall of the ileum) may be located between the magnetic field sensor 36 and the magnetic device 26. Additionally or alternatively, the second device 14 may be moved relative to the first device 12, and the properties of the magnetic field may be measured by the magnetic field sensor 36. An enhanced magnetic field may indicate that the magnetic field sensor 36 is getting closer to the magnetic device 26 along any relevant dimension. For example, if the magnetic field of the magnetic device 26 is configured to be detectable in a direction substantially perpendicular to the magnetic device 26 (e.g., because portions of the magnetic field emitted in other directions are shielded, as discussed herein), the strength of the measured magnetic field may increase (gradually or dramatically) when the magnetic field sensor 36 is in close proximity to the magnetic device 26. For example, the area of ​​the strongest measured magnetic field may be the area closest to the magnetic device 26. More details of the method of using the first device 12 in conjunction with the second device 14 will be discussed below.

[0030] Figure 2 More details of the distal portion 22 of the first device 12 are depicted. Figure 2 As shown in and discussed above, the distal portion 22 may have a distal tip 24 and a magnetic device 26. The magnetic device 26 may be a permanent magnet or an electromagnet. The two poles of the magnetic device 26 may be oriented in any suitable manner. For example, the magnetic device 26 (such as Figure 2 ) may be opposing magnets. The magnetic device 26 may have a circular perimeter, and the poles 40 and 42 of the magnetic device may be located on opposite sides of the diameter of the magnetic device 26. For example, the magnetic device 26 may include a first pole 40 that occupies an area of ​​the magnetic device 26 on one side of the diameter of the magnetic device 26. The first pole 40 may be, for example, the north pole of the magnetic device 26. The magnetic device 26 may also include a second pole 42 that occupies an area of ​​the magnetic device 26 on the other side of the diameter of the magnetic device 26 opposite the first pole 40. The second pole 42 may be, for example, the south pole of the magnetic device 26. Alternatively, the magnetic device 26 may be circular, but may have poles that are aligned along the radius of the magnetic device 26 (e.g., the interior of the magnetic device 26 may have one pole, wherein the exterior of the magnetic device 26 may have another pole), or may have poles that are separated along the height of the magnetic device 26 (e.g., the magnetic device 26 may be divided into two halves along the height of the magnetic device 26 so that each pole has a circular, cylindrical, or disk-like shape). Alternatively, magnetic device 26 may have poles of other shapes and configurations. For example, magnetic device 26 may be cylindrical, washer-shaped, polygonal, pyramidal, conical, or prismatic.

[0031] A portion of the shaft 20 of the first device 12 proximal to the magnetic device 26 may include a magnetic shield. The magnetic shield 44 may extend proximally from a position 0.5 cm to 1 cm proximal to the magnetic device 26. The magnetic shield 44 may extend proximally to an operating portion (e.g., a handle or driver) proximal to the shaft 20. Alternatively, the magnetic shield 44 may extend proximally only partially along the shaft 20. For example, the magnetic shield 44 may extend to a portion of the shaft 20 where the effect of the magnetic device 26 may no longer be significantly sensed. The magnetic shield 44 may include a coating on the surface of the shaft 20. The magnetic shield 44 may include, for example, a film coated on the shaft 20. Alternatively, the magnetic shield 44 may be made of a different material than the rest of the shaft 20. Any suitable material may be used to form the magnetic shield 44. For example, the magnetic shield 44 may be composed of a metal film containing, for example, nickel, aluminum, or other metal material that provides magnetic shielding. In addition or alternatively, a small disc may form a shield and may be made of any of the above materials.

[0032] The distal-most portion of the shaft 20 proximal to the distal tip 24 may also include a magnetic shield 46. The magnetic shield 46 may have any of the characteristics of the magnetic shield 44 described above. The magnetic shield 46 may extend from the distal tip 24 to a portion of the shaft 20 at a predetermined distance distal to the magnetic device 26 (e.g., 0.5 cm to 1 cm from the magnetic device 26). Alternatively, the magnetic shield 46 may not extend all the way to the distal tip 24. The magnetic shield 46 may extend distally far enough to a location where the magnetic field of the magnetic device 26 does not extend.

[0033] The unshielded portion 48 may be in close proximity to the magnetic device 26. The unshielded portion 48 of the device 12 may extend up to approximately 1 cm proximally and distally to the magnetic device 26, or may extend up to a full length of approximately 1 cm, thereby spanning the magnetic device 26. In each example herein, shielding is used to focus the magnetic field of the magnetic device 26. Alternatively, the unshielded portion 48 may extend proximally and / or distally from the magnetic device 26 to any suitable distance. The unshielded portion 48 may extend equidistantly relative to the magnetic device 26 in the proximal and distal directions. Alternatively, the unshielded portion 48 may be asymmetric relative to the magnetic device 26. For example, the unshielded portion 48 may extend further proximally or further distally relative to the magnetic device 26.

[0034] The magnetic shields 44 and 46 can block or redirect the passage of the magnetic field emitted by the magnetic device 26 so that the magnetic field does not pass through the wall of the component 20 at the location where the magnetic shields 44 and 46 are present. In contrast, the unshielded portion 48 can allow the magnetic field emitted by the magnetic device 26 to pass through the wall of the component 20 at the location where the unshielded portion 48 is present. The presence of the magnetic shields 44 and 46 can cause the magnetic field emitted by the magnetic device 26 to present a more concentrated shape. For example, in the area of ​​the unshielded portion 48, the magnetic field emitted by the magnetic device 26 can be mostly or substantially perpendicular to the longitudinal axis of the component 20. The shields 44 and 46 can block the passage of the magnetic field from the magnetic device portion 26, where the magnetic field will be relatively less perpendicular to the longitudinal axis of the component 22.

[0035] Figure 3A to Figure 3C More details regarding the magnetic device 26 are shown. Figure 3A to Figure 3C The magnetic device 26 is shown as a counter magnet. However, as mentioned above, the magnetic device 26 may have any suitable shape or configuration. For example, the magnetic device 26 may be an electromagnet that generates the same magnetic field as the counter magnet. Figure 3A to Figure 3C Exemplary magnetic field lines of magnetic device 26 are shown. Figure 3A shows a perspective view of the magnetic device 26, Figure 3B A side view of the magnetic device 26 is shown, Figure 3C A top view of the magnetic device 26 is shown. Figure 3A to Figure 3C The magnetic field lines shown in FIG. 2 are schematic only and do not depict the exact or specific magnetic field of the magnetic device 26. Instead, they are exemplary only and representative of the general characteristics of possible magnetic field lines of the magnetic device 26. Figure 3A to Figure 3C , magnetic field lines representing the magnetic field of magnetic device 26 may extend from pole 40 of magnetic device 26 to pole 42 of magnetic device 26. Pole 40 may be the north pole of magnetic device 26 and pole 42 may be the south pole of magnetic device 26. If, instead, pole 40 is the south pole and pole 42 is the north pole, the direction of the illustrated magnetic field lines may be reversed.

[0036] Figure 4The interaction between the magnetic device 26 and the magnetic field sensor 36 when the first device 12 and the second device 14 are inserted into the body cavity is shown. In an exemplary process, the first device 12 can be inserted into the intestinal cavity of the subject. For example, the distal portion 22 of the first device 12 can be inserted into the mouth of the subject, through the esophagus, through the stomach, and into the small intestine of the subject. The first device 12 may include features as known in the art for advancing the distal end 22 of the first device 12 to a known position (such as the jejunum or ileum) of the small intestine. For example, the distal end 22 of the first device 12 can be inserted into the small intestine of the subject for about 150 centimeters. The second device 14 can be inserted into the stomach cavity of the subject simultaneously, in advance, or subsequently. The distal portion 32 of the second device 14 can be inserted into the mouth of the subject and extend downward along the esophagus of the subject to the stomach of the subject. The second device 14 can be advanced distally into the stomach.

[0037] The magnetic field sensor 36 may be used when guiding the second device 14 through the gastric cavity of the subject. The distal portion 22 of the first device 12 (which includes the magnetic device 26) may be maintained at a desired position in the small intestine cavity (e.g., 150 cm into the small intestine). The operator may receive a signal from the magnetic field sensor 36, which is an indication of the magnetic field measured by the magnetic field sensor 36. The operator of the second device 14 may analyze the signal or other output from the magnetic field sensor 36 to look for the signature (magnetic trace) of the magnetic device 26. When the signature of the magnetic device is received (e.g., using a magnetic field directed perpendicularly to the tissue wall surrounding the intestinal cavity and / or gastric cavity, which is the magnetic field of the magnetic device 26, such as in Figure 3A to Figure 3C ), the operator can then know that the magnetic field sensor 36 is located in the portion of the stomach cavity adjacent to or in close proximity to the desired location in the small intestine (e.g., 150 cm into the small intestine). The operator can identify the tissue wall surrounding the second cavity that is in close proximity to and / or adjacent to the location in the first cavity where the magnetic device 26 is located. The system 10 can facilitate the operator to grasp or manipulate the tissue wall surrounding the first cavity and in close proximity to the magnetic device 26. For example, when the magnetic device is advanced 150 cm past the pylorus and into the small intestine, the operator can identify the portion of the stomach wall that is in close proximity to or in close proximity to the small intestine wall that is 150 cm past the pylorus. The same principles apply to other body cavities and / or other locations within the body cavity.

[0038] After using the magnetic field sensor 36 to identify the appropriate characteristics of the magnetic field of the magnetic device 26, the operator can then perform a surgery involving the confirmed tissue portion. The medical tool can be advanced from the first cavity to the second cavity. The tissue wall defining a portion of the first cavity can be connected to the tissue wall defining a portion of the second cavity via, for example, an eyelet in the wall surrounding the second cavity. The eyelet can be made at a position close to the magnetic device 26. For example, a first hole can be formed in the tissue wall defining the first cavity, and a second hole can be formed in the tissue wall defining the second cavity. The tissue wall defining the first cavity can be connected to the tissue wall defining the second cavity, so that the first hole and the second hole are interconnected. A continuous cavity can be formed between the first cavity and the second cavity via the first hole and the second hole. For example, the operator can perform a gastric bypass operation by forming a passage between the stomach and the confirmed portion of the patient's small intestine. A portion of the patient's stomach cavity can be connected to a portion of the intestinal cavity. Food can bypass the intestinal cavity portion proximal to the connection formed between the stomach cavity and the intestinal cavity. Food can pass through the intestinal cavity portion distal to the connection formed between the stomach cavity and the intestinal cavity. For example, food may travel from the pylorus through the luminal portion of the intestine for more than 150 cm.

[0039] Figure 5 An alternative system 100 is shown that uses an alternative second device 102. The second device 102 can have any of the characteristics of the second device 14 described above. The second device 102 can include a slender member 104, which can have any of the characteristics of the member 30 described above. The member 104 can have a distal portion 106, which can have any of the characteristics of the distal portion 32. The second device 102 can also include a tool 108. The tool 108 can be a tool of any suitable form, which can be inserted into a working lumen of the member 104 or contained in the member 104, for example. The member 104 can have one or more working lumens. For example, the member 104 can have a 3.8 mm working lumen and a 2.8 mm working lumen. The tool 108 can be passed through a working lumen of the member 104, such as the 2.8 mm working lumen of the member 104. For example, the tool 108 can be an atraumatic small intestine grasper or any other type of tool.

[0040] Tool 108 may include a magnetic field sensor 110. Magnetic field sensor 110 may have any of the characteristics described above with respect to magnetic field sensor 36. Magnetic field sensor 110 may be disposed at any location on tool 108, such as a distal shaft of tool 108. Alternatively, magnetic field sensor 110 may be disposed on component 104. Alternatively, magnetic field sensor 110 may be a separate device that may be inserted through a working cavity of component 104. Figure 1 to Figure 4Any of the methods described may be used in conjunction with the system 100. After or while performing this method, the tool 108 may be used to perform surgery (e.g., gastric bypass surgery) before or after the tool 108 detects the magnetic field signature (magnetic trace) of the magnetic device 26. For example, while the first device 12 is present in the intestinal cavity (or any other body cavity) of the subject, the second device 102 may be manipulated in the stomach cavity (or any other body cavity) of the subject. The magnetic field sensor 110 may be used to detect the magnetic field emitted by the magnetic device 26. When the magnetic field emitted by the magnetic device 26 is detected, the operator may understand the position of the magnetic device 26 relative to the second device 102. In order to detect the magnetic field emitted by the magnetic device 26, the operator may compare the data from the magnetic field sensor 110 with a predetermined characteristic (e.g., amplitude or direction) of the magnetic field, and / or may analyze the data from the magnetic field sensor 110 to determine, for example, that the strength or direction of the measured magnetic field is changing. This information may indicate the position of the magnetic device 26. For example, the operator can understand that the distal portion 106 is located in a first body cavity (such as the stomach) close to or adjacent to a predetermined position (e.g., 150 cm distal to the pylorus) where the first device 12 is inserted in a second body cavity (such as the small intestine). The operator can then advance and / or drive the tool 108 to perform a medical procedure. For example, the operator can use the tool 108 to grasp a portion of the small intestine 150 cm away from the subject's pylorus. Other suitable tools that can be used in conjunction with or as an alternative to the grasper include tools for perforating the stomach wall and / or the intestinal wall, tools for attaching the stomach wall to the intestinal wall, tools for sealing the attached wall, and / or tools for providing anastomosis between the stomach wall and the intestinal wall.

[0041] Figure 6An alternative system 200 is shown, which uses an alternative first device 202. The alternative first device 202 may have any of the characteristics of the first device 12 described above. The first device 202 may be used in conjunction with one of the second devices 14, 102 described above or an alternative device. The first device 202 may have an elongated member or shaft 204, which may have any of the characteristics of the member 20 described above. The member 204 may have a distal portion 206, which may have any of the characteristics of the distal portion 22. The distal portion 206 may have an elongated shape and have one or more rounded ends. The distal portion 206 may have a shape that is generally similar to a capsule. The distal portion 206 may be steered (turned) by a thin wire connection. For example, bidirectional steering (bidirectional directional steering) may be adopted. In contrast to a plastic tube catheter used in conjunction with the distal portion 206, a small wire may be tethered to the distal portion 206 and provide length measurement and / or power. Such a wire may be highly flexible and have a small diameter (e.g., a diameter smaller than the catheter). The distal portion 206 may include a magnetic device 210, which may have any of the properties described above for the magnetic device 26. The distal portion 206 may have any of the magnetic shielding properties of the distal portion 22 described above.

[0042] The distal portion 206 may also include an illumination portion 212. The illumination portion 212 may be embedded in the distal portion 206, may be located within the distal portion 206, may be mounted on the distal portion 206, or may be attached to the distal portion 206 in any other suitable manner. The illumination portion 212 may include, for example, one or more optical fibers, light emitting diodes (LEDs), or other suitable illumination devices. The illumination portion 212 may be configured to emit a steady light and / or a flashing light having any flashing pattern.

[0043] As described above, the distal portion 36 of the second device 14 may include a camera, a lens, or other optical device. Such a camera, a lens, or other optical device may be configured to detect light emitted from the illumination portion 212. The light emitted from the illumination portion 212 may be used to confirm a target body cavity portion (e.g., a portion of the small intestine approximately 150 cm from the pylorus) independently of or in conjunction with the magnetic device 210. For example, an operator may be able to visualize light emitted from the illumination portion 212 through the wall of the gastric cavity. The illumination portion 212 may be configured to focus light emission toward the cavity wall facing the second device 14. The operator may also utilize a signal from the magnetic field sensor 36.

[0044] Figure 7 An exemplary method for performing a medical procedure is shown, which may be applicable to any of the above method steps, devices or systems. Figure 7As shown in , a method 200 for performing a medical procedure (such as gastric bypass surgery) may include, in step 210, advancing a first device (e.g., first device 12 or first device 202) through a first body cavity, such as a small intestine cavity. The first device 12 or 202 may be advanced to a predetermined portion of the body cavity, corresponding to a location where an operator wishes to manipulate tissue surrounding the body cavity. As described above, the first device 12 or 202 may include a magnetic device (e.g., magnetic device 26 or 210), which may be, for example, a permanent magnet or an electromagnet. In step 220, the operator may advance a second device (e.g., second device 14 or second device 102) through a second body cavity (e.g., stomach). As described above, the second device 14 or 102 may include a magnetic field sensor (e.g., magnetic field sensor 36 or 110), which may be, for example, a permanent magnet or an electromagnet. In step 230, the operator may receive a signal from the magnetic field sensor 36 or 110. The received signal may indicate a measured magnetic field and may include information about the direction of the detected magnetic field, the magnitude of the detected magnetic field, or both. In step 240, it may be determined whether the signal received in step 230 matches the magnetic field of the magnetic device 26 or 210 (as described above). For example, it may be determined whether the direction of the received signal in step 230 matches a predetermined direction or a predetermined magnetic field characteristic. In addition or alternatively, it may be determined whether the received signal matches the magnetic field of the magnetic device 26 and / or 210 by analyzing changes in the readings from the magnetic field sensor 36 or 110. For example, the magnetic field of the magnetic device 26 or 210 may be matched by locating the strongest measured magnetic field or by locating another characteristic feature of the magnetic device 26 or 210.

[0045] If the received signal matches the magnetic field, the position of the magnet is confirmed in the first body cavity in step 250. Based on this information, the target predetermined area in the first body cavity (or the second body cavity) can be confirmed. For example, the operator can confirm the target area in the tissue wall surrounding the second body cavity, or can confirm the first body cavity portion (and / or surrounding tissue) that should be manipulated. If in step 240, the received signal does not match the magnetic field, step 220 can be repeated to move the second device 14 or 102 to a new portion of the second body cavity and analyze the magnetic field measured therein again.

[0046] Although the principles of the present disclosure are described herein with reference to illustrative examples for specific purposes, it should be understood that the present disclosure is not limited to these examples. Personnel with ordinary skills in the art and who can obtain the teachings provided herein will recognize that other modifications, uses, and replacements of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A medical device comprising an elongated member having a distal portion configured to be advanced into a first body lumen; and a magnetic field sensor disposed on a distal portion of the elongated member, in, The magnetic field sensor is configured to measure a magnetic field emitted by a magnetic device disposed in the second body cavity and transmit a signal corresponding to a position of the magnetic device relative to the magnetic field sensor.

2. The medical device of claim 1, further comprising a tool configured to perforate a wall of the first body cavity.

3. The medical device of claim 2, wherein the tool comprises an atraumatic grasper.

4. The medical device of claim 1, further comprising an optical device disposed on the distal portion of the slender member.

5. The medical device of claim 4, wherein the optical device comprises at least one of a camera or a lens.

6. The medical device of claim 4, wherein the optical device is configured to detect light from a second body cavity.

7. The medical device of claim 1, wherein the magnetic field sensor is at least one of a Hall effect sensor, a magnetoresistive sensor, a fluxgate, a flux coil, or a magnetic induction sensor.

8. The medical device of claim 1, wherein the signal comprises information regarding at least one of a direction or a magnitude of a magnetic field.

9. The medical device of claim 1, wherein the signal is compared to one or more parameters related to the magnetic field of the magnetic device to identify the position of the magnetic device relative to the magnetic field sensor.

10. A medical device comprising an elongated member having a distal portion configured to be advanced into a first body lumen; and a magnet disposed on a distal portion of the elongated member, in, The magnet emits a magnetic field that can be measured by a magnetic field sensor disposed in the second body cavity to identify the position of the magnet relative to the magnetic field sensor.

11. The medical device of claim 10, wherein the magnet is an opposing magnet.

12. The medical device of claim 10, further comprising at least one magnetic shielding portion disposed on the elongated member.

13. The medical device of claim 12, wherein the at least one magnetic shield portion comprises a first magnetic shield portion proximal to the magnet and a second magnetic shield portion distal to the magnet.

14. The medical device of claim 13, further comprising a magnetically non-shielding portion disposed on the distal portion and extending between the first magnetically shielding portion and the second magnetically shielding portion.

15. The medical device of claim 10, further comprising a light emitting source configured to emit light detectable by an optical device disposed in the second body cavity.

16. The medical device of claim 10, wherein the magnetic field is configured to have a direction perpendicular to a tissue wall defining the first body cavity.

17. The medical device of claim 10, wherein the distal portion of the elongated member is steerable.

18. The medical device of claim 10, further comprising an articulating joint disposed in the distal portion of the elongated member.

19. The medical device of claim 18, further comprising at least one actuator configured to control the articulating joint to steer the distal portion of the elongated member.

20. The medical device of claim 10, wherein the distal portion of the elongate member comprises an atraumatic distal tip configured to be advanced into a first body lumen.

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