Intrauterine devices, systems, and methods for inserting

Abstract

An intrauterine device (IUD) may include a magnetic field source and / or a shape sensing optical fiber that enables positional tracking of the IUD during placement. An insertion device (ID) for the IUD may also include a magnetic field source and / or a shape sensing optical fiber. An IUD placement system includes logic that processes magnetic field sensing data and / or optical shape sensing data to determine a real-time position and / or an orientation of the IUD or the ID with respect to the uterus during placement of the IUD. Logic may render, on a display, visual representations of the uterus and / or ultrasound images of the uterus obtained by an ultrasound probe of the system. Logic further overlays, atop the visual representations of the uterus and / or ultrasound images of the uterus, visual representations of the IUD or the ID at the real-time position and / or orientation.

Description

Docket No. 101672.0627PCTINTRAUTERINE DEVICES, SYSTEMS, AND METHODS FOR INSERTINGPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 712,986, filed October 28, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] The placement of an intrauterine device (IUD) within a uterus of a patient can present complications including injury risk to patient. Furthermore, accurate placement of the IUD within the uterus is required for the IUD to perform its intended purpose. Ultrasound imaging of the uterus can be used to determine that the IUD is properly positioned after the placement process. However, improper positioning of the IUD is a common error of the IUD placement process and repositioning of the IUD causes increased health care cost and increased risk to the patient. As such, there is a need to improve the IUD placement process and reduce the cost and risk associated with the IUD placement process. Disclosed herein are devices, systems, and methods that address the forgoing.SUMMARY

[0003] Disclosed herein is an intrauterine device (IUD) that, according to some embodiments, includes a post defining a proximal end and a distal end, and a first arm and a second arm, where each arm defines a fixed end and a free end, and where the fixed end of each arm is coupled with the post at the distal end of the post. The first and second arms extend laterally away from the post in opposite directions such that the free ends of first and second arms are disposed laterally away from the post when the IUD is transitioned to an expanded state, and the first and second arms are oriented substantially parallel to the post when the IUD is transitioned to a contracted state. The IUD includes a magnetic field or an optical fiber physically coupled with the post..

[0004] In some embodiments, the IUD includes the magnetic field source and the magnetic field source is positioned adjacent the distal end of the post. In some embodiments, the IUD further includes a second magnetic field source coupled with the post adjacent the proximal end of the post. Further, in some embodiments, the IUD further includes third and fourth magnetic field sources coupled with the first arm and the second arm, respectively,Docket No. 101672.0627PCT where the third and fourth magnetic field sources located adjacent the free ends of the first and second arms.

[0005] In some embodiments, the IUD includes the optical fiber, and the optical fiber includes a distal portion extending along the post and a distal end located adjacent the distal end of the post. Alternatively, the optical fiber extends along the post from the proximal end of the post to the distal end of the post, and the optical fiber separates into a first optical fiber extending along the first arm and a second optical fiber extending along the second arm.

[0006] Also disclosed herein is an IUD insertion device (ID) that, according to some embodiments, includes a tube defining a proximal end, a distal end, a lumen extending along the tube, and a tube wall, where the lumen is configured to receive the IUD therein; and a handle coupled with the tube at the proximal end of the tube, where the handle is configured for grasping by a clinician so that the clinician can manipulate the tube during an IUD insertion process. The ID includes a first tube magnetic field source disposed adjacent the distal end of the tube or an optical fiber extending along the tube.

[0007] In some embodiments, the ID further includes a rod disposed within and extending along the lumen, where the rod positionable between: an extended position, where a distal end of the rod is disposed adjacent the distal end of the tube; and a retracted position, where the distal end of the rod is proximally displaced away from the distal end of the tube such that a substantial entirety of an IUD can be disposed within the lumen between the distal end of the rod and the distal end of the tube.

[0008] In some embodiments, the ID further includes a slider coupled with the handle, wherein the slider, the rod, the tube, and the handle are operatively coupled with each other such that displacement of the slider with respect the handle causes a longitudinal displacement of the rod with respect to the tube. In some embodiments of the ID, the slider is fixedly coupled with the tube.

[0009] In some embodiments, the ID further includes a rod magnetic field source coupled with the rod at the distal end of the rod, and in some embodiments, the ID further includes a second tube magnetic field source coupled with the tube at a first location along the tube, the first location spaced proximally away from the distal end of the tube a distance substantially equal to a length of the post of the IUD.Docket No. 101672.0627PCT

[0010] In some embodiments, the ID includes the optical fiber and the optical fiber includes a plurality of optical fiber cores extending along the optical fiber from the proximal end of the optical fiber to the distal end of the optical fiber. Each optical fiber core includes a plurality of reflective gratings distributed along a length of the optical fiber core, where each of the plurality of reflective gratings are configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on a strain experienced by the optical fiber core. In some embodiments of the ID, the strain experienced by the optical fiber cores is defined by a bending of the tube. In some embodiments of the ID, the strain experienced by the optical fiber cores may also be defined by an axial compression of the tube.

[0011] In some embodiments, the optical fiber is disposed within and extends along a second lumen of the tube to a distal end of the tube. In some embodiments of the ID, the optical fiber cores also extend proximally along an optical cable to an optical connector.

[0012] Also disclosed herein is an intrauterine device (IUD) assembly that includes any one of the embodiments of the IUD described and any one of the embodiments of the ID described above, where the IUD is disposed within the tube of the ID in the contracted state.

[0013] Also disclosed herein is a system that, according to some embodiments, includes an IUD and an ID configured for utilization by a clinician during a placement process of the IUD within a patient. The ID includes a tube defining a proximal end, a distal end, a lumen, and a tube wall, where the IUD is disposed within the lumen. The ID further includes a handle coupled with the tube at the proximal end, where the handle is configured for grasping by a clinician so that the clinician can manipulate the tube during the placement process. The system further includes one or more magnetic field sources coupled with one or both of the IUD or the ID and a sensor module including a plurality of magnetic field sensors configured to detect one or more magnetic fields that are correspondingly defined by the one or more magnetic field sources, where the sensor module is configured for placement on the patient. The system further includes a console coupled with the sensor module, where the console includes a processor and a memory having logic stored thereon that, when executed by the processor, causes operations of the system. The operations include defining magnetic field data in accordance with the detected one or more magnetic fields and processing the magnetic field data to determine a real-time position of each of the one or more magnetic field sources, where the real-time position is defined with respect to the sensor module.Docket No. 101672.0627PCT

[0014] In some embodiments during use of the system, the sensor module located on the patient in alignment with one or more anatomical landmarks so as to be aligned with the uterus such that the real-time position with respect to the sensor module corresponds to a realtime position with respect to the uterus.

[0015] In some embodiments of the system, the IUD includes: a post defining a proximal end and a distal end; and a first arm and a second arm, where each arm defines a fixed end and a free end, and where the fixed end of each arm is coupled with the post at the distal end of the post.

[0016] In some embodiments of the system, the one or more magnetic field sources includes an IUD magnetic field source coupled with the IUD, such that the real-time position of the IUD magnetic field source defines a real-time position of the IUD. In some embodiments of the system, the operations further includes (i) rendering a top view visual representation of the uterus on the display, and (ii) overlaying a top view visual representation of the IUD atop the top view visual representation of the uterus at the real-time position of the IUD.

[0017] In some embodiments of the system, the one or more magnetic field sources includes ID magnetic field source coupled with the tube at the distal end of the tube, such that the real-time position of the ID magnetic field source defines a real-time position of the distal end of the tube. In some embodiments of the system, the operations further include (i) rendering a top view visual representation of the uterus on the display, and (ii) overlaying a top view visual representation of a distal portion the ID atop the top view visual representation of the uterus at the real-time position of the distal end of the tube.

[0018] In some embodiments of the system, the IUD further includes an IUD optical fiber coupled therewith, where the IUD optical fiber has a distal portion extending along at least a portion of the post and a proximal end physically coupled with the sensor module. The IUD optical fiber includes multiple optical fiber cores each of which includes a plurality of reflective gratings that enable shape sensing of the IUD optical fiber. The IUD optical fiber is optically coupled with the console and the operations further include (i) processing shape sensing data associated with the IUD optical fiber to determine a 3 -dimensional shape of the IUD optical fiber and (ii) further determining the real-time position of the IUD based on the 3- dimensional shape of the IUD optical fiber.Docket No. 101672.0627PCT

[0019] In some embodiments of the system, the operations further include determining a real-time orientation of the IUD based on the 3 -dimensional shape of the IUD optical fiber. In some embodiments of the system, the operations further include (i) rendering a side view visual representation of the uterus on the display, and (ii) overlaying a side view visual representation of the IUD atop the side view visual representation of the uterus at the real-time position and the real-time orientation of the IUD.

[0020] In some embodiments of the system, the ID further comprises an ID optical fiber coupled therewith, where the ID optical fiber has a distal portion extending along the tube and a proximal end physically coupled with the sensor module. The ID optical fiber includes multiple optical fiber cores each of which includes a plurality of reflective gratings that enable shape sensing of the ID optical fiber, and the ID optical fiber is optically coupled with the console. In such embodiments, the operations further include (i) processing shape sensing data acquired from the ID optical fiber to determine a 3 -dimensional shape of the ID optical fiber, and (ii) further determining the real-time position of the distal end of the tube based on the 3- dimensional shape of the ID optical fiber. In some embodiments of the system, the operations further include (i) rendering a side view visual representation of the uterus on the display, and(ii) overlaying a side view visual representation of the distal portion the ID atop the side view visual representation of the uterus at the real-time position of the distal end of the tube.

[0021] In some embodiments, the system further includes an ultrasound probe coupled with console, where the ultrasound probe is configured to obtain an ultrasound image of the uterus, and the operations further include (i) rendering the ultrasound image on a display coupled with the console, and (ii) overlaying the visual representation of the IUD at the realtime position atop the ultrasound image.

[0022] Also disclosed herein is a method of placing an IUD within a patient that, according to some embodiments, includes: (i) generating a magnetic field by a magnetic field source coupled with the IUD, where the IUD in a contracted state is disposed within a distal portion of a tube of an IUD insertion device (ID), and the distal portion is inserted into a uterus of the patient; (ii) detecting the magnet field by a magnetic field sensor placed on the patient;(iii) converting a magnetic field signal defined by the magnetic field sensor into magnetic field data; (iv) processing the magnetic field data to determine a real-time position of the IUD within the uterus; (v) obtaining a top view ultrasound image of the uterus via an ultrasound probe; (vi) rendering the top view ultrasound image on a display; (vii) overlaying atop the ultrasoundDocket No. 101672.0627PCT image a top view visual representation of the distal portion of the tube including the IUD at the real-time position; and (viii) overlaying a top view visual representation of the IUD removed from the distal portion of the tube at the real-time position in an expanded state.

[0023] In some embodiments of the method, the IUD includes an optical fiber having a distal portion extending along at least a portion of a post of the IUD and a proximal end physically coupled with the magnetic field sensor, and the optical fiber includes multiple optical fiber cores each of which includes a plurality of reflective gratings that enable shape sensing of the optical fiber. In such embodiments, the method further includes: (i) processing shape sensing data acquired from the optical fiber to determine a real-time 3 -dimensional shape of the optical fiber; (ii) determining a real-time orientation of the IUD based on the 3- dimensional shape of the optical fiber; (iii) obtaining a side view ultrasound image of the uterus; (iv) rendering the side view ultrasound image of the uterus on the display; and (v) overlaying a side view visual representation of the IUD at the real-time orientation atop the side view ultrasound image.

[0024] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0025] FIG. 1A illustrates a first embodiment of an intrauterine device (IUD), according to some embodiments disclosed herein.

[0026] FIG. IB illustrates a second embodiment of an IUD disposed within a uterus of a patient, according to some embodiments disclosed herein.

[0027] FIG. 1C illustrates a third embodiment of an IUD, according to some embodiments disclosed herein.

[0028] FIG. 2A illustrates an IUD insertion device (ID), according to some embodiments disclosed herein.

[0029] FIG. 2B is a detailed illustration of a distal portion of the ID of FIG. 2A including an optical fiber, according to some embodiments disclosed herein.Docket No. 101672.0627PCT

[0030] FIG. 2C is a detailed illustration of a distal portion of the ID of FIG. 2A including magnetic field sources, according to some embodiments disclosed herein.

[0031] FIG. 2D is a detailed illustration of a distal portion of the ID of FIG. 2A including an optical fiber disposed within a lumen, according to some embodiments disclosed herein.

[0032] FIG. 3 is a detailed illustration of a distal portion of an IUD assembly including an IUD and an ID, according to some embodiments disclosed herein.

[0033] FIG. 4 is an illustration of an IUD insertion system, according to some embodiments disclosed herein.

[0034] FIG. 5 is a block diagram of a console of the IUD insertion system of FIG. 4, according to some embodiments disclosed herein.

[0035] FIGS. 6A-6E illustrate various screen shots that my may be rendered on a display of the IUD insertion system of FIG. 4, according to some embodiments disclosed herein.

[0036] FIGS. 7A and 7B illustrate various screen shots including an ultrasound image that my may be rendered on the display of the IUD insertion system of FIG. 4, according to some embodiments disclosed herein.

[0037] FIGS. 8A and 8B illustrate a block diagram of a method of placing the IUD within a patient, according to some embodiments disclosed herein.DESCRIPTION

[0038] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. Furthermore, reference in the specification to "one embodiment" or "an embodiment" of the present principles, as well as other variations thereof, means that a particular feature, structure, characteristic, and so forth described in connection with the embodiment is included in at least one embodiment of the present principles. Thus, theDocket No. 101672.0627PCT appearances of the phrase "in one embodiment", "in an embodiment", or “in some embodiments”, as well any other variations, appearing in various places throughout the specification are not necessarily all referring to the same embodiment or embodiments.

[0039] It will also be understood that when an element such as a layer, region or material is referred to as being "on" or "over" another element, it can be directly on the other element or intervening elements may also be present. In contrast, when an element is referred to as being "directly on" or "directly over" another element, there are no intervening elements present. The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.

[0040] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0041] The terms “proximal” and “distal” refer to opposite ends of a medical device, including the devices disclosed herein. More specifically, the proximal end of a medical device is the end nearest a practitioner during use, and the distal end of a medical device is the end or portion nearest a patient during use. For example, the distal end or portion of a catheter is the end or portion of the catheter furthest disposed within the patient. Conversely, the proximal end or portion of the catheter is the end or portion disposed outside the patient.Docket No. 101672.0627PCT

[0042] The term “logic” may be representative of hardware, firmware or software that is configured to perform one or more functions. As hardware, the term logic may refer to or include circuitry having data processing and / or storage functionality. Examples of such circuitry may include, but are not limited or restricted to a hardware processor (e.g., microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit “ASIC”, etc.), a semiconductor memory, or combinatorial elements.

[0043] Additionally, or in the alternative, the term logic may refer to or include software such as one or more processes, one or more instances, Application Programming Interface(s) (API), subroutine(s), function(s), applet(s), servlet(s), routine(s), source code, object code, shared library / dynamic link library (dll), or even one or more instructions. This software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals). Examples of a non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; non-persistent storage such as volatile memory (e.g., any type of random access memory “RAM”); or persistent storage such as non-volatile memory (e.g., read-only memory “ROM”, power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device. As firmware, the logic may be stored in persistent storage.

[0044] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially straight” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely straight configuration.

[0045] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and / or use of specific steps and / or actions may beDocket No. 101672.0627PCT modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and / or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0046] FIG. 1A is front view of an intrauterine device (IUD) 100, according to some embodiments disclosed herein. The IUD 100 is generally configured for placement within a uterus of a patient. The IUD 100 includes a post 110 extending from a post proximal end 111 to a post distal end 112. The IUD further includes a left arm 124 extending between a left arm free end 124 A and left arm fixed end 124B. Similarly, the IUD further includes a right arm 125 extending between a right arm free end 125 A and right arm fixed end 125B. The left arm fixed end 124B and the right arm fixed end 125B are each flexibly coupled with the post distal end 112 to define a junction 116. The IUD 100 is transitional between an expanded state as illustrated in FIG. 1 and a contracted state (see FIG. 3). In the expanded state, the left arm 124 extends laterally away fro.m a left side of the post 110 and the right arm 125 extends laterally away from a right side of the post 110. In the contracted state, the left arm 124 and the right arm 125 may be disposed substantially parallel with the post 110 to accommodate placement of the IUD 100 within a tube.

[0047] The IUD 100 may be formed of any suitable material or combination of materials. In some embodiments, the IUD 100 include plastic material, such as a thermoplastic material, for example, formed via the injection molding process. In some embodiments, the IUD 100 may include a metallic material, such as stainless steel or Nitenol®, for example.

[0048] The post 110 includes a post lumen 115 extending distally along the post 110. A closed distal end of the lumen 115 is disposed adjacent the distal end 112 of the post and an open end of the lumen 115 is disposed adjacent the proximal end 111 of the post 110. A distal portion 130A of a stylet 130 is disposed within the lumen 115, while a proximal portion 130B of the stylet 130 exits the lumen 115 and extends proximally away from the proximal end 111 of the post 110.

[0049] The stylet 130 includes a number (e.g., 1, 2, 3, 4 or more) of magnetic field sources disposed along at least a distal portion of the stylet 130 are configured to enable theDocket No. 101672.0627PCT location and / or orientation at least a distal portion 130A of the slylet 130 of the IUD 100 to be magnetically determined before, during, and / or after placement of the IUD 100 within the uterus. In the illustrated embodiment, the stylet 130 includes the magnetic field source 132 disposed at the distal end of the stylet 130 so as to be positioned adjacent the distal end 112 of the post 110 to enable a location of the distal end 112 of the post 110 to be determined and / or tracked via a magnetic tracking system. In other embodiments, additional magnetic field sources (not shown) may be disposed along the distal portion 130A of the stylet 130 to enable an orientation of the post 110 to be determined and / or tracked via the magnetic tracking system.

[0050] The magnetic field sources are configured to be detectable by a magnetic field senser disposed outside of the patient body. The magnetic field sources may take any suitable form. In some embodiments, one or more of the magnetic field sources may include a permanent magnet or a magnetized portion of the metallic material. In some embodiments, one or more of the magnetic field sources may include a coiled wire that generates a magnetic field via current flow through the wire. Any or all of the magnetic field sources may define a dipole (i.e., a north pole and an opposite south pole) and the dipole may define an orientation of the magnetic field source that is detectable by the magnetic field senser disposed outside of the patient body. The magnetic field sources may be coupled with the IUD 100 in any suitable fashion that prevents displacement of the magnetic field source with respect to the IUD 100.

[0051] In some embodiments, although not required, the stylet 130 may include an optical fiber 134 extending along the stylet 130 including the distal portion 130A. A distal portion 134A of the optical fiber 134 may be disposed within the lumen 115. An optical connector 134B is disposed at a proximal end of the optical fiber 134. The optical fiber 134 is a multi-core fiber that includes a plurality of optical fiber cores. The optical fiber 134 is configured for shape sensing. The plurality of optical fiber cores include reflective gratings (e.g., Bragg gratings) that define a 3-dimentional shape sensing capability. Similarly, the optical fiber cores are distributed across a cross section of the optical fiber 134 such that a strain experienced by the optical fiber cores is associated with a shape of the optical fiber 134. In other words, a change in the shape of the optical fiber 134 along a length of the optical fiber cores is detectable by the reflective gratings. As such, a 3-dimentional orientation of the distal portion 134 with respect to any other length segment of the optical fiber 134 may be determined based on the shape of the optical fiber 134. The reflective gratings are distributed along a length of each optical fiber core, where each of the plurality of reflective gratings are configured toDocket No. 101672.0627PCT(i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber core, the strain caused by bending of the optical fiber. Further details regarding structure, features, and functionality of multi-core optical fibers configured for shape sensing are taught in U.S. Pub. No. 20210268229 which is incorporated herein in its entirety.

[0052] FIG. IB is a top view of an intrauterine device (IUD) 101 that can, in certain respects, resemble components of the IUD 100 described in connection with FIG. 1A. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the IUD 100 and related components shown in FIG. 1A may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the IUD 101 of FIG. IB. Any suitable combination of the features, and variations of the same, described with respect to the IUD 100 and components illustrated in FIG. 1 A can be employed with the IUD 101 and components of FIG. IB, and vice versa.

[0053] FIG. IB illustrates the IUD 101 disposed within a uterus 52 of a patient 50, according to some embodiments disclosed herein. The IUD 101 is generally configured for placement within the uterus 52. Also shown is a right fallopian tube 54A extending away from the uterus 52 on the right side and right fallopian tube 54B extending away from the uterus 52 on the left side. The cervix 56 is shown at the bottom of the uterus 52 and a back wall 58 of the uterus 52 is shown at the top.

[0054] The IUD 101 includes the post 110. A tether 119 (e.g., a string) is attached to the post 110 at the post proximal end 111. In the expanded state, the left arm 124 extends laterally away from the left side of the post 110 toward the left fallopian tube 54 and the right arm 125 extends laterally away from the right side of the post 110 toward the right fallopian tube 55. When the IUD 101 is correctly placed within the uterus 52, the junction 116 may be disposed adjacent the back wall 58.Docket No. 101672.0627PCT

[0055] The IUD 101 includes a number (e.g., 1, 2, 3, 4 or more) of magnetic field sources configured to enable the location and / or orientation of the IUD 101 to be determined before, during, and / or after placement of the IUD 101 within the uterus 52. In the illustrated embodiment, the post 110 includes a first post magnetic field source 151 disposed at the proximal end 111 and a second post magnetic field source 152 disposed at the distal end 112 (i.e., the junction 116). The left arm 124 includes a left arm magnetic field source 154 disposed at the left arm free end 124A, and right arm 125 includes a right arm magnetic field source 155 disposed at the right arm free end 125A. Various embodiments of the IUD 101 may include all or any subset of the first post magnetic field source 151, the second post magnetic field source 152, left arm magnetic field source 154, and the right arm magnetic field source 155. Similarly, in some embodiments, any of the first post magnetic field source 151 , the second post magnetic field source 152, left arm magnetic field source 154, and / or the right arm magnetic field source 155 may be omitted.

[0056] FIG. 1C is front view of an intrauterine device (IUD) 102 that can, in certain respects, resemble components of the IUDs 100, 101 described in connection with FIGS. 1A, IB. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the IUDs 100, 101 and related components shown in FIGS. 1 A, IB may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the IUD 102 of FIG. 1C. Any suitable combination of the features, and variations of the same, described with respect to the IUDs 100, 101 and components illustrated in FIGS. 1A, IB can be employed with the IUD 102 and components of FIG. 1C, and vice versa.

[0057] The IUD 102 includes an IUD optical fiber 140 extending along the post 110 and the left and right arms 124, 125. At the junction 116, the IUD optical fiber 140 separates into a left optical fiber 141 and a right optical fiber 142. The left optical fiber 124 extends along the left arm 124 such that a distal end 141A of the left optical fiber 141 is disposed adjacent the left arm free end 124 A. Similarly, right optical fiber 124 extends along the right arm 125Docket No. 101672.0627PCT such that a distal end 142A of the right optical fiber 142 is disposed adjacent the right arm free end 125 A. A proximal portion 143 of the IUD optical fiber 140 extends away from the post 110 (e.g., the proximal end 111 of the post 110) to an IUD optical fiber connector 140B.

[0058] The optical fiber 140 is a multi-core fiber that includes a plurality of optical fiber cores. A first subset of the optical fiber cores extend along the left arm 124 and a second subset of the optical fiber cores extend along the right arm 125. The optical fiber 140 is configured for shape sensing along its length. In the illustrated embodiment, the optical fiber 140, including the left and right optical fibers 141, 142, includes a plurality of reflective gratings distributed along the optical fiber 140 that define a shape sensing capability. Similarly, the optical fiber cores are distributed across a cross section of the optical fiber 140 such that a strain experienced by the optical fiber cores is associated with a shape of the optical fiber 140. In other words, a change in the shape of the optical fiber 140 causes a strain in the optical fiber cores that is detectable by the reflective gratings. A first subset of optical fiber cores are distributed across the cross section of the left optical fiber 141 to enable shape sensing of the left optical fiber 141. Similarly, A second subset of optical fiber cores are distributed across the cross section of the right optical fiber 142 to enable shape sensing of the right optical fiber 142. The left and right optical fibers 141, 142 are coupled with the left and right arms 124, 125 respectively, such that the shapes of the left and right optical fibers 141, 142 are consistent with (e.g., the same as) the shapes of the left and right arms 124, 125, including the shape and orientation of the left and right arms 124, 125 with respect to the post 110.

[0059] FIG. 2A is top view of an IUD insertion device (ID) 200, according to some embodiments disclosed herein. The ID 200 is generally configured to enable a clinician to safely and accurately place the IUD (i.e., the IUD 100, 101, or 102) within the uterus 52. The ID 200 generally includes a tube 220 coupled with a handle 210, where a proximal end 220 A of the tube 220 is disposed adjacent a distal end of the handle 210A. The tube 220 is generally configured for insertion into the uterus 52 via the cervix 56. The handle 210 and the tube 220 are elongated and may be (although not required) generally oriented parallel to the each other. The handle 210 defines a top side 211, a bottom side 212, a left side 213 and a right side 214. The tube 220 is coupled with the handle 210, such that axial rotation of the handle 210 defines a corresponding (i.e., the same) axial rotation of the tube 220. The tube 220 defines a lumen 222 extending along the tube 220.Docket No. 101672.0627PCT

[0060] The ID 200 further includes a rod 230 disposed within the lumen 222 and a slider 215 slidably coupled with the handle 210. The handle 210, the tube 220, the slider 215 and the rod 230 are operatively coupled together such that a displacement of the slider 215 with respect to the handle causes a displacement of the rod 230 with respect to the tube 220. In some embodiments, the slider 215 is attached the rod 230 and the handle 210 is attached to the tube 220 such that displacement of the slider 215 with respect to the handle 210, designated by the arrow 217A, causes a corresponding (i.e., the same) displacement of the rod 230 with respect to the tube 220, designated by the arrow 217B. In an alternative embodiment, handle 210 is attached the rod 230 and the slider 215 is attached to the tube 220, such that such displacement of the slider 215 with respect to the handle 210 causes a corresponding (i.e., the same) displacement of the tube 220 with respect to the rod 230.

[0061] The rod 230 is positionable with the lumen 222 between a retracted position and an extended position. In the retracted position, the distal end 230B is disposed proximally away from the distal end 220B of the tube 220 as illustrated FIG. 2A. In the extended position (not shown), the distal end 230B is disposed adjacent the distal end 220B of the tube 220. In the retracted position (shown) of the rod 230, the lumen 222 defines a chamber 224 extending between the distal end 230B of the rod 230 and the distal end 220B of the tube 220. A length of the chamber 224 is defined in accordance with a length of the IUD in the contacted state. As such, the chamber 224 is configured to receive a substantial entirety of any of the IUD 100- 102 in the contacted state.

[0062] FIG. 2B is detailed view of a distal portion of an ID 201 that can, in certain respects, resemble components of the ID 200 described in connection with FIG. 2A. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the ID 200 and related components shown in FIGS. 2 A may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the ID 201 of FIG. 2B. Any suitable combination of the features, and variations ofDocket No. 101672.0627PCT the same, described with respect to the ID 200 and components illustrated in FIGS. 2 A can be employed with the ID 201 and components of FIG. 2B, and vice versa.

[0063] The ID 201 includes the stylet 130 coupled with the rod 230. The distal portion 134A of the optical fiber 134 extends distally away from the distal end 230B of the rod 230. In the illustrated embodiment, the stylet 130 is fixedly attached to the rod 230. In other embodiments, the stylet 130 may be disposed within a lumen of the rod 230, such that the stylet 130 is slidably coupled with the rod 230. In some embodiments, the rod 230 may include a passageway 231 extending at least along a portion of a length of the rod 230, where the optical fiber 134 extends through the passageway 231.

[0064] FIG. 2C is detailed view of a distal end portion of an ID 202 that can, in certain respects, resemble components of the IDs 200, 201 described in connection with FIGS. 2A, 2B. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the IDs 200, 201 and related components shown in FIGS. 2 A, 2B may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the ID 202 of FIG. 2C. Any suitable combination of the features, and variations of the same, described with respect to the IDs 200, 201 and components illustrated in FIGS. 2A,2B can be employed with the ID 202 and components of FIG. 2C, and vice versa.

[0065] The ID 202 includes a number (e.g., 1, 2, 3 or more) of magnetic field sources configured to enable the location and / or orientation of the distal portion to be determined during placement of the IUD within the uterus 52. In the illustrated embodiment, the tube 200 includes a first tube magnetic field source 242 disposed adjacent the distal end 220B and a second tube magnetic field source 244 disposed a distance 228 from the distal end 220B. The rod 230 also includes a rod magnetic field source 246 disposed at the distal end 230B. The distance 228 is defined according to a length of the post 110 from the proximal end 111 of the post 110 to the distal end 112 of the post 110 (see FIG. 1). Various embodiments of the ID 202 may include all or any subset of the first tube magnetic field source 242, the second tubeDocket No. 101672.0627PCT magnetic field source 244, and the rod magnetic field source 246. Similarly, in some embodiments, any of the first tube magnetic field source 242, the second tube magnetic field source 244, and / or the rod magnetic field source 246 may be omitted.

[0066] The first tube magnetic field source 242 and the second tube magnetic field source 244 may be fixedly attached to the tube 220 in any suable fashion consistent the second tube magnetic field source 244 remaining fixed to the tube 220 during use of the ID 200. In the illustrated embodiment, although not required, the first and second tube magnetic field sources 242, 244 may include a hollow cylindrical shape. In such embodiments, the inside diameter or the hollow cylindrical shape is configured to allow placement of rod 230 and the IUD 100 (in the contracted state) therein. Further in the illustrated embodiment, the tube 220 includes a first annular recess 223 A extending into a tube wall 223 from an inside annular surface of the lumen 222 and the first tube magnetic field source 242 is disposed within the first annual recess 223 A. Similarly, the tube 220 includes a second annular recess 223B extending into a tube wall 223 from an inside annular surface of the lumen 222 and the second tube magnetic field source 242 is disposed within the second annular recess 223B. Such an attachment method, defines an uninterrupted outside surface of the tube 220 thereby minimize any pain or discomfort for the patient 50 during insertion of the tube 220 through the cervix 56. However, a skilled artisan would recognize that other attachment methods for the first and second tube magnetic field sources 242, 244 could be employed without destroying the intended functionality of the ID 200.

[0067] FIG. 2D is detailed view of a distal portion of an ID 203 that can, in certain respects, resemble components of the IDs 200-202 described in connection with FIGS. 2A- 2C. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the IDs 200-202 and related components shown in FIGS. 2A- 2C may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the ID 203 of FIG. 2D. Any suitable combination of the features, and variations of the same, described with respect to the IDs 200-202 and componentsDocket No. 101672.0627PCT illustrated in FIGS. 2A-2C can be employed with the ID 203 and components of FIG. 2D, and vice versa.

[0068] The ID 203 includes a tube optical fiber 250 extending along the tube 220. In some embodiments, the tube optical fiber 250 may extend along a substantially entire length of the tube 220 from the proximal end 220A of the tube 220 to the distal 220B of the tube 220. In the illustrated embodiment, the tube 220 includes wall lumen 227 disposed within a circumferential wall 226 (shown in cross section) of the tube 220 and the tube optical fiber 250 is disposed within the wall lumen 227. An optional closed end 227A of the lumen 227 is disposed adjacent the distal end 220B of the tube 220 and a distal end 251 of the optical fiber 250 is disposed adjacent the closed end 227A. The optical fiber 250 is configured for shape sensing in the same or similar manner as the optical fiber 134 described above in relation to FIG. 1A. The tube optical fiber 250 is coupled with the tube 220 such that the shape of the optical fiber 250 is consistent with a shape of the tube 220. As an alternative to the tube optical fiber 250 being disposed within a single lumen (i.e., the wall lumen 227), the optical fiber cores of the tube optical fiber 250 may be disposed within multiple wall lumens (not shown) distributed along the circumferential cross section of the tube 220. Although not shown, the tube optical fiber 250 passes through at least a portion of the handle 210 and a proximal portion 254 extends away from the handle 220 to a tube optical connector 254A.

[0069] In addition to the tube optical fiber 250 being configured for shape sensing, the tube optical fiber 250 may also be configured to detect a compressive strain experienced by the tube 220. The compressive strain may be caused by an axial force 257 applied to the distal end 220B of the tube 220. During placement of the IUD within the uterus 52, the distal end 220B of the tube 220 may contact the back wall 58 of the uterus 52 (see FIG. IB). The contact may, in some instances, cause injury to the back wall 58. As such, it may be advantageous to detect a contact of the tube 220 with the back wall 58. As a result of the contact, the back wall 58 may apply the axial force 257 to the distal end 220B of the tube 220. Accordingly, the tube optical fiber 250 may be configured to detect the contact. More specifically, the gratings of the tube optical fiber 250 may detect a compressive strain of the tube optical fiber 250 along at least a portion the tube optical fiber 250 extending along the tube 220.

[0070] FIG. 3 is an illustration of a distal portion of an IUD insertion assembly (assembly) 300. The assembly 300 includes any one of a number of combinations of the IDs 200-202 and the IUDs 100-102. In each case the IUD is disposed in the chamber 224 of theDocket No. 101672.0627PCTID with the IUD disposed in the contracted state. The proximal end 111 of the post 100 of the IUD is disposed adjacent the distal end 230B of the rod 230. In the illustrated embodiment, the left and right arms 124, 125 extend distally away from the post 110 such that the free ends 124A, 125A are disposed adjacent the distal end 220B of the tube 220. In other embodiments (not shown), the left and right arms 124, 125 may extend proximally along the post 110. The assembly 300 as illustrated in FIG. 3 may define a ready to use (i.e., ready to insert) state of the assembly 300.

[0071] In some embodiments, the IUD may be coupled with the rod 230 such that (1) distal displacement of the rod 230 with respect to the tube 220 causes distal displacement of the IUD with respect to the tube 220 and (2) proximal displacement of the rod 230 with respect to the tube 220 causes separation of the IUD from the distal end of the rod 230B. In other embodiments, the IUD may be coupled with the rod 230 such that (1) distal displacement of the rod 230 with respect to the tube 220 causes distal displacement of the IUD with respect to the tube 220 and (2) proximal displacement of the rod 230 with respect to the tube 220 causes proximal displacement of the IUD with respect to the tube 220 when at least a portion of the IUD is disposed within the lumen 115.

[0072] FIG. 4 is an illustration of an IUD insertion system (system) 400, according to some embodiments disclosed herein. The system 400 is generally configured to enable to the clinician to safely and accurately place the IUD within the uterus of the patient 50 as illustrated in FIG. IB. The system 400 provides feedback to the clinician during the placement process for the IUD. The feedback may include notification pertaining to a position and / or orientation of the IUD and / or the IUD insertion device (ID) with respect to the patient 50. The system 400 includes a system module 410 having a console (see FIG. 5), a sensor module 420 electrically coupled with the system module 410, and an IUD insertion assembly 300. A display 411 may be incorporated into the system module 410 or coupled to the system module 410. The sensor module 420 is electrically coupled to the system module 410 via the cable 452.

[0073] For description purposes, the sensor module 420 may define a X-Y-Z coordinate axis system as shown. For example, the X-Y plane may be defined by a bottom (i.e., patient contact) surface of the sensor module 420. The Y-Z plane extend centrally through the sensor module 420 with the Y-axis defining a longitudinal axis of the sensor module 420. In some The X-Y-Z coordinate axis system may define viewing perspectives for images rendered the display 411. For example, a top view image may be defined as perpendicular to the X-Y planeDocket No. 101672.0627PCT such that when a top view image is rendered, the screen surface of the display 411 is parallel with the X-Y plane. Similarly, a side view image may be defined as perpendicular to the Y-Z plane such that when a side view image is rendered, the screen surface of the display 411 is parallel with the Y-Z plane.

[0074] The sensor module 420 is configured for placement on the patient 50 and may be located over the uterus 52 of the patient 50. In some embodiments, the sensor module 420 may located on the patient 50 in relation to anatomical references (e.g., pelvic bones) of the patient so as to accurately place the sensor module 420 in relation to the uterus 52. The sensor module 420 includes a number (e.g., 3, 4 or more) magnetic field sensors (e.g., magnetometers) capable of detecting magnetic fields defined by magnetic field sources (e.g., any subset of the magnetic field sources shown in and described in relation to FIGS. 1A, IB, or 2C) disposed within the patient 50. The sensor module 420 is configured to determine the real-time location, including tracking, of the magnetic field sources based on the detection of the magnetic fields. In one embodiment, the magnetic field sources can be tracked using the teachings of one or more of the following U.S. Pat. Nos.: 5,775,322; 5,879,297; 6,129,668; 6,216,028; and 6,263,230, each of which is incorporated herein in its entirety.

[0075] In some embodiments, optical fibers (e.g., the optical fiber 134, IUD optical fiber 140, and / or tube optical fiber 250) may be optically coupled with system module 410. In some embodiments, any subset of the optical fibers may be optically coupled to the system module 410 by way of the sensor module 420 including by way of the cable 452. In some embodiments, the optical connectors of the optical fibers may be rigidly coupled to the sensor module 420 such that the sensor module 420 defines a location and / or orientation reference for the proximal end portions of the optical fibers.

[0076] By way of example, the tube optical connector 254A may be rigidly attached to the sensor module 420 such that the location of the proximal end of the tube optical fiber 250 is fixed at a known location (know by the logic) on the sensor module 420. As the sensor module 420 is accurately placed with respect to the uterus 52, by way of association, the proximal end of the tube optical fiber 250 is fixed at a known location with respect to the uterus. In a similar fashion, tube optical connector 254A may be rigidly attached to the sensor module 420 such that the orientation of the optical connector 254B is fixed with respect to the sensor module 420. As the sensor module 420 is placed on the patient over the uterus, by way of association, the orientation of a proximal end portion of the 250 adjacent the optical connectorDocket No. 101672.0627PCT254B may be fixed and known with respect to the uterus 52. The optical connector 134B and IUD optical connector 140B may be rigidly coupled to the sensor module 420 in a similar fashion to the tube optical connector 254A.

[0077] In some embodiments, the system 400 may further include an ultrasound probe 440 operatively coupled with the system module. The ultrasound probe 440 is configured to obtain an ultrasound image of the uterus 52 (see FIG. IB) of the patent 50 that can be rendered on the display 411. In some embodiments, the sensor module 420 include an interface 425 configured to engage the ultrasound probe 440 so as to fix a location of the ultrasound probe 440 with respect to the sensor module 420. In the illustrated embodiment, the interface 425 includes an aperture extending through the sensor module 420 from a top surface of the sensor module 420 (facing upward away from the sensor module 420) to a bottom surface (i.e., a patient contact surface) of the sensor module 420. The aperture is sized and shaped to receive a head of the ultrasound probe 440 such that a lateral position of the ultrasound probe 440 is fixed with respect to the sensor module 420. Similarly, the aperture may be shaped to limit axial rotation of the ultrasound probe 440 with respect to the sensor module 420. The interface 425 is positioned on the sensor module 420 so that when the sensor module 420 is accurately placed over the uterus 52, the ultrasound probe 440 is accurately placed to obtain the image of the uterus 52. It is noted that the aperture is just one example of the interface 425. Other examples may include a slot or notch, or a hinged attachment. In some embodiments, the ultrasound probe 440 may be omitted from the system 400.

[0078] FIG. 5 illustrates a block diagram of a console 500 of the system module 410, according to some embodiments. The console 500 is generally configured to govern the operation of the system 400. The console 500 includes a processor (or processors) 510 and memory 520 (e.g., a non-transitory computer-readable medium) having logic stored thereon. In the illustrated embodiment, the logic may include any subset of magnetic tracking logic 522, shape sensing logic 524, and ultrasound imaging logic 526. The console 515 is powered via a power source 502 (e.g., a facility poser source and / or a battery).

[0079] In some embodiments, the console 500 includes or is operatively coupled with the display 411 which may include a user interface (e.g., a graphical user interface) configured to directly receive input from a clinician and provide output to the clinician. The console 500 includes an electrical interface 504 (e.g., an electrical connector) to define operative coupling with the sensor module 420 and / or the ultrasound probe 440. A signal conditioner 512 convertsDocket No. 101672.0627PCT electrical signals from the sensor module 420 and / or the ultrasound probe 440 to digital data for processing by the processor 510 according to the magnetic tracking logic 522 and the shape ultrasound imaging logic 526, respectively. The console 500 includes an optical interface 530, including optical connectors, to define optical coupling of the light source 532 and the optical receiver 534 with the optical fiber 134, the IUD optical fiber 140 and the tube optical fiber 250. The light source 532 and the optical receiver 534 may be configured to operatively couple with all or any subset of the optical fiber 134, the IUD optical fiber 140, and the tube optical fiber 250 at the same time.

[0080] The magnetic tracking logic 522, shape sensing logic 524, and ultrasound imaging logic 526 are configured to generally cause or control the operation of the system 400 as a whole and specifically cause operations pertaining to tracking the magnetic field sources, defining the shapes of the optical fibers and facilitation operation of the ultrasound probe, respectively, including rendering images / visualizations on the display 411. In some embodiments, all or a portion of the ultrasound imaging logic 526 may be incorporated into the ultrasound probe 440. Operations caused by the magnetic tracking logic 522, the shape sensing logic 524, and the ultrasound imaging logic 526 may occur simultaneously and in a coordinated fashion with each other. Similarly, data processed by the magnetic tracking logic 522, the shape sensing logic 524, and the ultrasound imaging logic 526 may be shared between the magnetic tracking logic 522, the shape sensing logic 524, and the ultrasound imaging logic 526. Furthermore, portions of the operations pertaining magnetic tracking, shape sensing, and ultrasound imaging may be caused by any one of the magnetic tracking logic 522, the shape sensing logic 524, and the ultrasound imaging logic 526. As such, the term logic as used herein may apply any one of or any combination of the magnetic tracking logic 522, the shape sensing logic 524, and the ultrasound imaging logic 526.

[0081] The logic may receive magnetic field data in accordance with the detected one or more magnetic fields as cause by any (i.e., any one, all, or any subset) of the magnetic field sources described above. The logic may then process the magnetic field data to determine a real-time position of any of the magnetic field sources, where the real-time position is defined with respect to the sensor module. The real-time position is a position in 3D space with respect to the sensor module. In some embodiments, during use of the system, the sensor module 420 may be located (positioned by the clinician) on the patient in alignment with one or more anatomical landmarks, such as pelvic bones, for example) so that the sensor module 420 isDocket No. 101672.0627PCT accurately aligned with (i.e., placed accurately with respect to) the uterus 52. As the sensor module 420 may be accurately placed on the patient 50 with respect to the uterus 52, the realtime position with respect to the sensor module 420 is directly correlated with (i.e., directly corresponds to) a real-time position with respect to the uterus 52.

[0082] As the magnetic field sources are physically coupled with the IUD and / or the tube 220, the logic may detect (or determine) the position of the IUD and / or the tube 220 with respect to the uterus 52. In an embodiment, the logic may detect (or determine) the position of the magnetic field source 132 disposed at the distal end of the stylet 130. Since the distal end of the stylet 130 is physically coupled with the IUD 100, the logic may detect the position of the IUD 100 with respect to the uterus 52. Said another way, the logic may track the position of the IUD 100 with respect to the uterus 52 during placement of the IUD 100 within the uterus 52. Similarly, as the magnetic field sources 151, 152, 154, and 155 are physically coupled with respective portions of the IUD (see FIG. IB), the logic may determine the position of the IUD as a whole and / or the positions of the respective portions with respect to the uterus 52 as illustrated in FIG. IB.

[0083] As described below, in various embodiments, the logic may determine the realtime position of a magnetic field source with respect to the uterus 52, or a portion thereof, to determine a state of insertion of the IUD and provide a corresponding notification to the clinician. Similarly, the logic may determine the real-time position of one magnetic field source with respect to another magnetic field source to determine a state of insertion of the IUD and provide a corresponding notification to the clinician.

[0084] In an embodiment, the logic may determine that any one or any combination of the magnetic field sources 154, 155, or the first tube magnetic field source 242 is positioned in close proximity to the back wall 58 and provide notification to the clinician that the IUD is located at a position for deployment. In an embodiment, the logic may determine that the magnetic field source 151 and / or the rod magnetic field source 246 is disposed adjacent the second tube magnetic field source 244 and provide notification to the clinician that the first and second arms 124, 125 are deployed from the chamber 224. In an embodiment, the logic may determine that magnetic field source 132 is positioned adjacent the back wall 58 indicating that the junction 116 is positioned adjacent the back wall 58 consistent with the IUD disposed at the desired final position and provide notification to the clinician that the IUD properly placed at the desired final position. In an embodiment, the logic may determine that the magnetic fieldDocket No. 101672.0627PCT source 151 and / or the rod magnetic field source 246 is disposed adj acent the first tube magnetic field source 242 and provide notification to the clinician that the IUD is fully deployed from the chamber 224. In an embodiment, the logic may determine that magnetic field source 154 is spaced away from the magnetic field source 155 a defined distance and provide notification to the clinician that the IUD is transitioned to the expanded state.

[0085] FIGS. 6A-6E illustrate various examples of screen shots (i.e., visualizations) as that the logic may be render on the display 411. As illustrated in the screen shot 601 of FIG. 6A, the logic may render (i.e., cause to render) a top view visual representation of the uterus 652 on the display 411. The logic may further overlay a top view visual representation of the IUD 610 atop the top view visual representation of the uterus 652, where the position of the top view visual representation of the IUD 610 with respect to the top view visual representation of the uterus 652 is defined by the real-time position of the IUD with respect the uterus 52.

[0086] As illustrated in the screen shot 602 of FIG. 6B, the logic may render the top view visual representation of the uterus 652 on the display 411, and overlay a top view visual representation of a distal portion the tube 620 atop the top view visual representation of the uterus 652, where the position of the top view visual representation of the distal portion the tube 620 with respect to the top view visual representation of the uterus 652 is defined by the real-time position of the tube 220 with respect the uterus 52.

[0087] As described above, the IUD 100 can include the IUD optical fiber 134 coupled therewith, where the IUD optical fiber 134 has a distal portion extending along at least a portion of the post 110 and a proximal end physically coupled with the sensor module via the optical connector 134B. As the IUD optical fiber 134 is configured for shape sensing, the logic can process shape sensing data to determine a real-time shape of the IUD optical fiber 134 in 3D space. In an embodiment, a length of the IUD optical fiber 134 extending from the optical connector 134B at the proximal end of the IUD optical fiber 134 to the distal end of the IUD optical fiber 134 may be known by the logic. Accordingly, the logic may determine a real-time 3D position of any first portion of the IUD optical fiber 134 with respect to any second portion of the IUD optical fiber 134. More specifically, in the illustrated embodiment, the logic may determine a 3D position of the distal portion 134A with respect to the optical connector 134B (see FIG. 1 A). As the distal portion 134A is physically coupled with the post 110 of the IUD and as the optical connector 134B is physically coupled with the sensor module 420, the logic can determine the 3D position of the post 110 with respect to the sensor module 420.Docket No. 101672.0627PCTFurthermore, as the sensor module 420 is accurately placed with the respect to the uterus 52, the logic can determine the 3D position of the post 110 with respect to the uterus 52.

[0088] Similarly, the logic may determine a 3D orientation (i.e., a directional vector) of any first portion of the IUD optical fiber 134 with respect to a 3D orientation of any second portion of the IUD optical fiber 134. More specifically, in the illustrated embodiment, the logic may determine a 3D orientation of the distal portion 134A with respect to the orientation of the optical connector 134B which is rigidly coupled with the connector 134B. As the distal portion 134A is physically coupled with the post 110 of the IUD and as the optical connector 134B is physically coupled with the sensor module 420, the logic can determine the 3D orientation of the post 110 with respect to the orientation of the sensor module 420. Furthermore, as the sensor module 420 is accurately placed with the respect to the uterus 52, the logic can determine the 3D orientation of the post 110 with respect to the uterus 52. For example, as the Y-Z plane centrally subdivides the sensor module 420 and uterus 52 as viewed from the top (see FIG. 4), the logic can determine an angle of the post 110 with respect to the uterus 52 (i.e., a deviation from parallel with the Y-Z plane) as viewed from the top. In a similar fashion, the logic can determine an angle of the post 110 with respect to the uterus 52 (i.e., an angle of the post 110 relative to the X-Y plane) as viewed from the side. Similarly, as the IUD optical fiber 140 is coupled with the IUD 102 and extends along the post 110, and as the optical connector 140B is coupled with the sensor module 420, the logic may determine the 3D position and orientation of the IUD or a portion thereof with respect to the uterus 52 in the same or a similar manner to the optical fiber 134.

[0089] With the logic having detected the real-time orientation of the post 110 with respect to the uterus 52, the logic may orient the top view visual representation of the IUD 610 overlayed atop the top view visual representation of the uterus 652 consistent with the detected real-time orientation of the post 110 with respect to the uterus 52. For example, FIG. 6A illustrates the top view visual representation of the IUD 610 oriented in alignment with the uterus 52, i.e., consistent with an instance where the post 110 is aligned with the uterus 52. In an instance of misalignment, the overlay the top view visual representation of the IUD 610 would be oriented to indicate an angular deviation to the right or left from the center of the uterus 52.

[0090] As illustrated in the screen shot 603 of FIG. 6C, the logic may render (i.e., cause to render) a side view visual representation of the uterus 653 on the display 411. The side viewDocket No. 101672.0627PCT visual representation of the uterus 653 may include a visual representation of a portion of the sensor module 420 disposed on the patient, where the bottom side of the sensor module 420 defines the X-Y plane. The logic may further overlay a side view visual representation of the IUD 621 atop the side view visual representation of the uterus 653, where the orientation of the side view visual representation of the IUD 621 with respect to the side view visual representation of the uterus 653 is consistent with the orientation of the IUD as defined by the real-time orientation of the post 110 with respect the uterus 52.

[0091] Similar to the logic determining the position and / or the orientation of the post 110 via shape sensing the optical fiber 134 or the optical fiber 140, the logic may determine the position of the distal end 220B of the tube 220 of the ID 203 and / or the orientation of a distal portion (e.g., the chamber 224) of the tube 220 via shape sensing of the tube optical fiber 250. As the tube optical fiber 250 is coupled with the tube 220 and extends along the tube 220, and as the optical connector 254A is rigidly coupled with the sensor module 420, the logic may determine the 3D position of the distal end 220B and / or the orientation of the distal portion of the tube 220 with respect to the uterus 52 in the same or a similar manner described above in relation to the optical fiber 134. The logic may process shape sensing data acquired from (i.e., originating from) the tube optical fiber 250 to determine a 3-dimensional shape of the tube optical fiber 250, and thereby determine a real-time position of the distal end 251 of the tube optical fiber 250 and by association the distal end 220B of the tube 220. Similarly, the logic may process the shape sensing data acquired from the tube optical fiber 250 to determine a real-time orientation of a distal portion of the tube optical fiber 250 that extends along the chamber 224 of the tube 220 and by association the orientation of the distal portion of the tube 220 including the chamber 224.

[0092] With the logic having detected the real-time orientation of the distal portion of the tube 220 including the chamber 224 with respect to the uterus 52, the logic may orient the top view visual representation of the distal portion the tube 620 overlayed atop the top view visual representation of the uterus 652 consistent with the detected real-time orientation of the distal portion of the tube 220 with respect to the uterus 52. For example, FIG. 6B may illustrate the top view visual representation of the distal portion the tube 620 oriented in alignment with the uterus 52, i.e., consistent with an instance where the distal portion of the tube 220 is aligned with the uterus 52. In an instance of misalignment, the top view visual representation of a distalDocket No. 101672.0627PCT portion the tube 620 would be oriented to indicate an angular deviation to the right or left from the center of the uterus 52.

[0093] As illustrated in the screen shot 604 of FIG. 6D, the logic may render (i.e., cause to render) the side view visual representation of the uterus 654 on the display 411. The logic may further overlay a side view visual representation of the distal portion the tube 621 atop the side view visual representation of the uterus 653, where the orientation of the side view visual representation of the distal portion the tube 631 with respect to the side view visual representation of the uterus 653 is consistent with the detected real-time orientation of the distal portion of the tube 220 with respect to the uterus 52.

[0094] As illustrated in FIG. 6E, a combination screen shot may include a combination of other screen shots, such as the screen shots 601-604, for example. By way of one example, a combination screen shot 605 may include the screen shots 601 and 603 shown side by side. During some instances of the IUD placement process, it may be advantageous for the clinician to view the top view visualization of screen shot 601, and in other instances, it may be advantageous for the clinician to view the side view visualization of screen shot 603. To avoid having to switch between the screen shots 601 and 603, the logic may render both screen shots 601, 603 simultaneously on the display 411. As such, the clinician can view the real-time positions and orientations of the IUD or the tube 220 with respect to the uterus from the top and the side at the same time during placement of the IUD within the uterus.

[0095] As described above, the system 400 may include the ultrasound probe 440. Accordingly, the logic may process ultrasound data converted from ultrasound signals originating with the ultrasound probe 440 to render an ultrasound image of the uterus on the display 411. The logic may further overlay a visual representation of the IUD atop the ultrasound image. The ultrasound image may include a top view ultrasound image of the uterus or a side view image of the uterus. For example, alternatively or in addition to rendering the top view visual representation of the uterus 652 on the display 411 as shown in FIGS. 6A, 6C, the logic may render the top view ultrasound image atop which the logic may overlay the top view visualization of the IUD 610 or the top view visualization of the distal portion of the tube 620. Similarly, alternatively or in addition to rendering the side view visual representation of the uterus 653 on the display 411 as shown in FIGS. 6B, 6D, the logic may render the side view ultrasound image on the display 411 and overlay the side view visualization of the IUD 611 orDocket No. 101672.0627PCT the side view visualization of the distal portion of the tube 621 atop the side view ultrasound image.

[0096] FIG. 7A illustrates a screen shot 701 that includes a top view ultrasound image 710 of the uterus 52 with the top view visualization of the IUD 610 overlayed atop the top view ultrasound image 710. Similarly, FIG. 7B illustrates a screen shot 702 that includes the top view ultrasound image 710 of the uterus 52 with the top view visualization of the distal portion of the tube 620 overlayed atop the top view ultrasound image 710. As the ultrasound probe 440 may be accurately positioned with respect to the sensor module 420 via the interface 425, the logic may accurately position and / or orient the top view visual representation of the IUD 610 or the top view visual representation of the distal portion of the tube 620 atop the ultrasound image consistent with the position and / or orientation of the IUD 100-102 or the distal portion of the tube 220 with respect the uterus 52. Although not shown, other screen shots may include the side view visualization of the IUD 611 or the side view visualization of the distal portion of the tube 621 overlayed atop the side view ultrasound image.

[0097] As described above the tube optical fiber 250 may be configured to detect a compressive strain of the tube optical fiber 250, where the compressive strain may be caused by the axial force 257 applied to the distal end 220B of the tube 220 (see FIG. 2D). As the tube IUD optical fiber 250 is configured to detect the compressive strain, the logic can process strain sensing data to detect the contact of the distal end 220B of the tube 220 with the back wall 58 of the uterus 52. Having the detected the contact, the logic may provide notification to the clinician via the display 411 or another notification device (not shown), such as a visual device (e.g., a light), an audio device, or a haptic device. By detecting the contact with the back wall 58 and providing notification to the clinician, the system 400 may prevent injury to the back wall 58, or any other portion of the patient 50 that is contacted by the distal end 220B.

[0098] FIGS. 8A, 8B illustrate a block diagram of a method 800 of placing an IUD within a patient that, according to some embodiments, where FIG. 8A is a block diagram of a first portion of the method 800 and FIG. 8B is a block diagram of a second portion of (i.e., a continuation of) the method 800. The method 800 may include all or any subset of the following actions, steps, operations or processes. Some or all of the process may be performed by the system 400 including operations performed by logic that is executed by the processor 510. The method 800 may include generating a magnetic field by a magnetic field source coupled with the IUD (block 805). The IUD may be in the contracted state and disposed within a distalDocket No. 101672.0627PCT portion of a tube of an IUD insertion device (ID). The magnetic field by a magnetic field source may generate the magnetic field while the distal portion is exterior to, partially inserted into, or present within a uterus of the patient.

[0099] The method 800 may further include detecting the magnet field by a magnetic field sensor (block 810), where the magnetic field sensor may be placed on an exterior of the patient.

[0100] The method 800 may further include converting a magnetic field signal defined by the magnetic field sensor into magnetic field data (block 815), and processing the magnetic field data to determine a real-time position of the IUD within the uterus (block 820).

[0101] The method 800 may further include obtaining a top view ultrasound image of the uterus via an ultrasound probe (block 825) and rendering the top view ultrasound image on a display (block 830).

[0102] The method 800 may further include overlaying atop the top view ultrasound image a top view visual representation of the distal portion of the tube (block 835) including the IUD at the real-time position. The method 800 may further include overlaying a top view visual representation of the IUD removed from the distal portion of the tube at the real-time position in an expanded state (block 840).

[0103] The method 800 may further include processing shape sensing data associated with an optical fiber coupled with the IUD to determine a real-time 3-dimensional shape of the optical fiber (block 845), and determining a real-time orientation of the IUD based on the 3- dimensional shape of the optical fiber (block 850).

[0104] The method 800 may further include obtaining a side view ultrasound image of the uterus via the ultrasound probe (block 855) and rendering the side view ultrasound image of the uterus on the display (block 860). The method 800 may further include overlaying a side view visual representation of the IUD at the real-time orientation atop the side view ultrasound image (865).

[0105] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. AdditionalDocket No. 101672.0627PCT adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

Docket No. 101672.0627PCTCLAIMSWhat is claimed is:

1. An intrauterine device (IUD), comprising: a post defining a proximal end and a distal end; a first arm and a second arm, each arm defining a fixed end and a free end, wherein: the fixed end of each arm is coupled with the post at the distal end of the post, the first and second arms extend laterally away from the post in opposite directions such that the free ends of first and second arms are disposed laterally away from the post when the IUD is transitioned to an expanded state, and the first and second arms are oriented substantially parallel to the post when the IUD is transitioned to a contracted state; and a first magnetic field source or an optical fiber physically coupled with the post.

2. The IUD according to claim 1, wherein the IUD includes the first magnetic field source and the magnetic field source is positioned adjacent the distal end of the post.

3. The IUD according to claim 2, further including a second magnetic field source coupled with the post adjacent the proximal end of the post.

4. The IUD according to claim 3, further including third and fourth magnetic field sources coupled with the first arm and the second arm, respectively, wherein the third and fourth magnetic field sources are located adjacent the free ends of the first and second arms.

5. The IUD according to any one of claims 1-4, wherein: the IUD includes the optical fiber, and the optical fiber includes a distal end and an optical connector at a proximal end of the optical fiber, and a plurality of optical fiber cores extending along the optical fiber from the proximal end of the optical fiber to the distal end of the opticalDocket No. 101672.0627PCT fiber, each optical fiber core including a plurality of reflective gratings distributed along a length of the optical fiber core, wherein each of the plurality of reflective gratings are configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber core, the strain caused by bending of the optical fiber.

6. The IUD according to claim 5, wherein: a distal portion of the optical fiber extends along the post; the distal end of the optical fiber is located adjacent the distal end of the post,7. The IUD according to claim 5, wherein: the optical fiber: extends along the post from the proximal end of the post to the distal end of the post, and separates into a first optical fiber extending along the first arm and a second optical fiber extending along the second arm.

8. An insertion device (ID), comprising: a tube defining a proximal end, a distal end, a lumen extending along the tube, and a tube wall, the lumen configured to receive an intrauterine device (IUD) therein; and a handle coupled with the tube at the proximal end of the tube, the handle configured for grasping by a clinician so that the clinician can manipulate the tube during an IUD insertion process; and a first tube magnetic field source coupled with the tube adjacent the distal end of the tube or an optical fiber extending along the tube.

9. The ID according to claim 8, further comprising a rod disposed within and extending along the lumen, the rod positionable between: an extended position, wherein a distal end of the rod is disposed adjacent the distal end of the tube, andDocket No. 101672.0627PCT a retracted position, wherein the distal end of the rod is proximally displaced away from the distal end of the tube such that a substantial entirety of an IUD can be disposed within the lumen between the distal end of the rod and the distal end of the tube.

10. The ID according to claim 9, further comprising a slider coupled with the handle, wherein the slider, the rod, the tube, and the handle are operatively coupled with each other such that displacement of the slider with respect the handle causes a longitudinal displacement of the rod with respect to the tube.

11. The ID according to claim 10, wherein the slider is fixedly coupled with the tube.

12. The ID according to claim 11, further comprising a rod magnetic field source coupled with the rod at the distal end of the rod.

13. The ID according to any one of claims 8-12, further comprising a second tube magnetic field source coupled with the tube at first location along the tube, the first location spaced proximally away from the distal end of the tube a distance substantially equal to a length of a post of the IUD.

14. The ID according to any one of claims 8-13,wheren: the ID includes the optical fiber, and the optical fiber includes a distal end and an optical connector at a proximal end of the optical fiber, and a plurality of optical fiber cores extending along optical fiber from a proximal end of the optical fiber to the distal end of the tube, each optical fiber core including a plurality of reflective gratings distributed along a length of the optical fiber core, wherein each of the plurality of reflective gratings are configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber core.

15. The ID according to claim 14, wherein the optical fiber is disposed within and extends along a second lumen of the tube.Docket No. 101672.0627PCT16. The ID according to claim 15, wherein the strain experienced by the optical fiber cores is defined by a bending of the tube.

17. The ID according to claim 15 or claim 16, wherein the strain experienced by the optical fiber cores is defined by an axial compression of the tube.

18. An intrauterine device (IUD) assembly, comprising: the IUD according to any one of claims 1-7; and the insertion device (ID) according to any one of claims 8-17, wherein the IUD is disposed within the tube of the ID in the contacted state.

19. A system, comprising: an intrauterine device (IUD); and an IUD insertion device (ID) configured for utilization by a clinician during a placement process of the IUD within a patient, comprising: a tube defining a proximal end, a distal end, a lumen, and a tube wall, the IUD disposed within the lumen; a handle coupled with the tube at the proximal end, the handle configured for grasping by a clinician so that the clinician can manipulate the tube during the placement process; one or more magnetic field sources coupled with one or both of the IUD or the ID; a sensor module including a plurality of magnetic field sensors configured to detect one or more magnetic fields correspondingly defined by the one or more magnetic field sources, the sensor module placed on the patient; a console coupled with the sensor module, the console including a processor and a memory having logic stored thereon that, when executed by the processor, causes operations of the system, including: defining magnetic field data in accordance with the detected one or more magnetic fields; processing the magnetic field data to determine a real-time position of each of the one or more magnetic field sources, the real-time position defined with respect to the sensor module.Docket No. 101672.0627PCT20. The system according to claim 19, wherein during use of the system, the sensor module is placed on the patient in alignment with one or more anatomical landmarks so as to be aligned with the uterus such that the real-time position defined with respect to the sensor module corresponds to a real-time position with respect to the uterus.

21. The system according to claim 19 or claim 20, wherein the IUD includes: a post defining a proximal end and a distal end; and a first arm and a second arm, each arm defining a fixed end and a free end, wherein the fixed end of each arm is coupled with the post at the distal end of the post defining a junction.

22. The system according to any one of claims 19-21, wherein the one or more magnetic field sources includes an IUD magnetic field source coupled with the IUD, such that the real-time position of the IUD magnetic field source defines a real-time position of the IUD.

23. The system according to claim 22, wherein the operations further include: rendering a top view visual representation of the uterus on the display; and overlaying a top view visual representation of the IUD atop the top view visual representation of the uterus, wherein the top view visual representation of the IUD is positioned with respect to the top view visual representation of the uterus in accordance with the real-time position of the IUD with respect to the uterus.

24. The system according to any one of claims 19-21, wherein the one or more magnetic field sources includes ID magnetic field source coupled with the tube at the distal end of the tube, such that the real-time position of the ID magnetic field source defines a realtime position of the distal end of the tube.

25. The system according to claim 24, wherein the operations further include: rendering a top view visual representation of the uterus on the display; and overlaying a top view visual representation of a distal portion the ID atop the top view visual representation of the uterus, wherein the top view visual representation of the distal portion the ID is positioned with respect to the top view visual representation of the uterusDocket No. 101672.0627PCT in accordance with the real-time position of distal end of the tube with respect to the uterus.

26. The system according to any one of claims 19-25, wherein: the IUD further comprises an IUD optical fiber coupled therewith, the IUD optical fiber having a distal portion extending along at least a portion of the post and a proximal end physically coupled with the sensor module, the IUD optical fiber includes multiple optical fiber cores each of which includes a plurality reflective gratings that enable shape sensing of the IUD optical fiber, the IUD optical fiber is optically coupled with the console, and the operations further include: processing shape sensing data associated with the IUD optical fiber to determine a 3 -dimensional shape of the IUD optical fiber; and determining the real-time position of the IUD based on the 3 -dimensional shape of the IUD optical fiber.

27. The system according to claim 26, wherein the operations further include determining a real-time orientation of the IUD based on the 3 -dimensional shape of the IUD optical fiber.

28. The system according to claim 27, wherein the operations further include: rendering a side view visual representation of the uterus on the display; and overlaying a side view visual representation of the IUD atop the side view visual representation of the side view of the uterus wherein the side view visual representation of the IUD is oriented with respect to the side view visual representation of the uterus in accordance with the real-time orientation of the IUD with respect to the uterus..

29. The system according to any one of claims 19-28, wherein: the ID further comprises an ID optical fiber coupled therewith, the ID optical fiber having a distal portion extending along the tube and a proximal end physically coupled with the sensor module,Docket No. 101672.0627PCT the ID optical fiber includes multiple optical fiber cores each of which includes a plurality reflective gratings that enable shape sensing of the ID optical fiber, the ID optical fiber is optically coupled with the console, and the operations further include: processing shape sensing data acquired from the ID optical fiber to determine a 3 -dimensional shape of the ID optical fiber; and determining the real-time position of the distal end of the tube based on the 3 -dimensional shape of the ID optical fiber.

30. The system according to claim 29, wherein the operations further include: rendering a side view visual representation of the uterus on the display; and overlaying a side view visual representation of the distal portion the ID atop the side view visual representation of the uterus, wherein the side view visual representation of the distal portion the ID is positioned with respect to the side view visual representation of the uterus in accordance with the real-time position of distal end of the tube with respect to the uterus.

31. The system according to any one of claims 19-30, further comprising an ultrasound probe coupled with console, wherein: the ultrasound probe is configured to obtain a top view ultrasound image of the uterus, and the operations further include: rendering the top view ultrasound image on the display, and overlaying the top view visual representation of the IUD atop the top view ultrasound image, wherein the top view visual representation of the IUD is positioned with respect to the top view ultrasound image in accordance with the real-time position of the IUD with respect to the uterus.

32. A method of placing an IUD within a patient, comprising: generating a magnetic field by a magnetic field source coupled with the IUD, wherein:Docket No. 101672.0627PCT the IUD in a contracted state is disposed within a distal portion of a tube of an IUD insertion device (ID), and the distal portion is inserted into a uterus of the patient; detecting the magnet field by a magnetic field sensor placed on the patient; converting a magnetic field signal from the magnetic field sensor into magnetic field data; processing the magnetic field data to determine a real-time position of the IUD within the uterus; obtaining a top view ultrasound image of the uterus via an ultrasound probe; rendering the top view ultrasound image on a display; overlaying atop the top view ultrasound image a top view visual representation of the distal portion of the tube having the IUD disposed therein, wherein the top view visual representation of the distal portion of the tube is positioned with respect to the top view ultrasound image in accordance with the real-time position of the IDU with respect to the uterus, and overlaying a top view visual representation of the IUD removed from the distal portion of the tube, the IUD transitioned to an expanded state.

33. The method according to claim 32, wherein: the IUD includes an optical fiber having a distal portion extending along a post of the IUD and a proximal end physically coupled with the magnetic field sensor, and the optical fiber includes multiple optical fiber cores each of which includes a plurality of reflective gratings that enable shape sensing of the optical fiber, the method further comprising: processing shape sensing data associated with the optical fiber to determine a real-time 3 -dimensional shape of the optical fiber; determining a real-time orientation of the IUD based on the 3 -dimensional shape of the optical fiber; obtaining a side view ultrasound image of the uterus via the ultrasound probe; rendering the side view ultrasound image on the display; andDocket No. 101672.0627PCT overlaying a side view visual representation of the IUD atop the side view ultrasound image, wherein the side view visual representation of the IUD is oriented with respect to the side view ultrasound image in accordance with the real-time orientation of the IUD.

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