WO2017004034A1 - Uterine sound device and associated methods of use - Google Patents

Abstract

A uterine sound and method of use for the uterine sound, which comprises an inner rod telescoped through an outer tube. The outer tube comprises a proximal end, a distal end, and a window, wherein the proximal end comprises a handle, and the inner rod comprising an elongate shaft, a proximal end, and a distal end, the proximal end comprises a ring, the distal end comprises a pliable tip, and the distal end of the inner rod is telescoped through the outer tube along a central axis. A resistance mechanism is disposed between the outer tube and the inner rod and is configured to provide resistance to relative movement as between the outer tube and the inner rod as the inner rod is advanced.

Description

UTERINE SOUND DEVICE AND ASSOCIATED METHODS OF USE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application 62/185,780, "Uterine Sound," filed June 29, 2015, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] In many gynecological procedures, a device termed as a "uterine sound" is used to measure distances and the position of the uterus. With such a device, it can be difficult for physicians to know the amount of force they are applying to the uterine tissue. Unfortunately, this difficulty can lead to an unknown perforation or a tear in the uterine wall, which occurs 1 in every 100 procedures. Any technology that reduces the risk of perforation while maintaining the functionalities of a traditional uterine sound would provide a competitive advantage in the marketplace.

BRIEF DESCRIPTION OF THE DRAWINGS

[0003] For a detailed description of various embodiments, reference will now be made to the accompanying drawings in which:

[0004] FIGS. 1A and 1 B show views of a measurement system according to certain embodiments of the present disclosure.

[0005] FIGS. 2A - 2C show a first side view (2A), a second side view (2B), and a perspective view (2C) of an inner rod according to certain embodiments of the present disclosure.

[0006] FIGS. 3A and 3B show a side view (3A) and a perspective view (3B) of the outer tube according to certain embodiments of the present disclosure.

[0007] FIGS. 4A and 4B show a side view (4A) and a partial perspective view (4B) of a uterine sound according to certain embodiments of the present disclosure.

[0008] FIG. 5 is a flow chart of a method of measurement using a uterine sound according to certain embodiments of the present disclosure.

DEFINITIONS

[0009] "Tapered" and a term indicative of direction shall mean that a component has a diameter that decreases towards the stated direction. [0010] "Removably coupled" shall mean a first component coupled to a second component such that first component can be decoupled from the second component without destroying or rendering the first or second components non-functional.

[0011] Certain terms are used throughout the following description and claims to refer to particular system components. As one skilled in the art will appreciate, different companies may refer to a component by different names. This document does not intend to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms "including" and "comprising" are used in an open-ended fashion, and thus should be interpreted to mean "including, but not limited to... ." Also, the term "couple" or "couples" is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other devices and connections.

DETAILED DESCRIPTION

[0012] The following discussion is directed to various embodiments. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.

[0013] A uterine sound is used as a precursor to gynecological procedures that use calibration of specific tool lengths before inserting the tools into the uterine cavity. A majority of these procedures are considered to be minimally invasive and may comprise intrauterine device insertion, hysterectomy, hysteroscopy, dilation and curettage, artificial insemination, and endometrial ablation. Prior to inserting the uterine sound, a bimanual examination (e.g., using two hands) is performed to determine the position of the patient's uterus and the uterine sound is manually bent to mimic the observed uterine curvature. The sound is then inserted into the vagina (after opening the vagina with a speculum) and pushed through the opening of the cervix. Once inside of the uterus, the sound is further advanced until it reaches the uterine wall. The doctor will remove the sound and determine the calibration length by taking note of the level of biological fluids present on the sound once the sound is removed. [0014] The uterine sound measurement process can be difficult even for some of the most seasoned practitioners. Variables such as physician experience, varying uterine tissue properties, patient health and history, and uterine inversion can heavily influence the risk of perforation of the uterine wall. The uterine sound discussed herein provides a safe and effective solution at least by reducing the risk of perforation. Consequently, it is likely that users of the device will feel more confident in their own abilities throughout the duration of the measurement process and that patients will gradually begin to experience an increase in physician trust based upon the improved device and associated method of use.

[0015] In terms of patient comfort, the often roughly textured uterine sound markings of the prior devices have been reported to cause trauma to the uterine and cervical tissues. Doctors and patients also report an immense amount of patient discomfort as the sound of the prior art is pushed through the cervix and into the uterus. During the measurement process, a reflex known as the Ferguson reflex causes the patient to feel an intense and sharp pain. This reflex is the same reflex that provides pregnant women with the urge to push during labor.

[0016] A primary challenge to effectively using a uterine sound is understanding the proper amount of force to apply to the tool as it is guided toward the uterine wall (fundus). The prior devices were inserted by the physician with a pivot point of an elbow, a shoulder, or their feet, that is, the range of motion possible in the use of the prior devices contributes to the difficulty of use. In addition, since the position or inversion of a woman's uterus can vary, the physician may find it challenging to bend or turn the uterine sound to the perfect angle for insertion. This anatomical challenge can cause physicians to make potentially dangerous decisions regarding the amount of force they apply to the uterine sound when resistance is felt. According to the guidelines established by the United States Agency for International Development, the progression of the sound into the uterus should be stopped when a slight resistance is felt. It is emphasized that no force should be used during the procedure. When a user feels the need to use varying amounts of force during the procedure, this force can increase the risk of perforation and patient discomfort.

[0017] Another major challenge that is posed by prior uterine sound devices is an inability to inform the user regarding device position within the patient or proximity to the uterine wall(s). Although the bimanual exam can inform the physician regarding the general orientation of the uterus, it is still possible for misinterpretation to occur. The case of misinterpretation could be exceptionally dangerous if a uterine anomaly (irregularly shaped uterus) is present. With prior uterine sound devices, the physician "blindly" guides the instrument. If a morphological irregularity is present, the physician may be at a higher risk of perforating any portion of the uterus due to assuming healthy morphology.

[0018] A functional property of prior uterine sound devices that should not be overlooked is the user interface for measurement readings. The accuracy and precision of this method using prior art sound devices relies solely on the physician's interpretation of where biological fluid stops along the surface of the device. This user interface may be a factor to consider when evaluating methods to reduce the risk of perforation.

[0019] Discussed herein is a uterine sound designed, fabricated, and used to reduce the amount of applicable force on the uterine tissue in comparison to the prior art sound devices by employing a new single-handed method of advancement that allows for additional control and a smaller range of motion using the ring-and-winged handle mechanism discussed below. In addition, the new sound provides a more precise and accurate method of measuring uterine length while reducing abrasive contact with the tissue.

[0020] The uterine sound discussed herein comprises an outer component referred to as an outer tube and an inner component that may be referred to as an inner rod, though it may be hollow or solid. The outer tube comprises a measurement window that reports a specific measurement to the user in centimeters, millimeters, inches, or another measurement. The measurement is taken using the window and a plurality of markings on the inner rod, and correlates to the extension of the inner rod into the patient. The outer tube further comprises a winged handle under which the user can place an index finger and middle finger. During use, the outer tube serves to stabilize the uterine sound against the opening of the cervix and to guide the inner rod into the cervix.

[0021] The inner rod of the device is a rod with a largest diameter smaller than the inside diameter of the outer tube, and the inner rod's diameter may be tapered towards the distal end. At the proximal end of the inner rod is a ring in which the user will place their thumb during use to operate the device. The distal end of the inner rod is advanced into the cervix to dilate the cervix as the device is being inserted to reduce patient discomfort. The rubberized tip serves to reduce abrasive contact with the uterine tissue and reduce risk of perforation.

[0022] In an embodiment, the user may advance the uterine sound by placing their thumb in the ring and their index and middle finger under the wings and advance or pull back the device by pressing in or pulling back with their thumb. A resistance mechanism may be associated with the inner rod within the device, and the resistance mechanism helps regulate the advancement of the inner rod, giving the user more control of the uterine sound during insertion.

[0023] FIGS. 1A and 1 B show a uterine sound system used to take a measurement of a uterus in accordance with example embodiments. In FIG. 1A, a uterine sound 100A comprises an outer tube and an inner rod (not shown separately in FIGS. 1A and 1 B but discussed below) telescoped through the proximal end of the outer tube along a central axis 116. The uterine sound 100A shows the handle in a retracted state, the handle is shown at the proximal side 102 and comprises a ring 108 on the proximal end of the inner rod and a handle component 212 on a proximal end of the outer tube. In one example, the ring 108 comprise a thickness from 0.15" to about 0.40," and may be a circle with a diameter from about 1.0" to about 2.0. "or an ellipse with a first diameter along the central axis 1 16 from about 1.0" to about 2.0," and a second diameter with a second, smaller diameter from about 1.0" to about 2.0," as measured perpendicular to the central axis 1 16.

[0024] In an embodiment, the handle component 212 comprises at least two wings 212A extending outward from an outer surface of the outer tube, each wing 212A comprises a base coupled to the outer tube 106, a tip at a distal end of the wing, and a curved medial surface that opens toward the distal end 104 of the outer tube. In one example, the distance from the tip of the distal end of the wing to a middle point of the curved medial surface is from about 0.5" to about 1.0," and a thickness of each wing measured parallel to the central axis may be from about 0.15" to about 0.40."

[0025] A measurement window 110 is shown along an elongate shaft 106 of the outer tube of the uterine sound 100A. In an embodiment, the measurement window 1 10 may comprise a diameter from about 0.2" to about A pliable tip 112 is disposed at the distal end 104 and may be coated with a lubricant such as silicone. The pliable tip 1 12 and may comprise various configurations of lengths, materials, and cross- sectional geometries, and may taper towards the distal end 104. In the example in FIG. 1A, the pliable tip 1 12 is disposed at the entrance of an aperture 114 such as a uterus, and is extended through the aperture 114 as shown in 100B using the handle, in particular the ring 108 and the handle component 212, to abut a wall of a cavity accessed by the aperture 114. The pliable tip 112 is extended through the aperture 114 by way of the handle. In one example, the aperture 114 may be a cervix, and the pliable tip 112 may be advanced via the ring 108 and using the handle component 212 as leverage to move the ring 108. In an embodiment, the pliable tip 1 2 and the ring 108 are a part of the uterine sound, and are either formed as an integral part of or coupled to an inner rod (not shown) which is telescoped through an outer tube. The advancement of the inner rod via the ring 108 and handle component 212 may be performed using one hand, in contrast to currently employed methods.

[0026] FIGS. 2A and 2B show a first side view (2A) and a second side view (2B) of an inner rod 202. The inner rod 202 comprises a pliable tip 1 12 at the distal end 04, the ring 108 at the proximal end 102, and a pliable component 208, that may also be referred to as a resistance mechanism, is disposed on an elongate shaft 206 of the inner rod 202. In an embodiment, the inner rod 202 may be from about 10.0" to about 15.0" in length, comprise a diameter suitable for telescoping through the outer tube, and may comprise a consistent outer diameter along a first portion of the elongate shaft 106 and a diameter tapered towards the distal end 104 of the inner rod 202 along a second portion of the elongate shaft 106. This second portion may comprise the pliable tip 112 and, in some embodiments, a portion of the inner rod 202 adjacent to the pliable tip 112. In one example, the second (tapered) portion comprises 20%- 40% of the elongate shaft's 106 overall length.

[0027] The pliable component 208 may comprise a ring shape or another shape, and may be composed of any pliable material that, alone or with a lubricant coating, can create resistance between the inner rod 202 and an outer tube (not shown). The pliable component 208 may be removably coupled to the elongate shaft 206, or may be formed integrally of the same or a similar material as the inner rod 202. In some embodiments, the elongate shaft 206 comprises a mechanism to retain the pliable component 208, and the inner rod 202 is telescoped through the pliable component 208 so that the retention mechanism permanently or removably couples the pliable component 208 to the inner rod 202. In one example, the resistance mechanism may be an annular groove or a raised feature formed on the inner rod such that it retains the pliable component 208 during the sliding engagement of the inner rod 202 with the outer tube.

[0028] The pliable component 208 may be disposed at various points along the elongate shaft 206. In some embodiments, more than one pliable component 202 may be employed along the elongate shaft. In one example, at least two pliable components may be coupled to or formed as a part of the inner rod 202, and may be spaced to abut each other, or may be spaced at predetermined uniform or non-uniform intervals along the inner rod 202.

[0029] FIG. 2B additionally shows a magnified view of a portion of a plurality of markings 204 disposed along a portion of the elongate shaft. In various embodiments, the plurality of markings 204 may be formed integrally with the inner rod 202, and in alternate embodiments, the plurality of markings 204 may be printed by inkjet or other means, or may be stamped during or after the fabrication of the inner rod 202.

[0030] In an embodiment, the plurality of markings 204 comprise measurement markings and may be configured as to be molded into the inner rod 202, e.g., to be flush with the surface of the inner rod 202. The inner rod 202 may be formed from transparent or semi-transparent material, or other materials that enable markings to be indicated on or within the inner rod 202. In alternate embodiments, the inner rod 202 may be hollow in whole or in part and the markings may be molded or otherwise formed on the inside of the inner rod 202, so that the markings do not cause patient discomfort, but are still visible through a measurement window.

[0031] FIG. 2C shows a perspective view of an inner rod 202, as well as a magnified view of the elongate shaft 206 where the pliable component 208 is disposed, as well as an indication of where some of the plurality of markings 204 may be located with respect to the pliable component 208. The pliable component 208 may be telescoped over the inner rod 202 and may be permanently or removably coupled to the shaft 206. In an alternate embodiment, the pliable component 208 is formed integrally with the inner rod 202. While the pliable component 208 is shown in FIG. 2C in a particular location, it may be located along the elongate shaft 206 in different positions such that the pliable component 208 does not cover up and hinder the visibility of the plurality of markings 204. The plurality of markings 204 may extend along more or less of the elongate shaft 206 than is illustrated in FIG. 2C, and may comprise various units of measurement.

[0032] FIG. 3A shows a side view of an outer tube 302 of a uterine sound. The outer tube comprises a window 110 which may be formed, as viewed in the side view in FIG.3A, as a circle. In alternate embodiments, the window 110 may be formed as a square, triangle, or other polygon or combinations of shapes. The handle component 212 is disposed at the proximal side 306 and the elongate shaft 106 is open on the distal end 308. FIG. 3B is a perspective view of the outer tube 302, including the through hole 304 that extends from the distal end 308 to the proximal 306 end of the outer tube 302. In an embodiment, an overall length of the outer tube may be from about 8.0" to about 12.0." In an embodiment, a diameter of the through hole 304 may be from about 0.15" to about 0.33," and an outer diameter of the outer tube 302 may be from about 0.20" to about 0.45."

[0033] FIGS. 4A and 4B illustrate a uterine sound 100B comprised of an inner rod 202 telescoped through and slidingly engaged with an outer tube 302. FIG. 4A is a side view of the uterine sound 100B, at least some of the plurality of markings discussed above may be viewed through the window 1 10. FIG. 4A illustrates the inner rod 202 telescoped through the proximal end 306 of the outer tube 302. The outside diameter of the inner rod 202 is configured such that the inner rod 202 can be telescoped through an outer tube when the pliable component 208 is coupled to the inner rod wherein resistance is created between the inside surface of the outer tube 302 and the pliable component 208.

[0034] FIG. 4B is a partial cutaway view of the uterine sound 100B taken substantively along line 4B-4B in FIG. 1 B. FIG. 4B illustrates the elongate shaft 106 of the outer tube, and the pliable component 208 in contact with an inner surface of the elongate shaft 106 of the outer tube 302 as indicated by boundary line 404. The outer tube 106 comprises a thickness 406, and well as an outside surface 408 and an inner surface (not shown other than by boundary line 404). As discussed above, the pliable component 208 may be formed integrally with the inner rod 202. In another example, the inner rod 202 may be telescoped through the pliable component 208 such that the pliable component 208 is retained by a retention mechanism (not shown). The retention mechanism may be formed on the distal side and/or on the distal and proximal sides of a location along the inner rod 202 where the pliable component 208 is to be retained when the inner rod is slidingly engaged with the outer tube 302. This coupling example is indicated by the boundary line 410 in FIG. 4B.

[0035] FIG. 5 is a flow chart of a method 500 of measurement using a uterine sound. In some embodiments, at block 502, a resistance mechanism is telescoped over an inner rod comprising a plurality of markings along an elongate shaft, a ring at the proximal end and a pliable tip at the distal end. Subsequently, and/or in an embodiment where the resistance mechanism is pre-packaged with and already coupled to the inner rod, or where the resistance mechanism is formed integrally with the inner rod, the inner rod is telescoped through an outer rube at block 504 to form the uterine sound. In another example, the method 500 may begin at block 506, where the uterine sound is positioned at an aperture. The method 500 may begin at block 506, for example, if the uterine sound is provided to a healthcare provider already assembled, including the resistance mechanism.

[0036] At block 508, the inner rod including the pliable tip is advanced through the aperture by advancing the inner rod relative to the outer tube, the resistance mechanism provides a predetermined resistance via contact between the resistance mechanism and an inner surface of the outer tube to movement during translation of the inner rod relative to the outer tube. At block 510, a measurement associated with an amount of advancement of the inner rod is determined based upon at least some of the plurality of markings on the inner rod that are viewed through a window though the outer tube. At block 512, the inner rod and/or entire uterine sound device is retracted from the aperture. In an embodiment, the advancing of the inner rod at block 508 further comprises advance the inner rod by way of a ring coupled to a proximal end of the inner rod and a winged handle coupled to the same side of the outer tube. The advancement at block 508 and retraction at block 512 may be accomplished by a single actor using a single hand via the handle comprised of the ring and winged component discussed herein.

[0037] While exemplary embodiments of the invention have been shown and described, modifications thereof can be made by one skilled in the art without departing from the scope or teachings herein. The embodiments described herein are exemplary only and are not limiting. Many variations and modifications of the compositions, systems, apparatus, and processes described herein are possible and are within the scope of the invention. Accordingly, the scope of protection is not limited to the exemplary embodiments described herein, but is only limited by the claims that follow, the scope of which shall include all equivalents of the subject matter of the claims. Unless expressly stated otherwise, the steps in a method claim may be performed in any order and with any suitable combination of materials and processing conditions.

Claims

CLAIMS What is claimed is:

1. A uterine sound comprising:

an outer tube comprising a proximal end, a distal end, and a window, wherein the proximal end comprises a handle;

an inner rod comprising an elongate shaft, a proximal end, and a distal end, the proximal end comprises a ring, the distal end comprises a pliable tip, and the distal end of the inner rod is telescoped through the outer tube along a central axis;and

a resistance mechanism disposed between the outer tube and the inner rod, the resistance mechanism configured to provide resistance to relative movement as between the outer tube and the inner rod.

2. The uterine sound of claim 1 , wherein the elongate shaft is tapered towards the distal end such that the diameter of the elongate shaft decreases towards the distal end.

3. The uterine sound of claim 1 , wherein the pliable tip is tapered towards the distal end.

4. The uterine sound of claim 1 , wherein the inner rod comprises a plurality of markings disposed along a portion of the elongate shaft, and wherein the window is aligned with at least some of the plurality of markings when the inner rod is telescoped through the outer tube.

5. The uterine sound of claim 1 , wherein, when the inner rod is telescoped through the outer tube, the resistance mechanism is in contact with an inner surface of the outer tube.

6. The uterine sound of claim 1 , wherein the window comprises a shape selected from the group consisting of: a circle, a square, a rectangle, and an oval.

7. The uterine sound of claim 1 , wherein the handle comprises at least two wings extending outward from an outer surface of the outer tube, each wing comprises a base coupled to the outer tube, a tip at a distal end of the wing, and a curved medial surface that opens toward the distal end of the outer tube.

8. The uterine sound of claim 1 , further comprising a silicone coating disposed on the pliable tip.

9. The uterine sound of claim 1 , wherein the resistance mechanism is coupled to the inner rod and comprises a ring composed of pliable material.

10. A method of measurement comprising:

advancing, into an aperture, a distal end of a uterine sound device, the uterine sound device comprising an inner rod telescoped through an outer tube, a pliable tip disposed at the distal end of the inner rod, the inner rod comprising a plurality of markings disposed along a portion of the elongate shaft and a ring at a proximal end of the inner rod;

advancing the inner rod relative to the outer tube, the advancing including telescoping the inner rod through a resistance mechanism composed of a pliable material and coupled to the inner rod to provide a predetermined resistance via contact between the resistance mechanism and an inner surface of the outer tube to movement during translation of the inner rod relative to the outer tube;

determining an amount of advancement of the inner rod based upon the plurality of markings viewed through a window though the outer tube.

11. The method of claim 10, wherein advancing the inner rod further comprises advance the inner rod by way of a ring coupled to a proximal end of the inner rod and a winged handle coupled to the same side of the outer tube.

12. The method of claim 10, further comprising retracting, from the aperture, subsequent to determining the amount of advancement, the distal end of the inner rod.

13. The method of claim 10, further comprising retracting the inner rod.

A uterine sound comprising an outer tube comprising a proximal end, a distal end, and a window, wherein the proximal end comprises a handle;

an inner rod comprising an elongate shaft, a plurality of markings along a portion of the elongate shaft, a proximal end, and a distal end, the proximal end comprises a ring, the distal end comprises a pliable tip, and the distal end of the inner rod is telescoped through the outer tube along a central axis, wherein the window is aligned with at least some of the plurality of markings when the inner rod is telescoped into the outer tube;

a pliable material disposed on an outer surface of the elongate shaft of the inner rod, the pliable material configured to provide resistance to relative movement as between the outer tube and the inner rod.

15. The uterine sound of claim 14, wherein a diameter of the inner rod decreases towards the distal end.

16. The uterine sound of claim 14, wherein the handle comprises at least two wings extending outward from an outer surface of the outer tube, each wing comprises a base coupled to the outer tube, a tip at a distal end of the wing, and a curved medial surface that opens toward the distal end of the outer tube.

17. The uterine sound of claim 14, wherein the proximal end of the inner rod comprises a ring.

18. The uterine sound of claim 14, wherein the window comprises a shape selected from the group consisting of: a circle, a square, a rectangle, and an oval.

19. The uterine sound of claim 14, further comprising a silicone coating disposed on a portion of the inner rod including the pliable tip.

20. A uterine sound comprising:

an outer tube comprising a proximal end, a distal end, and a window comprising a shape selected from the group consisting of a circle, a square, a rectangle, and an oval, wherein the proximal end comprises a handle, wherein the handle comprises at least two wings extending outward from an inner surface of the outer tube, each wing comprises a base coupled to the outer tube, a tip at a distal end of the wing, and a curved medial surface that opens toward the distal end of the outer tube;

an inner rod comprising an elongate shaft, a plurality of markings along a portion of the elongate shaft, a proximal end comprising a ring, and a distal end, the proximal end comprises a ring, the distal end comprises a pliable tip with a silicone coating,

wherein the distal end of the inner rod is telescoped through the outer tube along a central axis, wherein the window is aligned with at least some of the plurality of markings when the inner rod is telescoped into the outer tube, and

wherein a diameter of the inner rod decreases towards the distal end; a resistance mechanism disposed between the outer tube and the inner rod, the resistance mechanism configured to provide resistance to relative movement as between the outer tube and the inner rod, wherein the resistance mechanism comprises a pliable material.

21. A method of measurement, comprising:

advancing, into an aperture, a distal end of a uterine sound device via a handle, the uterine sound device comprising an inner rod telescoped through an outer tube, a pliable tip disposed at the distal end of the inner rod, the inner rod comprising a plurality of markings disposed along a portion of the elongate shaft, and the handle comprising a ring at a proximal end of the inner rod and a grip a proximal end of the outer tube;

advancing the inner rod relative to the outer tube via the handle, the advancing including telescoping the inner rod through a resistance mechanism composed of a pliable material and coupled to the inner rod to provide a predetermined resistance via contact between the resistance mechanism and an inner surface of the outer tube to movement during translation of the inner rod relative to the outer tube;

determining an amount of advancement of the inner rod based upon the plurality of markings viewed through a window though the outer tube.