Endoscopic devices and related methods

Abstract

To provide endoscopic devices for viewing and / or performing a surgery on a patient's organ, such as a uterus.SOLUTION: In an embodiment, the endoscopic device includes a housing, a cannula, an imaging system, and a flexible printed circuit (FPC). The cannula is configured for insertion through a cervix into a uterus. The cannula has a lumen that extends from a proximal end of the cannula to a distal end of the cannula. The proximal end of the cannula is secured within the housing. The imaging system is located at a distal end of the cannula and includes a camera and one or more light-emitting diodes (LEDs). The FPC extends within the lumen of the cannula and electrically connects the camera and the LEDs to electrical components located in the housing. The lumen is configured to provide a passage for a working tool.SELECTED DRAWING: Figure 5A

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Application No. 62 / 825,962, filed March 29, 2019, which is incorporated by reference in its entirety.

[0002] The present disclosure relates to endoscopic devices and related methods. [Background technology]

[0003] A hysteroscope is an endoscope designed to examine a patient's uterus (e.g., uterine cavity). A hysteroscope typically includes a proximal portion that remains outside the patient's body during use and a distal portion that is inserted into the patient's uterus. The distal portion may include a tip that is sized to be inserted into the uterus through the cervix to view the uterus, while the proximal portion provides features for manipulating the distal portion. Images captured at the tip of the distal portion can be viewed by a physician to examine the uterine cavity. Once the examination is complete, the distal portion of the hysteroscope is withdrawn from the uterus through the patient's cervix. Summary of the Invention [Problem to be solved by the invention]

[0004] The present disclosure relates to endoscopic devices and related methods. Such endoscopic devices can be used to view and / or perform surgery on a patient's uterus. [Means for solving the problem]

[0005] In one aspect, an endoscopic device includes a housing, a cannula configured for insertion into a uterus through the cervix, the cannula having a lumen extending from a proximal end to a distal end of the cannula, the proximal end of the cannula being secured within the housing, an imaging system located at the distal end of the cannula, and a flexible printed circuit (FPC) extending within the lumen of the cannula and electrically connecting a camera and an LED to electrical components located within the housing. The imaging system includes a camera and one or more light emitting diodes (LEDs) configured to provide light to the camera to capture images of the uterus. The lumen is configured to provide passage for a power tool.

[0006] Implementations may include one or more of the following features.

[0007] In some embodiments, the cannula defines proximal and distal openings configured to allow a working instrument to enter the lumen through the proximal opening and exit the lumen through the distal opening.

[0008] In some embodiments, the electrical components within the housing include at least one of a printed circuit board (PCB), a display, a display cable, and an electrical connection port.

[0009] In some embodiments, the FPC is shaped to conform to the inner surface of the lumen, hi some embodiments, the FPC is located within the upper third of the lumen.

[0010] In some embodiments, the bore is configured to receive a power tool having a size of 5 French scale or smaller.

[0011] In some embodiments, the device further includes a tip element that holds the camera and one or more LEDs at the distal end of the cannula, the tip element configured to block light from entering a sensor of the camera.

[0012] In some examples, the tip element is configured so that the sensor detects substantially only reflected LED light. The tip element can include a partition wall separating the camera from the one or more LEDs. In some examples, the partition wall extends from the camera lens to the proximal end of the camera where the camera connects to the flex circuit.

[0013] The tip element can have a convex shape that projects outwardly from the distal end of the cannula. The tip element can form at least a portion of a tool channel configured to guide the working tool out of the endoscopic device. The tool channel can have a curved inner surface that projects outwardly toward the camera.

[0014] In some embodiments, the device further includes a tip element that holds the camera and the one or more LEDs at the distal end of the cannula, and a coupler positioned between the tip element and the shaft that defines the lumen, the coupler having a notch that fits within a notch at the distal tip of the shaft to prevent the coupler from rotating relative to the distal tip. In some examples, the coupler has threads formed by ridges on an inner surface of the coupler, the threads being located near where the coupler meets the distal tip of the shaft.

[0015] In some embodiments, the device further includes a tip element that holds the camera at the distal end of the cannula and that contacts the FPC via a ramp-shaped element that is configured to protect the camera's electrical contacts to the FPC from potential impacts caused by a power tool passing through the cannula toward the distal end of the cannula.

[0016] In some examples, the lamp-shaped element includes an adhesive material that bonds the lamp-shaped element to the FPC and is curable with UV light to form a rigid element.

[0017] In some embodiments, the ramp-shaped element includes a molded element positioned between the tip element and a distal end of the cannula shaft, the shaft defining the cannula lumen. The device can further include a coupler element positioned between the distal end of the shaft and the tip element, the coupler element extending along the FPC and surrounding a distal portion of the FPC and the molded element.

[0018] In some embodiments, the molded element has an outer surface including one or more grooves that receive one or more ribs on the inner surface of the coupler. The coupler can have an inner surface including one or more ribs disposed within one or more grooves on the outer surface of the molded element. In some embodiments, the molded element has an inner surface that drafts down in diameter as the molded element extends toward the tip element. The coupler can have an inner surface that drafts down in diameter as the coupler extends toward the tip element.

[0019] In some embodiments, the cannula is a dual lumen cannula having a first lumen and a second lumen, both of which extend along the cannula and are separated by a wall, hi some instances, the FPC passes through the first lumen and the working tool passes through the second lumen.

[0020] Particular embodiments of the subject matter described herein can be implemented to achieve one or more of the following advantages: Reducing the size of an endoscopic device plays a significant role in reducing stress on a patient during an examination. Certain embodiments of the present disclosure provide a single lumen cannula that provides a single passageway for fluids (saline), working tools, and electronic cables. The flexible printed circuit (FPC) used in the present disclosure provides reliable electrical communication between the distal tip and proximal region of the endoscopic device. The FPC is also small enough to leave space for working tools and fluids to pass through the lumen.

[0021] The small cannula diameter and tip dimensions of an endoscopic device can bring a working tool very close to and potentially hit the camera and the solder joints securing the camera to the FPC. To reduce the risk of the working tool contacting the solder joints and / or the camera, some embodiments of the present disclosure include a ramp element that guides the working tool away from the solder joints and camera. The ramp element can also be configured to reduce in diameter and provide more effective control of the working tool. Controlling the working tool improves the accuracy of placing the working tool at a desired location within a patient's body for examination and surgery. The distal end of the endoscopic device may also reduce in diameter along with the ramp element to provide a thinner tip. Such a thinner tip allows for easier and smoother penetration through a body cavity.

[0022] An LED located at the distal tip of the endoscopic device illuminates the patient's tissue so that a camera (also located at the distal tip) can capture images of the tissue. It is desirable to block light from other directions and from sources other than the LED from entering the camera sensor. Coating the camera and its sensor can be effective but can result in inconsistent light-blocking properties. Furthermore, the coating can be easily scratched, for example, by a working tool passing through the cannula and exiting the distal tip of the device. An implementation of the present disclosure provides a housing for the camera. The housing has walls that surround the camera and substantially block light that may enter the camera sensor from around the camera. The walls cover all sides of the camera except for the distal face, which captures images, and the proximal face, which is soldered to the FPC. While coatings could still be used to increase light-blocking properties, the housing provides more consistent and reliable blocking properties and reduces the risk of scratches on the coating.

[0023] It is understood that systems and methods according to the present disclosure can include any combination of the aspects and features described herein, i.e., methods according to the present disclosure are not limited to combinations of aspects and features specifically described herein, but rather include any combination of aspects and features provided.

[0024] [The present invention 1001] housing, a cannula configured to be inserted into a uterus through the cervix, the cannula having a lumen extending from a proximal end of the cannula to a distal end of the cannula, the proximal end of the cannula being secured within the housing; an imaging system disposed at the distal end of the cannula, the imaging system including a camera and one or more light emitting diodes (LEDs) configured to provide light to the camera to capture images of the uterus; and An endoscopic device having a flexible printed circuit (FPC) extending within the lumen of the cannula and electrically connecting the camera and the LED with electrical components located within the housing, the lumen being configured to provide a passageway for a working tool. [The present invention 1002] The device of the present invention 1001, wherein the cannula defines a proximal opening and a distal opening, the proximal and distal openings being configured to allow a working instrument to enter the lumen through the proximal opening and exit the lumen through the distal opening. [The present invention 1003] The device of the present invention 1001, wherein the electrical components within the housing include at least one of a printed circuit board (PCB), a display, a display cable, and an electrical connection port. [The present invention 1004] The device of the present invention 1001, wherein the FPC is shaped to conform to the inner surface of the lumen. [The present invention 1005] The device of the present invention 1001, wherein the FPC is located within the upper third of the lumen. [The present invention 1006] The apparatus of the present invention 1001, wherein the work tool has a size of 5 French scale or less. [The present invention 1007] The device of the present invention 1001 further comprises a tip element at the distal end of the camera that holds the camera and the one or more LEDs, the tip element being configured so that a sensor of the camera detects reflected LED light and blocks other light from entering the sensor of the camera. [The present invention 1008] The apparatus of claim 1007, wherein the tip element includes a partition wall separating the camera from the one or more LEDs. [The present invention 1009] The apparatus of the present invention 1008, wherein the partition wall extends from the lens of the camera to the proximal end of the camera where the camera connects to the FPC. [The present invention 1010] The device of claim 1007, wherein the tip element has a convex shape that projects outwardly from the distal end of the cannula. [The present invention 1011] The device of the present invention 1007, wherein the tip element forms at least a portion of a tool channel configured to guide the working tool out of the endoscopic device. [The present invention 1012] The apparatus of claim 1011, wherein the tool channel has a curved inner surface that protrudes outwardly toward the camera. [The present invention 1013] Furthermore, a tip element that holds the camera and the one or more LEDs at the distal end of the cannula; and a coupler positioned between the tip element and the shaft defining the lumen, the coupler having a coupler notch that fits into a notch in the distal tip of the shaft to prevent the coupler from rotating relative to the distal tip; The device of the present invention 1001 has: [The present invention 1014] The device of claim 1013, wherein the coupler has threads formed by ridges on its inner surface, the threads being located near where the coupler meets the distal tip of the shaft. [The present invention 1015] Furthermore, a tip element that holds the camera at the distal end of the cannula, the tip element contacting the FPC through a ramp-shaped element that is configured to protect the camera's electrical contact to the FPC from potential impacts caused by a power tool passing through the cannula to the distal end of the cannula; The device of the present invention 1001 has: [The present invention 1016] The apparatus of claim 1015, wherein the ramp-shaped element has an adhesive material that secures the ramp-shaped element to the FPC. [The present invention 1017] 1016. The apparatus of claim 10, wherein the lamp-shaped element is cured by UV light. [The present invention 1018] The device of claim 1015, wherein the ramp-shaped element has a molded element positioned between the tip element and the distal end of the shaft of the cannula, the shaft defining the lumen of the cannula. [The present invention 1019] The device of the present invention 1018 further includes a coupler element positioned between the distal end of the shaft and the tip element, the coupler element extending along the FPC and surrounding the distal portion of the FPC and the molded element. [The present invention 1020] The apparatus of claim 1019, wherein the molded element has an outer surface including one or more grooves that receive one or more ribs on the inner surface of the coupler element. [The present invention 1021] 1019. The apparatus of claim 1019, wherein the coupler has an inner surface including one or more ribs disposed within one or more grooves on the outer surface of the molded element. [The present invention 1022] 1019. The apparatus of claim 1019, wherein the molding element has an inner surface that decreases in diameter as it extends toward the tip element. [The present invention 1023] 1019. The apparatus of claim 1019, wherein the coupler element has an inner surface that decreases in diameter as it extends toward the tip element. [The present invention 1024] The device of the present invention 1001, wherein the cannula is a dual lumen cannula having a first lumen and a second lumen, both of which extend along the cannula and are separated by a wall. [The present invention 1025] The apparatus of the present invention 1024, wherein the FPC passes through the first lumen and the working tool passes through the second lumen. The details of one or more implementations of the disclosure are set forth in the accompanying drawings and the description below. Other features and advantages of the disclosure will be apparent from the following description and drawings, and from the claims. [Brief explanation of the drawings]

[0025] [Figure 1] FIG. [Figure 2] FIG. 2 is a side view of the endoscope device of FIG. 1. [Figure 3] FIG. 2 is a side cross-sectional view of the endoscopic device of FIG. 1. [Figure 4] 4 is a schematic diagram showing the cannula and flexible printed circuit of the endoscopic device of FIG. 3. [Figure 5A] 2 is a schematic diagram of some components of the distal end of the endoscopic device of FIG. 1; [Figure 5B] 2 is a schematic diagram of some components of the distal end of the endoscopic device of FIG. 1; [Figure 6] 2 is a schematic diagram of a coupler at the distal end of the endoscopic device of FIG. 1; [Figure 7] 2 is a schematic diagram of the distal end of the endoscopic device of FIG. 1; [Figure 8] 2 is a schematic diagram of a tip element at the distal end of the endoscopic device shown in FIG. 1. [Figure 9A] 9 is a schematic diagram of the tip element shown in FIG. 8. [Figure 9B] 9 is a schematic diagram of the tip element shown in FIG. 8. [Figure 10] 7 is a schematic diagram showing contacts between other parts of the camera shown in FIG. 4 and the coupler shown in FIG. 6; [Figure 11A] 2 is a schematic diagram illustrating a method of forming a lamp-shaped element of the endoscopic device shown in FIG. 1. [Figure 11B] 2 is a schematic diagram illustrating a method of forming a lamp-shaped element of the endoscopic device shown in FIG. 1. [Figure 12A] 9 is a schematic diagram showing how the tip element of FIG. 8 is attached to the coupler shown in FIG. 6. [Figure 12B] 9 is a schematic diagram showing how the tip element of FIG. 8 is attached to the coupler shown in FIG. 6. [Figure 13A] 1A-1C are schematic diagrams of different views of the distal end of an endoscopic device including a molded ramp element. [Figure 13B] 1A-1C are schematic diagrams of different views of the distal end of an endoscopic device including a molded ramp element. [Figure 13C]1A-1C are schematic diagrams of different views of the distal end of an endoscopic device including a molded ramp element. [Figure 13D] 1A-1C are schematic diagrams of different views of the distal end of an endoscopic device including a molded ramp element. [Figure 13E] 1A-1C are schematic diagrams of different views of the distal end of an endoscopic device including a molded ramp element. [Figure 14A] 13A-13E are schematic diagrams of the molded lamp elements shown in FIGS. [Figure 14B] 14B is a cross-sectional view of the molded lamp element of FIG. 14A. [Figure 15A] 1 is a schematic diagram illustrating the distal end of a dual lumen cannula of an endoscopic device. [Figure 15B] 1 is a schematic diagram illustrating the distal end of a dual lumen cannula of an endoscopic device. DETAILED DESCRIPTION OF THE INVENTION

[0026] 1 and 2 illustrate an endoscopic device 100 (e.g., a hysteroscope) that can be used to examine a patient's uterus (e.g., uterine cavity). Endoscopic device 100 includes a cannula 102 configured to be inserted into a body organ such as the uterus (e.g., through a body cavity such as the patient's vaginal canal and cervix), an imaging system 104 located at a distal end 106 of cannula 102 for imaging the uterus, and a housing 146 located at the proximal end 106 of camera 102 via a connection hub 108. Endoscopic device 100 also includes a display 112 for viewing images captured by imaging system 104, and a handle 114 that either extends from display 112 (as shown) or is in the form of a grip 174 along housing 146.

[0027] 1-3, cannula 102 is an elongated, generally tubular member dimensioned to pass through the cervix and into the uterus. Cannula 102 includes a shaft 120 and a coupler 126 that secures imaging system 104 to a distal end 106 of shaft 120. Shaft 120 includes a main portion 130 (e.g., including proximal end region 110) having a central axis that defines a major axis 122 of cannula 102, a distal end 106, and a distal bend 124 that connects main portion 130 to distal end 106.

[0028] The shaft 120 defines a lumen 128 that accommodates one or more electrical cables of the imaging system 104, allows the passage of fluid between the distal end 106 and the connection hub 108, and allows the passage of a working tool. The passageway extends distally from the proximal end region 110 of the cannula 102 to the distal end 106 of the cannula. The shaft 120 further defines a sidewall opening 144 along the proximal end region 110 through which fluid can be delivered to or withdrawn (e.g., aspirated) from the lumen 128.

[0029] The working tool can be used for surgical or biopsy purposes. The working tool can enter the endoscopic device 100 through the proximal opening 158 of the housing (see FIGS. 1 and 3), pass through the working channel 164 and the cannula 102, and exit through the lumen opening 132 in the coupler 126. The working tool can enter the endoscopic device 100 through the proximal opening 158 of the housing 146 (see FIGS. 1 and 3), pass through the working channel 164 and the lumen 102, and exit through the lumen opening 132. Exemplary working tools that can be passed through the working channel 164 include various biopsy instruments (e.g., tweezers, graspers, scissors) having dimensions of 5 French scale or less. For example, the working tool can have an outer diameter of 1.6 mm or less.

[0030] The electrical cabling of the imaging system 104 within the lumen 128 includes one or more flexible printed circuits (FPCs). Figure 3 shows an FPC 184 extending within the lumen 128 and electrically connecting the imaging system 104 to electrical components located within the housing 146. The electrical components within the housing 146 may include a PCB or ROM 182, a camera actuator 148, a display cable, a connection port 160 (e.g., a micro HDMI port or other type of port) to which the display 112 or a display cable may be connected, etc.

[0031] The FPC 184 has a proximal portion 184a and a distal portion 184b. The housing 146 has been removed in FIG. 4 to more clearly show the proximal portion 184a. The proximal portion is connected to the PCB or ROM 182. The FPC 184 extends from the proximal portion 184a along the lumen 128 to the distal portion 184b. The FPC 184 is located within an upper third of the lumen 128. The FPC 184 can be shaped (e.g., bent) to fit the interior shape of the lumen 128.

[0032] 5A and 5B show the distal portion 184b of the FPC 184. The distal portion 184b is electrically connected to the imaging system 104. The imaging system includes a camera 142 and one or more light-emitting diodes (LEDs) 138. The LEDs 138 are positioned on either side of the camera 142 to uniformly illuminate the surrounding tissue for image acquisition.

[0033] Figure 5B is a plan view of distal portion 184b. In Figure 5B, coupler 126 has been removed to show the electrical connection between distal portion 184b of FPC 184 and components of imaging system 104. As shown, camera 142 is soldered to end 190 of distal portion 184b of FPC 184. Adhesive 192 covers the solder area to protect the solder joint from movement and prevent undesired severing of the electrical connection between the camera and FPC 184. The adhesive can be any color epoxy or a clear epoxy.

[0034] Figure 6 shows a side view of the distal end of the endoscopic device 100, including a coupler 126 secured to the distal end 106 of the shaft 120. The coupler is connected to a tip element 186. Figure 7 shows the tip element 186 at the distal end of the endoscopic device. The tip element defines (at least a portion of) a lumen opening 132 (e.g., a forward-facing fluid port) through which fluid and uterine tissue (e.g., endometrial tissue) can enter and exit the lumen 128 of the shaft 120. The tip element also includes two lateral openings 134, 136 having LEDs 138 disposed therein and a recessed opening 140 having a camera 142 disposed therein.

[0035] The FPC 184 extends from the connection port 160 and / or PCB 182 to the camera 142 , the LED 138 and other electrical components that provide electrical communication among the various components of the imaging system 104 .

[0036] The lumen opening 132 in the tip element 186 of the coupler 126 allows fluid (e.g., saline, hypotonic solution, isotonic fluid) to flow out of the distal tip 106 into the uterus and direct tissue or other particulate matter away from the camera 142, improving the quality of images captured by the camera 142. For example, the lumen opening 132 may be useful in clearing tissue debris that may collect on the distal end of the endoscopic device and otherwise interfere with imaging due to light reflection from the debris causing the debris to appear excessively bright. In some cases, the lumen opening 132 may also facilitate insertion of the cannula 102, as fluid exiting the lumen opening 132 may provide a lubricating effect and partially open the tissue surrounding the distal tip 106. In this manner, the lumen opening 132 can reduce the risk of accidental injury to the vaginal cavity, cervix, or uterus while the cannula 102 is being inserted into a patient.

[0037] Lumen opening 132 is sized to allow passage of one or more working tools (e.g., biopsy tools of 5 French scale or smaller). For example, lumen opening 132 is typically about 0.03 cm 2 ~0.05cm 2 and is about 50% to about 80% of the cross-sectional area of the lumen 128 itself.

[0038] Fluid solution enters the cannula either through an inlet port 152 located at a proximal opening 158 of the housing 146 or through a fluid port 150 located adjacent the proximal end region 110 of the cannula 102. The fluid port 150 is configured as a T-junction and is typically constructed from one of several materials including polycarbonate, ABS, or polypropylene. One advantage of introducing fluid through the fluid port 150 (rather than through the proximal opening 158) is that the introduction of fluid does not interrupt the entry or operation of a power tool. The fluid port 150 is configured to engage a fluid device (e.g., a syringe or extension tubing set) for delivering or withdrawing fluid from the lumen 128 of the cannula 102.

[0039] As mentioned above, tip element 186 includes two lateral openings 134, 136 in which LEDs 138 are held and positioned, and recessed opening 140 in which camera 142 is held and positioned. Tip element 186 can be configured to substantially block light from entering the sensor of camera 142.

[0040] 8 shows the shield (or housing) 188 of the tip element 186. The shield 188 surrounds the camera 142 to substantially block light, so that the camera sensor detects only reflected LED light. The shield 188 extends from the distal end of the camera 142 (e.g., from the camera lens) to the proximal end of the camera 142, where the camera is soldered to the FPC 184. The shield 188 has a compartmentalized portion 188a, which separates the camera 142 from the LED 138. The shield covers all sides of the camera except for the distal face, which captures the image, and the proximal face, which is soldered to the end 190 of the FPC 184.

[0041] The tip element can be a molded solid material composed of a polymer such as liquid crystal polymer (LCP), and the tip can be black to prevent light leakage from the shield 188 to the camera sensor.

[0042] 9A and 9B show tip element 186. Tip element 186 has a convex shape that protrudes outward in direction D. The convex shape is configured to allow smooth movement of tip element 186 through the patient's uterine cavity (or other body cavity) and reduce the likelihood of scratching or tearing the cavity.

[0043] The tip element 186 forms at least a wall of a tool channel configured to guide a working tool out of the endoscopic device 100 through the lumen opening 132. This wall is shown in FIGS. 9A and 9B as an upper wall 198. The upper wall 198 can be curved (as shown) or straight. The upper wall 198 has a curved inner surface that protrudes outward toward the camera. The curvature of the upper wall 198 can be configured based on the curvature or diameter of the working tool to provide sufficient space for its passage. Alternatively, the tip element 186 can be configured to encompass the other walls of the working channel to form the entire lumen opening 132.

[0044] The coupler 126 serves as an interface between the tip element 186 and the distal end 106 of the shaft 120. The coupler 126 illustrated in Figure 10 includes a notch 200 that locks into a notch 194 in the distal end 106 to prevent rotation of the coupler.

[0045] Coupler 126 has an inner surface having a first diameter at a first portion of the coupler where it covers distal end 106 and a second diameter at a second portion of the coupler where it covers the distal portion of FPC 184. The first diameter can be equal to, greater than, or smaller than the second diameter. In some embodiments, coupler 126 has a cylindrical outer surface. In some embodiments, the diameter of the coupler varies (e.g., drafts down) along the coupler.

[0046] In some embodiments, coupler 126 includes threads (receptacles or slots) 202 formed as ridges on the inner surface of the coupler, transitioning from the first portion to the second portion of the coupler. Threads 202 enhance the locking characteristics of notch 200. Transitioning from the first portion to the second portion of the coupler, the threads can have a width w1 substantially equal to the width w2 of notch 200 (as shown in FIG. 10), or can have a width greater (as shown in FIG. 6) or less than the width of the notch.

[0047] As mentioned above, camera 142 is soldered to distal portion 184b of FPC 184, and the soldered area is protected by adhesive material 192. The adhesive material 192 shown in Figure 6 is applied to the top surface of distal portion 184b. Alternatively or additionally, the adhesive material can be applied to the bottom surface of distal portion 184b, as shown in Figure 13A.

[0048] 6 also shows a ramp-shaped element (hereinafter "ramp") 180 located on the bottom surface of distal portion 184b. Ramp 180 is configured to protect the camera's electrical contacts to the FPC from potential impacts caused by a working tool passing through the cannula toward bore opening 132. Ramp 180 guides the working tool away from the solder joint.

[0049] The ramp 180 has a height that varies along the distal portion 184b of the FPC as it moves toward the tip element 186. The ramp height is defined in a direction perpendicular to the FPC 184. The height value increases as one moves along the FPC from near the distal end 106 of the shaft 120 toward the tip element 186. As shown in FIG. 6 , a first height (h1) of the ramp adjacent the distal end 106 is lower than a second height (h2) of the ramp adjacent the tip element 186. This variation in ramp height directs a work tool passing through the tool channel 204 (shaded area) away from the adhesive material 192 and / or the camera 142.

[0050] Ramp 180 may be secured to the bottom surface of distal portion 184b of the FPC, to tip element 186, or both. Ramp 180 may be comprised of one or more adhesive substances or may be secured to the FPC or tip element by adhesive substances.

[0051] 11A-11B illustrate a method of forming lamp 180. In this method, the inner surface of nest 206 is filled with an adhesive material that has a lamp shape, so that when the adhesive hardens and is removed from nest 206, lamp-shaped element 180 is formed. Depending on the material used, the adhesive material can be cured by leaving it in the nest for a predetermined period of time or by exposing it to radiation (e.g., curing with UV light).

[0052] After forming the ramp 180, the tip element 186, along with the ramp 180, is attached to the coupler 126. Figures 12A and 12B illustrate a method of attaching the tip element to the coupler. The coupler 126 and shaft 120 are moved toward the tip element 186 (Figure 12A) and attached to the tip element 186 (Figure 12B). In some embodiments, the contact portion 208 of the coupler 126 is shaped to engage with the contact portion 210 of the tip element. In some instances, the contact portions 208 and 210 have one or more recesses or ledges that engage with each other and prevent rotation of the coupler and the tip element.

[0053] In some embodiments, a molded ramp element is used to guide the working tool within the working channel, which can be pre-fabricated and assembled into the endoscopic device.

[0054] 13A-13E show different views of the distal end of an endoscopic device incorporating a molded ramp element 212 according to the present disclosure. The molded ramp element 212 is positioned within the coupler 126 between the distal end 106 of the shaft 120 and the tip element 186. The molded ramp element 212 has an outer top surface that is in contact with the FPC 184, the adhesive material 192, or both. The molded ramp element 212 has an inner surface that drafts down, or decreases in diameter, as the molded ramp element extends toward the tip element 186.

[0055] Figure 14A shows an exemplary molded ramp 212 used in the apparatus of Figures 13A-13C. The molded ramp element 212 has a cavity that forms (at least a portion of) the tool channel 204 through which a work tool can pass. The molded ramp element has a flat outer top surface 218 for supporting the FPC from the bottom.

[0056] FIG. 14B shows a cross-sectional view of molded ramp element 212. Molded ramp element 212 has an inner surface 216. From a proximal portion 220 of molded ramp element 212 to a distal portion 222 of the molded ramp, the distance between an upper portion 224 of inner surface 216 and upper surface 218 varies such that a ramp shape 214 is formed on upper portion 224 of inner surface 216. This ramp shape is configured to guide a working tool away from adhesive material 192 when molded ramp element 212 is positioned between distal end 106 of shaft 120 and tip element 186 (see FIG. 14 ). In particular, the ramp shape guides the working tool away from contact surface 232 of adhesive material 192 under FPC 184 and the solder joint. This configuration protects the solder joint of camera 142 from impacts from the working tool.

[0057] The molded lamp element 212 can be configured with surface features on the coupler, the tip, or both to eliminate the need for adhesives to attach the molded lamp element to the FPC. For example, the molded lamp element 212 has an outer surface that includes one or more recesses (i.e., groves) 226 that engage with one or more ridges (i.e., ribs) 228 on the inner surface of the coupler 126 (see FIG. 13B). Alternatively, or additionally, the outer surface of the molded lamp element 212 can include one or more ridges (i.e., ribs) that engage with one or more recesses disposed on the inner surface of the coupler 126. FIG. 13E shows a bottom view of the molded lamp element 212 and the distal end of the endoscopic device.

[0058] The molded lamp element 212 shown in Figures 13A-14B includes two extensions 230 configured to prevent rotation of the molded element 212. Although Figures 13A-14B show two extensions, the molded lamp element can have any number of extensions or none.

[0059] Although the endoscopic devices shown in Figures 1-14B have a single lumen, the endoscopic devices described herein can have more than one lumen. Figures 15A-15B show the distal end of a dual lumen cannula 240.

[0060] 15A shows a cross-sectional view of the distal end of a dual lumen cannula 240. Cannula 240 has a first lumen 242 and a second lumen 244. Electrical cables, such as FPC 184, pass through first lumen 242, while working tools and fluids pass through second lumen 244. First lumen 242 is separated from second lumen 244 by a wall 246, which may extend continuously along the cannula.

[0061] Tip element 186 has been removed in Figure 15B to more clearly show the location of the camera and LED. As shown, molded element 212 separates the passage of the work tool from FPC 184 within coupler 126, allowing the work tool to exit bore opening 231 without contacting camera 142 or LED 138.

[0062] Depending on the size of the work tool, the molded ramp element 212 can be configured to draft down in diameter as it extends toward the tip element 186. The molded ramp element 212 has a ramp-shaped lower surface 248. From the proximal portion 220 of the molded ramp element 212 to its distal portion 222, the lower surface 248 slopes toward the ramp 180 (see FIG. 15A). A molded ramp element with a ramp-shaped lower surface allows for more effective control of the work tool, thus improving the accuracy of placing the work tool at a desired location within a patient's body.

[0063] In some embodiments, the coupler 126 has a drafted down diameter along the lower surface 248 of the molded ramp element 212. Such a coupler provides a narrower tip for the endoscopic device, which allows for easier and smoother penetration through the body cavity.

[0064] 1-2 , the connection hub 108 can provide several features for fluid and electrical communication between the proximal end region 110 of the cannula 102 and the distal end 106 of the cannula 102. For example, the camera actuator 148 (e.g., having two opposing push buttons 176) and the fluid port 150 can be part of the connection hub 108. In this case, the cannula 102, imaging system 104, and connection hub 108 together form a portion 116 of the endoscopic device 100 that can be used for a single-use operation to be discarded after examining a patient's uterus. The portion 116 can be provided in a sealed, sterilized package that can be stored until use. The display 112 and handle 114 together form a reusable portion 118 of the endoscopic device 100 that is configured to attach and detach several single-use portions 116 for repeated examinations of multiple patients' uteruses. The reusable portion 118 is sterilized (eg, cleaned and disinfected) after each patient's uterine examination (eg, before examining the next patient's uterus).

[0065] Cannula 102 typically has an overall length (e.g., measured along major axis 122) of about 30.0 cm to about 34.0 cm (e.g., about 32.0 cm). Proximal end region 110 of cannula 102 (e.g., the portion of cannula 102 disposed within connection hub 108) typically has a length of about 4.0 cm to about 4.6 cm (e.g., about 4.3 cm), with the remainder of cannula 102 extending distally from connection hub 108 and exposed for insertion into a patient. Distal bend 124 typically has a radius of about 2.5 cm to about 7.5 cm (e.g., about 5.0 cm). Shaft 120 typically has a wall thickness of about 0.03 cm to about 0.05 cm (eg, about 0.04 cm) and an inner diameter (eg, lumen diameter) of about 0.34 cm to about 0.36 cm (eg, 0.35 cm).

[0066] The shaft 120 is typically constructed from one or more materials that are flexible enough to allow the cannula 102 to bend a small amount to allow proper placement within the patient as desired, yet rigid enough to allow easy insertion into the vaginal canal. Typical exemplary materials from which the shaft 120 is constructed include nylon, polysulfone, and polyetheretherketone (PEEK). The cannula 102 is typically manufactured primarily via extrusion and through secondary processes that may include one or more of punching, laser cutting, forming, and / or printing. The coupler 126 is typically constructed from one or more materials, including liquid crystal polymer (LCP), and is typically secured to the distal end 106 of the shaft 120 via an adhesive.

[0067] Housing 146 generally has a generally curved shape that is axially aligned with major axis 122 of cannula 102 and laterally symmetrical. Housing 146 defines a distal opening 162 through which cannula 102 passes, an opening 154 (e.g., aligned with sidewall opening 144 of shaft 120) to which fluid port 150 is secured, and a top connection port 160 (e.g., a micro HDMI port or another type of port) to which display 112 or a display cable can be connected. In this regard, connection hub 108 also contains electrical components (e.g., a miniature PCB or flex circuit with EEPROM, not shown) that place camera actuator 148 in communication with connection port 160. The housing 146 further defines additional interior wall features (e.g., flanges, openings, brackets, tabs, etc.) that properly position the fluid port 150, the camera actuator 148, the connection port 160, and the entry port 152.

[0068] The housing 146 of the connection hub 108 typically has a length (e.g., measured along the major axis 122 of the cannula 102) of about 10 cm to about 20 cm (e.g., about 15 cm) and a maximum width of about 20 cm to about 30 cm (e.g., about 25 cm). The housing 146 typically has a handle seating width (e.g., defined by the distance between opposite surfaces of the receptacle 170) of about 1.4 cm to about 1.8 cm (e.g., about 1.6 cm). The housing 146 is typically constructed from one or more materials including acrylonitrile butadiene styrene (ABS) or polycarbonate or copolyester and is typically manufactured by injection molding.

[0069] The actuation channel 164 can contain the actuation conduit 156, which can be curved or straight. The actuation conduit is typically constructed of one or more materials, including polyvinyl chloride (PVC). In some embodiments, the curved shape of the actuation conduit 156 provides the space needed within the connection hub 108 for one or more electronic components, such as PCBs. The actuation conduit 156 is sized to allow passage of a working tool from the entry port 152 to the distal end 106 of the cannula 102.

[0070] Entry port 152 includes a valve assembly configured to receive a working tool without leakage of fluid or tissue from entry port 152. The valve components of entry port 152 are typically constructed from silicone or a thermoplastic elastomer. The posterior location of entry port 152 (e.g., at proximal opening 158) facilitates insertion of a working tool into endoscopic device 100, as compared to port placement along the top or side surfaces that is typical in prior devices.

[0071] The push buttons 176 on the camera actuator 148 are employed as snap / video buttons that control the capture (e.g., recording and / or storage) of still images and video from the camera 142, where pressing either or both of the push buttons 176 for a threshold period (e.g., 1 second) or less will capture a single still photo, while pressing either or both of the push buttons 176 for longer than the threshold period will capture a video recording. While video is being recorded, a single press of the push buttons 176 terminates video capture. The push buttons 176 can be easily pressed with one or more fingers of the hand holding or inserting the endoscopic device 100. The overhanging end 178 of the coupler 126 acts as a lens hood, blocking light from directly impinging on the LED 138 and from entering the aperture of the camera 142.

[0072] The camera 142 includes a complementary metal-oxide semiconductor (CMOS) sensor module, a lens, and a glass cover. The CMOS sensor module includes a low-voltage color CMOS image sensor core, an image sensor processor, and image output interface circuitry. By providing integrated digital video processing within the CMOS sensor module, some aspects of the video processing can be performed directly on the same printed circuit board (PCB) as the CMOS sensor module, or on the same substrate on which the CMOS is formed so that the imaging plane of the CMOS substantially coincides with the plane along which the video processing circuitry extends. Furthermore, the display 112 includes an image signal processing (ISP) chip, which can perform additional aspects of the image processing and can support various video formats. The video signal from the CMOS sensor module can be NTSC (National Television System Committee), PAL (Phase Alternating Line), or another common video format.

[0073] While this specification contains many specificities, these should not be construed as limitations on the scope of the disclosure or the scope of the claims, but rather as descriptions of specific features for particular embodiments. Certain features described in this specification in the context of separate embodiments may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, while several features may be described above as acting in a combination and initially claimed as such, one or more features from a claimed combination may, in some cases, be deleted from the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination.

[0074] Numerous implementations have been described. However, it will be understood that various modifications can be made without departing from the spirit and scope of the present disclosure. For example, steps can be reordered, added, or removed to use various configurations of the flows shown above. The endoscopic devices described herein can be used to examine any organ accessible through a body cavity. Accordingly, other implementations are within the scope of the following claims.

Claims

1. housing, a cannula configured to be inserted into a uterus through the cervix, the cannula having a lumen extending from a proximal end of the cannula to a distal end of the cannula, the lumen configured to permit passage of a working tool therethrough, the proximal end of the cannula being secured within the housing; an imaging system disposed at the distal end of the cannula, the imaging system including a camera and one or more light emitting diodes (LEDs) configured to provide light to the camera to capture images of the uterus; and a flexible printed circuit (FPC) extending within the lumen of the cannula and electrically connecting the camera and the one or more LEDs with electrical components located within the housing; a tip element that holds the camera at the distal end of the cannula, the tip element having a forward-facing surface and configured to be moved in a forward direction through the cervix, the forward-facing surface having an opening that exposes the camera at the distal end of the cannula; and a ramp-shaped guide element positioned within the cannula, the guide element having a first end positioned proximate to the tip element and a second end positioned further away from the tip element, the guide element at least partially defining a tool channel configured to allow passage of the power tool or positioned adjacent to the tool channel configured to allow passage of the power tool, the guide element having a thickness that varies between the first end and the second end, the difference in thickness between the first end and the second end causing the ramp-shaped guide element to guide the power tool away from an electrical contact for the FPC of the camera; An endoscope device having:

2. 2. The device of claim 1, wherein the cannula defines proximal and distal openings configured to allow the working tool to enter the lumen through the proximal opening and exit the lumen through the distal opening.

3. 10. The device of claim 1, wherein the electrical components within the housing include at least one of a printed circuit board (PCB), a display, a display cable, and an electrical connection port.

4. 10. The device of claim 1, wherein the FPC is shaped to conform to the inner surface of the lumen.

5. 2. The device of claim 1, wherein the FPC is located within the upper third of the lumen.

6. 2. The apparatus of claim 1, wherein said work tool has a size of 5 French scale or less.

7. 10. The device of claim 1, wherein the tip element carries the one or more LEDs at the distal end of the cannula, the tip element configured to allow a sensor of the camera to detect reflected LED light and to block other light from entering the sensor of the camera.

8. 8. The device of claim 7, wherein the tip element includes a partition wall separating the camera from the one or more LEDs.

9. 9. The apparatus of claim 8, wherein the partition wall extends from the lens of the camera to the proximal end of the camera where the camera connects to the FPC.

10. 8. The device of claim 7, wherein the tip element has a convex shape that projects outwardly from the distal end of the cannula.

11. 2. The device of claim 1, wherein said tip element defines at least a portion of said tool channel.

12. 12. The apparatus of claim 11, wherein the tool channel has a curved inner surface that protrudes toward the camera.

13. the tip element carries the one or more LEDs at the distal end of the cannula, and further The cannula a shaft defining the lumen; a coupler positioned between the shaft and the tip element, the coupler having a coupler notch that fits into a notch in the distal tip of the shaft to prevent the coupler from rotating relative to the distal tip; 10. The apparatus of claim 1, further comprising:

14. 14. The device of claim 13, wherein the coupler has threads formed by ridges on its inner surface, the threads being located near where the coupler meets the distal tip of the shaft.

15. 2. The apparatus of claim 1, wherein the thickness of the ramp-shaped guide element increases from the second end to the first end to protect the camera's electrical contacts to the FPC from potential impacts caused by passing the working tool through the cannula toward the distal end of the cannula.

16. The device of claim 1, wherein said cannula is a single lumen cannula.

17. 2. The apparatus of claim 1, wherein the ramp-shaped guide element is fixed to a surface of the FPC.

18. The apparatus of claim 17, wherein the ramp-shaped guide element is secured to the surface of the FPC using an adhesive.

19. The apparatus of claim 17, wherein said surface is a bottom surface of said FPC.

20. The apparatus of claim 1, wherein the ramp-shaped guide element comprises a cured adhesive.

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