Improved system with inflatable member and imaging device for arrangement in a respiratory tract of a patient

Abstract

A system with an inflatable member (10) configured for being arranged in a portion of the respiratory tract of a patient, the system comprising a catheter (20) carrying the inflatable member (10) to be arranged in the respiratory tract, said catheter being provided with a fluid line (25) for filling 5 the inflatable member (10) with a fluid; said catheter having a first end portion (21) intended to be located outside the body of the patient and a second end portion (22) intended to be located in the respiratory tract of the patient; an imaging device (30) attached to or integrated with the second end portion (22) of the catheter.

Description

Technical Field

[0001] The present invention relates to systems having an inflatable member configured for placement in a portion of a patient’s airway, and more particularly to systems for ultrasound imaging. Background Technology

[0002] WO00 / 53098 relates to an ultrasound imaging method called transesophageal echocardiography, now known as TEE. This method has become a widely used imaging technique for assessing cardiac structure, function, and valvular anatomy. TEE also provides a new perspective on the thoracic aorta, and mounting evidence suggests that this technique helps provide valuable and sometimes unique information about aortic structure and pathology.

[0003] TEE involves inserting an echo probe into the patient's esophagus and transmitting ultrasound waves across the chest in the direction of the heart and aorta. However, visualization of the ascending aorta via internal TEE is limited by air structures (i.e., the trachea and the main left and right bronchi). This is due to a significant physical limitation of ultrasound: absorption. This absorption depends on the medium and is expressed as the "half-power distance": the distance over which half of the ultrasound energy will be absorbed. For water, the half-power distance is 360 cm, for bone it is 0.2 cm, and for air it is 0.06 cm. This means that in practice, ultrasound waves will not travel through bone or air.

[0004] To address this issue, WO 00 / 53098 proposes the use of an inflatable member that can be placed in either the trachea or one of the bronchi and can be filled with an ultrasound-transmitting fluid, such as water or a low-concentration saline solution. This technique can only be performed during surgical procedures when the patient is on mechanical ventilation or cardiopulmonary bypass, because for it to be effective, the inflatable member must completely fill and block the trachea or bronchi. Summary of the Invention

[0005] The first problem encountered when attempting to introduce an inflatable device into the left bronchus is the difficulty in manipulating the flexible catheter carrying the device, which is the preferred location for visualizing the ascending aorta. Positioning the distal end of the flexible catheter anterior to the left bronchus allows the balloon to descend into that bronchus, often a trial-and-error problem. Secondly, during placement of the inflatable device in the patient's airway, contact occurs between the TEE device and the tracheal wall, potentially leading to tissue damage. Since this positioning must be performed during surgical intervention, timing is often critical, necessitating improvements.

[0006] The purpose of embodiments of the present invention is to provide a system having an inflatable member configured for placement in a portion of a patient’s airway, which can be more easily positioned and reduces the chance of tissue damage.

[0007] According to a first aspect of the invention, a system is provided having an inflatable member configured for placement in a portion of a patient's airway. The system includes a catheter and an imaging device, preferably a visible light imaging device. The catheter carries the inflatable member, which will be placed in the airway. The catheter is provided with a fluid line for filling the inflatable member with fluid. The catheter has a first end intended to be located outside the patient's body and a second end intended to be located within the patient's airway. The imaging device is attached to or integrated with the second end of the catheter.

[0008] Embodiments of the present invention are particularly based on the insight that by attaching or integrating the imaging device to the second end, the positioning of the inflatable member is achieved more efficiently. In effect, the operator receives more feedback—images captured by the imaging device during surgery—and the catheter is easier to manipulate. This results in a reduced likelihood of tissue damage.

[0009] Preferably, the imaging device includes a light source comprising a plurality of light-emitting diodes arranged along the periphery of the second end of the conduit, preferably at least three light-emitting diodes evenly distributed along the periphery of the second end of the conduit.

[0010] According to an exemplary embodiment, the imaging device is configured and arranged to position the second end of the catheter in, for example, the patient's airway or the patient's left main bronchus. In other words, the second end having the imaging device can be shaped such that the second end forms a stylet that serves as a guide when an inflatable member is inserted.

[0011] According to an exemplary embodiment, the system includes an ultrasound imaging device. Preferably, the ultrasound imaging device is configured to be disposed in the patient's esophagus and configured to transmit ultrasound waves across the chest via an inflatable member and to receive reflected ultrasound waves. The system allows for the assessment of organs within the patient's body using ultrasound.

[0012] According to an exemplary embodiment, the imaging device is configured to transmit collected data to a means outside the patient's body so that the data can be accessed by an operator (e.g., a surgeon or assistant) during clinical procedures. This transmission can be wired or wireless. In a preferred embodiment with wired transmission, the wire is arranged inside the catheter, but those skilled in the art will understand that other arrangements are possible, such as the wire being arranged within the wall of the catheter.

[0013] According to an exemplary embodiment, the imaging device includes a cylindrical housing aligned with the longitudinal axis of the catheter. Preferably, the cylindrical housing is at least partially disposed in the second end of the catheter, more preferably substantially entirely disposed in the second end of the catheter. Preferably, the housing comprises a metal such as stainless steel or a plastic such as polyvinyl chloride. These materials are more rigid than flexible catheters. Because the housing is cylindrical and at least partially disposed in the second end of the catheter, the second end is given a probe shape that can be easily inserted and can perform the function of guiding the catheter. With the housing present, the flexible catheter is easier to manipulate. Preferably, the diameter of the housing is between 0.01 mm and 9 mm, more preferably between 0.5 mm and 5 mm, more preferably between 1 mm and 3 mm. Preferably, the length of the housing is less than 10 mm, more preferably less than 7 mm. The housing can be adhesively fixed to the second end of the catheter. In this way, the housing and the catheter cooperate to allow the inflatable member to be positioned in an improved manner.

[0014] According to an exemplary embodiment, the imaging apparatus further includes an image sensor, preferably an active pixel sensor, such as a complementary metal-oxide-semiconductor (CMOS) sensor. Alternatively, the image sensor may be a charge-coupled device (CCD). Preferably, the image sensor is surrounded by a plurality of light-emitting diodes, more preferably surrounded in such a manner that the plurality of light-emitting diodes are uniformly distributed. Optionally, an optical fiber may be used to provide light next to the image sensor. In this way, the quality of the acquired image data can be improved.

[0015] According to an exemplary embodiment, the imaging device includes a lens disposed in front of an image sensor and projecting from a second end of a conduit. Preferably, the lens is adhesively fixed to the image sensor and / or the housing and / or the conduit. In this way, the lens forms a protective layer between the image sensor and particles that may potentially interfere with the operation of the image sensor. Preferably, the image sensor has a field of view oriented between 90 degrees and 180 degrees away from the second end of the conduit.

[0016] According to an exemplary embodiment, the system includes a fluid conduit. In some embodiments, a conduit forms the fluid conduit. The fluid conduit may be centrally formed within the conduit or within the wall of the conduit. In other embodiments, the fluid conduit is a separate conduit disposed inside or outside the conduit. The fluid conduit carries fluid (preferably ultrasonic fluid) from an external fluid source to the inflatable member. In this way, the amount of air that interferes with ultrasonic imaging is limited.

[0017] According to an exemplary embodiment, the system includes at least one wire disposed within a conduit and configured to connect the imaging device to a device external to the patient's body, typically a computer with a display screen for showing image data. In other embodiments, the imaging device may be configured to communicate with a device external to the patient's body without using a wire. In this case, the power to operate the imaging device may come from an internal energy storage device.

[0018] According to an exemplary embodiment, the system includes a catheter made of a flexible material, preferably a polymeric material. These materials can be polyvinyl chloride, silicone, or synthetic latex. In this way, the material makes the catheter flexible and resilient, allowing for non-invasive catheter insertion. The catheter can be coated, for example, with polytetrafluoroethylene (PTFE). In this way, the catheter is better protected against acids, solvents, and corrosion. Most importantly, the low coefficient of adhesion also allows for non-invasive catheter insertion.

[0019] According to an exemplary embodiment, the inflatable member in its non-expanded state has a volume between 20 ml and 60 ml, preferably between 30 ml and 50 ml. The material of the inflatable member is a thermoplastic elastomer, preferably a thermoplastic polyurethane elastomer.

[0020] According to yet another exemplary embodiment, the system further includes a pressure monitoring and control component disposed outside the patient's body. This component is in fluid communication with an inflatable component and is configured to receive fluid from the inflatable component during operation when the pressure inside the inflatable component increases above a predetermined threshold. When the pressure decreases below the threshold, the control component returns the received fluid. The pressure monitoring and control component is an elastically inflatable balloon made of a material configured to elastically expand when the pressure inside the balloon increases above a threshold pressure. When the pressure decreases below the threshold, the monitoring and control component contracts. In this way, high pressure that could potentially cause tissue damage is avoided while still maintaining sufficient pressure to limit airflow. Attached Figure Description

[0021] The accompanying drawings illustrate presently preferred, non-limiting exemplary embodiments of the system of the present invention. The above and other advantages of the features and objects of the invention will become more apparent, and the invention will be better understood, when read in conjunction with the accompanying drawings and in the following detailed description, in which:

[0022] Figure 1 The illustration shows a partial cross-sectional view of the upper body of a patient, illustrating an exemplary embodiment of a system having inflatable components arranged within the patient's body.

[0023] Figure 2This is a schematic diagram of another exemplary embodiment of the system of the present invention, including an imaging device, illustrating an inflatable member, a pressure and control member, and a device located outside the patient's body configured and arranged to receive data from the imaging device.

[0024] Figure 3 It comes from Figure 2 An enlarged view of the second end of the catheter shows a more detailed schematic diagram of the imaging device and the inflatable component.

[0025] Figures 4A to 4C The image is a cross-section of a different exemplary embodiment of the second end of the catheter, showing the imaging device.

[0026] Figure 5 This is a perspective view showing an exemplary embodiment of an imaging device comprising a housing, multiple wires, a light source, and an image sensor.

[0027] Figures 6A to 6D Exemplary embodiments of an imaging device with various possibilities for lens positioning are shown.

[0028] Figure 7 This is a schematic diagram of an exemplary embodiment of another system of the present invention, showing an inflatable member filled with a transport fluid.

[0029] Figure 8 yes Figure 7 A detailed magnified view of the surrounding area VIII.

[0030] Figure 9 Is with Figure 8 A similar view is shown, illustrating yet another exemplary embodiment of the system of the present invention. Detailed Implementation

[0031] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be associated with the invention as they are oriented in the accompanying drawings. However, it should be understood that the invention may take various alternative variations and sequences of steps unless expressly stated otherwise. It should also be understood that the specific apparatus and processes illustrated in the drawings and described in the following description are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0032] It should be understood that the present invention can take various alternative variations and sequences of steps unless expressly stated otherwise. It should also be understood that the specific apparatus and processes illustrated in the accompanying drawings and described in the following description are merely exemplary embodiments of the invention.

[0033] exist Figure 1In the preferred exemplary embodiment illustrated in the figure, the system includes an ultrasound imaging device 40 capable of imaging organs (particularly the heart or aorta 2) in the patient's body 1 through a portion of the patient's airway 3. The ultrasound imaging device 40 (e.g., an echo probe) is disposed in or on the patient's body 1. In the illustrated embodiment, the echo probe 40, carried on a flexible catheter 9, is introduced into the patient's esophagus 5. Another flexible catheter 20, carrying an inflatable member 10, is introduced into the airway 3. The inflatable member 10 is positioned at a predetermined location in the airway 3. When the organ to be imaged is the ascending aorta 2, the predetermined location will be in the top portion of the left bronchus 8. The flexible catheter 20 carrying the inflatable member 10 is guided through the patient's trachea 3 by first introducing an endotracheal tube 17 into the trachea 3. This tube 17 is slightly stiffer than the catheter 20, thus making it easier to control. The catheter 20 is then inserted into the endotracheal tube 17. After exiting the endotracheal tube 17, the second end 22 of the catheter 20 and the inflatable member 10 are guided into the left bronchus 8.

[0034] The catheter 20 has a first end 21 intended to be located outside the patient's body and a second end 22 intended to be located within the patient's airway. The system also includes an imaging device 30 attached to or integrated with the second end 22 of the catheter 20. Typically, the imaging device 30 includes an image sensor and a light source (e.g., one or more light-emitting diodes). The imaging device 30 is shaped such that the second end 22 of the catheter serves as a guide for positioning the inflatable member. The imaging device 30 is configured or connected to a device (not shown) that transmits image data to outside the patient's body, where the image data is displayed to a user. The presence of the imaging device 30 increases the stiffness of the second end 22 of the flexible catheter 20, improving directional control and predictability of movement, thereby allowing the inflatable member 10 to be positioned quickly and accurately within the airway 3.

[0035] The conduit 20 can be made of a flexible material (preferably a polymer material, more preferably polyvinyl chloride, silicone, or synthetic latex). In its non-expanded state, the inflatable member 10 can have a volume between 20 ml and 60 ml, preferably between 30 ml and 50 ml. The material of the inflatable member can be a thermoplastic elastomer, preferably a thermoplastic polyurethane elastomer.

[0036] Figure 2A second exemplary embodiment of the system is shown. The system includes at least one inflatable member 10 carried by a flexible catheter 20. For example, in practical ultrasound imaging, the flexible catheter 20 carrying the inflatable member 10 is guided through the patient's trachea into a right-side location, such as the patient's left main bronchus. In this embodiment, the catheter includes an imaging device 30 disposed at a second end 22 of the catheter 20. Positioning of the catheter 20 and the inflatable member 10 is accomplished by manipulating the second end of the catheter 20. Figure 2 A computer device 50 connected to the imaging apparatus 30 via wired or wireless means is also shown. This computer device 50 receives image data from the imaging apparatus 30 and displays the image data to an operator. The imaging apparatus 30 may have any of the features of the embodiments disclosed above and below.

[0037] The system also includes a pressure monitoring and control component 60 disposed outside the patient's body. This pressure monitoring component is in fluid communication with the inflatable component 10 and is configured to receive fluid from the inflatable component 10 during operation when the pressure increases above a predetermined threshold pressure, and to return the received fluid when the pressure decreases below the predetermined threshold pressure. The pressure monitoring and control component 60 may be an elastically inflatable balloon made of a material configured to elastically inflate when the pressure within the balloon increases above the predetermined threshold pressure and to contract when the pressure decreases below the predetermined threshold pressure.

[0038] After the inflatable member 10 has been positioned correctly in the airway, fluid, such as water or a low-concentration saline solution, is filled into the inflatable member 10 through the flexible conduit 20. In its non-inflated state, the inflatable member 10 has a volume between 30 ml and 70 ml, preferably between 40 ml and 60 ml. The fluid is injected into the conduit 20 using a syringe (not shown), which is connected to the filling connector 28 at the proximal end of the filling tubing 29.

[0039] The distal end of the filling tube 29 is connected to the proximal end of the catheter 20 via connector 27. The degree of filling of the inflatable member 10 can be visually determined by monitoring the elastically inflatable balloon 60 disposed at the end of the pilot tube. This pilot tube is also connected to the catheter 20 via connector 27. If the pressure within the inflatable member 10 increases to a threshold level, for example, during the movement of the echo probe in the esophagus 5 or the movement of the breathing tube in the airway, the pressure can cause fluid to flow back from the inflatable member 10 to the elastically inflatable balloon 60. Such backflow can cause the elastically inflatable balloon 60 to inflate, thereby limiting the pressure increase within the inflatable member to a safe level. The predetermined threshold pressure of the system is in the range of 30 mm Hg to 90 mm Hg, which ensures a safe pressure within the inflatable member, thereby minimizing or eliminating damage to the tracheal wall.

[0040] Figure 3 The arrangement of the imaging device 30 in the catheter 20 is shown in detail. The imaging device is at least partially arranged in the second end 22 of the catheter. Optionally, the imaging device 30 extends partially into the region of the inflatable member, but preferably only over a short distance (e.g., less than 1 cm) so that the ultrasound imaging is undisturbed.

[0041] Figures 4A-4C Three possible embodiments of an imaging device 30 disposed in the second end 22 of a catheter 20 are shown. The imaging device 30 is inserted into the second end 22 of the flexible catheter 20. Figure 4A In one embodiment, the imaging device 30 is fully inserted into the second end 22, and the flexible conduit 20 protrudes beyond the imaging device 30 in the longitudinal direction. Figure 4B In one embodiment, attachment or integration aligns the end portion of the imaging device 30 with the end portion of the flexible conduit 20. Figure 4C An exemplary embodiment is shown in which the imaging device 30 protrudes from the second end 22 of the catheter in the longitudinal direction.

[0042] Figure 5 An exemplary embodiment of the imaging apparatus is shown in detail. The imaging apparatus 30 includes a cylindrical housing 31 made of a material more rigid than a flexible catheter. This material can be a metal such as stainless steel and / or a plastic such as polyvinyl chloride. The cylindrical housing 31 is designed to be aligned with the longitudinal axis of the catheter, as discussed above. Figure 3 This can also be clearly seen in the diagram. Preferably, the diameter of the housing 31 is between 0.01 mm and 9 mm, more preferably between 0.5 mm and 5 mm, even more preferably between 1 mm and 3 mm, and / or the length of the housing is less than 10 mm, preferably less than 7 mm. Optionally, the housing 31 extends a short distance in the inflatable member 10, as discussed above. Figure 2 This can also be seen from the text.

[0043] The imaging device 30 also includes an image sensor 33 and at least one light source 32. The imaging device 30 can be connected to an external power source (not shown) and can output image data via one or more wires 35. Although wired solutions for both power supply and image data transmission are preferred, the use of batteries and / or wireless transmission devices in the imaging device 30 is also conceivable.

[0044] Image sensor 33 is arranged in housing 31 and may be, for example, an active pixel sensor, such as a CMOS sensor. Light source 32 includes a plurality of light-emitting diodes arranged around image sensor 33. Image sensor 33 may have a field of view between 90 degrees and 180 degrees, preferably between 100 degrees and 150 degrees.

[0045] Figures 6A to 6D An exemplary embodiment of an imaging device 30 is shown, which includes a centrally positioned image sensor 33, at least one light source 32, and a lens 34 disposed in front of the image sensor 33. More specifically, Figures 6A-6D Various possibilities for positioning the lens 34 at the second end 22 of the catheter are shown. In addition to its optical function, the lens 34 also serves as a protective layer for the image sensor 33, and in a preferred embodiment, the stiffness and shape of the lens help to position the second end 22 of the flexible catheter.

[0046] exist Figure 6A In this configuration, lens 34 is positioned in front of image sensor 33 and has a diameter smaller than that of housing 31. The diameter of lens 34 can be greater than, less than, or equal to the diameter of housing 31.

[0047] exist Figure 6B In this configuration, the image sensor is surrounded by the light source 32, and a lens 34 is arranged in front of the image sensor 33 and the light source 32, having a diameter equal to that of the housing 31. Those skilled in the art will understand that different curvatures are possible, and exemplary embodiments of lenses 34 with different curvatures are shown in... Figure 6C As shown in [the image]. Figure 6D In another exemplary embodiment shown, the lens 34 is arranged in front of the image sensor 33 and has a larger diameter than the housing 31.

[0048] Figure 7Another exemplary embodiment of a system comprising at least one inflatable member 10 carried by a flexible catheter 20 is illustrated. The flexible catheter 20 is provided with an imaging device 30, which may have any of the features of the embodiments disclosed above. Furthermore, the system includes a filling tube 29 connected to a three-way connector 70, which forms a connection between the filling tube 29, a pilot tube 26 leading to a pilot balloon 24, and the flexible catheter 20. Figure 8 It shows Figure 7 An enlarged view of section VIII in the diagram.

[0049] After the inflatable member 10 has been positioned, ultrasonic transmission fluid is filled into the inflatable member 10 through the flexible conduit 20. The fluid is injected into the conduit 20 using a syringe (not shown), which is connected to the filling connector 20 at the end of the filling conduit 21 (see [link to documentation]). Figure 8 The filling conduit 21 is then connected to the proximal end of the catheter 20 via a three-way connector 70. The degree of filling of the inflatable member 10 can be visually determined by monitoring the pilot balloon 24 disposed at the end of the pilot conduit 26. The pilot conduit 26 is also connected to the catheter 10 via the three-way connector 70.

[0050] When the degree of inflation of the lead balloon 24 indicates that the inflatable member 10 has been filled to completely cover the entire cross-sectional area of ​​the left bronchus, thus eliminating air between the echo probe and the organ to be imaged, the echo probe can be activated. Ultrasound waves are then transmitted from the echo probe through the transport fluid F in the inflatable member 10 to the ascending aorta. Reflections from the aorta are received at the echo probe and transmitted through a tubing extending through the catheter 10 to a processing and display device. Because of the presence of the inflatable member 10 filled with the transport fluid F (e.g., water or a low-concentration saline solution), the ultrasound waves can travel through the airway with minimal absorption. Therefore, very good aortic ultrasound images can be obtained.

[0051] The imaging device 30 can be connected to an external power source (not shown) via one or more wires 35, and the image captured by the imaging device 30 can be output via one or more external wires 35. Various possibilities exist for accommodating one or more wires 35 within the conduit 20. In a simple first variant, the conduit 20 has a main cavity for filling the inflatable member 10 with fluid for ultrasonic transmission, and one or more wires 35 are arranged within the main cavity. Alternatively, the conduit 20 may have a main cavity for ultrasonic fluid transmission and an additional cavity for accommodating one or more wires 35. In this way, one or more wires 35 do not interfere with the fluid supply function of the conduit 20. To allow one or more wires to pass through the device 50 outside the conduit 20, the three-prong connector 70 includes a central fork 71 and a cap 72 that carries the valve member 73.

[0052] Figure 9 Another exemplary embodiment of an alternative arrangement of one or more wires 35 is shown. This embodiment is similar to... Figure 7 and Figure 8 In one embodiment, the difference lies in that one or more wires 35 are eccentrically arranged into the flexible catheter 20. The advantage of this embodiment is that no special seal is required to pull one or more wires 35 out of the catheter 20, like... Figure 7 and Figure 8 As in the embodiment. On the other hand, a sealing channel may be provided at the second end to connect one or more wires 35 to the imaging device 30.

[0053] Although the invention has been described in detail for illustrative purposes, based on embodiments currently considered to be the most practical and preferred, it should be understood that such detail is for that purpose only, and the invention is not limited to the disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A system having an inflatable member (10) configured for placement in a portion of a patient's airway, the system comprising: A catheter (20) carrying an inflatable member (10) to be placed in a respiratory tract, the catheter being provided with a fluid conduit (25) for filling the inflatable member (10) with fluid; the catheter having a first end (21) intended to be located outside the patient's body and a second end (22) intended to be located in the patient's respiratory tract. An imaging device (30) is attached to or integrated with the second end (22) of the catheter, the imaging device having a distal end located distal to the inflatable member, and the imaging device is configured to form a pilot portion of the catheter as a guide for positioning the inflatable member.

2. The system according to claim 1, wherein the imaging device (30) includes a light source (32).

3. The system according to claim 2, wherein the light source (32) comprises a plurality of light-emitting diodes arranged around the periphery of the second end (22) of the conduit.

4. The system according to any one of claims 1-3, wherein the second end (22) of the catheter has a distal edge, and wherein the imaging device (30) has a distal edge; wherein the distal edge of the imaging device is aligned with the distal edge of the catheter, or wherein the distal edge of the imaging device protrudes distally from the distal edge of the catheter, such that the second end (22) of the catheter forms a probe serving as a guide for positioning the inflatable member; and wherein the catheter is concentric with the central axis of the inflatable member.

5. The system according to any one of claims 1-3 further includes an ultrasonic imaging device (40) configured to emit ultrasonic waves through the inflatable member (10) and receive reflected ultrasonic waves.

6. The system according to any one of claims 1-3, wherein the imaging device (30) is configured or connected to a device (50) for transmitting image data to the outside of the patient's body.

7. The system of claim 4, wherein the imaging device comprises a cylindrical housing (31) aligned with the longitudinal axis of the catheter.

8. The system according to claim 7, wherein the cylindrical housing (31) is at least partially disposed in the second end (22) of the conduit.

9. The system according to claim 7, wherein the diameter of the cylindrical housing (31) is between 0.01 mm and 9 mm, and / or the length of the housing is less than 10 mm.

10. The system of claim 3, wherein the imaging device (30) includes an active pixel sensor (33).

11. The system of claim 10, wherein the plurality of light-emitting diodes are arranged around the active pixel sensor (33).

12. The system according to any one of claims 10 to 11, wherein the imaging device (30) includes a lens (34) disposed in front of the active pixel sensor (33) and protruding from the second end (22).

13. The system according to any one of claims 1-3 and 8-11, wherein the imaging device (30) has a field of view between 90 degrees and 180 degrees.

14. The system according to any one of claims 1-3 and 8-11, wherein the conduit (20) comprises the fluid conduit (25).

15. The system according to any one of claims 1-3 and 8-11 further includes at least one wire (35) disposed in the conduit and configured to connect the imaging device to a device (50) outside the patient's body.

16. The system according to any one of claims 1-3 and 8-11, wherein the conduit is made of a flexible material.

17. The system according to any one of claims 1-3 and 8-11, wherein in the non-expanded state, the inflatable member (10) has a volume between 20 ml and 60 ml.

18. The system according to any one of claims 1-3 and 8-11, wherein the material of the inflatable member is a thermoplastic elastomer.

19. The system according to any one of claims 1-3 and 8-11, further comprising: A pressure monitoring and control component (60) is disposed outside the patient’s body, the pressure monitoring component is in fluid communication with the inflatable component and is configured to receive fluid from the inflatable component (10) during operation when the pressure increases to above a predetermined threshold pressure and to return the received fluid when the pressure decreases to below the predetermined threshold pressure; The pressure monitoring and control component is an elastically inflatable balloon made of a material configured to elastically inflate when the pressure in the balloon increases above a predetermined threshold pressure and to contract when the pressure decreases below the predetermined threshold pressure.

20. The system according to claim 1, in, The imaging device (30) is configured and arranged such that the second end (22) of the conduit serves as a guide for positioning the inflatable member, wherein the imaging device (30) includes an image sensor, and The system also includes: An ultrasonic imaging device (40) is configured to emit ultrasonic waves through the inflatable member (10) and receive reflected ultrasonic waves.

Images