JP2019517863A - Apparatus and method for operating on a narrow body lumen - Google Patents

Abstract

An apparatus is provided for use in a narrow body lumen. The apparatus has an outer shaft portion, a tube receivable in the outer shaft portion, and first and second ends, the first end sealed to the outer shaft portion, the second end The portion may include an elongated expandable body sealed against the tube. In the initial configuration, the elongate expandable body is received on the outer shaft portion. The tube is slidable relative to the outer shaft portion such that the elongated expandable body is everted as it moves out of the outer shaft portion. [Selected figure] Figure 12E.

Description

  The present invention relates generally to devices for management, treatment and / or diagnosis performed on narrow body lumens.

  For a variety of reasons, occlusion frequently occurs in narrow body lumens (ie, channels of tubular anatomical structures such as the fallopian tube, intestine, and coronary arteries) and has a medically relevant significance to the body. Have. The prior art used to maintain the health of the fallopian tube as an example of a narrow body lumen is described below.

  The fallopian tube is a vascular, non-fluid filled structure extending from the uterus to the ovary. On average, the fallopian tube is measured between 8 and 10 centimeters in length. The inner diameter of the fallopian tube changes significantly depending on the segment of the fallopian tube, with a minimum inner diameter of about 1 millimeter and a maximum inner diameter of 6 millimeters.

  Along the length of the lumen of the fallopian tube, millions of fine hairy villi beat in a wave motion at millions of times per second. This movement assists ova delivered from the ovary during ovulation through the fallopian tube to the uterine cavity. Cells located in the inner layer (endothelium) of the fallopian tube provide the egg with essential nutrients and provide lubrication along the pathway. The first contact of sperm with an ovum is in the fallopian tube. If the ova does not fertilize within 24 to 36 hours of reaching the fallopian tube, it degrades and is removed from the fallopian tube by the body's immune system.

  Oviductal disease often manifests as obstruction or thickening of the fallopian wall and can be caused by infection, as well as scarring. In particular, pelvic inflammatory disease (PID), urinary tract infections (UTI), as well as sexually transmitted infections (STI) can cause severe inflammation that subsequently blocks the fallopian tube. Endometriosis can also cause obstruction as the endometrium grows and becomes the fallopian tube. Additionally, appendectomy or other abdominal surgery may lead to obstruction of the fallopian tube as well.

  Occlusion can lead to hydroovial edema, which causes the oviduct to increase in diameter as the oviduct is filled with fluid regardless of the manner in which it is formed. The presence of fluid prevents both ova and sperm from migrating through the fallopian tube and prevents fertilization. Fallopian tube hydromas are believed to have the potential to reduce the success rate of in vitro fertilization to 8%.

  In the United States alone, there are at least 7 million cases of infertility each year, and an estimated 25-40% of these cases are caused by fallopian tube obstruction or disease.

  Uterine oviductogram (HSG), the most commonly used procedure for diagnosing oviduct disease, requires a radiologist to inject dye into the uterus under x-ray guidance. The dye enters the fallopian tube through a small hole (opening) located in the uterus. If the female fallopian tube is spread (opened), the dye will flow into the peritoneal cavity. A series of timed x-rays are taken to visualize the flow path.

  Unfortunately, this procedure has several drawbacks. As an example, HSG has a high false negative rate of 30% and a high false positive rate of 40% due to fallopian tube spasms or shadows (noise) in x-rays. This often requires additional steps. This high rate of inaccuracies is partly due to the fact that radiologists are not as accustomed to the twist and shape of the fallopian tube as gynecologists or infertility specialists.

  As another example of a shortcoming, HSG is a gynecologist or infertility specialist who is the patient's primary caregiver, as it requires substantial investment in the x-ray capital facilities that are mostly found in hospitals. Does not take place in the clinic. Patients typically visit a gynecologist, who typically conducts a series of blood tests to determine if HSG is needed. If it is deemed necessary, the patient will make an appointment with the radiologist to undergo the HSG procedure. At the end of the first procedure, the patient returns to either the gynecologist or the fertility specialist to discuss the results. Due to the high inaccuracy rate associated with HSG, the patient often returns to the radiologist for the second procedure, creating additional unnecessary costs for both the patient and the hospital.

  As yet another example, patients often complain of pain, and some patients are allergic to the dyes used during the procedure. Furthermore, HSG has to be done before the 12th day of the women's menstrual cycle, as the dye may damage potential term pregnancy, which limits options for both physicians and patients, and Further prolonging the waiting period for adequate infertility diagnosis, which places a mental burden on patients and their families.

  Different direct visualization techniques have been tried to overcome these drawbacks. FIG. 1 shows an endoscope using conventional fiber optic imaging techniques in an attempt to achieve direct visualization of the fallopian tube as an example. In this figure, the female reproductive anatomy 10 undergoing imaging includes the fallopian tube 12, the ovary 14, the uterine cavity 22, the neck 28, and the pili 30. An imaging catheter shaft 20 is introduced into the oviduct having the wet paper towel stiffness. The catheter shaft 20 passes through the fallopian tube in the uterus 18, beyond which point the fallopian tube 12 narrows and twists.

  Unfortunately, the stiffness of the wet paper towel does not provide adequate tactile feedback to the physician navigating the catheter 20 through the fallopian tube 12. As a result, during the imaging procedure, the physician is unaware of the excessive pressure acting on the fallopian tube, leading to the perforation 24. To this end, FIG. 1 shows a portion of the catheter 26 projecting from the perforation 24 in the fallopian tube 12. Perforation of the fallopian tube may prevent an egg from the patient's ovaries 14 from reaching the uterus 16 for fertilization, making it an unacceptable clinical adverse event in patients actively trying to become pregnant. In addition to risking perforating the fallopian tube, the above-described imaging procedure involves several steps and is therefore viewed by the physician as being complicated and difficult to perform accurately. Furthermore, the firmness of the wetted paper towel of the fallopian tube prevents the attempted imaging procedure from obtaining a sharp focused image. Specifically, during imaging, the stiffness of the wet paper towel "turns back" the wall of the fallopian tube onto the end of the endoscope to focus and take a clear image of the endoscope It makes it difficult to maintain a sufficient distance between the tip and the wall of the fallopian tube.

  Therefore, what is needed is a new diagnostic and therapeutic system and method that enables effective preservation of narrow body lumens without the drawbacks faced by the current and attempted systems and methods described above. .

  According to one aspect of the invention, an apparatus for use in a narrow body lumen includes an outer shaft portion, a tube receivable within the outer shaft portion, and first and second ends, the first The elongated expandable body sealed at its end to the outer shaft portion and at its second end to the tube, and in the initial configuration the elongated expandable body is received on the outer shaft portion, The tube is slidable relative to the outer shaft portion such that the elongated expandable body is everted as it moves out of the outer shaft portion.

  In at least one embodiment, the device is pressurizable and pressurization of the device causes the expandable body to expand.

  In at least one embodiment, pressurization of the device assists in reversing the elongated expandable body exiting the outer shaft portion.

  In at least one embodiment, the tube is slidable to selectively ablate the expandable body to a partial or full abduction state.

  In at least one embodiment, the tube is a rigid tube, and the apparatus further comprises a flexible tube extending from the distal end of the rigid tube.

  In at least one embodiment, upon sliding of the rigid tube for everting the expandable body, the flexible tube slides within the expandable body.

  In at least one embodiment, the device further comprises a visualization device acceptable within the tube.

  In at least one embodiment, the visualization device is slidable relative to the tube.

  In at least one embodiment, the visualization device is slidable such that the distal end of the visualization device extends distally of the expandable member when in the full abduction configuration.

  In at least one embodiment, the device further comprises a pressurized liquid passing between the tube and the visualization device.

  In at least one embodiment, the pressurized liquid comprises a therapeutic formulation.

  In at least one embodiment, the pressurized liquid is configured to expand the narrow body lumen to facilitate sliding of the visualization device thereon.

  In at least one embodiment, the device further includes a tether interconnecting the flexible tube and the expandable body.

  In at least one embodiment, the device further includes a handle portion that receives one or more luers, one of which is designed to provide pressure to pressurize the device.

  In at least one embodiment, the device further includes a wire luer, which is received by the handle portion and carries wires for carrying power and signals to facilitate the imaging function performed by the imaging portion. Designed to provide.

  In at least one embodiment, the expandable body includes a length extending beyond the oviductal junction and out of the foramen of the fallopian when fully abducted.

  In at least one embodiment, the visualization tool comprises a fiberscope.

  In at least one embodiment, the apparatus further comprises a pressure sensor, the pressure sensor measuring the pressure being applied to the narrow body lumen, and the measurement of pressure being at a predetermined value of pressure It is designed to trigger an alarm signal if it equals or exceeds.

  In another aspect of the present invention, a method of operating on a narrow body lumen comprises pressurizing the device and an initial configuration in which the expandable body extends partially out of the distal end of the outer shaft portion of the device. Configuring, inserting the partially extending expandable body into the narrow body lumen, and the expandable body being fully deployed out of the distal end of the outer shaft portion and of the narrow body lumen Completely abducting the expandable body to extend deeper further into the body, delivering at least one of the visualization device and the treatment distally through the opening in the expandable body and into the narrow body lumen And the step of

  In at least one embodiment, the narrow body lumen is a fallopian tube, and inserting includes inserting the partially extending expandable body into the foramen of the fallopian tube.

  In at least one embodiment, completely abducting comprises abducting the expandable body such that it extends past the oviductal junction.

  In at least one embodiment, at the time of delivery of the visualization device, the distal end of the visualization device is at least one of the advancement and retraction of the visualization device to visualize one or more target areas within the narrow body lumen. Moved according to

  In at least one embodiment, the treatment is delivered while the visualization device extends through the opening in the expandable body.

  In at least one embodiment, the treatment is delivered through an opening in the expandable body without a visualization device extending therethrough.

  In at least one embodiment, the method further includes retracting the expandable body back into the outer shaft portion.

  In at least one embodiment, the expandable body is attached through the tether to the tube received in the outer shaft portion, and retraction of the tube relative to the outer shaft portion with the assistance of the tether inserts the expandable body into the outer shaft portion Retract back to go back.

  In at least one embodiment, the method further includes retracting the visualization device back into the outer shaft portion and retracting the expandable body back into the outer shaft portion.

  These and other features of the present invention will become apparent to those persons skilled in the art upon reading the details of the devices, methods and systems as more fully described below.

  The following detailed description will refer to the accompanying drawings. These figures show different aspects of the invention, and where appropriate, reference numerals indicating similar structures, components, materials and / or elements in different figures are likewise labeled. It is understood that various combinations of structures, components, materials, and / or elements other than those specifically illustrated are contemplated and are within the scope of the present invention.

FIG. 1 shows an endoscope being navigated through the fallopian tube and major organs of the female reproductive system by existing methods. FIG. 1 is a side cross-sectional view of a diagnostic device according to an embodiment of the invention in an inactive state. FIG. 3 is an enlarged view of the distal tip of the shaft portion of the diagnostic device shown in FIG. 2; FIG. 7 is a side cross-sectional view of the distal tip of the shaft portion of a diagnostic device according to one embodiment of the present invention. 5 is a side cross-sectional view of a shaft portion according to another embodiment of the present invention in the actuated state of the diagnostic device of FIG. 2; FIG. 5 is a perspective view of two different oval distal tips usable in a guidewire based diagnostic imaging device or in a guidewire lumen based therapeutic intervention device according to embodiments of the present invention. FIG. 4B is a top view of the distal tip shown in FIG. 4A. FIG. 7 is a perspective view of a conical distal tip that may be used with a guidewire based diagnostic imaging device or with a guidewire lumen based medical intervention device according to embodiments of the present invention. FIG. 5B is a top view of the distal tip shown in FIG. 5A. FIG. 5 is a side view of a non-distending conical distal tip usable with a non-guidewire based diagnostic imaging device or with a non-guidewire lumen based therapeutic intervention device according to embodiments of the present invention. FIG. 6B is a side view of the conical distal tip of FIG. 6A in its expanded state. FIG. 6 is a side view of a non-distending oval-shaped distal tip usable in a non-guidewire based diagnostic imaging device or in a non-guidewire lumen based therapeutic intervention device according to embodiments of the present invention. FIG. 7B is a side view of the oval distal tip of FIG. 7A in its expanded state. FIG. 6 is a side view of a non-distending dome shaped distal tip that may be used with a non-guidewire based diagnostic imaging device or with a non-guidewire lumen based therapeutic intervention device according to embodiments of the present invention. FIG. 8B is a side view of the dome shaped distal tip of FIG. 8A in its expanded state. FIG. 8C shows certain major components in a distal tip as shown in FIG. 8B according to one embodiment of the present invention. FIG. 6 is a process flow diagram according to an embodiment of the invention using a hydraulic propulsion mechanism for diagnostic imaging. FIG. 5 is a process flow diagram according to an embodiment of the present invention using a guidewire mechanism for diagnostic imaging. FIG. 7 shows a distal end portion of a device according to another embodiment of the present invention. FIG. 11B shows the device of FIG. 11A in an initial deployment configuration. FIG. 11C shows the device of FIG. 11A with the expandable body fully deployed. FIG. 11C shows the device of FIG. 11A with the expandable body fully deployed and the visualization device extending distally of the expandable body. FIG. 11B is an additional view of the device of FIG. 11A. FIG. 11B is an additional view of the device of FIG. 11A. FIG. 12B shows the device of FIG. 12A in an initial deployment configuration. FIG. 12B shows the device of FIG. 12A with the expandable body fully deployed. FIG. 12B shows the device of FIG. 12A with the expandable body fully deployed and the visualization device extending distally of the expandable body. FIG. 7 shows events that can be performed in a method of using an apparatus according to an embodiment of the present invention. FIG. 7 shows events that can be performed in a method of using an apparatus according to another embodiment of the present invention.

  Before describing the apparatus, methods, and systems of the present invention, it should be understood that the present invention is not limited to the particular embodiments described, and of course can be modified. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

  It is understood that, when providing a range of values, each intervening value to the lower tenth unit is also specifically disclosed between the upper and lower limits of the range, unless indicated otherwise. Ru. Each smaller range between any standard value or intervening value within a standard range and any other standard or intervening value within that standard range is included within the invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range, and any ranges that do not include any, or both limits are included in the smaller ranges are also standard ranges Are also included within the invention according to any specifically excluded limit. Where the standard range includes one or both of the limits, ranges excluding either or both of those including the limits are also included in the invention.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, preferred methods and materials are described herein. All documents described herein are incorporated herein by reference to disclose and describe the present methods and / or materials in which the documents are cited.

  As used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. It must be noted that. Thus, for example, a reference to "a tube" includes a plurality of such tubes, a reference to "the lumen" refers to one or more lumens and their equivalents known to those skilled in the art Including references etc.

  The documents discussed herein are provided solely for their disclosure prior to the filing date of the present application. The dates of the documents provided may be different from the actual publication dates, which may need to be independently confirmed.

  In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that the present invention may be practiced without limitation to some or all of these specific details. In other instances, well known method steps have not been described in detail in order not to unnecessarily obscure the present invention.

  In certain embodiments, the present invention provides a new system and method for accurate real-time visualization that dynamically diagnoses oviduct dysfunction.

  As part of the system, in at least some embodiments, the provision of single use, disposable products, and procedures associated therewith overcome many of the shortcomings faced by current and attempted diagnostic approaches. The more accurate dynamic procedure of the present invention is typically the first and main point of contact for infertile patients, understanding the anatomy in question and requiring further clarification. It can be done at the office of a gynecologist or fertility specialist who is better trained to change or repeat the steps dynamically in the procedure. As a result, the number of office visits and costs to both the patient and the hospital is significantly reduced while at the same time the benefits of the patients involved are significantly increased. Furthermore, the high false positive rates of 20% to 40% encountered by conventional diagnostic systems and procedures can also be reduced by the ability of the present invention to directly visualize the fallopian tube.

  The preferred embodiment of the present invention recognizes that it may depend to some extent on conventional diagnostic procedures to carry out certain initial steps of the inventive procedure. As an example, certain inventive procedures require visualization of the opening (small hole) of the fallopian tube in the uterus such that the fallopian tube is accessible. While those skilled in the art have primarily used conventional hysteroscopy to assess and maintain uterine health, minimally invasive infertility procedures such as Essure and Adiana (while the oviduct is intentionally blocked) With recent advances in dissemination, numerous (eg, up to 7,500 Essure alone) gynecologists and infertility specialists introduce hysteroscopes, visualize the fallopian tube, and access vaginally Will recognize. The invention proposes to use the working channel of the hysteroscope in certain embodiments of the invention. With a gynecologist or fertility specialist having or renting a hysteroscope (and associated capital equipment), they have no restrictions as to what procedure they can perform using their hysteroscope So it is free to use the inventive procedure of the invention using the hysteroscopic actuation channel. It is worth mentioning that the working channel of any catheter that can visualize and gain access to the foramen of the fallopian tube in utero can be utilized according to the present invention.

  According to one embodiment, the present invention provides a hydraulic propulsion device that accesses the ostium of the fallopian tube using the actuating channel of the hysteroscope. For this purpose, FIG. 2 shows a hydraulic propulsion device 100 having a handle portion 102, a shaft portion 104 and a seal producing portion 106. As shown in FIG. 2A, which shows an enlarged view of the tip of the hydraulic propulsion device 100, the device 100 includes an imaging subassembly 108 and a capsule 110.

  Referring back to FIG. 2, the handle portion 102 may be equipped with a hydraulic pusher port 112 designed to receive hydraulic push (eg, saline solution) from a hydraulic pusher reservoir such as a syringe. The hydraulic pusher port 112 is preferably communicatively coupled to a hydraulic lumen (not shown to simplify the drawing) which extends through the shaft portion 104 to a location near the imaging subassembly 108 from the handle portion 102 Be done.

  Similarly, an electrical wire 118 is communicatively coupled to the imaging subassembly 108 from the handle portion 102 through the shaft portion 104. Electrical wire 118 enters the handle portion at electrical access port 114 that connects to the wire lumen. An electrical wire 118 is disposed inside the wire lumen that also extends through the shaft portion 104 from the handle portion 102 to a location near the imaging subassembly 108.

  The seal producing portion 116 of FIG. 2 facilitates the step of producing a seal in the foramen 18 of the fallopian tube 12 (see FIG. 1) or within the proximal region of the fallopian tube. These anatomy are shown in FIG. In particular, the seal producing portion 116 of FIG. 2 is communicatively coupled to a seal producing lumen that carries the material necessary to produce a seal for the seal producing portion 106. In a preferred embodiment, the seal producing portion 106 of the present invention is an inflatable body and the seal producing port 116 is an inflatable port. In these embodiments, the seal-producing lumen is configured to carry air or other gas that inflates the expandable body, and the seal-producing lumen may be referred to as an "inflation lumen".

  In addition to one or more of the ports and lumens described above, the handle portion 102 preferably includes a housing 120 for holding the coiled wire 118 'in place, as shown in FIG. And wire recovery mechanism 122 for recovering the hydraulic propulsion wire in the activated state of device 200). Not all features of the housing 120 are shown to simplify the drawing, and those skilled in the art will recognize that the wire recovery mechanism 122, in the preferred embodiment of the present invention, is a reel for throwing and recovering the fishing line. It will be recognized that it is similar to a fishing rod with a mechanism. In this embodiment, the retrieval mechanism 122 includes the flexible wire 118 and a reel capable of unwinding the flexible wire from the propelled state. During operation of the apparatus 100, the imaging subassembly 108 is preferably withdrawn from the propulsive state back into the handle portion 102 when the reel is activated.

  In another embodiment of the present invention, the retrieval mechanism 122 includes an electronically actuated reel that electronically initiates the recovery of the reel from the reel's propelled state. In this embodiment, the device of the present invention provides an electrically actuated reel mechanism such that the electrically actuated reel mechanism stops collecting the imaging subassembly 108 if the pressure exceeds a predetermined value of pressure. It includes a pressure sensor for transmitting pressure measurements. The pressure sensor can be designed to sense the pressure acting on the imaging subassembly 108 as it is withdrawn from the narrow body lumen.

  As part of the shaft portion 104, a seal-producing portion 106 (eg, an expandable body) is positioned outside of and distal to the handle portion 102. In this embodiment and when the device 100 is in operation, the imaging portion 108 forms a seal with the inside diameter of the hydraulically driven lumen, as shown in FIG. 2A. This seal allows hydraulic propulsion of the imaging portion 108, as described later in connection with FIG. In another embodiment of the present invention, the device 100 includes a locking mechanism that locks the imaging portion 108 within the inner diameter of the hydraulic propulsion lumen until the required pressure is achieved to allow hydraulic propulsion.

  The imaging subassembly 108 preferably includes an image sensor and a light source. The image sensor can be any object that can sense an image. In a preferred embodiment of the invention, the image sensor comprises at least one member selected from the group consisting of charge coupled devices (CCDs), complementary metal oxide semiconductors (CMOS), and optical fibers. The light source comprises a fiber optic light source or a light emitting diode (LED).

  In certain embodiments of the present invention, the expandable object is positioned such that the imaging sensor is spaced approximately near or at a focal distance away from the narrow body lumen when the expandable body is expanded. An image sensor and a light source are included to enable focus imaging of the body lumen. In this embodiment, the focal length is associated with the imaging sensor. Where the image sensor is a camera, the focal length described herein is that of the camera.

  As shown clearly in FIG. 2A, capsule 110 protects a portion of imaging subassembly 108. In one embodiment of the present invention, the capsule 110 is lubricated to facilitate hydraulic propulsion or recovery of the capsule through a narrow body lumen.

  The capsule 110 preferably encloses a wireless transmitter for wireless transmission of the image captured by the imaging sensor of the imaging subassembly 108. In certain embodiments, the capsule 110 of the present invention encloses a pressure sensor, which senses the amount of pressure being applied to a narrow body lumen, to block an occlusion in the narrow body lumen. Determine the existence.

  The capsule 110 is substantially round, thus avoiding the occurrence of tissue trauma that is a drawback of the previously attempted diameter visualization device. Furthermore, the capsule 110 centers the imaging portion 108 therein. The positioning of the imaging portion 108 within the capsule 110 overcomes the drawback of the fallopian tube covering the distal end of the catheter and prevents an insufficient focal length and thus an obscured image being taken.

  In one embodiment of the present invention, capsule 110 is designed to enclose the expandable body to enhance the buoyancy of the portion of imaging subassembly 108 deployed inside the narrow body lumen during hydraulic propulsion. In such embodiments, the capsule 110 of the present invention facilitates hydraulic propulsion of the propulsive imaging portion as the expandable body more easily carries the capsule by hydraulic propulsion.

  In certain embodiments of the present invention, the capsule 110 encloses a micro-generator that provides power for a light source or imaging sensor using hydraulic propulsion. In this embodiment, the micro-generator of the present invention converts hydraulic energy into electrical energy. This electrical energy is then used to power the imaging portion 108 of the device. In another embodiment of the invention, capsule 110 facilitates imaging by transmitting imaging signals from within the capsule to the outside of capsule 110 and to an imaging sensor positioned distal to handle portion 102. Encapsulate the fiber.

  FIG. 2B shows the tip of an apparatus 100 according to an alternative embodiment of the present invention in which an optical fiber 111 is used to image. In this embodiment, the optical fiber 111 conveys the captured image signal to an image sensor positioned outside and relative to the shaft 104 of the device 100 during operation of the device 100. As a standard inventory, the optical fiber may be found to have an outer diameter of less than 5 mm, and the diameter of the capsule 110 in this embodiment can be reduced as it does not contain a sensor. As a result, the tip of this embodiment is more easily navigated through the narrow and tortuous path of the fallopian tube, and the use of optical fiber 111 represents an alternative embodiment of the present invention.

  FIG. 3 shows a portion of a device 200 (which is an actuated state of the device 100) according to an embodiment of the present invention. Apparatus 200 includes flexible wire 218, fallopian tube access device 228, shaft portion 204, seal generation portion 206, imaging subassembly 208, and capsule 210. Wires 218, shaft portion 204, seal producing portion 206, imaging subassembly 208, and capsule 210, except that device 200 indicates that imaging subassembly 208 and capsule 210 are hydraulically propelled during operation of device 200. Are substantially similar to their counterparts shown in FIG. 1 (ie, wire 118, shaft portion 104, seal producing portion 106, imaging subassembly 108, and capsule 110). In one preferred embodiment of the present invention, the apparatus 200 includes a sail surrounding the imaging subassembly 208 such that when the imaging subassembly is hydraulically propelled, the sail expands to enhance the hydraulic propulsion of the imaging subassembly.

  While hydraulic propulsion is described as propelling the imaging subassembly 108, imaging optical fiber 111, or capsule 110 with reference to FIGS. 2, 2A, 2B, and 3, other preferred embodiments of the present invention are narrow. We are considering water pressure propulsion treatment to the body lumen. In this embodiment, there is no imaging subassembly 108, imaging optical fiber 111, or capsule 110, and the electrical access port 114 is replaced by a treatment port. Additionally, the treatment port is communicatively coupled to the treatment lumen replacing the wire lumen. Effective treatments contemplated by the present invention are detailed below. In another embodiment of the present invention, the electrical and therapeutic ports allow direct visualization when the treatments are being co-administered.

  In order to substantially preserve the fallopian tube, the present invention also provides a non-hydraulic propelled imaging or therapeutic device. In certain embodiments of the invention, a guidewire and / or a catheter positioned over the guidewire facilitate imaging or treatment. In another embodiment, the guidewire lumen of the present invention facilitates therapeutic intervention.

  FIG. 4A is shown as part of a single distal tip 326 that can be designed to function either as a guidewire based diagnostic imaging device or as a guidewire lumen based medical intervention device. Fig. 2 shows two different oval protective shields according to certain embodiments. FIG. 4B is a top view of the same distal tip 326 'as the distal tip 326 but in a different orientation. Although two different protective shields, namely the first protective shield 330 and the second protective shield 330 ', are shown in FIG. 4A as being part of a single distal tip 326, one of ordinary skill in the art would It will be appreciated that one protective shield is required in this embodiment of the invention.

  As shown in FIG. 4A, the distal tip 326 of the catheter of the present invention includes a shaft 304, one or more light sources 332, an imaging portion 308, and a guide wire 334. Guidewire 334 guides the catheter of the present invention, for example, during an imaging procedure inside the fallopian tube.

  However, according to embodiments of the present invention, guidewire 334 may preferably be designed to provide light or to sense an image. For this purpose, the guide wire 334 can contain an illumination fiber or an imaging fiber. Where the catheter of the present invention contains an illumination fiber, the associated guidewire which guides the catheter during operation can include an imaging fiber. Alternatively, where the catheter of the present invention contains an imaging fiber, the associated guidewire 334 can include an illumination fiber. According to the invention, in this way, structures for performing illumination and imaging functions can be distributed between the catheter and the guide wire associated therewith. Separating the light source from the image sensor allows the device user to control the amount and angle of light needed to capture a sharper image (similar to a professional photographer with an external flash) .

  In certain embodiments of the present invention, guidewire 334 includes an optical fiber for providing light to facilitate imaging and can be made of an optical fiber. According to one embodiment of the present invention, during operation of the device having the distal tip 326, the guide wire 334 is such that the light is delivered from a location outside the fallopicus to a location inside the fallopian tube Extend from an outside location to another location inside the fallopian tube. Leaving the light source outside the fallopian tube will reduce the heat exposure to the fallopian tube.

  In at least some embodiments of the catheter of the present invention, the guidewire 334 includes a plurality of substantially transparent portions along the length of the guidewire. Each of the plurality of substantially transparent portions allow light to pass through. During operation of the catheter, each of the substantially transparent portions illuminates a plurality of different locations along the length of the fallopian tube adjacent to the substantially transparent portion. In this embodiment, a light emitting diode (LED) can be positioned at or around the tip of the guidewire such that incident light emanating from the LED exits the substantially transparent portion to illuminate the tissue.

  The catheter of the present invention may further include an image sensor positioned at the proximal end of the catheter shaft (e.g., 104 in FIG. 2) or inside the handle portion of the catheter (e.g., 102 in FIG. 2). In these configurations of the catheter of the present invention, the imaging fiber described above allows the imaging fiber to facilitate imaging by transmitting imaging signals from the distal end of the catheter to the imaging sensor during operation of the catheter. , Extends along the length of the catheter shaft. Keeping the sensor outside the catheter reduces the outer diameter of the catheter, thus allowing the physician to easily navigate the fallopian tube, reducing the possibility of tissue trauma.

  In an alternative embodiment of the invention, the catheter can further include an image sensor for sensing an image. In this embodiment, the image sensor is positioned outside the fallopian tube by an imaging fiber or electrical wire, wherein the image of the fallopian tube sensed by the imaging sensor during operation of the catheter extends along the length of the catheter shaft It is positioned at the distal end of the catheter shaft so as to be transported to the display unit. While this configuration may increase the outer diameter of the catheter, it provides a sharper image as the sensor is positioned closer to the image being taken.

  The protective shield 330 or 330 'of FIG. 4A preferably protects the image sensor and / or the imaging fiber during the operating state of the device, so as to obtain substantially focused imaging. It further provides an adjacent focal length (related to the image sensor) between the and the fallopian tube. The protective shield 330 or 330 'of the present invention overcomes the drawback that the fallopian tube covers the tip of the catheter, which makes it more difficult to capture sharper images.

  In other embodiments, the catheters of the present invention may have a catheter shaft as far away as the substantially transparent protective shield (eg, protective shield 330 or 330 'of FIG. 4A) protects the imaging sensor and / or the imaging fiber. A light source (e.g., light source 332 shown in FIG. 4A) positioned at the proximal end may be included, with the light source being located outside the protective shield as shown in FIG. 4A. This embodiment prevents distorting the illumination of the fallopian tube by the presence of a substantially transparent protective shield.

  The present invention recognizes that, during imaging operation, the tubal tissue may fold over the light source and shut off the illumination, thereby preventing proper illumination of the target location. In an alternative embodiment, the catheter of the present invention can include a light source protected by a substantially transparent protective shield. In this embodiment, the presence of the protective shield prevents the fallopian tissue from folding over and blocking the light source.

  In order to reduce the risk of piercing the fallopian tube during imaging operations as encountered in certain imaging trials discussed above, the catheter of the present invention can include a pressure sensor. In one implementation of this embodiment, the pressure sensor is positioned at the distal end of the guidewire and / or the catheter. During imaging operation, the pressure sensor can measure the value of pressure exerted by the guidewire and / or the catheter on the fallopian tube. The pressure sensor can be communicatively coupled to a processor that provides an alarm signal during an imaging operation. When the value of the pressure exerted by the guide wire and / or the catheter inside the fallopian tube during imaging operation is equal to or exceeds a predetermined unacceptable value of the pressure, the processor is configured to: Provide an alarm signal to (eg, activate a red warning light on the handle).

  The catheter of the present invention can further include a guidewire lumen defining a channel therein for a guidewire (eg, guidewire 334 in FIG. 4A). During operation of the catheter and when there is no guidewire inside the guidewire lumen (when the imaging operation is finished), the channel inside the guidewire lumen can carry the treatment to the fallopian tube.

  The treatment comprises at least one member selected from the group consisting of an anti-inflammatory agent, a bioabsorbable stent, and a drug-coated expandable body. In certain embodiments of the present invention, the liquid anti-inflammatory agent is locally applied to the affected area. Inflammation (also caused by infection) is thought to lead to the main cause of tubal obstruction.

  In those embodiments of the invention where the treatment comprises a bioabsorbable stent, the stent can provide both mechanical support and drug to the fallopian tube, which treats the local disease and the occlusion recurs To prevent Optionally, the stent can be bioabsorbable. In such embodiments, after the stent has been absorbed by the body and the disease has been treated, eggs can pass uninterruptedly from the ovary to the uterus through the fallopian tube.

  The debris found in the fallopian tube is caused by the force acting on the balloon to expand when the expandable body (such as a balloon) is expanded during operation of the catheter in relation to the drug coated expandable body. It can be removed. Additionally, the expandable body can be positioned within the partial closure. In this case, the expansion force will function to apply sufficient mechanical force to the occlusion to clear the occlusion.

  In addition, drug coatings (eg, anti-inflammatory agents) on the expandable body prevent the recurrence of these occlusions for an adequate time to allow conception. On the other hand, drug coated balloons used to treat coronary artery disease face the challenge of continuous blood flow, which ultimately removes the drug from the artery. As a result, the patient only sees the benefit of the treatment temporarily, and the treatment of coronary artery disease needs to last for the life of the patient. In contrast, the fallopian tube is essentially not filled with fluid. Thus, the drug will last longer at the lesion site of the fallopian tube. Furthermore, the effect of the drug only needs to last as long as it takes for the patient to become pregnant (on average 0-12 months). These occlusions do not cause any pain or discomfort to the patient when the drug dissipates and the occlusion occurs at some point after conception.

  FIG. 5A shows a conical distal tip 426 according to one embodiment of the present invention. The conical distal tip 426 is preferably part of a guidewire based diagnostic imaging device or a guidewire lumen based therapeutic interventional device.

  Regardless of the manner in which the distal tip 426 is implemented, it includes the shaft portion 404, one or more light sources 432 (labeled in FIG. 5B), an imaging portion 408, a protective shield 430, and a guide wire 434, 4A (ie, shaft portion 304), except that FIG. 5A shows a conical distal tip and provides the imaging sensor with a different focal length than that provided by the oval distal tip of FIG. 4A. , Substantially identical to their counterparts shown in one or more light sources 332, imaging portion 308, protective shield 330, and guide wire 334), the protective shield 430 includes an entry opening 436 and an exit opening 438. It is determined there. During imaging operation, a guidewire 434 positioned outside of the protective shield 430 can enter through the entry opening 436 and exit through the exit opening 438. In other words, the openings 436 and 438 allow the guide wire 434 to pass through the protective shield 430 to access a location in the fallopian tube distal to the protective shield 430. This will allow the physician to push away from the wall of the fallopian tube using a guide wire if additional distance is needed to capture a sharper image.

  Furthermore, the conical shape is believed to introduce smaller tissue trauma than the oval protective shield. FIG. 5B is a top view of a distal tip 426 'that is the same as the distal tip 426 shown in FIG. 5A except that the distal tip 426' has a different orientation than the distal tip 426.

  At least some of the embodiments of the present invention also provide a non-guidewire based diagnostic imaging device or a non-guidewire lumen based therapeutic interventional device. A non-guidewire based diagnostic imaging device includes a sensing lumen, a solution lumen, and optionally a treatment lumen. Next, the sensing lumen includes a sensing portion and an inflatable portion. The sensing portion can sense information regarding the fallopian tube (eg, imaging information).

  The solution lumen is designed to provide a solution that facilitates the sensing performed by the sensing portion. The solution is also designed to flush the fallopian tubes, removing residual blood and mucus from it that would otherwise obscure the image. Furthermore, the presence of the solution facilitates dilation of the fallopian tube, thereby reducing the chance of causing perforation. Finally, therapeutic solutions used in therapeutic devices are discussed in more detail above.

  During the operating state of the non-guidewire based diagnostic device, in the presence of the solution, the sensing part senses information about the oviduct, including but not limited to the sterile implant and the pressure of the naturally occurring occlusion. The expandable portion expands to create space around the sensing portion. This space takes a sharper image (e.g., a sharper image is present when the sensing portion is a standard optical camera or a scatter optical system) as there is a sufficient focal distance between the sensing portion and the fallopian wall Enables to facilitate the capture of However, when the sensing portion is comprised of an acoustic imaging system, the expandable portion creates a seal so that the oviduct can be filled with a liquid medium through which sound waves can propagate.

  The sensing portion can include at least one member selected from the group consisting of a light source, a camera, an acoustic imaging system, and a scattered light imaging system. Certain current techniques used for cardiovascular imaging (eg, intravascular ultrasound ("IVUS") and optical coherence tomography ("OCT")) utilize light scattering and acoustic imaging techniques, but Because of their stiffness, they themselves are not useful for imaging the fallopian tube. Furthermore, current cardiovascular IVUS catheters can not produce a seal that facilitates imaging of an essentially liquid-free structure because the absence of a medium prevents sound waves from advancing. Since the fallopian tube is not filled with liquid, the seal needs to be generated before imaging using sound waves can take place, and the fallopian tube needs to be filled with a liquid medium such as saline That deserves attention. Furthermore, these catheters have relatively large dimensions which make it difficult to access the full length of the narrow and tortuous oviduct.

  To this end, the invention proposes that IVUS and OCT catheter designs can be modified in a manner consistent with different related inventive catheters. The inventive catheters described herein are not limited to IVUS and OCT applications, as well as other optical imaging techniques (eg, imaging performed by complementary metal oxide semiconductor ("CMOS") or optical fibers) Works well. According to a preferred embodiment, the catheter of the present invention comprises a unique intact tip and / or an expandable body, as described below.

  The imaging information collected by the imaging portion 508 (FIG. 6A) relates to naturally occurring occlusions, inflammations, hydroovial edema, sterile implants operatively placed with the fallopian tube, and fallopian tube such as fallopian tube disease Provide information. This information is particularly valuable for diagnosing fallopian tube disease and allows for disease specific therapeutic intervention as needed.

  FIG. 6A shows a non-guidewire based diagnostic device in which the sensing portion senses image information about the fallopian tube, allowing the physician to diagnose the disease. In particular, FIG. 6A shows a non-distending conical distal tip according to an embodiment of the present invention preferably used in a non-guidewire based diagnostic imaging device or in a non-guidewire lumen based therapeutic intervention device It is a side view of 526. FIG. The distal tip 526 includes an imaging portion 508, an expandable portion 506, and a shaft portion 504. Imaging portion 508 and shaft portion 504 are substantially similar to their counterparts of FIG. 5A (ie, imaging portion 408 and shaft portion 404), except that shaft portion 404 of FIG. 5A contains guidewire 434. There is.

  According to at least one embodiment, the distal tip of the present invention is positioned at the distal end of the catheter and is designed to measure the value of the pressure exerted by the catheter during operation of the device. Including. The features of the above-described pressure sensor that alert the user with excessive pressure above need can also be incorporated into this embodiment.

  FIG. 6B is a side view of the conical distal tip of FIG. 6A in its expanded state. The expandable portion 506, in its expanded state (i.e., the expanded portion 506 'of FIG. 6B), has an intact shape which is one shape selected from the group consisting of conical, oval and dome-shaped.

  FIG. 7A is a side view of another non-expanding oval distal tip 626 according to an embodiment of the present invention preferably used in a non-guidewire based diagnostic imaging device or also in a non-guidewire lumen based therapeutic intervention device It is. The distal tip 626 is substantially similar to the distal tip 526 of FIG. 6A except that the expandable portion 606 of FIG. 7A has a different shape than the expandable portion 506 of FIG. 6A (ie, the imaging portion 608 and shaft portion 604 are substantially similar to imaging portion 508 and shaft portion 504 of FIG. 6A). The difference in shape between the expandable portions 506 and 606 is apparent in their respective expandable states and can correspond to different focal lengths and different amounts of tissue trauma. FIG. 7B is a side view of the oval distal tip 626 'of the distal tip 626 of FIG. 7A in an expanded state.

  FIG. 8A is a side view of a non-inflated domed distal tip 726 according to an embodiment of the present invention preferably used in a non-guidewire based diagnostic imaging device or in a non-guidewire lumen based therapeutic interventional device . The distal tip 726 is substantially similar to the distal tip 526 of FIG. 6A except that the expandable portion 706 of FIG. 8A has a different shape than the expandable portion 506 of FIG. 6A (ie, the imaging portion 708 and shaft portion 704 are substantially similar to imaging portion 508 and shaft portion 504 of FIG. 6A). As with the differences between the expandable portions 506 and 606, the differences in shape between the shaft portions 506, 606 and 706 are apparent in their respective expandable states. FIG. 8B is a side view of the oval distal tip 726 'in an expanded state of the distal tip 726 of FIG. 7A.

  FIG. 8C shows certain major components according to an embodiment of the present invention with an expanded distal tip 826 substantially similar to the expanded distal tip 726 'of FIG. 8B. FIG. 8C shows the more detailed structure preferably contained within the expandable portion 806. FIG. In accordance with FIG. 8C, the expandable portion 806 includes an expandable component 806A and a non-expandable component 806B. During the operative state of the device, the expandable component 806A expands but the non-expandable component 806B does not expand and functions to provide mechanical support to the expandable portion 806.

  FIG. 9 shows a process flow diagram 900 according to an embodiment of the invention that uses a hydraulic propulsion mechanism for diagnostic imaging. Preferably, the process 900 begins at step 902 with the establishment of a channel in the area proximal to the narrow body lumen or proximal area of the narrow body lumen from the outside of the narrow body lumen. As an example, a hysteroscope is used to visualize and access the foramen of the fallopian tube in the uterus. In this case, the hysteroscopic working channel establishes a channel of stage 902 from the outside of the fallopian tube in the uterus to the foramen of the fallopian tube.

  Next, step 904 of FIG. 9 includes disposing an imaging device or treatment device through the channel. Following the above example of the hysteroscope, step 904 is until the distal end of the shaft portion 104 is slightly distal to the distal end of the actuating channel of the hysteroscope, or the distal end of the shaft portion 104 This is carried out by introducing the shaft portion 104 of the device 100 of FIG. 2 through the working channel of the hysteroscope until it is positioned in the adjacent region of the fallopian tube.

  In this configuration, step 906 of FIG. 9 is performed. Step 906 seals the narrow body lumen or the outside thereof so that, in the presence of hydraulic propulsion, the narrow body lumen is pressurized to allow for diagnostic imaging or therapeutic treatment of the narrow body lumen. Including the steps of To create a seal in the fallopian tube, for example, the seal-producing portion 106 of FIG. 2 can be expanded either proximal to the fallopian tube of the uterus or in the proximal region of the fallopian tube. The seal will allow pressure to build up on the part of the device that is to be hydraulically propelled.

  Next, another step 908 of FIG. 9 is hydraulically driven using a hydraulic propulsion, an imaging portion (108 of FIG. 2A) or a therapeutic device contained in a capsule (110 of FIG. 2A) through a narrow body lumen. Including promoting. As an example, the device 200 of FIG. 3 shows a capsule 210 attached to the handle portion 102 of FIG. 2 by a wire 218 of FIG. 3 that is hydraulically propelled. Several steps can be taken to assist in the propulsion of the capsule (eg, capsule 210 of FIG. 3). Capsules that can be made of a substantially transparent material are preferably expanded. Alternatively, the capsule can contain an expandable body such as a balloon which is preferably expanded. These steps increase capsule buoyancy to help drive the capsule. Furthermore, in its propelled state, the sail 238 of FIG. 3 attached to the imaging subassembly 208 is deployed and will capture hydraulic propulsion (which captures the power of the wind to propel forward movement of the boat) Same as the sail on the sail boat).

  After step 908 and with reaching the pathological portion of the fallopian tube or the pilus of the fallopian tube, step 910 of FIG. 9 includes treating or imaging a narrow body lumen. As discussed above with reference to FIGS. 2, 2A, 2B, and 3, imaging is performed by the imaging subassembly 108 of FIG. 2A. Imaging according to certain embodiments of step 908 of the present invention is performed in antegrade fashion (during forward propulsion of imaging subassembly 108) and / or retrograde fashion (during retrieval of imaging subassembly 108). For treatment of narrow body lumens, when pathology is imaged, flushing with saline to remove debris from the fallopian tube, adding an anti-inflammatory agent in liquid form, and an expandable body (eg, FIG. 2) Preferably, one treatment selected from the group consisting of applying mechanical force to the occlusion using the seal-forming portion 104) is performed.

  Process 900 preferably ends at step 912 of FIG. 9 with the step of retrieving the imaging device from the narrow body lumen. As an example, the retrieval mechanism 122 of FIG. 2 is activated to retrieve the imaging device from the fallopian tube. The retrieval mechanism is preferably activated by engagement with a reel mechanism (eg, mechanism 122 of FIG. 2) disposed on the handle. Alternatively, the entire device can be withdrawn in the direction of the user to remove it from the narrow body lumen.

  It should be noted that steps 902 and 904 of FIG. 9 are optional, and the steps described above need not be performed using any particular sequence. Rather, the above sequence of steps represents a more preferred embodiment of the present invention. Process 900 may be performed using any structure and is not limited to any of the structures shown in FIGS. 2, 2A, 2B, and 3. The structures shown in these figures serve as an example and are used to facilitate the discussion regarding the process 900.

  FIG. 10 shows a process flow diagram 1000 according to an embodiment of the invention that uses a guide wire mechanism for diagnostic imaging. Preferably, the process 1000 begins at step 1002 with establishing a channel from the outside of the female anatomy to the proximal region of the fallopian tube or fallopian tube in the uterus. Stage 1002 is substantially similar to the imaging aspect of stage 902 of FIG.

  Next, stage 1004 includes steering the guidewire through the channel to a target location in the lumen of the fallopian tube, which can provide light or imaging. As one example, the guidewire 334 of FIG. 4A includes a bundle of optical fibers that can provide light or image the fallopian tube.

  In this configuration, step 1006 is performed. Stage 1006 includes placing a catheter that facilitates imaging or treatment over the guidewire. Depending on whether the guidewire 334 of FIG. 4A can be imaged or illuminated, the catheter contains additional structures that facilitate imaging.

  Next, another step 1008 includes imaging the fallopian tube using a guide wire and a catheter. As an example, imaging as this step requires may be for a catheter (eg, catheter 304 in FIG. 4A) so that the exact amount and angle of light illuminates the portion of the fallopian tube being imaged. This is performed by positioning the guidewire 334 of FIG. 4A.

  Additionally, a protective shield (eg, shield 330 of FIG. 4A) can be positioned such that an appropriate focal length is obtained between the fallopian wall and the imaging portion (eg, imaging portion 308 of FIG. 4A).

  After stage 1008, stage 1010 includes removing the guidewire from the channel.

  Following the guidewire example of FIG. 4A, guidewire 344 is removed from the working channel of the hysteroscope referred to in step 1002 of FIG. This allows the guidewire channel to be used for therapeutic applications.

  Next, step 1012 includes introducing a local treatment to the fallopian tube through the channel. The treatment at this stage is preferably introduced in liquid form by means of an additional treatment catheter or through the guide wire channel discussed above.

  The process 1000 ends at step 1014 with the step of treating the fallopian tube using a local treatment or catheter. The treatment at this stage preferably comprises adding an anti-inflammatory agent in liquid form, introducing a drug-coated balloon (eg coated with an anti-inflammatory agent), introducing a bioabsorbable stent, and from the fallopian tube One treatment solution selected from the group consisting of flushing with saline to remove debris.

  Note that steps 1002, 1010, 1012, and 1014 are optional, and the above steps need not be performed using any particular sequence. Rather, the above sequence of steps represents a more preferred embodiment of the present invention. In one preferred embodiment of the invention, additional steps can be added. Specifically, after imaging has been completed at the end of step 1008, another step is preferably performed, including the step of withdrawing the catheter from the fallopian tube. Process 1000 can be implemented using any structure and is not limited to any of the structures shown in FIGS. 4A, 4B, 5A, and 5B. The structures shown in these figures serve as an example and are used to facilitate the discussion regarding process 1000.

  FIG. 11A shows a distal end portion of a device 1100 according to another embodiment of the present invention. In this embodiment, the expandable body 1106 (such as a balloon) is sealed against the distal end portion of the shaft portion 1104. In the embodiment of FIG. 11A, the distal end portion 1104D is narrowed to facilitate coupling of the expandable body around its periphery. However, this narrow portion is optional as the expandable body can be coupled around the circumference of the distal end portion of the shaft portion even when it is not narrowed. Bonding / sealing can be done by hot melt and / or adhesive and / or other known bonding or sealing methods. In the illustrated embodiment, the expandable body 1106 is about. Although a PET (polyethylene terephthalate) balloon having an outer diameter of 038 ", other materials and dimensions can be used. The unexpanded outer diameter of the expandable body is about. 030 " It can be a value in the range of 050 ''. In the embodiment shown in FIG. 11A, the shaft portion 1104 is made of nylon and has an inner diameter of 4 French (about 1.33 mm). The material and dimensions of the shaft portion 1104 may be different than other relatively rigid ones, and the biocompatible material may be replaced by nylon, and the inner diameter may range from about 1 mm to about 2.5 mm. You can have

  The expandable body 1106 is an elongated body and is flipped so that it passes into the shaft portion that is coupled to the opposite end of the tube 1108 at the distal end portion 1108D of the tube 1108. Bonding / sealing can be done by hot melt and / or adhesive and / or other known bonding or sealing methods. The tube 1108 is rigid. The flexible tube 1110 is coupled to the distal end portion 1108D of the rigid tube 1108 at a location distal to where the expandable body 1106 is coupled to the rigid tube 1108. The expandable body 1110 is flexibly configured to allow it to bend easily as it is inserted therein to follow the curvature of the natural body lumen. In the illustrated embodiment, the rigid tube 1108 is approximately. A stainless steel tube having an outer diameter of 028 "and an inner diameter of about 0.020". However, these materials and dimensions may vary. For example, titanium or other biocompatible metals or rigid polymers can be substituted for stainless steel. The outer diameter is about. 022 "to about. The value can be in the range of 035 "and the inner diameter is about. 015 "to about. It can be a value in the range of 028 ". The flexible tube 1110 of the illustrated embodiment has approximately. It is a coiled wire tube made of wire filament having an outer diameter of 004 ''. The coiled wire tube is approximately. It has an inner diameter of 020 ". However, these dimensions may be different. For example, the wire outer diameter is about. 002 "to about. The outer diameter of the flexible tube 1110 can be about 1.00 ". 022 "to about. The value can be in the range of 035 "and the inner diameter is about. 013 "to about. It can be a value in the range of 028 ". Additionally, the flexible tube can be a tube made of a compatible material such as "Nylon", "Pebax", or other material. Furthermore, the flexible tube need not be coiled and can be, for example, braided, woven or solid material.

  The visualization device 1112 is received through and slides against the lumen of the rigid tube 1108 and distally past the expandable body 1106 through the flexible tube 1110 as described in detail below. You can pass through. In the illustrated embodiment, the visualization device comprises approximately. It is a fiberscope with an outer diameter of 45 mm. However, other visualization devices can be substituted as long as they are dimensioned such that they can slide distally into and against the rigid tube 1108 and flexible tube 1110. The outer diameter is also about. 30 mm to about. It may be different with values in the range of 60 mm.

  FIG. 11A shows the device 1100 in an initial state prior to use, in which the expandable body 1106 is not pressurized. FIG. 11B shows the device 100 in an initial deployment configuration placed therein before the device is inserted into a natural body lumen. When used in the fallopian procedure, this initial deployment state is preferably configured on the outside of the patient, but can be configured on the inside of the uterus before being inserted into the foramen of the fallopian tube. The device is pressurized (using a pressure source as described in the previous embodiment or alternative pressure source), and the rigid tube 1108 is attached to the distal end 1104DE of the shaft portion 1104 as shown in FIG. 11B. Distally advanced relative to the shaft portion 1104 to partially deploy the distally expanded expandable body 1106. The expandable body 1106 in the initial deployed configuration extends from the distal end 1104DE a distance sufficient to pass through, or at least enters the ostium of the fallopian tube.

  In the initial deployed configuration, the device 1108 is inserted vaginally into the uterus (if it was not placed in the uterus prior to initial deployment) and the expandable body 1106 is steered to Put in the small hole 18 With the expandable body 1106 passing through the stoma while maintaining pressurization, the rigid tube 1108 is further distal to the shaft portion 1104 to fully deploy the expandable body as shown in FIG. 11C. Proceeded to As the expandable body is everted during deployment, its flexibility allows the contour of the fallopian tube to be followed in such a way that it is intact. The fully inverted expandable body 1106 shown in FIG. 11C has a length sufficient to pass through the foramen 18 and across the oviductal junction 19 (see FIG. 1). The distal advancement of the rigid tube 1108 simultaneously advances the flexible tube 1110 deployed within the central expandable body 1106 to establish a lumen through which the visualization lumen can pass.

  With the passage intact established through the foramen 19 through the foramen 18, the visualization device 1112 then, while keeping the shaft portion 1104 and the rigid tube 1108 relatively stationary, the visualization device 1112 By pressing against the proximal end portion, it is advanced distally relative to the shaft portion 1104, the rigid tube 1108, the flexible tube 1110, and the expandable body 1106. The distal end of the visualization device 1112 is advanced distal to the expandable body 1106 and the distal end of the flexible tube 1110 (FIG. 11D), which can be advanced into the fallopian tube to perform its visualization Be The visualization 1112 can be advanced distally relative to other components of the opening 1100 as needed to achieve target positioning along the fallopian tube, pili, etc. The pressurization of the device 1100 / expandable body 1106 is maintained in all of the configurations shown in FIGS. 11B-11D. A fluid 1114 such as saline, water, or other biocompatible fluid is optionally pressed or pumped around the visualization device 1114 and within the tube 1108 and tube 1110 and at the distal end the tube 1110 To inflate the fallopian tube and further facilitate advancement of the visualization device 1112 through the fallopian tube.

  Although the embodiments of FIGS. 11A-11D are described with respect to the navigation of visualization device 1112 through the fallopian tube, this embodiment may, for example, be as in the previous embodiments, eg, coronary artery, urinary tract, gastrointestinal tract, lymphatic It can be used to visualize other body vessels such as systems or other blood vessels. Additionally, the device 1100 can be used without or in addition to a visualization device to provide therapy as described above in the previous embodiments. In this embodiment, the treatment can be applied through the lumen formed by the rigid tube 1108 and the flexible tube 1110 / expandable body 1106.

  12A-12E show the device 1100 of FIGS. 11A-11D in a straight-out external configuration with the tube 1110, the expandable body 1106, and the visualization device 1112 as they do not match the natural curvature of the body vessel. There is. 12A-12B show the device in its initial state. FIG. 12B shows a tether 1116 that can extend between the distal end portion of the flexible tube 1110 and the distal end portion of the expandable body 1106 (when everted), where they are attached at both ends. It is fixed to the component of. The tether 1116 facilitates re-inversion of the expandable body 1106 back to the shaft portion 1104 after the visualization and / or treatment procedure is completed. Optionally, the device 1100 can be depressurized prior to retraction of the expandable body, but this need not be the case. By pulling rigid tube 1108 proximally relative to shaft portion 1104, it then pulls flexible tube 1110 proximally relative to shaft portion 1104. Continuation of the proximal withdrawal of the tubes 1108, 1110 returns the expandable body 1106 back to the shaft portion 1104 through the tether 1116 and thus out of the fallopian tube and fallopian tube, at which point the device can be removed from the patient it can. FIG. 12C shows an apparatus 1100 in an initial deployment configuration corresponding to that shown in FIG. 11B. FIG. 12D shows the device 1100 with the expandable body 1106 in a fully deployed configuration corresponding to that shown in FIG. 11C. FIG. 12E shows the device 1100 in a fully deployed configuration with a visualization device 1112 extending distally to the distal end of the expandable body 1106 / flexible tube 1110 corresponding to that shown in FIG. 11D.

  FIG. 13 illustrates events that may be performed in process 1300 using apparatus 1100 according to an embodiment of the present invention. These events are, of course, intended to limit processing as other unlisted events such as, for example, patient preparation, equipment and instrument preparation, post-surgery procedures, etc. will be performed. Absent. At Event 1302, the device 1100 is configured to be pressurized from a non-pressurized initial configuration (see, eg, FIGS. 11A and 12A) to an initial deployment configuration (eg, shown in, eg, FIGS. 11B and 12C). Event 1302 is preferably performed prior to vaginally inserting the device into the uterus, but may alternatively be performed after vaginal insertion into the uterus.

  With the distal end portion of the device placed in the uterus (this can be guided by visualization with an instrument such as, but not limited to, hysteroscope, fluoroscopy, or other visualization mechanism) The device is maneuvered by the surgeon to insert the partially deployed (partially inverted) expandable body 1106 into the foramen 18 of the target fallopian tube 12 during event 1304. This insertion can, for example, be guided by the visualization provided by the hysteroscope.

  At Event 1306, the expandable member is fully deployed (fully inverted) so that it extends past the uterotubal junction 19 in the manner as described above with respect to FIG. 11C. While maintaining pressurization, the rigid tube 1108 is advanced further distally relative to the shaft portion 1104 to deploy a fully expandable body, as shown in FIG. 11C. As the expandable body is everted during deployment, its flexibility allows it to follow the contour of the fallopian tube intact. The fully inverted expandable body 1106 shown in FIG. 11C has a length sufficient to pass through the foramen 18 and across the oviductal junction 19 (see FIG. 1). The distal advancement of the rigid tube 1108 simultaneously advances the flexible tube 1110 deployed within the central expandable body 1106 to establish a lumen through which the visualization lumen can pass.

  With the passage intact established through the foramen 18 past the oviductal junction 19, the visualization device 1112 then allows the visualization device to keep the shaft portion 1104 and the rigid tube 1108 relatively stationary. Depression against the proximal end portion of 1112 advances the shaft portion 1104, the rigid tube 1108, the flexible tube 1110, and the expandable body 1106 distally at event 1308. The distal end of the visualization device 1112 is advanced distal to the expandable body 1106 and the distal end of the flexible tube 1110 (FIG. 11D) to advance it into the fallopian tube for visualization be able to. At Event 1310, the visualization tool 1112 can be freely advanced and / or retracted to visualize the associated location. The visualization 1112 can be freely advanced distally relative to other components of the opening 1100 as long as it is necessary to visualize the target location along the fallopian tube, pili, etc. The pressurization of the device 1100 / expandable body 1106 is maintained in all of the configurations provided during events 1302-1308 and subsequent visualization. A fluid, such as saline, water, or other biocompatible fluid, is optionally pressed or pumped around visualization device 1114 and into tube 1108 and tube 1110, with tube 1110 at the distal end. The oviduct can exit and expand, further facilitating the advancement of the visualization device 1112 through the oviduct.

  At the end of the visualization procedure, the visualization device 1112 retracts at event 1312 back to the shaft portion 1104 and the rigid tube retracts to retract the expandable member as well. Device 1100 can be removed from the uterus at event 1314 and can perform a post-surgery procedure.

  FIG. 14 shows events that may be performed in process 1400 using apparatus 1100 according to another embodiment of the present invention. These are, of course, not intended to limit processing as other events not listed, such as, for example, patient preparation, equipment and instrument preparation, post-surgery procedures, etc. will be performed. At Event 1402, the device 1100 is configured to be pressurized, such as from a non-pressurized initial configuration (see, eg, FIGS. 11A and 12A) to an initial deployed configuration (eg, shown in, eg, FIGS. 11B and 12C). Event 1402 is preferably performed prior to vaginally inserting the device into the uterus, but may alternatively be performed after vaginal insertion into the uterus.

  With the distal end portion of the device placed in the uterus (this can be guided by visualization with an instrument such as, but not limited to, hysteroscope, fluoroscopy, or other visualization mechanism) The device is steered by the surgeon to insert the partially deployed (partially inverted) expandable body 1106 into the foramen 18 of the target fallopian tube 12 during event 1404. This insertion can, for example, be guided by the visualization provided by the hysteroscope.

  At Event 1406, the expandable member is fully deployed (fully inverted) so that it extends past the uterotubal junction 19 in the manner as described above with respect to FIG. 11C. While maintaining pressurization, the rigid tube 1108 is advanced further distally relative to the shaft portion 1104 to deploy a fully expandable body, as shown in FIG. 11C. As the expandable body is everted during deployment, its flexibility allows it to follow the contour of the fallopian tube intact. The fully inverted expandable body 1106 shown in FIG. 11C has a length sufficient to pass through the foramen 18 and across the oviductal junction 19 (see FIG. 1). The distal advancement of the rigid tube 1108 simultaneously advances the flexible tube 1110 deployed within the central expandable body 1106 to establish a lumen through which visualization and treatment can be performed.

  With the passage intact established through the foramen 18 past the uterotubal junction 19, a therapeutic treatment as described above may be performed at event 1408. When the treatment to be applied is a liquid formulation, the visualization device 1112 may be pressed against the proximal end portion of the visualization device 1112 while keeping the shaft portion 1104 and the rigid tube 1108 relatively stationary. 1104, rigid tube 1108, flexible tube 1110, and distal to expandable body 1106 can be advanced at event 1408, the liquid therapeutic agent is visible around visualization device 1114 and within tube 1108 and tube 1110 Can be pushed or pumped out of the tube 1110 at the distal end. A liquid therapeutic agent may optionally be used to inflate the fallopian tube to further facilitate advancement of the visualization device 1112 through the fallopian tube and / or additional fluid such as saline or water optionally. It can be used for

  The visualization device 1114 can be removed from the device if the treatment being delivered is not completely liquid, as in the delivery of a stent or other non-liquid therapeutic agent, and the inside of the rigid tube 1108 and flexible tube 1110 can be removed. The cavity can be used to deliver the treatment.

  At the end of the treatment procedure, the visualization device is retracted back into the shaft portion 1104 if present. Optionally, the device can be depressurized, but it need not be. In either case, the rigid tube retracts at event 1410 to retract the expandable member as well. Device 1100 may then be removed from the uterus at event 1412 and post-operative treatment may be performed.

  While exemplary embodiments of the present invention have been illustrated and described, other modifications, changes, and substitutions are intended. As an example, the present invention discloses the fallopian tube as an example of a narrow body lumen that can be preserved, and preserves other anatomical structures such as coronary arteries to other natural body vessels as well. be able to. Accordingly, it is appropriate that the invention be construed broadly and in a manner consistent with the scope of the present disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, one or more process steps to the purpose and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

Claims (27)

A device for use in a narrow body lumen,
The outer shaft portion,
A tube receivable within the outer shaft portion;
An elongated expandable body having first and second ends, the first end sealed to the outer shaft portion and the second end sealed to the tube;
Including
In the initial configuration, the elongated expandable body is received in the outer shaft portion;
The tube is slidable relative to the outer shaft portion such that the elongated expandable body is ablated as the elongated expandable body moves out of the outer shaft portion.
An apparatus characterized by The device is pressurizable,
Device pressurization causes the inflatable body to expand.
An apparatus according to claim 1, characterized in that.   3. The device of claim 2, wherein the pressurization of the device assists in the abduction of the elongated expandable body exiting the outer shaft portion.   The device according to claim 1 or 2, wherein the tube is slidable to selectively abduct the expandable body into a partial abduction state or a full abduction state.   The device according to claim 1 or 2, wherein the tube is a rigid tube and the device further comprises a flexible tube extending from a distal end of the rigid tube.   6. The apparatus of claim 5, wherein the flexible tube slides within the expandable body upon sliding of the rigid tube for ablating the expandable body.   The apparatus according to claim 1 or claim 2, further comprising a visualization device acceptable in the tube.   The apparatus of claim 7, wherein the visualization device is slidable relative to the tube.   9. The apparatus of claim 8, wherein the visualization device is slidable such that the distal end of the visualization device extends distally of the expandable member when in the full abduction configuration.   The apparatus of claim 7, further comprising a pressurized liquid passing between the tube and the visualization device.   11. The device of claim 10, wherein the pressurized liquid comprises a therapeutic formulation.   11. The apparatus of claim 10, wherein the pressurized liquid is configured to widen the narrow body lumen to facilitate sliding of the visualization device thereon.   6. The device of claim 5, further comprising a tether interconnecting the flexible tube and the expandable body.   A handle portion for receiving one or more luers according to claim 1 or 2, characterized in that one of the luers is configured to apply pressure to pressurize the device. Device.   The method further comprises a wire luer designed to provide a wire for transmitting power and signals to facilitate the imaging function received by the handle portion and performed by the imaging portion. The apparatus according to item 14.   3. A device according to claim 1 or claim 2, wherein the expandable body comprises a length extending from the foramen of the fallopian tube beyond the oviductal junction when fully abducted.   The apparatus of claim 7, wherein the visualization device comprises a fiberscope. Designed to measure the pressure being applied to the narrow body lumen and to trigger an alarm signal if the measurement of pressure is equal to or exceeds a predetermined value of pressure Pressure sensor,
The apparatus according to claim 1 or 2, further comprising: A method of operating on a narrow body lumen,
Pressurizing the device and configuring the device in an initial configuration in which the expandable body extends partially out of the distal end of the outer shaft portion of the device;
Inserting the partially extending expandable body into the narrow body lumen;
Completely abbreviating the expandable body such that the expandable body is fully deployed out of the distal end of the outer shaft portion and extends deeper into the narrow body lumen;
Delivering at least one of a visualization device and a treatment distally through an opening in the expandable body and into the narrow body lumen;
A method characterized by comprising. The narrow body lumen is the fallopian tube,
The inserting step includes inserting the partially extending expandable body into the foramen of the fallopian tube.
21. The method of claim 19, wherein:   21. The method according to claim 19 or 20, wherein said fully abducting comprises abducting said expandable body such that it extends past a uterotubal junction.   At the time of delivery of the visualization device, the distal end of the visualization device is moved according to at least one of advancing and retracting the visualization device to visualize one or more target areas within the narrow body lumen. The method according to claim 19 or 20, characterized in that:   21. A method according to claim 19 or 20, wherein treatment is effected through the opening of the expandable body with the visualization device extending through the opening of the expandable body.   21. The method of claim 19 or 20, wherein treatment is provided through the opening in the expandable body without the visualization device extending through the opening in the expandable body.   21. The method of claim 19 or 20, further comprising: depressurizing the device; and retracting the deflated expandable body back into the outer shaft portion. The expandable body is attached through a tether to a tube received within the outer shaft portion,
Retraction of the tube relative to the outer shaft portion retracts the deflated expandable body back into the outer shaft portion with the assistance of the tether.
26. A method according to claim 25, characterized in that.   Further comprising retracting the visualization device back into the outer shaft portion, depressurizing the device, and retracting the deflated expandable body back into the outer shaft portion. 21. A method according to claim 19 or 20, characterized in that

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