CN109069161A

CN109069161A - Device and process for being operated in narrow body lumen

Info

Publication number: CN109069161A
Application number: CN201780027521.8A
Authority: CN
Inventors: 克里斯蒂娜·斯基勒; 杰西·马加纳; 戴维·斯诺; 苏比希·萨娜
Original assignee: Nvision Medical Corp
Current assignee: Boston Scientific Scimed Inc
Priority date: 2016-05-26
Filing date: 2017-05-25
Publication date: 2018-12-21
Also published as: BR112018074067A2; AU2017269385B2; KR20190008367A; AU2020202733A1; CA3015921A1; JP2019517863A; AU2017269385A1; EP3463110A4; WO2017205646A1; MX2018014544A; EP3463110A1

Abstract

It provides for the device used in narrow body lumen and process.Device may include: outer axial portion；It may be housed in the pipe in outer axial portion；And elongate inflatable ontology, it has a first end and a second end, first end is sealed to outer axial portion, and second end is sealed to pipe.In initial configuration, elongate inflatable ontology is contained in outer axial portion.Pipe can be slided relative to outer axial portion, to make elongate inflatable ontology turn up when elongate inflatable ontology is moved to outside outer axial portion.

Description

Device and process for being operated in narrow body lumen

Technical field

The present invention generally relates to the devices of the manipulation executed on narrow body cavity, treatment and/or diagnosis.

Background technique

Due to various reasons, occlusion usually occurs in narrow body cavity (that is, the channel of tubular anatomical structure, such as defeated ovum Pipe, intestines and coronary artery) in, and there is the relevant influence of medicine on body.It is described below and maintains fallopian tubal (as narrow The example of body cavity) health routine techniques.

Fallopian tubal is the structure for extending to the tubulose of ovary from uterus and filling without fluid.On average, the length of fallopian tubal It is measured between 8 to 10 centimetres.The internal diameter of pipe significant changes according to the section of pipe, wherein minimum diameter is about 1 millimeter, Maximum inner diameter is 6 millimeters.

Along the length of the lumen of fallopian tubal, millions of small hairy ciliums are with the rate of hundreds of times every second with wave Unrestrained formula movement is pulsed.The ovum that this movement conveys during facilitating ovulation from ovary reaches uterine cavity by fallopian tubal. Cell in the inner membrance (endothelium) of fallopian tubal provides important nutrition for ovum, and provides lubrication along path.Sperm is first Ovum is first contacted in fallopian tubal.If ovum is not fertilized in 20 four to three ten six hours for reaching fallopian tubal, Ovum will go bad and be removed from fallopian tubal by the immune system of body.

Diseases of fallopian tubes is usually expressed as the occlusion of tubal wall or thickens, and may be drawn by infection and scar It rises.Particularly, pelvic inflammatory disease (PID), urinary tract infections (UTI) and Sex transmitted pathogen (STI) may cause serious inflammation, in turn Block fallopian tubal.When endometrium is grown into fallopian tubal, mullerianosis may also lead to occlusion.Appendectomy or Other abdominal operations further may similarly cause tubal occlusion.

Regardless of the generation type occluded, occlusion can cause hydrosalpinx, and the diameter of median oviduct increases, because It is filled with fluid.The presence of fluid prevents ovum and sperm from being advanced through fallopian tubal, prevents fertilization.It is believed that defeated ovum Pipe ponding may make success rate in vitro fertilization reduce up to 8%.

Only in the U.S., at least 7,000,000 infertilities every year, and it is by defeated ovum that 25-40% is estimated to be in these cases Caused by pipe occlusion or disease.

Hysterosalpingography (HSG) is a kind of operation of most common diagnosis diseases of fallopian tubes, needs radiologist Under X-ray guidance by Dye Injections into uterus.Dyestuff enters fallopian tubal by the mouth (opening) being located in uterus.If female Property fallopian tubal be unobstructed (open), dyestuff will flow into abdominal cavity.In order to visualize fluid path, a series of timings are shot X-ray.

Regrettably, there are several disadvantages for this operation.For example, due to the shade in fallopian tubal spasm or X-ray (noise), there are 30% high false negative rates and 40% high false positive rate by HSG.This usually requires further surgery.It is this The inaccuracy of height ratio is also partially due to following facts: radiologist unlike gynaecologist or reproductive endocrine expert that Sample is familiar with the complications and pattern of fallopian tubal.

As another example of disadvantage, HSG is not by gynaecologist or reproductive endocrine expert (the main nurse of patient People) implement in an office, because it needs to carry out great amount of investment to X-ray asset equipment present in hospital.Patient is logical Chang Shouxian visits gynaecologist, which carries out a series of blood tests and determine whether HSG is necessary.It must if it is considered to having It wants, then patient schedule and radiologist reserve to carry out HSG operation.At the end of first operation, patient returns to gynaecology Doctor or reproductive endocrine expert discussion result.Due to high inaccurate rate relevant to HSG, patient is usually brought back to dept. of radiology It carries out performing the operation for second at doctor, this all causes patient and hospital additional unnecessary expense.

As another example, patient often complains that pain, and some patients are to the dye allergy used during operation.This Outside, HSG must be carried out before the 12nd day of menstrual cycle of female, because dyestuff may damage possible full-term pregnancy, this The selection of doctor and patient are limited, and further extends the waiting time of complete infertility diagnosis, this is to patient and family Cause affectional burden in front yard.

In order to overcome these disadvantages, different direct visualizztion technologies has been had attempted to.Fig. 1 is shown using traditional fiber The endoscope of imaging technique, as the exemplary trial for realizing fallopian tubal direct visualizztion.In the figure, receive the women of imaging Reproductive anatomy 10 includes fallopian tubal 12, ovary 14, uterus 16, uterine cavity 22, cervix 28 and umbrella end 30.By imaging catheter Axis 20 is introduced into fallopian tubal, and fallopian tubal has the viscosity of hygenic towelette.Catheter shaft 20 surpasses by the fallopian tubal mouth 18 in uterus The point is crossed, fallopian tubal 12 is narrow and tortuous.

Regrettably, the viscosity of hygenic towelette cannot provide enough touchings by the doctor of fallopian tubal 12 for manipulation conduit 20 Feel feedback.Therefore, during operation is imaged, doctor does not recognize the excess pressure being applied on fallopian tubal, results in perforation 24.For this purpose, Fig. 1 shows a part of conduit 26 except the perforation 24 being projected into fallopian tubal 12.The perforation of fallopian tubal may Ovum from her ovaries 14 can be prevented to reach uterus 16 to be fertilized, so that perforation is to the patient for actively attempting to become pregnant as can not The clinical adverse events of receiving.Other than the risk for risking tubal perforation, above-mentioned imaging operation further relates to several steps, and Therefore complexity is considered as by doctor and is difficult to be appropriately carried out.In addition, the hygenic towelette viscosity of fallopian tubal prevent attempted at As operation obtains clearly focusedimage.Specifically, during imaging, hygenic towelette viscosity is caused including the wall " folding " of fallopian tubal On the end of sight glass, make it difficult to maintain enough distances between the end of endoscope and the wall of fallopian tubal to focus and acquire Clearly picture.

Therefore, it is necessary to a kind of novel Clinics and Practices system and methods, allow effectively to maintain narrow body cavity, and The shortcomings that being encountered there is no the System and method for attempted at present described above.

Summary of the invention

It according to an aspect of the present invention, include: outer axial portion for the device used in narrow body lumen；It may be housed in Pipe in outer axial portion；Elongate inflatable ontology, has a first end and a second end, and first end is sealed to outer axial portion, and Second end is sealed to the pipe；Wherein, in initial configuration, elongate inflatable ontology is contained in outer axial portion, and wherein Pipe can be slided relative to outer axial portion, to keep elongate inflatable sheet external when elongate inflatable ontology is moved to outside outer axial portion It turns over.

In at least one embodiment, device can pressurize, and the pressurization of device inflates inflatable body.

In at least one embodiment, the pressurization of device helps elongate inflatable ontology to turn up outside outer axial portion.

In at least one embodiment, pipe is slidable, so that inflatable body selectively turn up by the outer part that turns to State or state of turning up completely.

In at least one embodiment, pipe is rigid pipe, and the device further comprises the distal end from rigid pipe The flexible pipe of extension.

In at least one embodiment, when rigid pipe slides so that inflatable body is turned up, flexible pipe is at inflatable Sliding in vivo.

In at least one embodiment, which further comprises the visualization instrument that may be housed in pipe.

In at least one embodiment, visualization instrument can be slided relative to pipe.

In at least one embodiment, visualization instrument is slidable, so that turning up completely when inflatable member is in When configuration, the distal end of visualization instrument extends to the distal side of inflatable member.

In at least one embodiment, which further comprises by the fluid under pressure between pipe and visualization instrument.

In at least one embodiment party example, fluid under pressure includes treatment preparation.

In at least one embodiment, fluid under pressure is constructed such that narrow body lumen is expanded, in order to visualization instrument phase For its sliding.

In at least one embodiment, which further comprises being by what flexible pipe and inflatable body interconnected Rope.

In at least one embodiment, which further comprises handle portion, which accommodates one or more Female Luer, one of female Luer are designed to provide pressure, so that the device pressurizes.

In at least one embodiment, which further comprises conducting wire female Luer, and the conducting wire female Luer is by handle Part accommodates, and is designed to provide the conducting wire for being used for transmission electric power and signal, in order to execute imaging function by imaging moiety Energy.

In at least one embodiment, when turning up completely, inflatable body includes extending beyond uterus from fallopian tubal mouth The length of fallopian tubal joint.

In at least one embodiment, visualization instrument includes fibrescope.

In at least one embodiment, device further comprises pressure sensor；Wherein the pressure sensor is designed to The pressure being applied in narrow body lumen is measured, and if pressure measurements equal or exceed scheduled pressure value, just triggering police The number of notifying.

In another aspect of this invention, the process operated in narrow body lumen includes: to pressurize to device, and device is constructed At initial configuration, wherein inflatable body is partly extended to outside the distal end of the outer axial portion of device；Part is extended Inflatable body is inserted into narrow body lumen；Inflatable body is set to turn up completely, so that inflatable body is in the remote of outer axial portion It is fully deployed and is further extended into narrow body lumen outside side end；And by least one of visualization instrument and therapeutant By the opening in inflatable body to its can distal side be delivered in narrow body lumen.

In at least one embodiment, narrow body lumen is fallopian tubal, and being inserted into includes inflatable for extending part Body is inserted into fallopian tubal mouth.

In at least one embodiment, it turns up completely including making inflatable body turn up, so as to extend past uterus defeated for it Oviduct joint.

In at least one embodiment, it when delivering visualization instrument, according to propulsion and retracts in visualization instrument extremely It is few it is a kind of come mobile visualization instrument distal end so that one or more target areas in narrow body lumen visualize.

In at least one embodiment, therapeutant is delivered into the opening by inflatable body, wherein visualization instrument is prolonged Extend through the opening.

In at least one embodiment, therapeutant is delivered through to the opening of inflatable body, wherein visualization instrument is not Extend through the opening.

In at least one embodiment, which further comprises that inflatable body is retracted into outer axial portion.

In at least one embodiment, inflatable body is attached on the pipe being contained in outer axial portion via tether, and And wherein with the help of tether, which be retracted into inflatable body in outer axial portion relative to the retraction of outer axial portion.

In at least one embodiment, which further comprises that visualization instrument is retracted into outer axial portion, and incites somebody to action Inflatable body is retracted into outer axial portion.

When reading the details for the device, method and system being described more fully below, these and other features of the invention Those skilled in the art will become obvious.

Detailed description of the invention

In following detailed description process, attached drawing will be referred to.Those figures show different aspects of the invention, suitable In the case where, the appended drawing reference for showing similar structure, component, material and/or element in different figures has similarly been marked. It should be appreciated that other than those of specifically illustrating combination, the various combinations of structure, component, material and/or element are expectable , and within the scope of the invention.

Fig. 1 is shown to be peeped according to being navigated in fallopian tubal and major organs by female reproductive system for existing method Mirror.

Fig. 2 shows the sectional views of the diagnostic device according to an embodiment of the invention in non-operating state.

Fig. 2A shows the enlarged view of the distal end of the shaft portion of diagnostic device shown in Fig. 2.

Fig. 2 B shows the side section view of the distal end of the shaft portion of therapeutic device according to an embodiment of the invention Figure.

Fig. 3 shows the shaft portion of the mode of operation of the diagnostic device according to another embodiment of the present invention in Fig. 2 Sectional view.

Fig. 4 A is the perspective view of two according to an embodiment of the present invention different oval distal ends, can be used in and be based on leading In the diagnostic imaging device of silk or in the therapy intervention device based on guidewire lumen.

Fig. 4 B is the top view of distal end shown in Fig. 4 A.

Fig. 5 A is the perspective view of conical shape distal end according to an embodiment of the present invention, can be used in the diagnosis based on seal wire In therapy intervention device in imaging device or based on guidewire lumen.

Fig. 5 B is the top view of distal end shown in Fig. 5 A.

Fig. 6 A is the side view of unaerated conical shape distal according to an embodiment of the present invention end, can be used in be not based on and lead In the diagnostic imaging device of silk or it is not based in the therapy intervention device of guidewire lumen.

Fig. 6 B is that the conical shape distal end of Fig. 6 A is in the side view of its inflated condition.

Fig. 7 A is the side view of the oval distal end of unaerated according to an embodiment of the present invention, can be used in and be not based on seal wire Diagnostic imaging device in or be not based in the therapy intervention device of guidewire lumen.

Fig. 7 B is that the oval distal end of Fig. 7 A is in the side view of its inflated condition.

Fig. 8 A is the side view of unaerated cheese distal end according to an embodiment of the present invention, can be used in be not based on and lead In the diagnostic imaging device of silk or it is not based in the therapy intervention device of guidewire lumen.

Fig. 8 B is that the cheese distal end of Fig. 8 A is in the side view of its inflated condition.

Fig. 8 C shows certain main components in distal end shown in Fig. 8 B according to an embodiment of the invention.

Fig. 9 shows process flow diagram flow chart according to an embodiment of the invention, which uses hydraulic-feed mechanism Carry out diagnosing image.

Figure 10 shows process flow diagram flow chart according to an embodiment of the invention, which is carried out using thread guide mechanism Diagnosing image.

Figure 11 A shows the distal end portion of device according to another embodiment of the present invention.

Figure 11 B shows the device of Figure 11 A in initial deployment configuration.

Figure 11 C shows the device for Figure 11 A that inflatable body is fully deployed.

Figure 11 D shows the figure that inflatable body is fully deployed and visualization instrument extends to the distal side of inflatable body The device of 11A.

Figure 12 A-12B is other views of the device of Figure 11 A.

Figure 12 C shows the device of Figure 12 A in initial deployment configuration.

Figure 12 D shows the device for Figure 12 A that inflatable body is fully deployed.

Figure 12 E shows the figure that inflatable body is fully deployed and visualization instrument extends to the distal side of inflatable body The device of 12A.

Figure 13, which is shown, can use the item that device according to an embodiment of the present invention executes in the process.

Figure 14, which is shown, can use the item that device according to another embodiment of the present invention executes in the process.

Specific embodiment

Before the description present apparatus, method and system, it should be understood that the present invention is not limited to described particular implementations Example, therefore can of course change.It will also be appreciated that terms used herein are used only for the purpose of describing specific embodiments, and It is not intended to be limited to.

In the case where providing numberical range, it should be understood that unless the context is clearly stated, otherwise in the range Upper and lower bound between each median, until lower limit unit 1/10th, be also specifically disclosed.In the range It is lesser each of between interior any described value or median and any other described value or median in the range Range is included in the present invention.These small range of upper and lower bounds can be independently include in range or not be included in It in range, and include any one boundary, two boundaries or each model not comprising any boundary in smaller range It encloses and is also included in the present invention, any boundary specifically excluded being limited by the range.It include one in the range Or in the case where two boundaries, the range that either one or two of those of included boundary is excluded is also included within the present invention It is interior.

Unless otherwise defined, otherwise all technical and scientific terms used herein have with it is of the art general Logical technical staff is generally understood identical meaning.Although can in implementation or test of the invention use and side described herein The method any method similar or equivalent with material and material, but what be will now be described is preferred method and material.It is mentioned above All public publications be both incorporated herein by reference, to disclose and describe method related with recited public publication And/or material.

It must be noted that as herein and as used in the appended claims, singular " one ", "one" and "the" Including plural object, unless the context is clearly stated.Thus, for example, the referring to thing of " pipe " includes multiple such pipes, And the referring to thing of " lumen " include one or more lumens referring to thing and its equivalent well known by persons skilled in the art, Etc..

Public publication discussed in this article is only for its disclosure information before the filing date of the present application.It is provided Publication date may be different from practical publication date, this may need individually to confirm.

In the following description, numerous specific details are set forth in order to provide thorough understanding of the invention.However, for ability Field technique personnel are it is readily apparent that the present invention can be real in the case where being not limited to some or all of these details It applies.In other cases, well-known process steps are not described in, in order to avoid unnecessarily obscure the present invention.

In certain embodiments, the present invention provides for accurately visual novel system and method in real time, Dynamically diagnose the illness of fallopian tubal.

As a part of system, at least some embodiments, the disposable products and its correlation of single use are provided Process overcomes many disadvantages that the diagnostic method currently attempted encounters.It can doing in gynaecologist or reproductive endocrine expert More accurate dynamic of the invention is carried out in public room to perform the operation, the doctor is usually the person of dominant touch first of infertile patient, Understand discussed anatomical structure, and preferably trained, in the case where needing further to find out dynamically change or Each step in repeat surgery.Therefore, the physician office visits for patient and hospital's the two and expense significantly reduce, and same When, significantly improve the convenience of each side concerned.In addition, the false sun of 20% to 40% height that conventional diagnostic system and operation encounter Property rate reduced also by the ability of directly observation fallopian tubal of the invention.

The preferred embodiment of the present invention recognizes, can be one in order to execute certain initial steps of operation of the invention Determine to rely on traditional diagnosis operation in degree.For example, certain operations of the invention need to make opening for the fallopian tubal in uterus Mouth (mouth) visualization, so as to approach fallopian tubal.It would be recognized by those skilled in the art that although traditional hysteroscope is mainly used Assess and maintain the health in uterus, but due to recently in smaller invasive sterile surgical (for example, Essure and Adian (operation Period fallopian tubal is deliberately occluded)) in terms of progress, it is a large amount of (for example, up to 7500) gynaecology cures only for Essure Raw and reproductive endocrine expert has used hysteroscope, and to visualize, simultaneously Via vagina is close to enter fallopian tubal.Of the invention certain In embodiment, the invention proposes the service aisles for using hysteroscope.Once gynaecologist or reproductive endocrine expert possess or It rents hysteroscope (and relevant asset equipment), they just utilize the service aisle of hysteroscope freely to use wound of the invention The property made operation, because they are not limited in the operative connection that hysteroscope progress can be used.It is worth noting that, this Invention can use the service aisle of any conduit, this can visualize and obtain the access into intrauterine fallopian tubal mouth.

According to one embodiment, the present invention provides a kind of hydraulic drive equipment, using the service aisle of hysteroscope come Into the mouth of fallopian tubal.For this purpose, Fig. 2 shows hydraulic feed device 100, with handle portion 102, shaft portion 104 and close Envelope forms part 106.As shown in Figure 2 A, it illustrates the enlarged view of the end of hydraulic feed device 100, device 100 includes Sub-component 108 and pouch 110 is imaged.

Referring back to Fig. 2, handle portion 102 can be equipped with hydraulic pressure port 112, which is designed to from hydraulic thrust Hydraulic propellant (for example, salting liquid) is received into agent reservoir (for example, syringe).Hydraulic pressure port 112 preferably communicatively joins It is connected to hydraulic pressure lumen (for simplified illustration, being not shown), which passes through shaft portion 104 from handle portion 102 and extend to The position near sub-component 108 is imaged.

Similarly, electric wire 118 extends through shaft portion 104 from handle portion 102, and is communicatively coupled to imaging subgroup Part 108.Electric wire 118 enters handle portion being electrically accessed at port 114, this is electrically accessed port and is connected to guidewire lumen.Electric wire 118 It is arranged in guidewire lumen, guidewire lumen also passes through shaft portion 104 from handle portion 102 and extends near imaging sub-component 108 Position.

The sealing of Fig. 2 formed port 116 facilitate at the mouth 18 (see Fig. 1) of fallopian tubal 12 or fallopian tubal proximal region The step of sealing is formed inside domain.These anatomical structures are shown in FIG. 1.Specifically, the sealing of Fig. 2 forms the connection of port 116 Ground is connected to sealing and forms lumen (for simplified illustration, being not shown), which forms necessity that lumen will be used to form sealing Material is transported to sealing and forms part 106.In a preferred embodiment, it is inflatable body that sealing of the invention, which forms part 106, And sealing and forming port 116 is inflatable port.In these embodiments, sealing formed lumen be designed to transmission make to fill The air or other gases of gas ontology inflation, and sealing forms lumen and is properly termed as " inflation lumen ".

Other than above-described one or more ports and lumen, handle portion 102 is preferably included: shell 120, For coil 118' to be held in place；And conducting wire retraction mechanism 122, for (being shown in device 100 in Fig. 3 with equipment 200) Mode of operation under withdraw by the conducting wire of hydraulic drive.For simplified illustration, all features of shell 120, and this is not shown Field is it will be recognized that in a preferred embodiment of the invention, conducting wire retraction mechanism 122, which is similar to, to be had for dishing out With the fishing rod for the drum mechanism built for withdrawing fishing line.In this embodiment, retraction mechanism 122 includes flexible wire 118 and can From the reel of advanced state backrush flexible wire.During the mode of operation of device 100, when starting reel, sub-component is imaged 108 are preferably recovered in handle portion 102 from advanced state.

In another embodiment of the invention, retraction mechanism 122 includes the reel electrically activated, from the advanced state of reel Electrically activate the withdrawal of reel.In this embodiment, equipment of the invention includes pressure sensor, for passing pressure measurements It is defeated to electrically activating drum mechanism built, to electrically activate drum mechanism built if pressure is more than scheduled pressure value and just stop being retracted into As sub-component 108.Pressure sensor can be designed to that sensing is applied to imaging when withdrawing imaging sub-component from narrow body cavity Pressure on sub-component 108.

As a part of shaft portion 104, sealing forms part 106 (for example, inflatable body) and is located at handle portion 102 Outside and distal side.In such configuration and when device 100 is in mode of operation, imaging moiety 108 and hydraulic drive agent The internal diameter of lumen forms sealing, as shown in Figure 2 A.As in conjunction with explaining Fig. 3, this sealing allows imaging moiety 108 hereinafter Hydraulic drive.In other embodiments of the invention, device 100 includes locking mechanism, which locks imaging moiety 108 It is scheduled in the internal diameter of hydraulic drive agent lumen, until reaching required pressure to be able to carry out hydraulic drive.

Imaging sub-component 108 preferably includes imaging sensor and light source.Imaging sensor, which can be, can sense image Any object.In a preferred embodiment of the invention, imaging sensor includes concentrating at least selected from the group being made up of One component: charge-coupled device (CCD), complementary metal oxide semiconductor (CMOS) and optical fiber.Light source includes optical fiber source Or light emitting diode (" LED ").

In certain embodiments of the present invention, inflatable articles accommodate imaging sensor and light source, so that working as inflatable When body is inflated, imaging sensor is positioned at or near the substantially focal length far from narrow body lumen, to allow the poly- of narrow body lumen Coke imaging.In this embodiment, focal length is related with imaging sensor.If imaging sensor is camera, referred herein Focal length is the focal length of camera.

As best seen in Fig. 2A, a part of the protection imaging sub-component 108 of pouch 110.In an implementation of the invention In example, pouch 110 is coated with lubricant, passes through narrow body lumen in order to hydraulic drive pouch or withdraws pouch.

Pouch 110 preferably encapsulates wireless transmitter, for being wirelessly transmitted by the imaging sensor of imaging sub-component 108 Captured image.In certain preferred embodiments, pouch 110 of the invention encapsulates pressure sensor, pressure sensor sensing The pressure size being applied in narrow body lumen, to determine in narrow body lumen with the presence or absence of obstruction.

Pouch 110 is substantially circular, and therefore avoids tissue trauma, this wound be previously attempted it is direct The shortcomings that visualization device.In addition, pouch 110 keeps imaging moiety 108 at its center.Imaging moiety 108 is in pouch 110 Positioning overcomes the disadvantage that fallopian tubal is suspended in the distal end of conduit, prevents focal length not enough and therefore shoots unsharp Image.

In one embodiment of the invention, pouch 110 is designed to encapsulation inflatable body, with enhancing imaging The buoyancy for the part that component 108 is unfolded in narrow body lumen during hydraulic drive.In such embodiments, capsule of the invention Bag 110 is conducive to the hydraulic drive for the imaging moiety being pushed into, because inflatable body is easier pouch by hydraulic drive Agent carries.

In certain embodiments of the present invention, pouch 110 encapsulate microgenerator, using hydraulic drive agent be light source or Imaging sensor provides electric power.In this embodiment, hydraulic energy is converted into electric energy by microgenerator of the invention.Then, sharp It is powered with the imaging moiety 108 that the electric energy is equipment.In other embodiments of the invention, 110 packaged fiber of pouch, passes through It sends imaging signal to out of pouch positioned at pouch 110 is outer and the imaging sensor in 102 distal side of handle portion is conducive into Picture.

Fig. 2 B shows the end of the device 100 of alternate embodiment according to the present invention, and wherein optical fiber 111 is for being imaged. In this embodiment, during the mode of operation of device 100, captured image signal is transferred to positioned at device 100 by optical fiber 111 Axis 104 outside and nearside imaging sensor.Because the ready-made optical fiber of standard with the outer diameter less than 0.5mm can be found, So the diameter of the pouch 110 of the present embodiment can reduce, because it does not include sensor.Therefore, the end of the embodiment is more It is easy navigation and passes through the narrow zigzag path of fallopian tubal, and indicate alternate embodiment of the invention using optical fiber 111.

Fig. 3 shows a part of device 200 (it is the mode of operation of device 100) according to an embodiment of the present invention.Dress Setting 200 includes that flexible wire 218, fallopian tubal enter equipment 228, shaft portion 204, sealing form part 206, imaging sub-component 208 and pouch 210.Conducting wire 218, the sealing of shaft portion 204 form part 206, imaging sub-component 208 and the substantially class of pouch 210 Be similar to it is shown in FIG. 1 they counterpart (that is, conducting wire 118, shaft portion 104, sealing formed part 106, imaging sub-component 108 With pouch 110), in addition to device 200 shows the imaging sub-component 208 during the mode of operation of equipment 200 by hydraulic drive With pouch 210.In a preferred embodiment of the invention, device 200 includes the sail part around imaging sub-component 208, is made When proper imaging sub-component is by hydraulic drive, the expansion of sail part is to enhance the hydraulic drive that sub-component is imaged.

Although describing hydraulic drive in conjunction with Fig. 2, Fig. 2A, Fig. 2 B and Fig. 3 to promote imaging sub-component 108, imaging fibre 111 or pouch 110, but other preferred embodiments of the invention are imagined therapeutant hydraulic drive into narrow body lumen.At this In kind embodiment, there is no imaging sub-component 108, imaging fibre 111 or pouches 110, and are electrically accessed the treated end in port 114 Mouth replaces.In addition, treatment port is communicatively coupled to treatment lumen, the treatment lumen is instead of guidewire lumen.It is explained in detail below Effective treatment contemplated by the present invention.In another embodiment of the invention, electric port and treatment port coexist, to allow throwing Direct visualizztion when sending therapeutant.

In order to effectively maintain fallopian tubal, the present invention also provides the imaging of non-hydraulic propulsion or therapeutic devices.In this hair In bright some embodiments, seal wire and/or the conduit being located on seal wire are conducive to be imaged or treat.In other embodiments, Guidewire lumen of the invention is conducive to therapy intervention.

Fig. 4 A shows two according to certain embodiments of the present invention different oval protective covers, is shown as single A part of distal end 326, the protective cover can be designed as the diagnostic imaging device based on seal wire or be used as base In the therapy intervention device of guidewire lumen.Fig. 4 B shows the top view of distal end 326', other than in different orientations, The distal end is identical as distal end 326.Although two different protective covers are (that is, the first protective cover 330 and in Figure 4 A Two protective cover 330') it is shown as a part of single distal end 326, but those skilled in the art will appreciate that in this hair A protective cover is only needed in the bright embodiment.

As shown in Figure 4 A, the distal end 326 of conduit of the invention include shaft portion 304, one or more light source 332, Imaging moiety 308 and seal wire 334.For example, seal wire 334 guides conduit of the invention during intratubal imaging operation.

However, according to an embodiment of the invention, seal wire 334 is preferably designed to provide light or can sense image. For this purpose, seal wire 334 may include illumination fiber or imaging fiber.If conduit of the invention includes illumination fiber, grasping The related seal wire of the conduit is guided to may include imaging fiber during work.Alternatively, if conduit of the invention includes that imaging is fine Dimension, then relevant seal wire 334 may include illumination fiber.According to the present invention, in this way, for execute illumination functions and The structure of imaging function can be distributed between the relative seal wire of conduit.Light source is separated into permission equipment with imaging sensor The amount and angle of light needed for user controls the apparent image of capture are (similar to the Professional Photography device with external flashing lamp Material).

In certain embodiments of the present invention, seal wire 334 includes the optical fiber for providing light in order to imaging, and can be with It is made of optical fiber.According to one embodiment of present invention, during the mode of operation of the device with distal end 326, seal wire 334 position outside fallopian tubal extends to the another location inside fallopian tubal, so that light is from the location transmission outside fallopian tubal Position inside to fallopian tubal.Light source is set to stay in the heat exposure outside fallopian tubal by reduction to fallopian tubal.

In at least some embodiments of conduit of the invention, seal wire 334 includes along the multiple substantially saturating of guidewire length Bright part.Each of multiple substantially transparent parts allow light through.During the mode of operation of conduit, each substantially transparent Illuminate the multiple and different positions neighbouring with substantially transparent part along fallopian tubal length in part.In this embodiment, luminous two And therefore pole pipe (" LED ") can be located at seal wire end or surrounding, from the incident light that LED is issued from substantially transparent part It projects and illuminates tissue.

Conduit of the invention may further include positioned at the proximal end of catheter shaft (for example, 104 of Fig. 2) or positioned at leading The internal imaging sensor of the handle portion (for example, 102 of Fig. 2) of pipe.In these constructions of conduit of the invention, mention above And imaging fiber extend along the length of catheter shaft so that during the mode of operation of conduit, imaging fiber will be by that will be imaged Signal is sent to imaging sensor from the distal end of conduit and is conducive to be imaged.Sensor is retained in outer catheter shaft to reduce The outer diameter of conduit, and to allow doctor more easily to navigate fallopian tubal and a possibility that reduce tissue trauma.

In alternative embodiments of the present invention, conduit may further include the imaging sensor for sensing image.? In the embodiment, imaging sensor is located at the distal end of catheter shaft, so that during the operation of conduit, by imaging sensor The image of the fallopian tubal of sensing is transferred to by imaging fiber or by electric wire (it extends along the length of catheter shaft) positioned at defeated Display unit outside oviduct.Although this construction may increase the outer diameter of conduit, when sensor is positioned closer to just In the image of shooting, clearer image is provided.

During the mode of operation of device, the protective cover 330 or 330' of Fig. 4 A preferably protect imaging sensor and/or at As fiber, and approximate focal length is further provided between imaging sensor and/or imaging fiber and fallopian tubal (with image sensing Device is related), to obtain the image substantially focused.Protective cover 330 of the invention or 330' overcome fallopian tubal and are suspended on conduit Disadvantage on end, the disadvantage make it difficult to capture clearly image.

In other embodiments, conduit of the invention may include light source (for example, light source 332 shown in Fig. 4 A), should Light source is located at the distal end of catheter shaft, so that the protective cover (for example, protective cover 330 or 330' of Fig. 4 A) of substantially transparent is protected Imaging sensor and/or imaging fiber are protected, and light source is located at the outside of protective cover, as shown in Figure 4 A.Since presence is substantially saturating Bright protective cover, the embodiment prevent the illumination of fallopian tubal abnormal.

Present invention recognizes that during imaging operation, oviduct tissue may be folded on light source and stop to illuminate, and from And prevent the suitable radiation of target position.In alternative embodiments, conduit of the invention may include the protection by substantially transparent Cover the light source of protection.In this embodiment, the presence of protective cover prevents oviduct tissue to be folded on light source and stops light source.

In order to reduce the wind that the tubal perforation during imaging operation encountered is attempted in certain imagings as discussed above Danger, conduit of the invention may include pressure sensor.In an embodiment of this embodiment, pressure sensor is located at At the distal end of seal wire and/or conduit.During imaging operation, pressure sensor can be measured and be applied by seal wire and/or conduit The pressure value being added on fallopian tubal.Pressure sensor can be communicably coupled to processor, and the processor is during imaging operation Alarm signal is provided.If be equal to during imaging operation by the pressure value that seal wire and/or conduit apply inside fallopian tubal or More than scheduled unacceptable pressure value, then processor provides alarm signal (for example, on starting handle to the user of conduit Red warning lamp).

Conduit of the invention may further include guidewire lumen, wherein defining for seal wire (for example, the seal wire of Fig. 4 A 334) channel.During the mode of operation of conduit, and inside guidewire lumen be not present seal wire in the case where (for example, working as When imaging operation is over), therapeutant can be transported to fallopian tubal by the channel inside guidewire lumen.

Therapeutant includes at least one component in the group collection being made up of: anti-inflammatory agent, biological absorbable support With the inflatable body of drug coat.In certain embodiments of the present invention, liquid anti-inflammatory agent is locally delivered to illness portion Position.The main reason for inflammation (may be caused by infection) is considered as tubal occlusion.

It include in those of biological absorbable support embodiment in wherein therapeutant of the invention, bracket can be to fallopian tubal Mechanical support and drug are provided, drug therapy local disease simultaneously prevents occlusion from recurring.Optionally, bracket can be biological absorbable 's.In such embodiments, it is absorbed by the body in bracket and after disease cured, ovum can be worn from ovary incessantly It crosses fallopian tubal and is transmitted to uterus.

About the inflatable body of drug coat, during the mode of operation of conduit, when inflatable body (such as sacculus) When expansion, the clast that is found in fallopian tubal may the power as needed for making balloon inflation and shift.In addition, inflatable body can To be located in partial blockage object.In this case, expansive force will apply enough mechanical forces to obturator, and be used to remove Obturator.

In addition, the medication coat (for example, anti-inflammatory agent) in inflatable body prevents those obturators from being enough to allow to be pregnant Time in recurrence.On the other hand, it for treating the sacculus of the drug coat of coronary artery disease, faces and finally drug is discharged The challenge of the continuous blood flow of artery.Therefore, patient only temporarily sees the benefit for the treatment of, wherein the treatment of coronary artery disease It needs to continue in the service life of patient.On the contrary, fallopian tubal is not fluid filling.Therefore, drug will be in the trouble of fallopian tubal Lesion lasts much longer in domain.In addition, the influence of drug need to only continue to keep patient's pregnancy so long time (average 0 to 12 months).If drug has dissipated and obturator occurs in some time after pregnancy, those obturators will not be to patient Cause any pain or discomfort.

Fig. 5 A shows conical shape distal end 426 according to an embodiment of the invention.Conical shape distal end 426 It is preferably based upon a part of the diagnostic imaging device of seal wire or is based in the therapy intervention device of guidewire lumen.

Embodiment regardless of distal end 426, it includes shaft portion 404,432 (label of one or more light sources In Fig. 5), imaging moiety 408, protective cover 430 and seal wire 434, it is all these to be all substantially similar to shown in Fig. 4 A them Counterpart (that is, respectively shaft portion 304, one or more light source 332, imaging moiety 308, protective cover 330 and seal wire 334) it, is provided provided by the oval distal end with Fig. 4 A in addition to Fig. 5 A shows conical shape distal end to imaging sensor The different focal length of focal length, and protective cover 430 has ingate 436 defined therein and outlet opening 438.In the imaging operation phase Between, being located in the seal wire 434 outside protective cover 430 can be entered by ingate 436 and be left from outlet opening 438.In other words It says, hole 436 and 438 allows seal wire 434 to pass through protective cover 430, and enters the position positioned at 430 distal side of protective cover in fallopian tubal It sets.If necessary to additional distance to capture clearly image, this will allow doctor to push away tubal wall using seal wire.

In addition, cone shape can introduce less tissue trauma than oval protective cover.Fig. 5 B is distal end 426' Top view, the distal end is identical as distal end 426 shown in Fig. 5 A, in addition to distal end 426' has and distal end 426 different orientations.

At least some embodiments of the invention additionally provide the diagnostic imaging device for being not based on seal wire or are not based on wire leading pipe The therapy intervention device of chamber.The diagnostic imaging device for being not based on seal wire includes sensing lumen, solution lumen and optional treatment tube Chamber.Sensing lumen then includes sensing part and inflatable part.Sensing part can sense the information (example about fallopian tubal Such as, image-forming information).

Solution lumen is designed to provide the solution for helping to execute sensing by sensing part.Solution is also designed for rinsing defeated Oviduct eliminates remaining blood and mucus, and otherwise they can make image fuzzy.In addition, the presence of solution has conducive to fallopian tubal Expansion, and thereby reduce the chance for causing perforation.Finally, to discuss used in therapeutic device treatment molten for more in detail above Liquid.

During the mode of operation for the diagnostic device for being not based on seal wire, inflatable partial inflation is with the shape around sensing part At space, so that sensing part senses the information about fallopian tubal there are solution, including but not limited to sterilizing is planted Enter the presence of the obturator of object and Lock-in.The space allows to have enough cokes between sensing part and tubal wall Away from, with facilitate capture clearly image (for example, if sensing part be normalized optical camera or light wave scattering optical system, Can shooting clear image).However, inflatable part forms close if sensing part is made of acoustic imaging system Envelope, so that can be filled can be with the liquid medium of conduct acoustic waves for fallopian tubal.

Sensing part may include selected from be made up of group collection at least one component: light source, camera, acoustics at As system and scattering photoimaging systems.Certain technologies currently used for angiocarpy imaging are (for example, intravascular ultrasound (" IVUS ") Light scattering and acoustic imaging techniques is utilized with optical coherence tomography (" OCT ")), but they are made due to their rigidity Itself it is unsuitable for that fallopian tubal is imaged.In addition, current cardiovascular IVUS conduit cannot be created a seal in non-streaming itself The structure imaging of body filling, because sound wave will not be propagated in the case where no medium.It is worth noting that, because fallopian tubal It is that nonfluid is filled, so before it can occur using acoustic imaging, it is necessary to be formed and seal and liquid medium must be used (such as salt water) fills fallopian tubal.Even, these conduits have relatively large size, this makes it difficult to close to narrow complications The length of fallopian tubal.

For this purpose, the invention proposes can improve IVUS's and OCT in a manner of consistent from the conduit of different related inventions Catheter design.The conduit of invention described herein is not limited to IVUS and OCT application, and the conduit and other optical imageries Technology (for example, the imaging executed by complementary metal oxide semiconductor (" CMOS ") or optical fiber) cooperating.According to preferred Embodiment, conduit of the invention include unique hurtless measure end as described below and/or inflatable body.

The information about fallopian tubal is provided by the image-forming information of image section 508 (Fig. 6 A) acquisition, such as Lock-in Obturator, inflammation, hydrosalpinx, the sterilizing implantation material and diseases of fallopian tubes being operably placed in fallopian tubal.It is this Information is especially valuable when diagnosing fallopian tubal illness, and if desired, allows disease specific therapy intervention.

Fig. 6 A shows the diagnostic device for being not based on seal wire, and wherein sensing part senses the image information about fallopian tubal, Allow diagnosis disease.Specifically, Fig. 6 A is unaerated conical shape distal according to an embodiment of the invention end 526 Side view, be preferably used in the diagnostic imaging device for being not based on seal wire or be not based on the therapy intervention device of guidewire lumen In.Distal end 526 includes imaging moiety 508, inflatable part 506 and shaft portion 504.Imaging moiety 508 and shaft portion 504 Their corresponding part (that is, imaging moiety 408 and shaft portion 404) being substantially similar in Fig. 5 A, in addition to the axle portion of Fig. 5 A Dividing 404 includes seal wire 434.

According at least one embodiment, distal end of the invention includes the pressure sensing at the distal end of conduit Device, and it is designed to measure the pressure value applied during the mode of operation of device by conduit.Warning user described above The sensor characteristics of improper excess pressure can also be in conjunction in this embodiment.

Fig. 6 B is that the conical shape distal end of Fig. 6 A is in the side view of its inflated condition.Filling in its inflated condition Gas part 506 (that is, inflatable part 506' of Fig. 6 B) has hurtless measure shape, this be it is a kind of selected from by conical, oval and The shape that the group of cheese composition is concentrated.

Fig. 7 A is the side view of the oval distal end 626 of another unaerated according to an embodiment of the present invention, preferably In the diagnostic imaging device for be not based on seal wire or it is not based in the therapy intervention device of guidewire lumen.626 base of distal end This is similar to the distal end 526 of Fig. 6 A (that is, imaging moiety 608 and shaft portion 604 are substantially similar to the imaging moiety of Fig. 6 A 508 and shaft portion 504), in addition to Fig. 7 A inflatable part 606 have the shape different from the inflatable part 506 of Fig. 6 A.It can Shape difference between injection section 506 and 606 is under their own inflated condition it is obvious that and can correspond to difference Focal length and different tissue trauma amounts.Fig. 7 B is the side view of oval distal end 626', is the distal end 626 of Fig. 7 A Inflated condition.

Fig. 8 A is the side view of unaerated cheese distal end 726 according to an embodiment of the present invention, is preferably used in It is not based in the diagnostic imaging device of seal wire or is not based in the therapy intervention device of guidewire lumen.Distal end 726 is substantially Similar to Fig. 6 A distal end 526 (that is, imaging moiety 708 and shaft portion 704 are substantially similar to the imaging moiety of Fig. 6 A 508 and shaft portion 504), in addition to Fig. 8 A inflatable part 706 have the shape different from the inflatable part 506 of Fig. 6 A.With Difference between inflatable part 506 and 606 is the same, and the shape difference between inflatable part 506,606 and 706 is each at them From inflated condition under it is apparent.Fig. 8 B is the side view of oval distal end 726', is filling for the distal end 726 of Fig. 7 A Gaseity.

Fig. 8 C shows the distal end 826 of inflation according to an embodiment of the present invention, and (which is substantially similar to filling for Fig. 8 B The distal end 726' of gas) in certain main components.Fig. 8 C show be preferably included in inflatable part 806 more in detail Thin structure.According to Fig. 8 C, inflatable part 806 includes inflatable part 806A and non-inflatable part 806B.In device During mode of operation, inflatable part 806A inflation, rather than inflatable part 806B is non-aerating, but is used to be inflatable part 806 provide mechanical support.

Fig. 9 shows process flow diagram flow chart 900 according to an embodiment of the present invention, is diagnosed into using hydraulic-feed mechanism Picture.Preferably, process 900 starts from step 902, which includes: to establish outside narrow body lumen to the nearside of narrow body lumen Region or channel close to the region of narrow body lumen.For example, it is visualized and is obtained defeated into intrauterine using hysteroscope The access of oviduct mouth.In this case, the service aisle of hysteroscope establish step 902 outside fallopian tubal to intrauterine The channel of fallopian tubal mouth.

Then, the step 904 of Fig. 9 includes placing imaging device or therapeutic equipment by channel.Continue the above hysteroscope Example executes step 904 by the way that the shaft portion 104 of the device 100 of Fig. 2 is directed across the service aisle of hysteroscope, until The distal end of shaft portion 104 is located slightly away from the distal end of the service aisle of hysteroscope, or until the distal side of shaft portion 104 End is located near fallopian tubal in region.

In such configuration, the step 906 of Fig. 9 is executed.Step 906 includes: portion's formation sealing in or beyond narrow body lumen, So that narrow body lumen is pressurized to allow at diagnosing image or the treatment of narrow body lumen there are hydraulic drive agent Reason.For example, the sealing of Fig. 2 forms part 106 can be in the fallopian tubal mouth nearside in uterus in order to form sealing in fallopian tubal Or the proximal region intramedullary expansion in fallopian tubal.Sealing will allow pressure to carry out being intended to by the part of hydraulic drive of construction device.

Then, another step 908 of Fig. 9 include: using hydraulic drive agent will include in pouch (the 110 of Fig. 2A) at As part (the 108 of Fig. 2A) or therapeutic equipment hydraulic drive pass through narrow body lumen.For example, the device 200 of Fig. 3 is shown just By the pouch 210 of hydraulic drive, the handle portion 102 of Fig. 2 is attached to by the conducting wire 218 of Fig. 3.Several steps can be taken To help to promote pouch (for example, pouch 210 of Fig. 3).Pouch can be made of the material of substantially transparent, preferably inflate 's.Alternatively, pouch may include inflatable body, such as sacculus, preferably inflate.These steps increase pouch Buoyancy, help the propulsion of pouch.In addition, under its advanced state, the sail part 238 for being attached to imaging sub-component 208 of Fig. 3 By expansion to capture hydraulic drive agent (it is similar to sail of the capture wind-force on sailing boat to push ship to travel forward).

After step 908 and once reach the diseased part of fallopian tubal or the umbrella end of fallopian tubal, the step 910 of Fig. 9 It include: that narrow body lumen is treated or is imaged.As discussed above with reference to Fig. 2, Fig. 2A, Fig. 2 B and Fig. 3, pass through Fig. 2A's Sub-component 108 is imaged to execute imaging.The some embodiments of process in accordance with the present invention 908, imaging executed in a manner of direct motion ( Imaging sub-component 108 pushes ahead period) and/or with retrograde manner (during the withdrawal of imaging sub-component 108) execution.It closes In treatment narrow body lumen once disease state is imaged it is just preferably carried out a kind of therapy, which, which is selected from, is made up of Group collection: salt water is rinsed to remove clast, the anti-inflammatory agent in the form of applicating liquid from fallopian tubal and use inflatable body (example Such as, the sealing of Fig. 2 forms part 104) apply mechanical force to occlusion.

Process 900 preferably ends at the step 912 of Fig. 9, which includes that imaging device is withdrawn from narrow body lumen.It lifts For example, start the retraction mechanism 122 of Fig. 2 to withdraw imaging device from fallopian tubal.Preferably, it is arranged on handle by engagement Drum mechanism built (for example, mechanism 122 of Fig. 2) start retraction mechanism.Alternatively, it can be pulled back towards user dynamic entire Device from narrow body lumen to remove it.

It is worth noting that, the step 902 of Fig. 9 and 904 is optional, and step mentioned above is not needed with any Particular order executes.On the contrary, the sequence of above-mentioned steps represents more preferred embodiment of the invention.Process 900, which can be used, appoints What structure executes, and is not limited to any structure shown in Fig. 2, Fig. 2A, Fig. 2 B and Fig. 3.These structures shown in figure As example, and it is used to help the discussion about process 900.

Figure 10 shows process flow diagram flow chart 1000 according to an embodiment of the present invention, is diagnosed into using thread guide mechanism Picture.Preferably, process 1000 starts from step 1002, which includes establishing outside female anatomy to the close of fallopian tubal The channel of side end region or intrauterine fallopian tubal mouth.In terms of step 1002 is substantially similar to the imaging of the step 902 of Fig. 9.

Then, step 1004 includes manipulation seal wire by the channel arrival intraluminal target position of fallopian tubal, and this is led Silk is capable of providing light or imaging.For example, the seal wire 334 in Fig. 4 A includes that can provide light or can be to defeated ovum to fallopian tubal The fiber optic bundle of pipe imaging.

In such configuration, step 1006 is executed.Step 1006 includes: that the conduit that will be helpful to be imaged or treat is arranged in On seal wire.Whether can be imaged or illuminate according to the seal wire 334 of Fig. 4 A, conduit includes complementary structure to help to be imaged.

Then, another step 1008 includes: that fallopian tubal is imaged using seal wire and conduit.For example, by relative to Conduit (for example, conduit 304 of Fig. 4 A) positioning Fig. 4 A seal wire 334 make appropriate light quantity and angle illuminate fallopian tubal by As part, come imaging needed for executing the step.

Furthermore, it is possible to position protective cover (for example, cover 330 of Fig. 4 A) so that tubal wall and imaging moiety (for example, The imaging moiety 308 of Fig. 4 A) between realize focal length appropriate.

After step 1008, step 1010 includes that seal wire is removed from channel.

The seal wire example for continuing Fig. 4 A, by seal wire 344 from the service aisle for the hysteroscope that the step 1002 of Figure 10 is related to It removes.This allows silk guide passage to be used to delivering therapeutant.

Next step 1012 includes that local treatment object is introduced fallopian tubal by channel.Therapeutant in the step is preferred Ground is introduced by means of additional treatment conduit or is introduced in liquid form by above-mentioned silk guide passage.

Process 1000 preferably ends at step 1014, which includes using local treatment object or the defeated ovum of catheter treatment Pipe.Therapeutant in the step is preferably a kind for the treatment of solution concentrated selected from the group being made up of: applicating liquid form Anti-inflammatory agent, introduce drug coat sacculus (for example, be coated with anti-inflammatory agent), introduce biological absorbable support and use salt water It rinses to remove clast from fallopian tubal.

It is worth noting that, step 1002,1010,1012 and 1014 are optional, and step mentioned above is not required to It to be executed with any particular order.On the contrary, the sequence of above-mentioned steps represents more preferred embodiment of the invention.Of the invention In one preferred embodiment, another step can be added.Specifically, after the imaging that step 1008 is completed terminates, more preferably Ground executes another step, which includes withdrawing conduit from fallopian tubal.Any structure can be used to execute in process 1000, And it is not limited to Fig. 4 A, Fig. 4 B, any structure shown in Fig. 5 A and Fig. 5 B.These structures shown in figure are used as example, and And it is used to help the discussion about process 1000.

Figure 11 A shows the distal end portion of device 1100 according to another embodiment of the present invention.In the embodiment In, inflatable body 1106 (such as sacculus etc.) is sealed to the distal end portion of shaft portion 1104.In the embodiment of Figure 11 A In, distal end portion 1104D constriction, to be conducive to the combination that inflatable body surrounds its periphery.However, the neck down portions are Optionally, because even when it does not have necking down, inflatable body still can be around the outer of the distal end portion of shaft portion Week combines.Combination/sealing can be executed by hot melt and/or adhesive and/or other known combination or encapsulating method.? Shown in embodiment, inflatable body 1106 is PET (polyethylene terephthalate) sacculus, is had in unaerated About 0.038 " outer diameter, however other materials and size can be used.The unaerated outer diameter of inflatable body can be about Value in the range of 0.030 " to about 0.050 ".In the embodiment shown in Figure 11 A, shaft portion 1104 is made and is had by nylon There is the internal diameter of 4French (about 1.33mm).The material and size of shaft portion 1104 can change, because of the life of other relative stiffnesses Object compatibility material can replace nylon, and internal diameter can have value in the range of about 1mm to about 2.5mm.

Inflatable body 1106 is slender body and is squeezed to enter in shaft portion, wherein inflatable body 1106 It is incorporated at the opposite end of pipe 1108 at the distal end portion 1108D of pipe 1108.Hot melt and/or adhesive can be passed through And/or other known combination or encapsulating method executes combination/sealing.Pipe 1108 is rigid.In inflatable body 1106 At the position in the binding site distal side of rigid pipe 1108, flexible pipe 1110 is integrated to the distal end portion of rigid pipe 1108 1108D.Flexible pipe 1110 is flexibly constructed so that when its be inserted into body cavity in when, flexible pipe 1110 can easily be bent with Comply with the nature the curvature of body cavity.In an illustrated embodiment, rigid pipe 1108 is stainless steel tube, with about 0.028 " outer diameter and About 0.020 " internal diameter.But these materials and diameter can change.For example, titanium or other biocompatibility metals or rigidity Polymer can replace stainless steel.Outer diameter can be value in the range of about 0.022 " to about 0.035 ", and internal diameter can be with It is value in the range of about 0.015 " to about 0.028 ".Flexible pipe 1110 in illustrated embodiment is by having about 0.004 " Coil pipe made of the wire of outer diameter.The coil pipe has about 0.020 " internal diameter.But these diameters can change.Example Such as, wire diameter can be value in the range of about 0.002 " to about 0.006 ", and the outer diameter of flexible pipe 1110 can be about Value in the range of 0.022 " to about 0.035 ", and internal diameter can be value in the range of about 0.013 " to about 0.028 ". In addition, flexible pipe can be the pipe made of conforming materials, such as nylon, nylon elastomer (Pebax) or other materials.And And further, flexible pipe does not need to coil, but can be such as braiding, weaving or solid material.

The lumen that visualization instrument 1112 passes through rigid pipe 1108 is received, and can be slided relative to the lumen, with Across flexible pipe 1110 and distad by inflatable body 1106, as described in detail later.In an illustrated embodiment, may be used It is fibrescope depending on changing instrument, the outer diameter with about 0.45mm.However, it is possible to substituted by other visualization instruments, as long as they It is dimensioned to the sliding in rigid pipe 1108 and flexible pipe 1110 and is slided to its distal side.Outer diameter also can change, tool There is value in the range of about 0.30mm to about 0.60mm.

Figure 11 A shows the device 1100 for being in original state before the use, and wherein inflatable body 1106 is not added Pressure.Figure 11 B shows the device 1100 in initial deployment configuration, wherein will fill before device is inserted into nature body cavity It is placed in initial deployment configuration.When being used for operation on fallopian tube, this initial, expanded condition is preferably constructed outside the patient's body, but Be can also be constructed in intrauterine, but need to insertion fallopian tubal mouth in front of.To device pressurization (using such as about preceding embodiment Described pressure source or substitution pressure source), and rigid pipe 1108 is distally advanced relative to shaft portion 1104, so as to axle portion The inflatable body 1106 of inflation is unfolded with dividing the distal part of 1104 distal end 1104DE, as shown in Figure 11 B.In first The inflatable body 1106 of beginning deployed configuration extends certain distance from distal end 1104DE, which is enough by fallopian tubal mouth Or at least enter fallopian tubal mouth.

Once being in initial deployment configuration, device 1108 is just inserted into uterus by vagina (if before initial deployment It is not placed in uterus), and inflatable body 1106 is maneuvered into fallopian tubal mouth 18.Once inflatable body 1106 It is sent in fallopian tubal mouth, while keeping pressure, further distally advances rigid pipe with respect to shaft portion 1104 1108, to be fully deployed inflatable body, as shown in Figure 11 C.Since inflatable body is turned up during expansion, its flexibility permits Perhaps the profile of fallopian tubal is complied with to its hurtless measure.The inflatable body 1106 turned up completely shown in Figure 11 C has enough Length is to pass through fallopian tubal mouth 18 and cross uterotubal junction 19 (see Fig. 1).The distal side of rigid pipe 1108 promotes simultaneously Distally advance flexible pipe 1110, the flexible pipe is unfolded in center inflatable body 1106, to establish visualization instrument The transmittable lumen passed through.

In hurtless measure establish pass through mouth 18 and by uterotubal junction 19 access after, followed by It is pushed on the proximal end part of visualization instrument 1112 and stably keeps shaft portion 1104 and rigid pipe 1108 relatively simultaneously, it will Visualization instrument 1112 is distad pushed away relative to shaft portion 1104, rigid pipe 1108, flexible pipe 1110 and inflatable body 1106 Into.The distal side of distal end and flexible pipe 1110 to inflatable body 1106 promotes the distal end of visualization instrument 1112 (Figure 11 D), wherein it can be advanced to the visualization that fallopian tubal is executed in fallopian tubal.Visualization instrument 1112 can be to dress The distal side for setting 1100 other components freely promotes, and is advanced and holds in the target location along fallopian tubal, umbrella end etc. Degree needed for row visualization.In all configurations shown in Figure 11 B-11D, keep to 1100/ inflatable body 1106 of device Pressurization.Fluid 1114 (for example, salt water, water or other biocompatible fluids) can optionally be pushed or pumped visual Change around instrument 1114 and in pipe 1108 and pipe 1110, to leave pipe 1110 at the distal end and make dilatation tubal, with Further pass through fallopian tubal convenient for the propulsion of visualization instrument 1112.

Although the embodiment of Figure 11 A-11D is described for the navigation of visualization instrument 1112 by fallopian tubal, with elder generation Preceding embodiment is the same, the pipe for example, embodiment can be used for visualizing other body pipes, such as in coronary artery, the urinary tract disappears Change road, lymphatic system or other blood vessels.Further, device 1100 can use in the case where no visualization instrument, or Person can be used for delivering therapeutant, such as therapeutant described in preceding embodiment other than visualization instrument.In the implementation In example, therapeutant can be delivered to the lumen by being formed by rigid pipe 1108 and 1110/ inflatable body 1106 of flexible pipe.

Figure 12 A-12E shows the device 1100 of Figure 11 A-11D in external environment, wherein pipe 1110, inflatable body 1106 and the straight extension of visualization instrument 1112, because they do not comply with the natural torsion of body pipe.Figure 12 A-12B is shown Device under original state.Figure 12 B shows tether 1116, the tether can flexible pipe 1110 distal end portion with can It inflates and extends between the distal end portion (when turning up) of ontology 1106, wherein tether is fixed on these portions at opposite end Part.Tether 1116 is convenient for making the reset of inflatable body 1106 return to shaft portion after completing visualization and/or treatment operation In 1104.It is alternatively possible to be depressurized before inflatable body retraction to device 1100, but it is not required.By relative to Shaft portion 1104 pulls rigid pipe 1108 to nearside, this then pulls flexible pipe 1110 to nearside relative to shaft portion 1104.Pipe 1108,1110 continue to recall to nearside, pull inflatable body 1106 via tether 1116 and return in shaft portion 1104, and thereby It is drawn out fallopian tubal and fallopian tubal mouth, device can be removed from patient's body at this time.Figure 12 C is shown corresponding to shown in Figure 11 B The device 1100 in the initial deployment configuration.Figure 12 D is shown corresponding to device 1100 shown in Figure 11 C, wherein can fill Gas ontology 1106 is in fully extended configuration.Figure 12 E is shown corresponding to the device for being in fully extended configuration shown in Figure 11 D 1100, wherein visualization instrument 1112 extends to the distal side of the distal end of 1106/ flexible pipe 1110 of inflatable body.

Figure 13, which is shown, can use the item that device 1100 according to an embodiment of the present invention executes in process 1300.This A little items are not intended to be limited to the process, for example, because other certain unlisted items will be executed, for example prepare patient；Prepare Device and instrument, surgical operation it is subsequent etc..In item 1302, to device 1100 pressurize, and by device from it is uninflated just Beginning configuration (for example, such as Figure 11 A and Figure 12 A) is configured to initial deployment configuration (for example, as shown in such as Figure 11 B and Figure 12 C).Thing Item 1302 preferably executes before being inserted into device in uterus by vagina, and alternatively can pass through vagina insertion It is executed after into uterus.

During item 1304, once the distal end portion of device has been placed to intrauterine, (this can be by visual Change, guided by instrumentation, be such as but not limited to hysteroscope, fluoroscopy or other visualization mechanisms), just cured by surgery Manipulation device is from birth the inflatable body 1106 of the partially unfolded (partially turning up) to be inserted into the mouth 18 of target fallopian tubal 12. For example, this insertion can be guided by the visualization provided by hysteroscope.

In item 1306, inflatable member is fully deployed and (turns up completely), so that it is above for described in Figure 11 C Mode extends past uterotubal junction 19.While keeping pressurization, rigid pipe 1108 is further relative to shaft portion 1104 distally advance, to be fully deployed inflatable body, as shown in Figure 11 C.Because inflatable body is turned up during expansion, Therefore its flexibility complies with the profile of fallopian tubal with allowing its hurtless measure.The inflatable body turned up completely shown in Figure 11 C 1106 have enough length, to pass through mouth 18 and cross uterotubal junction 19 (see Fig. 1).The distal side of rigid pipe 1108 It promotes while distally advances flexible pipe 1110, the flexible pipe is unfolded in center inflatable body 1106, can with foundation The lumen that can pass through depending on changing instrument.

It in hurtless measure establishes by mouth 18 and after the access of uterotubal junction 19, next in item In 1308,1104 He of shaft portion is stably kept relatively simultaneously by pushing on the proximal end part of visualization instrument 1112 Rigid pipe 1108, by visualization instrument 1112 relative to shaft portion 1104, rigid pipe 1108, flexible pipe 1110 and inflatable body 1106 distally advance.The distal side of distal end and flexible pipe 1110 to inflatable body 1106 promotes visualization instrument 1112 Distal end (Figure 11 D), wherein it can be advanced to the visualization that fallopian tubal is executed in fallopian tubal.In item 1310 Place, visualization instrument 1112 optionally can be promoted and/or be retracted so that interested position visualizes.Visualization instrument 1112 It can freely promote, be advanced in the target along fallopian tubal, umbrella end etc. to the distal side of other components of device 1100 Degree needed for executing visualization at position.What is provided during item 1302-1308 and during subsequent visualization is all In configuration, the pressurization to 1100/ inflatable body 1106 of device is kept.Liquid is (for example, salt water, water or other biocompatibilities Fluid) it can optionally be pushed or pumped around visualization instrument 1114 and in pipe 1108 and pipe 1110, in distal side End leaves pipe 1110 and makes dilatation tubal, to be further convenient for the propulsion of visualization instrument 1112 to pass through fallopian tubal.

In item 1312, when completing visualization operation, visualization instrument 1112 is retracted into shaft portion 1104；Contracting Rigid pipe is returned, so that inflatable member also retracts.Then device 1100 can be removed from uterus in item 1314, and can To execute postoperative surgical.

Figure 14, which is shown, can use what device according to another embodiment of the present invention 1100 executed in process 1400 Item.These items are not intended to be limited to the process, for example, because other certain unlisted items will be executed, for example prepare to suffer from Person；Preparation device and instrument, surgical operation it is subsequent etc..In item 1402, pressurize to device 1100, and device is never added The initial configuration of pressure makes (for example, seeing Figure 11 A and Figure 12 A) and is configured to initial deployment configuration (for example, in such as Figure 11 B and Figure 12 C It is shown).Item 1402 preferably executes before being inserted into device in uterus by vagina, and can alternatively pass through Vagina executes after being inserted into uterus.

During item 1404, once the distal end portion of device has been placed to intrauterine, (this can be by visual Change, guided by instrumentation, be such as but not limited to hysteroscope, fluoroscopy or other visualization mechanisms), just cured by surgery Manipulation device is from birth the inflatable body 1106 of the partially unfolded (partially turning up) to be inserted into the mouth 18 of target fallopian tubal 12. For example, this insertion can be guided by the visualization provided by hysteroscope.

In item 1406, inflatable member is fully deployed and (turns up completely), so that it is above for described in Figure 11 C Mode extends past uterotubal junction 19.While keeping pressurization, rigid pipe 1108 is further relative to shaft portion 1104 distally advance, to be fully deployed inflatable body, as shown in Figure 11 C.Because inflatable body is turned up during expansion, Therefore its flexibility complies with the profile of fallopian tubal with allowing its hurtless measure.The inflatable body turned up completely shown in Figure 11 C 1106 have enough length, to pass through mouth 18 and cross uterotubal junction 19 (see Fig. 1).The distal side of rigid pipe 1108 It promotes while distally advances flexible pipe 1110, the flexible pipe is unfolded in center inflatable body 1106, can with foundation To execute visualization/treatment lumen by it.

It in hurtless measure establishes by mouth 18 and after the access of uterotubal junction 19, in item 1408 In, it can execute than treatment processing as described above.If the therapeutant of application is liquid preparation, can be in item 1408 In by pushing on the proximal end part of visualization instrument 1112 opposite simultaneously stably keep shaft portion 1104 and rigidity Pipe 1108, by visualization instrument 1112 relative to shaft portion 1104, rigid pipe 1108, flexible pipe 1110 and inflatable body 1106 Distally advance, and liquid undergoing treatment object can be pushed or is pumped into around visualization instrument 1114 and pipe 1108 and pipe In 1110, to leave pipe 1110 at the distal end.Liquid undergoing treatment object can be optionally for dilatation tubal be made, with further It promotes convenient for visualization instrument 1112 through fallopian tubal, and/or can optionally use other liquid, such as salt water or water.

In the case where therapeutant to be delivered is not exclusively liquid, for example, being treated in delivering stent or other on-liquids In the case where object, it can be removed from the apparatus visualization instrument 1114, and lumen and flexible pipe 1110 in rigid pipe 1108 It can be used for delivering therapeutant.

When completing treatment operation, visualization instrument (if present) is retracted into shaft portion 1104.It is alternatively possible to Device is depressurized, but is not required.In item 1410, under any circumstance, rigid pipe is retracted, so that inflatable member It retracts.Then device 1100 can be removed from uterus in item 1412, and postoperative surgical can be executed.

Although illustrative embodiments of the disclosure have been shown and described, but expectable other modification, change and Substitution.For example, the example the invention discloses fallopian tubal as the narrow body lumen that can be subjected to maintenance, but other dissections Structure (such as coronary artery to other natural body pipes) can be safeguarded similarly.Therefore, the present invention is suitable for broadly being solved Release, and be suitable for by with disclosure range it is consistent in a manner of explain.Furthermore it is possible to many modifications be carried out, so that specific situation, material Material, material composition, process, process steps or each step adapt to the purpose of the present invention and range.All such modifications, which are intended to, to be fallen Enter in scope of the appended claims.

Claims

1. one kind is used for the device used in narrow body lumen, described device includes:

Outer axial portion；

Pipe, can be contained in the outer axial portion；

Elongate inflatable ontology, has a first end and a second end, and the first end is sealed to the outer axial portion, and described Second end is sealed to the pipe；

Wherein, in initial configuration, the elongate inflatable ontology is contained in the outer axial portion, and wherein, the pipe It can be slided relative to the outer axial portion, it is described to make when the elongate inflatable ontology is moved to outside the outer axial portion Elongate inflatable ontology turns up.

2. the apparatus according to claim 1, wherein described device can pressurize, and the wherein pressurization of described device Inflate the inflatable body.

3. the apparatus of claim 2, wherein the pressurization of described device helps the elongated inflation ontology in institute It states and turns up outside outer axial portion.

4. device according to claim 1 or 2, wherein the pipe can slide so that the inflatable body is selective Ground turns up state or completely to turn up state partially to turn up.

5. device according to claim 1 or 2, wherein the pipe is rigid pipe, and described device further comprises from described The flexible pipe that the distal end of rigid pipe extends.

6. device according to claim 5, wherein when the rigid pipe slides so that the inflatable body is turned up, The flexible pipe slides in the inflatable body.

7. device according to claim 1 or 2 further comprises the visualization instrument that can be contained in the pipe.

8. device according to claim 7, wherein the visualization instrument can be slided relative to the pipe.

9. device according to claim 8, wherein the visualization instrument can be slided, so that working as the inflatable structure Part is in when turning up configuration completely, and the distal end of the visualization instrument extends to the distal side of the inflatable member.

10. device according to claim 7 further comprises by the pressurization between the pipe and the visualization instrument Liquid.

11. device according to claim 10, wherein the fluid under pressure includes treatment preparation.

12. device according to claim 10, wherein the fluid under pressure is constructed such that the narrow body lumen expansion, In order to which the visualization instrument is slided relative to the narrow body lumen.

13. device according to claim 5 further comprises tether, the tether is by the flexible pipe and described fills Gas ontology is connected with each other.

14. device according to claim 1 or 2 further comprises handle portion, the handle portion accommodates one or more A female Luer, one of female Luer are designed to provide the pressure for making described device pressurize.

15. device according to claim 14 further comprises conducting wire female Luer, the conducting wire female Luer is by described Handle portion accommodates, and is designed to provide the conducting wire for being used for transmission electric power and signal, in order to be held by the imaging moiety Row imaging function.

16. device according to claim 1 or 2, wherein the inflatable body includes when turning up completely from fallopian tubal Mouth extends beyond the length of uterotubal junction.

17. device according to claim 7, wherein the visualization instrument includes fibrescope.

18. device according to claim 1 or 2, further comprises,

Pressure sensor；

Wherein the pressure sensor is designed to the pressure that measurement is applied in the narrow body lumen, and if the pressure The scheduled pressure value that equals or exceeds of measurement result, just trigger alarm signal.

19. a kind of process operated in narrow body lumen, the process include:

It pressurizes to device, and described device is configured to initial configuration, wherein inflatable body is partly extended to described device Outer axial portion distal end outside；

The inflatable body that part extends is inserted into the narrow body lumen；

The inflatable body is set to turn up completely, so that the inflatable body is complete outside the distal end of the outer axial portion It is unfolded and further extends into the narrow body lumen；

And at least one of visualization instrument and therapeutant are passed by the opening in the inflatable body to its distal side It is sent in the narrow body lumen.

20. process according to claim 19, wherein the narrow body lumen is fallopian tubal, and the wherein insertion packet It includes and the inflatable body that part extends is inserted into fallopian tubal mouth.

21. process described in 9 or 20 according to claim 1, wherein described to be turned up completely including making outside the inflatable body It turns over, so that it extends past uterotubal junction.

22. process described in 9 or 20 according to claim 1, wherein when delivering the visualization instrument, according to propulsion and contracting At least one of described visualization instrument is returned to move the distal end of the visualization instrument, so that in the narrow body lumen One or more target areas visualization.

23. process described in 9 or 20 according to claim 1, wherein therapeutant is delivered opening by the inflatable body Mouthful, wherein the visualization instrument extends through the opening.

24. process described in 9 or 20 according to claim 1, wherein therapeutant is delivered opening by the inflatable body Mouthful, wherein the visualization instrument does not extend through the opening.

25. process described in 9 or 20 according to claim 1, further comprises: depressurize described device, and by deflation can Inflation ontology is retracted into the outer axial portion.

26. process according to claim 25, wherein the inflatable body is attached to via tether to be contained in outside described Pipe in shaft portion, and wherein, with the help of the tether, the pipe makes to deflate relative to the retraction of the outer axial portion Inflatable body be retracted into the outer axial portion.

27. process described in 9 or 20 according to claim 1, further comprises: the visualization instrument is retracted into the outer shaft In part, described device is depressurized, and the inflatable body of deflation is retracted into the outer axial portion.