CN1938063A - Apparatus for accessing a body cavity and methods of making same - Google Patents

Abstract

Apparatus is provided for accessing a body cavity comprising a tubular member having a deflated insertion configuration and an inflated expanded configuration that facilitates viewing within the body cavity. The apparatus is formed by everting a length of material upon itself to form a tube having a single circumference seam at the distal end, and includes an inflation tube that is sufficiently rigid to assist in inserting the tubular member into a body cavity in the deflated insertion configuration. The tubular member further includes a pattern of staggered contact areas that configured so as to avoid the creation of longitudinal features that preferentially bend when loaded, thereby ensuring that tubular member provides a substantially circular central lumen.

Description

Be used to the method that enters the inflatable device of body cavity and make this device

Technical field

The present invention relates to enter the method and apparatus of body cavity, and especially specifically, relate to the method and apparatus that acquisition enters the path of female urine reproductive tract.

Background technology

Examination per vagina and associated dissection utilize sight glass to carry out usually, thereby this sight glass holds it in the path that swelling state provides vagina then by the vaginal dilation chamber.As employed now, conventional speculum comprises the pair of metal jaw, and this metal jaw is inserted into vaginal canal and is used to open passage then.For most patients, the insertion of sight glass and operation are very uncomfortable and make patient go short of, and make whole inspection very difficult like this, otherwise then can not realize.

Developed sight glass, for example described in the U.S. Patent No. 5716329 of Dieter with inflatable exterior walls.Sight glass described in this patent comprises a rigid interior wall and an inflatable exterior walls, and this inflatable exterior walls utilizes fluid expansion to alleviate the discomfort that expands and cause owing to vaginal canal after insertion.Yet the device described in this patent is quite complicated, and because it has made up reusable and disposable elements, and make and can not commercially use.

Consider low-cost requirement, need a kind of disposable speculum product of commericially feasible, other people attempts to develop a kind of sight glass, comprises inflatable sac or rib, for example in international patent publication WO97/24975 and described in the HOII P No.9100599.Yet the product described in these open files and patent appears not have the actual needed enough expansion strengths of using.

In the U.S. Patent No. 5743852 of Johnson a kind of inflatable speculum has been described, comprise an inflatable cone structure, this cone structure comprises the inner and outer wall element, and is sealed together along the edge of inside and outside wall, and comprises the grid contact area with grid pattern.This patent has been described the insertion rod that is arranged in the sight glass and has been inserted with auxiliary, and engages with outer sheath, and this outer sheath is passed the central chamber of device and regained when insertion rod is regained.Pyramidal structure can be inserted in the expansible sight glass, in case it expands sight glass is remained on swelling state, in addition, and provides supporting for optical fiber source or other apparatus.

The patent of above-mentioned Johnson has appeared to provide relatively and many advantages of other inflatable speculum designs.Yet the structure of insertion rod of being expected and sheath cover is problematic, moves near side (ns) (patient's furthest inside) to from far-end (the most close gynaecologist) during its mesotheca is enclosed within and removes, and can cause over-drastic friction and discomfort.In addition, because disclosed internal supporting structure does not extend to the near-end of sight glass in this patent, possible is to make the sight glass proximal part subside by the patient body applied force.At last, utilize,, but produce scraping patient's cervix uteri and cause the relative stiffness structure of patient's discomfort especially at the sight glass near-end along the edge of the peripheral seal of inner and outer wall element.

The U.S. Patent Publication text US2003/1099737 of Deslauriers etc. has described a kind of inflatable speculum with a plurality of longitudinal extension ribs, arranges that described rib limits Dove prism in the sight glass volume.As in above-mentioned WO open file and HOII P, the appearance of longitudinal rib is to expect according to qualifications the central chamber of sight glass is deformed to narrow ellipse in the Deslauriers device, rather than a round cavity basically is provided.

Consider the defective of above-mentioned known devices, expectation be, the method and apparatus that enters body cavity is provided, it is little and be easy to be inserted into body cavity and be comfortable when inserting body cavity and work.

Further it is desirable for provides the method and apparatus that enters body cavity, provides sufficient intensity will utilize lower cost materials can abandon after single uses to allow device simultaneously with the expansion body cavity.

Also it is desirable for the device that is provided for entering body cavity, it provides enough radial strength with the body cavity that in most of the cases expands, but it can be included in particular cases, is for example checking or is handling in the adiposis patient the other selectable unit of use.

The method that provides processing to enter the device of body cavity also further is provided, and it has eliminated the appearance of longitudinal rib or part basically, and these longitudinal ribs or part cause device at expansible state priority bending, has therefore guaranteed circular basically working chamber.

The method that provides processing to enter the device of body cavity is provided equally, and it has eliminated weld seam or the sealing that occurs along the proximal peripheral of device basically, has therefore reduced the danger of patient's discomfort.

Summary of the invention

In view of aforementioned content, an object of the present invention is to provide the device that is used to enter body cavity, it is little and be easy to insert body cavity and be comfortable when inserting body cavity and work.

Another object of the present invention provides the method and apparatus that enters body cavity, and it provides sufficient intensity will utilize lower cost materials can abandon after single uses to allow device simultaneously with the expansion body cavity.

Another object of the present invention provides the device that is used to enter body cavity, it provides enough radial strength with the body cavity that in most of the cases expands, but it can be included in particular cases, is for example checking or is handling in the adiposis patient the other selectable unit of use.

Further purpose of the present invention provides the method that processing enters the device of body cavity, and it has eliminated the appearance of longitudinal rib or part basically, and these longitudinal ribs or part cause device at expansible state priority bending, has therefore guaranteed circular basically working chamber.

Another purpose of the present invention provides the method that processing enters the device of body cavity, and it has eliminated weld seam or the sealing that occurs along the proximal peripheral of device basically, has therefore reduced the danger of patient's discomfort.

According to principle of the present invention, the device that being used to of being provided enters body cavity comprises the expandable bodies that is formed by single piece of material, described material is rolled and sealed along its remote edge (near doctor physician), therefore eliminated the appearance of distal seal or welded seam area and atraumatic proximal end is provided.Expandable bodies inserts body cavity with deflated configuration, is then inflated to expanded configuration, therefore opens body lumen wall.Expandable bodies comprises that a plurality of contact points of being basically even graphical layout are to allow when expanding basically uniformly pressure distribution in expandable bodies.According to principle of the present invention, contact area is so arranged feasible vertical feature that do not produce basically, but provides circular basically central chamber when expandable bodies is inflated under loading.

Expandable bodies passes and extends into and terminate in inflatable intravital one section hard relatively pipe and be engaged on the aerating device, for example ball or pump.This sucker pushes expandable bodies in the patient aperture to allow the clinicist to apply force on the expandable bodies that is in structure for conveying enough firmly.In addition, a regracting, pre-lubricated sheath can be arranged in the aperture of outside with auxiliary device insertion patient of expandable bodies.

Optionally, this device comprises interior support parts, and it is inserted in after expansion in the central chamber of expandable bodies.Support unit preferably includes a cheap plastic components that is installed on the dilator, is disposed in the sight glass with the radial strength of intensifier then and prevents that the near-end of expandable bodies from subsiding.This optional support unit can be especially favourable be used for adiposis patient.

In certain embodiments, expandable bodies can comprise that one or more interior capsules of central chamber that are arranged in expandable bodies remain on optical fiber source or other apparatus in the inner chamber with permission.In addition, expandable bodies can comprise the one section tube-carrier that extends to the apparatus adjacent near-end to allow emptying during treatment of organs, for example the flue gas that produces during the leep conization.

According to a further aspect in the invention, device can be used for promoting the conveying of medicine at organ or intracavity.In certain embodiments, the outer surface of expandable bodies can apply one or more medicines, and these medicines are gone into patient's tissue by elution when device is arranged into patient's health or organ.In another embodiment, expandable bodies defines one and accepts a cylindrical container, and this cylinder has the drug-filled chambers in one or more expandable bodies inner chambers that are configured to fit in inflation, and a predetermined profile that discharges medicine is provided.

In further another embodiment, device comprises the one handle assembly, and it can be attached to expandable bodies and insert body cavity to promote expandable bodies, or is beneficial to the orientation again in the visual field of the central chamber that passes expandable bodies.

The method of processing device of the present invention also is provided.

Description of drawings

Above-mentioned and other purposes of the present invention and advantage be by considering following detailed description and will be apparent from reference to the accompanying drawings that wherein same Reference numeral is represented same parts all the time, and wherein:

Fig. 1 is the side view that is in the device of the present invention of deflated configuration;

Fig. 2 A and 2B are in the cross-sectional view of the device of aerofluxus and swelling state along view line 2-2 among Fig. 1;

Fig. 3 A and 3B are respectively side view and the end perspective view that is in the expandable bodies of swelling state among Fig. 1;

Fig. 4 is the perspective view that is beneficial to the sheath cover of expandable bodies conveying;

Fig. 5 A-5C is the side view of another design that comprises the gentle suction pipe of optional side capsule of expandable bodies in the depiction 1;

Fig. 6 is used for the supporting member of apparatus of the present invention and the side view of dilator part section;

Fig. 7 rolls expandable bodies to reduce the perspective view of the method for optimizing of patient's discomfort during launching;

Fig. 8 is the flow chart of preferable process of describing the device of shop drawings 1;

Fig. 9 is the side view that comprises the expandable bodies of the present invention of medicine coating or other bioactive substance;

Figure 10 is the cross-sectional view of another embodiment of the present invention's expandable bodies of being suitable for conveying bioactivator;

Figure 11 A-11C is respectively side view and the perspective view that is used for the Handleset of apparatus of the present invention, and describes Handleset and the expandable bodies view as vaginal speculum;

Figure 12 A-12C be respectively be used for apparatus of the present invention another Handleset side view and along the cross-sectional view of the Handleset of line 12B-12B among Figure 12 A and 12C-12C;

Figure 13 A-13C is respectively the side view of element of the Handleset of Figure 12 A, along the cross-sectional view of the element of Figure 13 A center line 13B-13B be used for the sectional view of element of Figure 12 A of the device of Fig. 1;

Figure 14 is the sectional view of another embodiment of the device of Figure 13 C;

Figure 15 A-15E is respectively the sectional view of Figure 12-13 device in patient's vaginal canal, has the sectional view that is arranged in inflatable intravital cylindrical device among Figure 15 A-15B, along the cross-sectional view of the line 15D-15D of Figure 15 C; And the cylindrical end-view of Figure 15 E;

Figure 16 A-16E is respectively the sectional view of patient's vaginal canal, the sectional view of the device of the Figure 15 in vaginal canal and have the sectional view of the device of the cylindrical Figure 15 B-15C in central chamber;

Figure 17 is the sectional view that is used for from the device of Figure 15 of cervix uteri resection organization;

Figure 18 is the sectional view that is used for the device of Figure 15 of delivery of radiation seeds in vaginal canal.

The specific embodiment

With reference to figure 1-3, the device that the present invention constitutes provides and has been used for the body cavity that expands, for example the disposable apparatus that uses of the low-cost single of vaginal canal.Device 10 comprises expandable bodies 11, inserts sheath cover 12, gas tube 13, aerating device 14, valve 15 and isolation cover 16.When utilizing when intuitively being illustrated as globular aerating device 14 inflations, expandable bodies 11 changes expanded configuration (Fig. 2 B) into from flat tubulose (Fig. 2 A) basically.

In expanded configuration, expandable bodies 11 forms the annular body portion 17 that limits central chamber 18, and this central chamber 18 provides doctor physician to enter the passage of the inside of organ or inner chamber.According to an aspect of the present invention, bendable also is hard in addition still during inflatable tube 13, and therefore the power that is applied on the gas tube can be used to expandable bodies is pushed in patient's the hole.Gas tube 13 is inflated or aerofluxuss to allow expandable bodies 11 with the internal communication of main part 17.

Preferably, thus valve 15 does not need balls 14 to keep pressured states for check valve remains on pressure in the main part 17.Valve 15 optionally drives to give main part 17 venting.Ball 14 and valve 15 preferred by the conventional luer means for engaging to gas tube, thereby these parts can remove inflatable tube 13 from expandable bodies 11 and can reuse later on like this.Ball 14 and valve 15 preferred arrangements isolation cover 16 for example in the plastic bag to prevent by patient's humoral pollution.

Insert sheath cover 12 and comprise a light plastic sheath cover, this sheath cover is limited in organ or the inner chamber that punctured position is beneficial to insert patient with expandable bodies 11.Sheath cover 12 comprises the antisitic defect shape of a division round end, and the auxiliary described device of this shape inserts and withdraws from the gas tube far-end during expandable bodies launches.

Describe as Fig. 2 and 3, expandable bodies 11 preferably includes polymeric no latex material (latex-free material) and so forms, and outer wall 20 is connected with inwall 21 at contact area 22 places of a plurality of pillow seaming like this.Preferably, contact area 22 is arranged to even figure to allow the uniform basically pressure distribution of aeration period in expandable bodies 11.In a preferred embodiment, 16 row contact areas are around the circumference of expandable bodies and axially skew.

According to principle of the present invention, contact area row be distributed into axial dipole field or interlaced arrangement to avoid producing vertical feature at expandable bodies.This feature that occurs in existing known devices causes device priority bending and to allow the central chamber torsional deformation be narrow ellipse under load.Yet, strengthened the radial strength of expandable bodies in the inflatable structure at offset grid figure illustrated in fig. 1, and guaranteed that central chamber 18 keeps circle basically at inflated condition even under load.

With reference to figure 3, expandable bodies 11 preferably includes a from one piece, and this single-piece is rolled on himself with formation and is approximately gap between the bimetallic tube of half length of material original paper.So, seam or weld seam 23 only form along an end of expandable bodies, described in Fig. 3 A, preferably at the far-end (near doctor physician) of expandable bodies.This has been avoided seam or weld seam to appear at the near-end 24 of expandable bodies, and has provided soft a, pillow-like atraumatic proximal end, has avoided the danger of scratch or damage organ or interior intraluminal tissue, as shown in Fig. 3 B.

With reference to figure 4, insert sheath cover 12 and comprise a soft polymer tube, heat-shrink tube for example, this pipe remains on the contraction insert structure with expandable bodies 11.Sheath cover 12 comprises that distal end flange 25 provides handle to firmly grasp and to draw back the sheath cover of far-end to the doctor.The seam 26 that sheath cover 12 also is included in the round end 27 allows Bao Ye (leaves) 28 between the seam 26 outwards to open when the withdrawal of sheath cover.

It is preferably lubricated by biocompatible lubricant to insert sheath cover 12, inserts patient's body cavity then, for example vagina.According to an aspect of the present invention, gas tube 13 is enough hard, and this allows the doctor on the other hand expandable bodies stably to be remained in the body cavity, will insert sleeve pipe expandable bodies withdrawal from afar with the another hands simultaneously.To insert the sheath cover then and remove, and then valve 15, ball 14 and isolation cover 16 will be connected to luer and go up to allow expandable bodies to be inflated from luer at the gas tube far-end.

With reference now to Fig. 5 A and 5B,, described being applicable to colposcopy, another embodiment of the expandable bodies of the present invention of leep-conization or other operations.Colposcopy is to utilize glasses or other Optical devices to observe the operation of cervix uteri and vagina, and requires vaginal illumination usually.The Leep-conization is this operation, and wherein electronic snare is used to remove tissue from the inner surface of patient's inner chamber or organ, and causes generating and must discharge so that the flue gas in the visual field clearly to be provided to doctor physician.

In Fig. 5 A and 5B, expandable bodies 30 comprises gas tube 31, has the central chamber 32 of capsule or pipeline 33 and the vacuum-pumping tube 34 that assembles along its length.Pipeline 33 can be used for that for example optical fiber source or other apparatus are fixed on appropriate position in the central chamber 32 with instrument 35.Vacuum-pumping tube 34 preferably along the length of expandable bodies 30 extend and comprise a distance terminal, this distance terminal allow pipe 34 be connected with suitable vacuum source with in operation in the body cavity discharge flue gas or gas.Advantageously, pipeline 33 and vacuum-pumping tube 34 hands that discharged doctor physician makes it to do other thing.In addition, thereby help the operation of requirement vaginal illumination, and pipeline 33 is used to keep other apparatus for the light source of body cavity illumination can replace vacuum-pumping tube 34.

With reference to figure 6, optional support unit 40 of the present invention has been described.People, especially certain section of obese women goes up observedly at duration of test first, and expandable bodies of the present invention can not provide enough radial strengths, thereby the clear visual field of passing central chamber can not be provided.In Fig. 6, support unit 41 comprises the hard disposable plastic pipe 42 with distal end flange 43 and central chamber 44.Pipe 42 is sized to dilator 45 is received in the central chamber 44.Dilator comprises smooth proximal end 46, flange 47 and handle 48.Flange 47 is configured to abut against flange 43, is applied to urges dilator 45 and the pipe 42 in the central chamber of the expandable bodies of Fig. 1 device on the handle 48 like this.

What describe now is the vaginal speculum that device in the illustrative Fig. 1 of utilization and 6 is used for obese women.At first, be arranged in the expandable bodies that inserts in the sheath cover 12 and be inserted into vagina.When insertion tube is drawn back from afar, gas tube 13 is maintained fixed then.Ball 14, valve 15 and isolation cover 16 are connected to the luer terminal of inflatable tube 13 and inflate to expandable bodies then.To be furnished with on it that pipe dilator of 42 45 inserts the central chamber of expandable bodies and then by applying to proximad power to handle 48 and pushed away forward.In case dilator 45 and pipe 42 are fully inserted into, and extract dilator 45 out, pipe 42 is stayed the appropriate position in the central chamber of expandable bodies.Advantageously, because pipe 42 preferably extends to the near-end of expandable bodies, this provides until the Cervical clear visual field.

With reference to figure 7, the expandable bodies rolled among Fig. 1 has been described to reduce the method for optimizing of sense of discomfort upon deployment.Present inventors have observed that, in conventional jaw formula (jaw-type) sight glass, by jaw apply advocate will forward direction and the back to.What can believe is to be considered to cause discomfort because be applied to the edgewise power of vagina.Therefore, according to an aspect of the present invention, expandable bodies at first is flattened, and is rolled into the S type structure with preceding guide vane A and backward curved vane P then, as depicted in figure 7.When rolling in this way, be applied to during expandable bodies launches on the vaginal wall advocate will be in forward direction and back to, therefore reduced the discomfort of patient when device expands.

With reference now to Fig. 8,, the method for installing among the construction drawing 1-3 has been described.In step 50, the rectangular-shaped piece of plastic sheet, the urethanes of 8 mils for example is cut into the size of requirement.For example, if expandable bodies is made with the nominal length of 12cm and the swell diameter of 3.8cm, then corresponding thin film size can be 15cm * 23cm.In step 51, sheet material is formed cylinder, and forms a longitudinal seam.In step 51, the gas tube of certain-length is attached to far-end 1/2nd length of cylinder outside.In step 53, cylindrical near-end 1/2nd length are rolls-up onto on the cylindrical far-end 1/2nd to form double-walled annular tube.

In step 54, therefore far-end formation sealing and weld seam in double-walled annular tube form sealed tube.As mentioned above, the weld seam that only has at the far-end of expandable bodies provides slick, atraumatic proximal end to expandable bodies.In step 55, the pattern of contact area is shaped along the length and the circumference of double-walled annular tube, to form expandable bodies.Similarly, as described above, contact area axial dipole field or staggered, when expansion of inflatable body, the not preferential significantly vertically feature that allows canal curvature or part to collapse forms, as in the design known to former like this.

In step 56, on gas tube, use isolation cover 16, and in step 57, can be with the far-end of luer terminal applies at gas tube.Alternatively, can use the luer terminal, and use isolation cover after a while, for example after insertion tube is removed.After expansible elements was finished, in step 57, it can be rolled into S shape structure, as described with reference to figure 7, and be inserted into one in step 58 and inserted in the sheath cover.In step subsequently, insertion tube heated make it to shrink down on the expandable bodies the packaged and sterilization of this device then.

With reference to figure 9, another embodiment of expandable bodies of the present invention has been described.The similar of the embodiment of expandable bodies 60 and above-mentioned Fig. 1 comprises in addition still and holds medicine that for example antibiotic coating 61 is used in body cavity or interior intracavity local allocation.In addition, coating 61 can comprise gene vector (gene vetor) or protein coat.By coating is provided on outer wall, medicine, gene vector or protein can be delivered directly to vaginal wall during inspection and treatment.As an example, coating 61 can comprise novocaine, contraceptive, fertilization preparations, coagulant and range gene and protein.Depend on how various medicines, gene and proteinic medicinal property (pharmicokinetics) and they are absorbed, and coating 61 can comprise more than a kind of medicine that is transported to vagina in vagina.

In order to be beneficial to medicine, gene or proteinic conveying, can on outer wall, provide feature (feature) or figure.Alternatively, coating 61 can be slick and polish in being exposed to water the time, therefore reduces the frictional force that suffers from when device inserts.As another selection scheme, device elder generation's preliminary wetting in warm water before insertion keeps the heat of some warm water to reduce patient's discomfort because wish expandable bodies.

In another possibility that Figure 10 described, expandable bodies 63 comprises internal layer 64a, intermediate layer 64b and outer 64c.Internal layer 64a and intermediate layer 64b are corresponding to inwall among the embodiment of Fig. 2 A 21 and outer wall 20, and outer 64c comprises many micropores 65.Endless belt between internal layer 64a and the intermediate layer 64b is full of the gas or the liquid of expansion expandable bodies 63, and the endless belt between intermediate layer 64b and outer 64c forms capsule 66, and this capsule can inject medicine, protein or the gene vector of fluid or gel form.When expandable bodies expanded in patient's body cavity, medicine, protein or the gene vector in the capsule 66 was forced through micropore 65 and is transported on the wall of body cavity.

With reference to the embodiment of figure 9 and 10, coating 61 or capsule 66 can comprise the medicine that is used to handle yeast infection, for example terconazole (triaconazole), fluconazol, miconazole and Gynazole.In addition, coating 61 or capsule 66 can comprise the medicine that is used to handle bacterial infection, for example metronidazole and clindamycin.

Figure 11 A-11C has described to be used for the structure with reference to the Handleset 70 of the described expandable bodies 11 of figure 1-3.Handleset 70 comprises intravaginal processus hyoideus part 71 and is used to control grip portions 72 with the operating grip assembly.Processus hyoideus part 71 comprises front surface 71a, and it is preferably the outline of concave surface with coupling expandable bodies 11.Handleset 70 promotes the insertion of exhaust apparatus and the operation that vagina is dissected.Processus hyoideus part 71 preferably includes and is configured to the lip 73 that engages with patient's vaginal canal, thereby cervix uteri can be operated with visual.

With reference to figure 11A, the relative grip portions 72 angled X of processus hyoideus part 71 arrange, therefore allow user to be communicated to processus hyoideus part 71 with leverage basically when controlling grip portions 72.Preferably, angle X is greater than 90 degree, especially preferably between 120 and 160 degree.This angle between gripping and processus hyoideus part is beneficial to the insertion of device and reduces the demand that patient reorientates.Advantageously, this allows patient to be seated in the majority inspection or recumbency and be in more comfortable position.

In certain embodiments, grip portions 72 comprises that thumb rest 74 is beneficial to gripping cosily and lives grip portions 72 when being intended to perform the operation.Thumb rest 74 is usually placed on the front surface 72a of the grip portions 72 that is close to gripping and processus hyoideus part joint.Thumb rest 74 preferably includes the material that allows handle to grip fastenedly and strengthen the user sense of touch, for example rubber.

As shown in Figure 11 B, the front surface of processus hyoideus part 72 comprises surveying marker alternatively, and this surveying marker is included in visible radiopaque line 76 under the fluoroscopy.Radiopaque line 76 allows to have centered on around object and for example measures when organ, tumor, tissue and bone.As an example, radiopaque line 76 can be used for determining the degree of depth and the location of tumor.The rear surface 72b of grip portions 72 comprises guide rail 78, and described guide rail 78 is included in the 78a of U-lag basically that securely supports inflatable chamber 13 in the operation.Guide rail 78 can comprise that the permission inflatable chamber is pressed into cooperation or snap fit arrives the interior flexible material of U-lag 78a.

In Figure 11 C, comprise that the expandable bodies 79 of optional big envelope 80a and 80b is attached to the front surface of processus hyoideus part 71, expandable bodies outwards launches from front surface like this.Expandable bodies 79 preferably utilizes suitable binding agent, ultrasonic bonding or hot weld to be attached to processus hyoideus part 71.In other words, expandable bodies can utilize quick connector to be attached to the processus hyoideus part.In addition, inflatable chamber 81 can be pressure fitted in the flexible guide rail 78 and preferably include adapter 82, and for example the conventional luer-type adapter is used to be connected to suitable aerating device, for example pump or ball.

In Figure 11 C, expandable bodies 79 and Handleset 70 are positioned in patient's the vaginal canal V.Lip 73 and big envelope 80b preferable configuration are and the tip engages of vagina V that patient's cervix C can be processed and visual like this.The power that doctor physician produces is applied to grip portions, and composite force is applied in the vaginal canal terminal and subsequently and dissects.Therefore the operation of grip portions makes cervix uteri present, thereby allows doctor physician in the angle observation cervix uteri of any requirement and the connection between the vaginal canal.

Figure 12 A-12C has described to be suitable for use in another Handleset 90 of the expandable bodies 11 of Fig. 1-3.Handleset 90 is the assembled assembly, comprises intravaginal processus hyoideus part 91 and detachable grip part 92.But preferred processus hyoideus and grip portions utilize luer type adapter known in the field 95 to be connected releasedly with 96.Especially specifically, the end of processus hyoideus part 91 comprises male luer component 95, is suitable for and is arranged in the corresponding female luer component 96 in grip portions 92 upper ends closely cooperating.These luer elements preferably engage the twistlock part of standard to engage and to separate.Alternatively, processus hyoideus can be connected by frictional fit, pressure fitted or snap fit releasedly with grip portions.Preferably, processus hyoideus can be connected and take apart easily with grip portions, but in use can by mistake not take apart.

As describing among Figure 12 A, processus hyoideus part 91 preferably includes protruding front surface 91a, and it is configured to the interior outline with expandable bodies 11.In the illustrated embodiment, the columniform basically and front surface 91a of processus hyoideus part 91 wraps one or more air-filled pores 93 expandable bodies 11 that is used to expand.Grip portions 92 comprises a female luer component 94, is configured to closely cooperate with the corresponding male luer component of aerating device.

Figure 12 B is the cross-sectional view of the grip portions of Figure 12 A along first 12B-12B, and Figure 12 C is the cross-sectional view of the processus hyoideus part of Figure 12 A along first 12C-12C.Grip portions 92 comprises along grip portions length and passes through the inner chamber 97 that adapter 91 is communicated with aerating device.Although the cross section of grip portions is depicted as rectangle, it is other shape also, includes, but are not limited to square, circular, triangle and ellipse, does not all deviate from scope of the present invention.

With reference to figure 12C, processus hyoideus part 91 also can comprise along the length of processus hyoideus part and the inner chamber 98 that is communicated with inner chamber 97 and air-filled pore 83.Although the cross section of processus hyoideus part is depicted as circle, it is other shape also, includes, but are not limited to square, circular, triangle and ellipse, does not all deviate from scope of the present invention.

With reference to figure 12A, processus hyoideus part 91 arranges with respect to the angled X of grip portions 92, therefore allow user when controlling grip portions 92 basically lever be connected to processus hyoideus part 91.Preferably, angle X is greater than 90 degree, and especially preferred is between 120 degree and 160 degree.This angle between grip portions and processus hyoideus part is beneficial to the insertion of device and has reduced reorientation patient's demand.Should be noted in the discussion above that as above this advantage allows patient to sit down and lie down to be in more comfortable position in the majority inspection.

Be similar to preceding embodiment, Handleset 90 is beneficial to the insertion of exhaust apparatus and the operation of vagina internal anatomy.Processus hyoideus part 91 comprises the termination 99 that is configured to patient's vaginal canal tip engages, and so cervix uteri can be processed and visual.The processus hyoideus part provides the Cervical processing to patient by engaging with the part that is connected of vaginal canal.Processus hyoideus and grip portions all preferably include the hollow plastic spare that for example utilizes injection moulding to make.In addition, but other material of processus hyoideus and grip portions, for example metal and wood.

With reference to figure 13A-13C, before insertion, there is not the expandable bodies of inflation to be attached to processus hyoideus part 91, like this, the air-filled pore 93 in processus hyoideus part 91 aligns with the corresponding air-filled pore in the inwall of expandable bodies 100.Expandable bodies 100 is the structures that are similar to the expandable bodies of Fig. 1-3, and comprises interior big envelope 102a and 102b and inwall 103.Preferably, processus hyoideus partly is arranged in the softer relatively expandable bodies 100, therefore provides maximum comfort level for patient.Expandable bodies 100 can utilize suitable binding agent, ultrasonic bonding and hot weld to be attached to processus hyoideus part 91.

Adopt sheath cover 101 to be beneficial to the insertion of processus hyoideus and expandable bodies.Sheath cover 101 is suitable for partly maintaining expandable bodies against processus hyoideus when inserting.In addition, sheath cover 101 is suitable for splitting when expansion of inflatable body.Cracking when sheath cover 101 can comprise a series of holes with the promotion inflation.Sheath cover 101 can be after operation remove by doctor physician and, optionally, can be configured in vaginal canal, dissolve.

In another optional embodiment that Figure 14 described, expandable bodies 100 ' be taper, like this, in expansible structure, the diameter of near-end is greater than the diameter of far-end.In addition, the diameter of big envelope 102b ' is greater than the diameter of big envelope 102a '.This structure helps expansible expandable bodies 100 ' the remain on appropriate position of patient's vaginal canal.

Preferably, patient can select oneself to insert sight glass.Advantageously, in case for patient handle portion remove the back to insert processus hyoideus partly be very simple.As shown in Figure 13 A, processus hyoideus part 91 is similar to has a periphery that extends and the tampon of bullet-shaped distal tip 99.After insertion, grip portions is connected with 96 by luer type adapter 95 alternatively.In many cases, cervix uteri need not be inserted any operation of Retrovaginal Handleset and be visual.Like this, do not need to connect grip portions, so that the female luer adapter can be directly connected on the aerating device.Yet when cervix uteri was invisible, grip portions can be attached to processus hyoideus and think that partly operation processus hyoideus part 91 provides suitable leverage.

Processus hyoideus part 91 is designed to will enough thickly can be used as the lever use and can not disconnect, but also wants enough thin so that patient comfort.In addition, processus hyoideus part 91 is preferably used different sizes for handling different patients.Preferably, processus hyoideus partly has the diameter of about 10mm to 15mm.Certainly, be understandable that for those skilled in the art that the processus hyoideus part can have the diameter that is different from 10mm to 15mm scope and not deviate from scope of the present invention.

Expandable bodies of the present invention preferably has multiple size, is included as the junior size of young woman and atrophy menopausal women design, is the medium size of " common " women design, and the queen size that designs for obese women.Junior size preferably has the diameter greater than the length of 10cm and about 2.5cm.Medium size preferably has the length of about 12cm and the diameter of about 4.0cm.Queen size preferably has the length of about 18cm and the diameter of about 6cm.

Vagina and rectum are the natural organs that can absorb the medicine that enters Venous system effectively.At present, existence is arranged in intravaginal to allow providing a kind of and multiple medicine continuously with hormone devices.Yet this device is difficult to and often very painfully inserts.In addition, some devices of different size have to be mounted before finding suitable assembling, and some patient may be between model, are difficult to reach suitable adaptive like this.

With reference to Figure 15, adopt as being beneficial to the conveying of medicine in patient's vagina V with reference to disclosed Handleset 90 of figure 12-13 and expandable bodies 100.Handleset 90 is assembled assemblies, comprises intravaginal processus hyoideus part 91 and detachable grip part 92.Figure 13 is described as reference, and deflated expandable bodies 100 and processus hyoideus part 91 are inserted into vagina V, and expandable bodies is inflated then.

With reference to figure 15A, according to an aspect of the present invention, processus hyoideus part 91 is connected with a plurality of securing members 105 by one releasedly with expandable bodies 100.But securing member 105 preferably includes hasp or any other suitable interlocking releasing member or holding member.In when inflation, securing member 105 keeps correctly arranging between the corresponding air-filled pore of the air-filled pore 93 of processus hyoideus part 91 and expandable bodies 100.With reference to figure 13B, after inflation, securing member 80 is untied or is otherwise discharged, and therefore allows processus hyoideus part 91 to remove fully from the central chamber of expandable bodies.

With reference to figure 15C, after processus hyoideus part 91 was regained from central chamber, the cylinder 112 that holds one or more medicines was in this location.Especially specifically, the end 112a of cylinder 112 is inserted into and passes big envelope 102a, and cylinder in central chamber by to the distant place translation.Cylinder 112 is preferably by keeping joint 114 or being fixed in the central chamber by other suitable fasteners.In the illustrated embodiment, far-end and near- end 112a and 112b extend beyond distal cuff and proximal cuff respectively.Alternatively, far-end 112a and near-end 112b are sized to when in the central chamber that is placed on expandable bodies and flush with distal cuff 102b and proximal cuff 102a.

With reference to figure 15D, cylinder 112 preferably includes a plurality of inner chamber 116 separation chambers 120,122,124,126 on every side that are arranged in.One or more are suitable for each chamber 120,122,124,126 inflatable continuously and/or the medicine of intermittent delivery.In addition, for example water or saline of one or more chamber other liquid of inflatable.Chamber 120,122,124,126 preferably includes rigidity or semi-rigid walls 117, and described wall provides structure support to prevent the lateral vaginal convergence.The suitable combination materials that is used for locular wall 100 comprises silicon and polyurethane.

With reference to figure 15E, provide the near-end of salable in use cylinder 112 can remove end cap 118.End cap 118 preferably is attached on the cylinder 112 by pressure fitted or frictional fit.In addition, end cap 118 can comprise and inner chamber 116 aligned holes 119.Hole 119 allows body fluid and overdose of medicine product to be discharged from by inner chamber 116.

Refer again to Figure 15 C, each chamber 120,122,124,126 preferably also comprises pump 120a, 122a, 124a, the 126a that is communicated with respective nozzle 120b, 122b, 124b, 126b fluid.Advantageously, utilize independent pump to prevent mixing unnecessary between the medicine.Pump 120a, 122a, 124a, 126a preferably include and comprise timing mechanism, are used to control medicine with scheduled volume and are assigned to target treatment in the vagina V.Nozzle 120b, 122b, 124b, 126b are preferably rotatable, but like this they before cylinder 112 inserts pre-determined bit so that medicine is assigned on the specific objective processing region.Have four cylinders although cylinder is depicted as, for those skilled in the art as can be known be that cylinder 112 can comprise many chambers (and corresponding pump and nozzle) and not deviate from scope of the present invention.Alternatively, cylinder 112 can comprise many chambers and single pump/nozzle assembly, and this assembly is configured to optionally to divide power dispensers from a plurality of chambers arbitrary.

Continue with reference to figure 15C, one or more O shape ring sealing rings 103 are arranged between cylinder 112 and the expandable bodies 100 in case the leakage of fluid stopping body.According to some embodiment, allow inner chamber 100 to keep open to allow natural drainage and to protect from infection.Cylinder preferably also comprises handle 130, and this handle has tapping end 131 and is used for releasedly inner chamber 116 in conjunction with cylinder 112.Handle 130 is beneficial to cylinder and regains from the central chamber of expandable bodies 110.In addition, handle can be used for cylinder is rotated to its appropriate position in central chamber.

Medicine with fast Absorption performance is particularly suitable for utilizing cylinder 112 to carry, so the absorbed target tissue region of medicine is very close in the zone of drug delivery.The medicine that utilizes cylinder 112 to carry includes but are not limited to: antihypertensive, for example atenolol, Diltiazem, bicolorin, metoprolol and nifedipine; Antibiotic; The medicine that gives for a long time is chemical drugs (chemo) for example; Oral hypoglycemia medicine is terconazole (triaconazole), fluconazol, miconazole and gynazole for example; And the medicine that is used to handle bacterial infection for example metronidazole and clindamycin.

According to an one exemplary embodiment, be filled chremophor in the chamber 120 and be filled paclitaxol in the chamber 122.Timing mechanism in pump 120a is constructed to once the chremophor of controlled quentity controlled variable is transported to target treatment for example per 3 days of particular time interval.Equally, the timing mechanism in pump 122a can be configured in specified time interval once the paclitaxol of controlled quentity controlled variable to be transported to target treatment in for example per 6 days.Optionally, pump 120a, 122b can be configured to carry continuously chremophor and paclitaxol to target treatment.

According to another one exemplary embodiment, postmenopausal women or the women that carried out uterectomy carried out hormone the replacing operation of plan, filled with estrogen in the chamber 120 are filled with progestogen in the chamber 122 and are filled with water in the chamber 124.Each week that timing mechanism in pump 120a, 122a is configured to continuous three weeks, estrogen and the progestogen with controlled quentity controlled variable were transported to target treatment respectively.Around, the timing architecture in pump 124a is configured to the water of controlled quentity controlled variable is transported to target treatment.The repetition of the preferred endless of this drug delivery timetable (for example the medicine in three weeks then the water in a week) needs doctor physician to refill up to a Room wherein.

The intravital chamber of cylinder is suitable for regularly being filled with by doctor or doctor physician.For example, doctor physician can inject the prescription of multiple medicine to indoor, the time of the sustainable pre-fixed length of wherein should writing out a prescription.Advantageously, can provide a great convenience to many patients especially elderly woman at the multiple medicine of indoor injection.In addition, throw in the medicine that absorbs continuously and provide less transmutability than oral dose.

Occur vaginocele when vagina is strained, its antetheca or rear wall protrude like this.In addition, prolapsus also can appear at bladder, urethra, rectum or uterus.The different modes that prolapsus is handled depends on the order of severity of deviating from and patient's age.On the one hand, younger patient selects surgical operation to solve usually, and this is necessary, forbids the device in the vagina because most of younger patient sexual behaviour is active.On the other hand, aging patient does not have sexual behaviour usually.Therefore the insertion of preferred embodiment usually.

Usually, it is extremely successful owing to have many defectives to insert device.Should be noted that as above the active patient of sexual behaviour selects surgical operation to avoid the interruption of their sexual lifes usually.In addition, the insertion of device and removal are not made us comfortable and may be caused infecting very much.Therefore, even for aging people, also select surgical operation to solve usually.Yet many among these patients all are not outstanding operative candidates.Prolapsus causes the protrusion on the vaginal wall or deviates from the zone continually.These areas of prolapse may often apply a large amount of pressure to intravaginal device and be easy to conventional equipment is released vagina fully.

With reference to Figure 16, adopt Handleset 90 and expandable bodies 100, as disclosed, to alleviate the symptom in patient's vagina V with reference to figure 12-13.Especially specifically, expandable bodies is suitable for remaining on for example some days of continuous a period of time, week or the moon in the vagina V with expanded configuration.Referring to Figure 16 A, vagina V comprises areas of prolapse may P, and this areas of prolapse may causes incontinence, obstruction, do not accommodate other symptom.With reference to figure 16B, deflated expandable bodies 100 and processus hyoideus part 91 are inserted into vagina V, the aforesaid expansion of expandable bodies then.Processus hyoideus part 91 is connected by one or more securing members 105 releasedly with expandable part 100, and the processus hyoideus part can be removed after the expandable bodies inflation like this.

With reference to figure 16C, expandable bodies 100 advantageously supports vaginal canal a period of time, therefore prevents further developing of vaginocele zone.In addition, the central chamber of expandable bodies 100 provides the pipeline by body fluid, has therefore prevented because the obstruction that areas of prolapse may causes.And expandable bodies 100 is suitable for decorporating or even continuing during complete obiteration to keep a period of time in vaginal canal when areas of prolapse may.

According to some embodiment, the central chamber of expandable bodies keeps opening, and it allows normal fluid to flow out like this.Advantageously, this has suppressed infection and has reduced the abnormal smells from the patient that blocked discharge in the past causes.Can provide waste material deposit pond to collect liquid emission.With reference to figure 16D,, for example can be inserted in the expandable bodies with reference to the described cylinder 112 of Figure 15 according to other embodiment.Cylinder 112 provides the synthetic increase of the side radial force of the structural rigidity that increases and expandable bodies 100.Certainly, although the relative power of areas of prolapse may is arranged, the side radial force of increase helps expandable bodies is remained in the vagina V.In addition, as describing among Figure 16 E, the outer wall of expandable bodies 100 can comprise landform part 135, and it has increased the friction between outer wall and the vaginal wall.As an example, the landform part can include but are not limited to, flange, recess, groove, projection, groove and other suitable irregular surface.

The Leep conization is the general surgery with women of uterus carcinoma in early stage.This operation is adopted to have and is burnt the metal wire that electric current is flowed through, and this metal wire is used for cutting and passes the uterus and generate sample.In order to can be used for this operation, conventional metal speculums must be processed with a non-conductive coating layer, and this makes this sight glass quite expensive.

With reference to Figure 17, expandable bodies 100 is used for helping the cervix C resection organization from patient.In operation, deflated expandable bodies 100 and processus hyoideus part 91 are inserted into vagina V, and expandable bodies expands as described above then.Processus hyoideus part 91 is pulled down and is regained then.Expandable bodies 100 is nonmetal and therefore non-conductive.Thereby the central chamber of expandable bodies provides can be for the pipeline that carries out the leep conization.

Still with reference to Figure 17, utilize metal wire 140 to realize from cervix C resection organization, this metal wire has handle 141 that is attached to far-end 142 and the electrode 143 that is attached to near-end 144.Metal wire 140 and electrode 143 and power supply 148 electric connections.The end 143 that handle 141 is used to operate metal wire 140 enters endocorvix E, and electrode 143 contacts with cervix C like this.Especially specifically, doctor physician uses handle 141 with respect to expandable bodies 100 and cervix C rotation and translation metal wire 140.

In case electrode 143 is in and the cervix C position contacting, utilize handle 141 rotating metallic lines 140, therefore cause electrode 143 cutting cervical tissue layers.Metal wire is removed by the tissue samples of regaining from far-end and being used to handle then.When operation was finished, expandable bodies was allowed to the power aerofluxus automatically that chamber per vaginam applies.

Embodiment with reference to figure 5 is described, preferably provides vacuum-pumping tube to get rid of the flue gas that produces when cervical tissue excises.For example, when electrode contact shoe cervix uteri, can generate a skewed slot.Provide suction source 154 to pass through vacuum-pumping tube 152 emptying skewed slots.

Exist intracavitary radiation device to be used to handle gynecological cancer.One type intracavitary radiation device comprises an oval doughnut, and this oval doughnut comprises a narrow central cylindrical hole.Radiation medium as seed crystal is provided, and before device is installed to vagina, has been loaded onto in the device.This conventional intracavitary radiation device is owing to the difference of vaginal canal size has multiple size.Yet conventional custom-sized in advance device does not often obtain comfortable adaptive for most patients.

With reference to Figure 18, expandable bodies 100 of the present invention can be used for promoting the conveying one for the treatment of radiant matter to handle vagina V and near the pathological tissues of cervix C.In operation, deflated expandable bodies 100 and processus hyoideus part 91 are inserted in the vagina V, and expandable bodies is aforesaid then is inflated.Then, processus hyoideus part 91 is removed and regains from the central chamber of expandable bodies.According to an aspect of the present invention, central chamber provides the pipeline that is used for delivery of radiation seeds 160 in vagina V.Radiation seeds 160 can be granular, bar-shaped, lamellar, balled form or any form that other is fit to.

Radiation seeds 160 utilizes the cylinder 162 of elongation to be transported to diseased tissue area, and the cylinder 162 of this elongation comprises far-end 162a and near-end 162b and inner chamber 164, and inner cavity size is decided to be the passage of radiation seeds 160.The cylinder 162 of elongation preferably comprises that also one is arranged in the handle 166 of far-end 162a.Doctor physician uses handle 166 with the position of manipulate proximal end 162b to the adjacent lesion tissue regions, for example around the tissue of cervix C.In case near-end 162b correctly locatees, the vicinity that push rod 168 is shifted onto in the inner chamber 164 by doctor physician is located, and therefore sprays radiation seeds 160 from near-end 162b.When operation is finished, allow per vaginam chamber applied force aerofluxus automatically of expandable bodies.Advantageously, the expandable bodies 100 per vaginam size of V determines expansible level, therefore how many patients to provide comfortable fit to.

Although described the preferred embodiments of the present invention above, can make variations and modifications in the case of without departing from the present invention to it will be clear to someone skilled in the art that.This variation of all that are covered in accessory claim and modification all fall in the spirit and scope of the present invention.

Claims (32)

1, a kind of device that is used to enter body cavity comprises:

Tubular part with near-end and far-end and an inside, this tubular part is rolled on himself to limit one by one section material only to have the main part of a circumferential seam and forms at far-end, and this tubular part has a expanded configuration when being used to insert an endoceliac deflated configuration and an inflation; With

Be arranged to the gas tube with the internal communication of this tubular part,

Wherein, tubular part has a plurality of staggered contact areas, and described contact area is arranged like this, thereby in expanded configuration, described contact area does not form vertical feature and tubular part limits circular basically central chamber under load.

2, device as claimed in claim 1 is characterized in that, tubular part also comprises proximal cuff and distal cuff.

3, device as claimed in claim 1 is characterized in that, the near-end of tubular part is configured to protect patient's cervix uteri zone not rubbed or scratch.

4, device as claimed in claim 1 is characterized in that, the material of rolling forms an inwall and an outer wall, and gas tube is inserted between the inner and outer wall.

5, device as claimed in claim 1 is characterized in that, gas tube enough transmits power firmly when being in the deflated configuration when tubular part.

6, device as claimed in claim 1 comprises that also one is arranged in the passage in the central chamber, and this passage helps setting tool during the course.

7, device as claimed in claim 1 also comprises the aerating device that connects with gas tube.

8, device as claimed in claim 7 comprises that also one is inserted in the check valve between aerating device and the tubular part.

9, device as claimed in claim 1 is characterized in that, tubular part also comprises slick external skin.

10, device as claimed in claim 1 also comprises the isolation cover of the pollution that reduces aerating device.

11, device as claimed in claim 1 is characterized in that, tubular part also comprises and is used to be applied topically to endoceliac coating.

12, device as claimed in claim 11 is characterized in that, described coating comprises medicine, gene vector or protein.

13, device as claimed in claim 11 is characterized in that, described coating comprises the medicine that is used to handle yeast infection.

14, device as claimed in claim 1 is characterized in that, tubular part also comprises exterior layer, and this exterior layer comprises the micropore of the passage of a plurality of medicines that are used to be liquid or gel form.

15, device as claimed in claim 1 also comprises Handleset, and this Handleset comprises that intravaginal processus hyoideus part and is used to control and operate the grip portions of this processus hyoideus part.

16, device as claimed in claim 15 is characterized in that, described processus hyoideus partly comprises a lip, and this lip is configured to close with a termination of patient's vaginal canal.

17, device as claimed in claim 15 is characterized in that, described processus hyoideus part is arranged at angle with respect to grip portions.

18, device as claimed in claim 15 is characterized in that, Handleset has modular structure, and this modular structure allows the processus hyoideus part to pull down from grip portions.

19, device as claimed in claim 18 is characterized in that, the processus hyoideus part utilizes luer type adapter to be connected releasedly with grip portions.

20, device as claimed in claim 1, also comprise one during inserting body cavity around the sheath cover of expandable bodies.

21, device as claimed in claim 1 also comprises a rigid support, and it can be inserted into the interior rigidity with the reinforcement tubular parts of tubular part.

22, device as claimed in claim 1 comprises that also one has the cylinder of one or more chambers, and this cylindrical configuration is for being assemblied in the central chamber.

23, device as claimed in claim 15 is characterized in that, Handleset is attached on the tubular part releasedly by one or more securing members.

24, device as claimed in claim 22 is characterized in that, described one or more indoor bioactive substances that are filled with.

25, device as claimed in claim 24 also comprises one or more pumps that are used for distributing from described one or more chambers bioactive substance.

26, device as claimed in claim 22 is characterized in that, described one or more indoor antihypertensive drug that hold.

27, device as claimed in claim 22 is characterized in that, described one or more indoor antibiotic that hold.

28, device as claimed in claim 22 is characterized in that, described one or more indoor long-term administered agents of holding.

29, device as claimed in claim 22 is characterized in that, described one or more indoor oral hypoglycemia medicines that hold.

30, device as claimed in claim 22 is characterized in that, described one or more indoor medicines that are used to handle yeast infection that hold.

31, device as claimed in claim 22 is characterized in that, described one or more indoor medicines that are used to handle bacterial infection that hold.

32, device as claimed in claim 1 also comprises the device that is used for delivery of radiation seeds in body cavity.

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