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

Expandable device for accessing a body cavity and method of manufacturing same

technical field

The present invention relates to methods and devices for accessing body cavities, and more particularly, to methods and devices for gaining access to the female urogenital tract.

Background technique

Vaginal examinations and dissections related thereto are usually performed with a speculum which provides access to the vagina by dilating the vaginal cavity and then maintaining it in an inflated state. As used today, conventional speculums consist of a pair of metal jaws which are inserted into the vaginal cavity and then used to open the passage. For most patients, the insertion and manipulation of the speculum is uncomfortable and strains the patient, making the entire examination difficult, otherwise impossible.

Speculums having inflatable outer walls have been developed, such as described in Dieter, US Patent No. 5,716,329. The speculum described in this patent includes a rigid inner wall and an expandable outer wall that expands with a fluid after insertion to relieve discomfort due to vaginal cavity distension. However, the device described in this patent is rather complex and not commercially applicable due to its combination of reusable and disposable elements.

In view of the low cost requirement, there is a need for a commercially viable disposable speculum product, others have attempted to develop a speculum comprising an inflatable bladder or ribs, for example in International Patent Publication WO 97/24975 and Dutch Patent No. 9100599 described in. However, the products described in these publications and patents do not appear to have sufficient swelling strength for practical use.

Johnson's U.S. Patent No. 5,743,852 describes an expandable speculum comprising an expandable conical structure comprising inner and outer wall elements sealed together along the edges of the inner and outer walls, and comprising a The grid contact area of the grid graphic. The patent describes an insertion rod disposed within the speculum to aid insertion and engages an outer sheath that is retracted through the central lumen of the device as the insertion rod is retracted. The tapered structure may be inserted into an inflated speculum, hold the speculum in the expanded state once it is inflated, and additionally provide support for a fiber optic light source or other instrumentation.

The aforementioned Johnson patent appears to offer a number of advantages over other expandable speculum designs. However, the desired configuration of the insertion rod and sheath is problematic, wherein the sheath is pulled from distal (closest to the gynecologist) to proximal (furthest inside the patient) during removal, which can cause excessive friction and discomfort. Additionally, because the internal support structure disclosed in this patent does not extend to the proximal end of the scope, it is possible that the forces exerted by the patient's body cause the proximal portion of the scope to collapse. Finally, utilizing sealed edges along the periphery of the inner and outer wall elements, especially at the proximal end of the scope, creates a relatively rigid structure that can scrape the patient's cervix and cause discomfort to the patient.

US Patent Publication US 2003/1099737 to Deslauriers et al. describes an expandable speculum having a plurality of longitudinally extending ribs arranged to define trapezoidal prisms within the speculum volume. The presence of the longitudinal ribs in the Deslauriers device, as in the aforementioned WO publication and the Netherlands patent, is expected to preferentially deform the central lumen of the speculum into a narrow ellipse rather than providing a substantially circular lumen.

In view of the above-mentioned drawbacks of known devices, it is desirable to provide methods and devices for accessing body cavities that are small and easy to insert into a body cavity and are comfortable to insert into and work with.

It is further desirable to provide methods and devices for accessing body lumens that provide sufficient strength to expand the body lumen while utilizing low cost materials to allow the device to be disposable after a single use.

It is also desirable to provide a device for accessing a body cavity that provides sufficient radial strength to expand the body cavity in most cases, but which may include additional Optional components.

It is still further desirable to provide methods of fabricating devices that enter body cavities that substantially eliminate the presence of longitudinal ribs or features that cause the device to preferentially bend in the expanded state, thus ensuring a substantially circular function cavity.

It would also be desirable to provide a method of fabricating a device for entry into a body cavity that substantially eliminates welds or seals along the proximal peripheral edge of the device, thereby reducing the risk of patient discomfort.

Contents of the invention

In view of the foregoing, it is an object of the present invention to provide a device for accessing a body cavity that is small and easy to insert into a body cavity and is comfortable to insert into and work on.

Another object of the present invention is to provide a method and device for accessing a body cavity that provides sufficient strength to expand the body cavity while utilizing low cost materials to allow the device to be disposable after a single use.

Another object of the present invention is to provide a device for accessing a body cavity that provides sufficient radial strength to expand the body cavity in most cases, but which may include use in special cases, such as in examination or treatment of obese patients. additional optional components.

It is a further object of the present invention to provide a method of fabricating a device for entry into a body cavity that substantially eliminates the presence of longitudinal ribs or features that cause the device to preferentially bend in the expanded state, thus ensuring a substantially circular shape. working cavity.

It is a further object of the present invention to provide a method of fabricating a device for entry into a body cavity that substantially eliminates welds or seals along the proximal peripheral edge of the device, thereby reducing the risk of patient discomfort.

In accordance with the principles of the present invention, devices are provided for accessing body cavities comprising an expandable body formed from a single piece of material rolled and sealed along its distal edge (closest to the physician), thus eliminating the need for distal The presence of an end seal or weld area does provide atraumatic protection proximally. The expandable body is inserted into the body lumen in a deflated configuration, and then expanded to the expanded configuration, thereby expanding the walls of the body lumen. The expandable body includes a plurality of contact points arranged in a substantially uniform pattern to allow substantially uniform pressure distribution within the expandable body upon expansion. According to the principles of the present invention, the contact areas are arranged such that substantially no longitudinal features are created, but instead provide a substantially circular central lumen when the expandable body is inflated under load.

The expandable body is joined to an inflatable device, such as a ball or pump, through a length of relatively stiff tube extending into and terminating in the expandable body. The tube is stiff enough to allow the clinician to apply force to the expandable body in the delivery configuration to push the expandable body into the patient's orifice. Additionally, a retractable, pre-lubricated sheath may be disposed on the exterior of the expandable body to aid in insertion of the device into the patient's orifice.

Optionally, the device includes an internal support member which is inserted within the central lumen of the expandable body after expansion. The support member preferably comprises an inexpensive plastic element mounted on the dilator and then disposed within the scope to increase the radial strength of the device and prevent the proximal end of the expandable body from collapsing. This optional support member may be particularly advantageous for bariatric patients.

In certain embodiments, the expandable body may include one or more balloons disposed within the central lumen of the expandable body to allow retention of a fiber optic light source or other instrument within the lumen. Additionally, the expandable body may include an additional length of tubing extending adjacent the proximal end of the device to allow evacuation of smoke generated during manipulation of the organ, such as during leep conization.

According to another aspect of the invention, the device may be used to facilitate delivery of a drug within an organ or cavity. In certain embodiments, the outer surface of the expandable body may be coated with one or more drugs that are eluted into the patient's tissue when the device is deployed into the patient's body or organ. In another embodiment, the expandable body defines a receptacle that receives a cylinder having one or more drug filling chambers configured to fit within the inflatable expandable lumen and provide a release Scheduled outline of medicines.

In yet another embodiment, the device includes a handle assembly attachable to the expandable body to facilitate insertion of the expandable body into a body cavity, or to facilitate reorientation of the visual field through the central lumen of the expandable body.

Methods of fabricating the devices of the invention are also provided.

Description of drawings

The above and other objects and advantages of the present invention will be apparent upon consideration of the following detailed description, with reference to the accompanying drawings, in which like reference numerals refer to like parts throughout, and in which:

Figure 1 is a side view of the device of the present invention in the exhaust configuration;

Figures 2A and 2B are cross-sectional views of the device in the deflated and expanded states of Figure 1, respectively, along view line 2-2;

3A and 3B are side and end perspective views, respectively, of the expandable body of FIG. 1 in an expanded state;

Figure 4 is a perspective view of a sheath facilitating delivery of an expandable body;

5A-5C are side views depicting another design of the expandable body of FIG. 1 including optional side bags and a suction tube;

Figure 6 is a side view, partly in section, of a support and dilator for the device of the present invention;

Figure 7 is a perspective view of a preferred method of rolling the expandable body to reduce patient discomfort during deployment;

Figure 8 is a flow chart describing a preferred process for manufacturing the device of Figure 1;

Figure 9 is a side view of an expandable body of the present invention including a drug coating or other bioactive substance;

Figure 10 is a cross-sectional view of another embodiment of the expandable body of the present invention suitable for delivery of biologically active substances;

11A-11C are side and perspective views, respectively, of a handle assembly for a device of the present invention, and views depicting use of the handle assembly and expandable body as a colposcope;

12A-12C are side views, respectively, of another handle assembly for the device of the present invention, and cross-sectional views of the handle assembly along lines 12B-12B and 12C-12C in FIG. 12A;

13A-13C are side views, respectively, of elements of the handle assembly of FIG. 12A , cross-sectional views of elements along line 13B-13B in FIG. 13A , and side sectional views of elements of FIG. 12A for the device of FIG. 1 ;

Figure 14 is a side cross-sectional view of another embodiment of the device of Figure 13C;

Figures 15A-15E are side cross-sectional views of the device of Figures 12-13 in the vaginal cavity of a patient, respectively, side cross-sectional views of the device of Figures 15A-15B having a cylinder disposed within an expandable body, cross-sectioned along line 15D-15D of Figure 15C Figures; and the end view of the cylinder of Figure 15E;

16A-16E are side sectional views of a patient's vaginal canal, a side sectional view of the device of FIG. 15 within the vaginal canal, and side sectional views of the device of FIGS. 15B-15C with a cylinder in the central cavity, respectively;

Fig. 17 is a side cross-sectional view of the device of Fig. 15 used to resect tissue from the cervix;

18 is a side cross-sectional view of the device of FIG. 15 for delivery of radiation seeds within the vaginal canal.

Detailed ways

Referring to Figures 1-3, the device constructed according to the present invention provides a low cost single use disposable device for dilating a body cavity, such as the vaginal cavity. The device 10 includes an expandable body 11 , an insertion sheath 12 , an inflation tube 13 , an inflation device 14 , a valve 15 and a shield 16 . When inflated using the intuitively spherical inflator 14, the expandable body 11 transforms from a substantially flattened tubular shape (FIG. 2A) to an expanded configuration (FIG. 2B).

In the expanded configuration, the expandable body 11 forms an annular body portion 17 defining a central lumen 18 that provides a physician with access to the interior of a body organ or lumen. According to one aspect of the invention, the inflatable tube 13 is bendable but otherwise rigid so that force applied to the tube can be used to push the expandable body into the patient's orifice. The inflation tube 13 communicates with the interior of the main body portion 17 to allow the inflatable body 11 to be inflated or deflated.

Preferably, the valve 15 is a one-way valve so as to maintain pressure within the body portion 17 without requiring the ball 14 to remain under pressure. Valve 15 is selectively actuatable to deflate body portion 17 . The ball 14 and valve 15 are preferably joined to the inflation tube by conventional luer fittings so that these parts can be detached from the inflatable body 11 so that the inflatable tube 13 can be reused later. The ball 14 and valve 15 are preferably disposed within an isolation enclosure 16, such as a plastic bag, to prevent contamination by the patient's bodily fluids.

Insertion sheath 12 comprises a lightweight plastic sheath that constrains expandable body 11 in a retracted position to facilitate insertion into a patient's organ or lumen. The sheath 12 includes a split rounded atraumatic shape that facilitates insertion of the device and retraction from the distal end of the inflation tube during deployment of the expandable body.

As depicted in Figures 2 and 3, the expandable body 11 preferably comprises a polymeric latex-free material and is formed such that the outer wall 20 is joined to the inner wall 21 at contact areas 22 of a plurality of pillow-like stitches. Preferably, the contact areas 22 are arranged in a uniform pattern to allow a substantially uniform pressure distribution within the expandable body 11 during inflation. In a preferred embodiment, 16 columns of contact areas are arranged around the circumference of the expandable body and are axially offset.

According to the principles of the invention, the assignment of the columns of contact areas is axially offset or staggered to avoid longitudinal features in the expandable body. This feature, present in prior known devices, causes the device to preferentially bend under load and allows the central lumen to distort into a narrow ellipse. However, the offset grid pattern illustrated in Figure 1 enhances the radial strength of the expandable body within the inflatable structure and ensures that the central lumen 18 remains substantially circular in the inflated state even under load.

Referring to Fig. 3, the expandable body 11 preferably comprises a single piece of material that is rolled up on itself to form a double intertube gap approximately half the length of the original piece of material. As such, the seam or weld 23 is formed along only one end of the expandable body, as depicted in Figure 3A, preferably at the distal end of the expandable body (closest to the physician). This avoids seams or welds to appear at the proximal end 24 of the expandable body, but provides a soft, pillow-like atraumatic proximal end that avoids the risk of scratching or damaging organs or tissues within the lumen, as shown in FIG. Shown in 3B.

Referring to FIG. 4, the insertion sheath 12 includes a soft polymer tube, such as a heat shrink tube, which holds the expandable body 11 in the collapsed insertion configuration. The sheath 12 includes a distal flange 25 to provide the physician with a handle to grasp and withdraw the distal sheath. The sheath 12 also includes slits 26 within the knob 27, allowing leaves 28 between the slits 26 to flare outward when the sheath is retracted.

Insertion sheath 12 is preferably lubricated with a biocompatible lubricant and then inserted into a patient's body cavity, such as the vagina. According to one aspect of the present invention, the inflatable tube 13 is stiff enough to allow the physician to hold the expandable body stably within the body cavity with one hand while withdrawing the insertion cannula from the distal expandable body with the other hand. The insertion sheath is then removed from the luer at the distal end of the inflation tube, and the valve 15, ball 14 and isolation cap 16 are attached to the luer to allow the expandable body to be inflated.

Referring now to Figures 5A and 5B, another embodiment of the expandable body of the present invention suitable for use in colposcopy, leep-conization or other procedures is described. Colposcopy is the use of glasses or other optical devices to view the cervix and vagina and usually requires vaginal lighting. A Leep-conization is a procedure in which an electric snare is used to remove tissue from the patient's lumen or internal surface of an organ, resulting in the generation of smoke that must be expelled to provide a physician with a clear view.

In Figures 5A and 5B, the expandable body 30 comprises an inflatable tube 31, a central lumen 32 with a bladder or tube 33, and an evacuated tube 34 fitted along its length. The tubing 33 may be used to hold a tool 35 such as a fiber optic light source or other instrument in place within the central lumen 32 . Evacuation tubing 34 preferably extends along the length of expandable body 30 and includes a distal termination that allows tubing 34 to be connected to a suitable vacuum source to evacuate fumes or gases from the body cavity during surgery. Advantageously, tubing 33 and evacuation tube 34 free the physician's hands to do other things. Additionally, the light source for illuminating the body cavity can replace the evacuated tube 34 to facilitate procedures requiring vaginal lighting, while the tube 33 is used to hold other instruments.

Referring to Figure 6, an optional support member 40 of the present invention is depicted. As observed during the first trials on certain segments of people, especially obese women, the expandable body of the present invention does not provide sufficient radial strength to provide a clear view through the central lumen. In FIG. 6 , the support member 41 comprises a rigid disposable plastic tube 42 having a distal flange 43 and a central lumen 44 . Tube 42 is sized to receive dilator 45 within central lumen 44 . The dilator includes a smooth proximal end 46 , a flange 47 and a handle 48 . Flange 47 is configured to abut against flange 43 such that force exerted on handle 48 pushes dilator 45 and tube 42 within the central lumen of the expandable body of the device of FIG. 1 .

Now described is an illustrative colposcope for obese women using the device of FIGS. 1 and 6 . First, the expandable body disposed in the insertion sheath 12 is inserted into the vagina. The inflation tube 13 is then held in place while the insertion tube is withdrawn distally. The ball 14, valve 15 and isolation cap 16 are then connected to the luer terminal of the inflatable tube 13 and inflate the expandable body. The dilator 45 with the tube 42 disposed thereon is then inserted into the central lumen of the expandable body and pushed forward by applying proximal force to the handle 48 . Once the dilator 45 and tube 42 are fully inserted, the dilator 45 is withdrawn, leaving the tube 42 in place within the central lumen of the expandable body. Advantageously, since the tube 42 preferably extends to the proximal end of the expandable body, this provides a clear view to the cervix.

Referring to Figure 7, a preferred method of rolling up the expandable body of Figure 1 to reduce discomfort upon deployment is described. The inventors have observed that in conventional jaw-type scopes, the forces exerted by the jaws are mainly in the forward and rearward directions. It is believed to be because force applied laterally to the vagina is thought to cause discomfort. Thus, according to one aspect of the present invention, the expandable body is first flattened and then rolled into an S-shaped configuration with forward-facing wings A and rearward-facing wings P, as depicted in FIG. 7 . When rolled up in this manner, the forces exerted on the vaginal walls during deployment of the expandable body are primarily in the anterior and posterior directions, thereby reducing patient discomfort as the device expands.

Referring now to FIG. 8, a method of making the apparatus of FIGS. 1-3 is described. At step 50, a rectangular piece of plastic sheet material, such as 8 mil urethane, is cut to the desired size. For example, if the expandable body is made with a nominal length of 12 cm and an expanded diameter of 3.8 cm, the corresponding membrane size may be 15 cm x 23 cm. In step 51, the sheet is formed into a cylinder and a longitudinal seam is formed. At step 51, a length of inflatable tubing is attached to the outer distal half length of the cylinder. At step 53, the proximal half length of the cylinder is rolled onto the distal half of the cylinder to form a double layered annular tube.

In step 54, a seal and weld are formed at the distal end of the double layered annular tube, thus forming a closed tube. As noted above, having the weld only at the distal end of the expandable body provides a smooth, atraumatic proximal end for the expandable body. At step 55, the pattern of contact areas is shaped along the length and circumference of the bilayer annular tube to form the expandable body. Also as described above, the contact areas are axially offset or staggered so that when the expandable body expands, no significant longitudinal features are formed which would preferentially allow the tube to bend or partially collapse, as in previously known designs.

At step 56, the spacer 16 is applied over the inflation tube, and at step 57, a luer terminal may be applied to the distal end of the inflation tube. Optionally, a luer termination can be applied and the isolation cap applied later, for example after the insertion tube has been removed. When the expandable member is complete, it may be rolled into an S-shaped configuration at step 57 as described with reference to FIG. 7 and inserted at step 58 into an insertion sheath. In a subsequent step, the insertion tube is heated to shrink and collapse onto the expandable body, and the device is packaged and sterilized.

Referring to Figure 9, another embodiment of the expandable body of the present invention is depicted. The expandable body 60 is similar in structure to the embodiment of Fig. 1 described above, but additionally includes a coating 61 containing a drug, such as an antibiotic, for localized distribution within a body cavity or lumen. Additionally, coating 61 may include a gene vetor or protein coating. By providing a coating on the outer wall, drugs, genetic agents or proteins can be delivered directly to the vaginal wall during examinations and treatments. As examples, coating 61 may include novocaine, contraceptives, fertilization agents, coagulation accelerators, and various genes and proteins. Depending on the pharmacokinetics of the various drugs, genes and proteins and how they are absorbed in the vagina, coating 61 may include more than one drug to be delivered to the vagina.

To facilitate the delivery of drugs, genes or proteins, features or graphics can be provided on the outer wall. Optionally, the coating 61 may be smooth and become smooth when exposed to water, thus reducing the friction encountered when the device is inserted. As another option, the device is pre-soaked in warm water prior to insertion to reduce patient discomfort, since it is desirable that the expandable body retain some of the heat of the warm water.

In another alternative depicted in Fig. 10, the expandable body 63 comprises an inner layer 64a, a middle layer 64b and an outer layer 64c. The inner layer 64a and the middle layer 64b correspond to the inner wall 21 and the outer wall 20 in the embodiment of FIG. 2A , while the outer layer 64c includes a plurality of micropores 65 . The annulus between the inner layer 64a and the middle layer 64b is filled with a gas or liquid that inflates the expandable body 63, while the annulus between the middle layer 64b and the outer layer 64c forms a bladder 66 into which a fluid or gel can be filled. forms of pharmaceuticals, proteins or genetic media. When the expandable body is inflated in the patient's body cavity, the drug, protein or gene agent in the balloon 66 is pressed through the micropore 65 and delivered to the wall of the body cavity.

Referring to the embodiment of Figures 9 and 10, the coating 61 or capsule 66 may include a drug for the treatment of yeast infections, such as terconazole, fluconazole, miconazole and Gynazole. Additionally, coating 61 or bladder 66 may include medications used to treat bacterial infections, such as metronidazole and clindamycin.

11A-11C depict the structure of the handle assembly 70 for the expandable body 11 described with reference to FIGS. 1-3. The handle assembly 70 includes an intravaginal lingual portion 71 and a grip portion 72 for holding and operating the handle assembly. The tongue portion 71 includes a front surface 71a which is preferably concave to match the outer contour of the expandable body 11 . The handle assembly 70 facilitates insertion of the vent and manipulation of the vaginal anatomy. The tongue portion 71 preferably includes a lip 73 configured to engage the patient's vaginal cavity so that the cervix can be manipulated and visualized.

Referring to FIG. 11A , tongue portion 71 is arranged at an angle X relative to grip portion 72 , thus allowing the user to communicate to tongue portion 71 with substantial leverage when gripping grip portion 72 . Preferably, the angle X is greater than 90 degrees, especially preferably between 120 and 160 degrees. This angle between the grip and tongue portion facilitates insertion of the device and reduces the need for patient repositioning. Advantageously, this allows the patient to be in a more comfortable position sitting or lying down for most exams.

In certain embodiments, the grip portion 72 includes a thumb rest 74 intended to facilitate comfortable gripping the grip portion 72 during surgery. Thumb rest 74 is generally disposed on front surface 72a of grip portion 72 adjacent the junction of the grip and tongue portions. Thumb rest 74 preferably comprises a material, such as rubber, that allows the handle to be held securely while enhancing the user's tactile feel.

As shown in FIG. 11B , the anterior surface of tongue portion 72 optionally includes measurement markers including radiopaque scribe lines 76 visible under fluoroscopy. The radiopaque scribe 76 allows measurements to be taken when surrounding objects such as organs, tumors, tissue and bones. As an example, radiopaque scribe 76 may be used to determine the depth and location of a tumor. The rear surface 72b of the grip portion 72 includes a guide rail 78 that includes a substantially U-shaped channel 78a that securely supports the inflatable lumen 13 during surgery. Rail 78 may comprise a flexible material that allows the inflation chamber to be press-fit or snap-fit into U-shaped slot 78a.

In FIG. 11C , expandable body 79 including optional wrappers 80a and 80b is attached to the front surface of tongue portion 71 such that the expandable body expands outwardly from the front surface. The expandable body 79 is preferably attached to the tongue portion 71 using a suitable adhesive, ultrasonic welding or heat welding. In other words, the expandable body can be attached to the tongue portion using a quick connector. Additionally, an inflation cavity 81 may be press fit into the flexible rail 78 and preferably includes a connector 82, such as a conventional luer type connector, for connection to a suitable inflation device, such as a pump or a ball.

In FIG. 11C , the expandable body 79 and handle assembly 70 are positioned within the vaginal cavity V of a patient. The lip 73 and cuff 80b are preferably configured to fit over the end of the vagina V so that the patient's cervix C can be manipulated and visualized. Physician-generated forces are applied to the gripping portion and the resultant force is applied into the terminal vaginal canal and subsequently dissected. Manipulation of the gripping portion thus brings the cervix into view, allowing the physician to observe the connection between the cervix and the vaginal canal at any desired angle.

12A-12C depict another handle assembly 90 suitable for use with the expandable body 11 of FIGS. 1-3. The handle assembly 90 is an assembled assembly, including an intravaginal lingual part 91 and a detachable holding part 92 . Preferably the tongue and graspable portion are releasably connected using luer type connectors 95 and 96 as are known in the art. In particular, the end of the tongue portion 91 includes a male luer element 95 adapted to closely fit with a corresponding female luer element 96 arranged at the upper end of the grip portion 92 . These luer elements preferably engage standard twist lock parts for engagement and disengagement. Alternatively, the tongue and grip portion may be releasably connected by a friction fit, press fit or snap fit. Preferably, the tongue and grip portion can be easily attached and detached, but cannot be inadvertently detached during use.

As depicted in FIG. 12A , tongue portion 91 preferably includes a convex front surface 91 a configured to match the inner contour of expandable body 11 . In the illustrated embodiment, the tongue portion 91 is substantially cylindrical and the front surface 91a includes one or more inflation holes 93 for expanding the expandable body 11 . Grip portion 92 includes a female luer element 94 configured to mate with a corresponding male luer element of the inflatable device.

12B is a cross-sectional view of the grip portion of FIG. 12A along line 12B-12B, and FIG. 12C is a cross-sectional view of the tongue portion of FIG. 12A along line 12C-12C. Grip portion 92 includes a lumen 97 along the length of the grip portion and in communication with the inflator through connector 91 . Although the grip portion is depicted as rectangular in cross-section, it may also be of other shapes, including but not limited to square, circular, triangular, and elliptical, all without departing from the scope of the present invention.

Referring to FIG. 12C , tongue portion 91 may also include a lumen 98 along the length of the tongue portion and in communication with lumen 97 and inflation hole 83 . Although the cross-section of the tongue portion is depicted as circular, it may be of other shapes including, but not limited to, square, circular, triangular, and elliptical, all without departing from the scope of the present invention.

Referring to FIG. 12A , the tongue portion 91 is arranged at an angle X relative to the grip portion 92 , thus allowing the user to substantially leverage the tongue portion 91 while holding the grip portion 92 . Preferably, the angle X is greater than 90 degrees, especially preferably between 120 and 160 degrees. This angle between the grip portion and the tongue portion facilitates insertion of the device and reduces the need to reposition the patient. As noted above, this advantage allows the patient to sit and lie down in a more comfortable position for most examinations.

Similar to the previous embodiments, the handle assembly 90 facilitates insertion of the deflation device and manipulation of the vaginal internal anatomy. Tongue portion 91 includes a tip 99 configured to mate with the end of a patient's vaginal canal so that the cervix can be manipulated and visualized. The tongue portion provides access to the patient's cervix by engaging the connecting portion of the vaginal canal. Both the tongue and the grip part preferably comprise a hollow plastic part manufactured, for example, by injection moulding. In addition, the tongue and grip can be made of other materials, such as metal and wood.

Referring to FIGS. 13A-13C , prior to insertion, the non-inflated expandable body is attached to the tongue portion 91 such that the inflation holes 93 in the tongue portion 91 line up with the corresponding inflation holes in the inner wall of the expandable body 100 . The expandable body 100 is of similar construction to the expandable body of FIGS. 1-3 and includes inner envelopes 102a and 102b and an inner wall 103 . Preferably, the tongue portion is disposed within the relatively soft inflatable body 100, thus providing maximum comfort to the patient. The expandable body 100 may be attached to the tongue portion 91 using a suitable adhesive, ultrasonic welding and heat welding.

A sheath 101 is used to facilitate insertion of the tongue and expandable body. The sheath 101 is adapted to hold the expandable body against the tongue portion during insertion. Additionally, the sheath 101 is adapted to rupture upon expansion of the expandable body. The sheath 101 may include a series of holes to facilitate rupturing when inflated. The sheath 101 can be removed by the physician after surgery and, optionally, can be configured to dissolve within the vaginal cavity.

In an alternative embodiment depicted in FIG. 14, the expandable body 100' is tapered such that, in the expanded configuration, the diameter of the proximal end is greater than the diameter of the distal end. Additionally, the diameter of the envelope 102b' is greater than the diameter of the envelope 102a'. This structure helps to maintain the expanded expandable body 100' in place in the patient's vaginal canal.

Preferably, the patient has the option of inserting the speculum himself. Advantageously, it is simple for the patient to insert the tongue portion once the handle portion is removed. Tongue portion 91 resembles a tampon having an elongated cylindrical surface and bullet-shaped distal tip 99, as shown in FIG. 13A. After insertion, the grips are optionally connected by luer-type connectors 95 and 96 . In many cases, the cervix is visualized without any manipulation of the handle assembly after insertion into the vagina. In this way, there is no need to connect the grip part, so that the female luer connector can be connected directly to the inflatable device. However, the grip portion may be attached to the tongue portion to provide suitable leverage for manipulating the tongue portion 91 when the cervix is not visible.

Tongue portion 91 is designed to be thick enough to be used as a lever without breaking off, but thin enough for patient comfort. In addition, tongue portion 91 preferably uses different sizes for treating different patients. Preferably, the tongue portion has a diameter of approximately 10mm to 15mm. Of course, it will be understood by those skilled in the art that the tongue portion may have a diameter other than the range of 10 mm to 15 mm without departing from the scope of the present invention.

The expandable bodies of the present invention preferably come in a variety of sizes, including a small size for young women and atrophic postmenopausal women, a medium size for "normal" women, and a large size for obese women. The small size preferably has a length greater than 10 cm and a diameter of about 2.5 cm. The medium size preferably has a length of about 12 cm and a diameter of about 4.0 cm. The large size preferably has a length of about 18 cm and a diameter of about 6 cm.

The vagina and rectum are natural organs that can efficiently absorb drugs that enter the venous system. Currently, there are hormonal devices that are placed intravaginally to allow continuous delivery of one or more medications. However, such devices are difficult and often painful to insert. Additionally, several devices of different sizes have to be fitted before a suitable fit can be found, and some patients may be between models, making it difficult to achieve a proper fit.

Referring to Fig. 15, a handle assembly 90 and expandable body 100 as disclosed with reference to Figs. 12-13 are employed to facilitate delivery of medication within the vagina V of a patient. The handle assembly 90 is an assembled assembly, including an intravaginal lingual portion 91 and a detachable holding portion 92 . As described with reference to FIG. 13, the deflated expandable body 100 and tongue portion 91 are inserted into the vagina V, and the expandable body is inflated.

Referring to FIG. 15A , tongue portion 91 and expandable body 100 are releasably connected by one or more fasteners 105 in accordance with one aspect of the present invention. Fastener 105 preferably includes a buckle or any other suitable interlocking releasable element or retention component. When inflated, the fasteners 105 remain properly aligned between the inflation holes 93 of the tongue portion 91 and the corresponding inflation holes of the expandable body 100 . Referring to Figure 13B, after inflation, the fasteners 80 are unfastened or otherwise released, thus allowing the tongue portion 91 to be completely removed from the central lumen of the expandable body.

Referring to Figure 15C, after tongue portion 91 is withdrawn from the central cavity, cylinder 112 containing one or more medications is positioned there. More particularly, the end 112a of the cylinder 112 is inserted through the envelope 102a while the cylinder is translated distally within the central lumen. The cylinder 112 is preferably secured within the central lumen by retaining joints 114 or by other suitable fasteners. In the illustrated embodiment, the distal and proximal ends 112a and 112b extend beyond the distal and proximal envelopes, respectively. Optionally, the distal end 112a and the proximal end 112b are sized to be flush with the distal cuff 102b and the proximal cuff 102a when placed within the central lumen of the expandable body.

Referring to FIG. 15D , the cylinder 112 preferably includes a plurality of separation chambers 120 , 122 , 124 , 126 arranged around the inner cavity 116 . Each chamber 120, 122, 124, 126 may be filled with one or more drugs suitable for continuous and/or intermittent delivery. Additionally, one or more chambers may be filled with other liquids such as water or saline. The chambers 120, 122, 124, 126 preferably include rigid or semi-rigid walls 117 that provide structural support to prevent the lateral vaginal walls from converging. Suitable compound materials for chamber wall 100 include silicon and polyurethane.

Referring to Figure 15E, a proximal removable end cap 118 is provided which seals the cylinder 112 in use. The end caps 118 are preferably attached to the cylindrical body 112 by a force fit or a friction fit. Additionally, the end cap 118 may include a bore 119 aligned with the lumen 116 . Aperture 119 allows bodily fluids and excess medication to be drained through lumen 116 .

Referring again to FIG. 15C, each chamber 120, 122, 124, 126 preferably also includes a pump 120a, 122a, 124a, 126a in fluid communication with a respective nozzle 120b, 122b, 124b, 126b. Advantageously, the use of separate pumps prevents unwanted mixing between drugs. The pumps 120a, 122a, 124a, 126a preferably include a timing mechanism for controlling the dispensing of a predetermined amount of drug to a targeted treatment area within the vagina V. Nozzles 120b, 122b, 124b, 126b are preferably rotatable so that they can be pre-positioned prior to insertion of cylinder 112 to dispense drug onto a particular target treatment area. Although the cylinder is depicted as having four barrels, it will be appreciated by those skilled in the art that the cylinder 112 may include any number of chambers (and corresponding pumps and nozzles) without departing from the scope of the present invention. Alternatively, cylinder 112 may include a plurality of chambers and a single pump/nozzle assembly configured to selectively dispense drug from any of the plurality of chambers.

With continued reference to FIG. 15C , one or more O-ring seals 103 are disposed between cylinder 112 and expandable body 100 to prevent fluid leakage. According to some embodiments, the lumen 100 is allowed to remain open to allow natural drainage and prevent infection. The cylinder preferably also includes a handle 130 having a tapped end 131 for releasably engaging the lumen 116 of the cylinder 112 . The handle 130 facilitates withdrawal of the cylinder from the central lumen of the expandable body 110 . Additionally, the handle can be used to rotate the cylinder into its proper position within the central lumen.

Drugs with fast absorption properties are particularly suitable for delivery using the cylinder 112, so that the target tissue area where the drug is absorbed is very close to the area where the drug is delivered. Drugs delivered by cylinder 112 include, but are not limited to: antihypertensive drugs such as acetrolol, diltiazem, horse chestnut, metoprolol, and nifedipine; antibiotics; chronically administered drugs such as chemicals (chemos); oral hypoglycemic drugs such as terconazole, fluconazole, miconazole, and gynazole; and drugs used to treat bacterial infections such as metronidazole and clindamycin.

According to an exemplary embodiment, chamber 120 is filled with chremophor and chamber 122 is filled with paclitaxol. The timing mechanism within pump 120a is configured to deliver a controlled amount of chremophor to the target treatment area at specific time intervals, eg, once every 3 days. Likewise, a timing mechanism within pump 122a may be configured to deliver a controlled amount of paclitaxol to the target treatment area at specific time intervals, such as once every 6 days. Optionally, pumps 120a, 122b may be configured to continuously deliver chremophor and paclitaxol to the target treatment area.

According to another exemplary embodiment, where hormone replacement surgery is planned for postmenopausal women or women who have undergone hysterectomy, chamber 120 is filled with estrogen, chamber 122 is filled with progestin and chamber 124 is filled with water. A timing mechanism within pumps 120a, 122a was configured to deliver controlled amounts of estrogen and progestin, respectively, to the targeted treatment area each week for three consecutive weeks. During the fourth week, a timing structure within pump 124a is configured to deliver a controlled amount of water to the targeted treatment area. This drug delivery schedule (eg, three weeks of drug followed by one week of water) is preferably repeated indefinitely until one of the chambers needs to be refilled by the physician.

The chamber within the cylinder is adapted to be periodically filled by a physician or physician. For example, a physician may fill the room with a prescription for multiple drugs, where the prescription may last for a predetermined length of time. Advantageously, multiple medicines can be injected indoors, which provides great convenience to many patients, especially elderly women. Additionally, continuous dosing of absorbed drug products provides less variability than oral dosing.

Vaginal prolapse occurs when the vagina is strained so that its front or back wall bulges out. In addition, prolapse can occur in the bladder, urethra, rectum, or uterus. Prolapses are managed in different ways depending on the severity of the prolapse and the age of the patient. On the one hand, young patients often opt for surgical resolution, which is necessary because most young patients are sexually active and contraindicated for intravaginal devices. Elderly patients, on the other hand, are usually asexual. Insertion of the device is therefore generally preferred.

In general, insertable devices have not been very successful due to a number of drawbacks. As noted above, sexually active patients often opt for surgery to avoid disruption of their sexual lives. Furthermore, insertion and removal of the device is very uncomfortable and can lead to infection. Therefore, even in elderly people, surgery is often the solution. However, many of these patients are not good candidates for surgery. Frequent prolapse results in a bulge or protruding area on the vaginal wall. These prolapsed areas often exert substantial pressure on the intravaginal device and tend to push conventional devices completely out of the vagina.

Referring to Fig. 16, the handle assembly 90 and expandable body 100 are employed, as disclosed with reference to Figs. 12-13, to relieve symptoms within the vagina V of a patient. In particular, the expandable body is adapted to remain in the vagina V in the expanded configuration for a continuous period of time, such as days, weeks or months. Referring to Figure 16A, the vagina V includes areas of prolapse P that cause incontinence, obstruction, discomfort, and other symptoms. Referring to Figure 16B, the deflated expandable body 100 and tongue portion 91 are inserted into the vagina V, and the expandable body is then expanded as described above. Tongue portion 91 and inflatable portion 100 are releasably connected by one or more fasteners 105 so that the tongue portion can be removed after inflation of the inflatable body.

Referring to Figure 16C, the expandable body 100 advantageously supports the vaginal canal for a period of time, thus preventing further development of the vaginal prolapsed area. In addition, the central lumen of the expandable body 100 provides a conduit for the passage of bodily fluids, thus preventing blockage due to the prolapsed area. Furthermore, the expandable body 100 is adapted to remain in the vaginal cavity for a period of time as the prolapsed area recedes or even disappears completely.

According to certain embodiments, the central lumen of the expandable body remains open such that it allows normal fluid outflow. Advantageously, this inhibits infection and reduces odor caused by discharge clogging in the past. Waste holding basins are available to collect liquid discharges. Referring to FIG. 16D , according to other embodiments, a cylinder 112 such as that described with reference to FIG. 15 may be inserted into an expandable body. The cylinder 112 provides increased structural rigidity and a resultant increase in lateral radial force of the expandable body 100 . Of course, the increased lateral radial force helps to keep the expandable body within the vagina V despite the relative force of the prolapsed area. Additionally, as depicted in Figure 16E, the outer wall of the expandable body 100 may include topographic features 135 that increase the friction between the outer wall and the vaginal wall. As examples, topographical features may include, but are not limited to, flanges, indentations, grooves, protrusions, grooves, and other suitable irregular surfaces.

Leep cervical conization is common surgery for women with pre-stage uterine cancer. The procedure uses a wire with a cauterizing current flowing through it that is used to cut through the uterus and generate a sample. To be useful for this procedure, conventional metal speculums must be machined with a non-conductive coating, which makes such speculums rather expensive.

Referring to Fig. 17, an expandable body 100 is used to facilitate excision of tissue from the cervix C of a patient. In the procedure, the deflated expandable body 100 and lingual portion 91 are inserted into the vagina V, and the expandable body is then expanded as described above. The tongue portion 91 is then detached and retracted. The expandable body 100 is non-metallic and therefore does not conduct electricity. Thus, the central lumen of the expandable body provides a conduit for leep conization.

Still referring to FIG. 17 , resection of tissue from the cervix C is accomplished using a wire 140 having a handle 141 attached to a distal end 142 and an electrode 143 attached to a proximal end 144 . Metal wire 140 and electrode 143 are in electrical communication with power source 148 . The handle 141 is used to manipulate the end 143 of the wire 140 into the endocervix E so that the electrode 143 is in contact with the cervix C. More particularly, the physician rotates and translates the wire 140 relative to the expandable body 100 and the cervix C using the handle 141 .

Once the electrode 143 is in position in contact with the cervix C, the wire 140 is rotated using the handle 141, thus causing the electrode 143 to cut through the layers of cervical tissue. The wire is then withdrawn from the distal end and the tissue sample for processing is removed. When the procedure is complete, the expandable body is allowed to deflate automatically by the force exerted by the vaginal cavity.

As described with reference to the embodiment of Figure 5, it is preferred to provide an evacuated tube to remove fumes from cervical tissue excision. For example, when the electrodes touch the cervix, a chute is created. A suction source 154 is provided to evacuate the chute through a vacuum line 152 .

Intracavitary radiation devices exist for the management of gynecological cancers. One type of intracavity radiation device includes an oblong annular chamber including a narrow central cylindrical bore. An irradiated medium is provided as a seed and loaded into the device before it is installed in the vagina. Such conventional intracavity radiation devices come in a variety of sizes due to the size of the vaginal cavity. However, conventional pre-sized devices do not often provide a comfortable fit for most patients.

Referring to Fig. 18, the expandable body 100 of the present invention can be used to facilitate the delivery of therapeutic radiation - treating diseased tissue near the vagina V and cervix C. In the procedure, the deflated expandable body 100 and lingual portion 91 are inserted into the vagina V, and the expandable body is expanded as described above. Next, tongue portion 91 is detached and withdrawn from the central lumen of the expandable body. The central lumen provides a conduit for delivery of radiant seeds 160 within the vagina V, according to one aspect of the invention. Radiation seeds 160 may be in the form of pellets, rods, flakes, spheres, or any other suitable form.

Radiation seeds 160 are delivered to the area of diseased tissue using an elongated cylinder 162 comprising distal and proximal ends 162a, 162b and a lumen 164 sized for passage of radiation seeds 160 . The elongated cylinder 162 preferably also includes a handle 166 disposed at the distal end 162a. The physician uses the handle 166 to manipulate the proximal end 162b to a location adjacent to an area of diseased tissue, such as tissue surrounding the cervix C. Once the proximal end 162b is properly positioned, the push rod 168 is pushed by the physician into proximity within the lumen 164, thereby ejecting the radiation seeds 160 from the proximal end 162b. When the procedure is complete, the expandable body is allowed to deflate automatically by the force exerted by the vaginal cavity. Advantageously, the expandable body 100 expands to a level dictated by the size of the vagina V, thus providing a comfortable fit for most patients.

While the preferred embodiment of the present invention has been described above, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the invention. All such changes and modifications are within the spirit and scope of the invention as covered by the appended claims.

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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