US 20050021069 A1
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.
1. Apparatus for accessing a body cavity, comprising:
a tubular member having proximal and distal ends and an interior, the tubular member formed by everting a length of material upon itself to define a main body portion having a circumferential seam only at distal end, the tubular member having a deflated configuration for insertion into the body cavity and an expanded configuration when inflated; and
an inflation tube disposed in communication with an interior of the tubular member,
wherein the tubular member has a plurality of staggered contact areas arranged so that, in the expanded configuration, the contact areas do not form longitudinal features and the tubular member defines a substantially circular central lumen under load.
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The present invention relates to methods and apparatus for accessing a body cavity, and more particularly, to methods and apparatus for gaining access to the female urogenitary tract.
Examination of the vagina and its associated anatomy is typically performed using a speculum, which provides access to the vagina by dilating the vaginal canal and then holding it in an expanded state. As currently used, a conventional speculum consists of a pair of metal jaws that are inserted into the vaginal canal and then actuated to expand the canal. For most patients, insertion and operation of the speculum is uncomfortable and may cause the patient to become tense, thus making a thorough examination difficult, if not impossible.
Speculums having inflatable exterior walls have been developed, such as described in U.S. Pat. No. 5,716,329 to Dieter. The speculum described in that patent includes a rigid interior wall and an inflatable exterior wall that may be inflated with fluid after insertion to alleviate discomfort associated with expansion of the vaginal canal. The device described in that patent, however, is fairly complicated and because it combines both reusable and disposable components, may not be commercially practicable.
In view of the low cost needed to have a commercially viable disposable speculum product, others have attempted to develop speculums that comprise inflatable sacs or ribs, such as described in International Patent Publication No. WO97/24975 and Dutch Patent No. 9100599. The products described in these publications and patents do not appear to possess sufficient expansile strength for practical use, however.
U.S. Pat. No. 5,743,852 to Johnson describes an inflatable speculum comprising an inflatable cone-like structure comprising inner and outer wall elements that are sealed together along their edges, and which further includes a grid of contact areas comprising a grid pattern. That patent describes an insertion rod disposed within the speculum to assist in insertion, and is coupled to an external sheath that is withdrawn through the central lumen of the device when the insertion rod is withdrawn. A cone-shaped structure that may be inserted within the inflated speculum once it is inflated to retain the speculum in the expanded state, and in addition, to provide support for a fiber-optic light or other instruments.
The foregoing Johnson patent appears to provide a number of advantages with respect to other inflatable speculum designs. However, the configuration of the insertion rod and sheath are expected to be problematic, in that the sheath is drawn from the distal (nearest the gynecologist) to the proximal edge (furthest within the patient) during removal, and may cause undue rubbing and discomfort. In addition, because the internal support structure disclosed in that patent does not extend to the proximal end of the speculum, it is possible for the forces applied by the patient's body to partially collapse the proximal end of the speculum. Finally, the use of sealed edges along the periphery of the inner and outer wall elements, especially at the proximal end of the speculum, may create a relative rigid structure capable of scraping the patient's cervix and causing patient discomfort.
U.S. Patent Publication US2003/1099737 to Deslauriers et al. describes an inflatable speculum having a plurality of longitudinally extending ribs arranged to delimit trapezoidal prisms within the volume of the speculum. As in the above-described WO publication and Dutch patent, the presence of the longitudinal ribs in the Deslauriers device is expected to preferentially distort to a central lumen of the speculum to a narrow elipse, rather than providing a substantially circular lumen.
In view of the aforementioned drawbacks of previously known devices, it would be desirable to provide methods and apparatus for accessing a body cavity that is small, easy to insert into the body cavity and comfortable once inserted and actuated within the body cavity.
It further would be desirable to provide methods and apparatus for accessing a body cavity that provides sufficient strength to expand the body cavity while using low-cost materials that permit the apparatus to be discarded after a single use.
It also would be desirable to provide apparatus for accessing a body cavity that provides sufficient radial strength to expand a body cavity in the vast majority of cases, but which may include a further optional component for use in special situations, e.g., in examining or treating obese patients.
It still further would be desirable to provide methods for manufacturing apparatus to access a body cavity that substantially eliminate the presence of longitudinal ribs or features that cause preferential bending of the device in the inflated state, and thereby ensure a substantially circular working lumen.
It also would be desirable to provide methods for manufacturing apparatus to access a body cavity that substantially eliminate the presence of welds or seals along the proximal peripheral edges of the device, thereby reducing the risk of patient discomfort.
In view of the foregoing, it is an object of the present invention to provide apparatus for accessing a body cavity that is small, easy to insert into the body cavity and comfortable once inserted and actuated within the body cavity.
It is another object of this invention to provide methods and apparatus for accessing a body cavity that provide sufficient strength to expand the body cavity while using low-cost materials that permit the apparatus to be discarded after a single use.
It is another object of this invention to provide apparatus for accessing a body cavity that provides sufficient radial strength to expand a body cavity in the vast majority of cases, but which may include a further optional component for use special situations, e.g., in examining or treating obese patients.
It is a further object of the present invention to provide methods for manufacturing apparatus to access a body cavity that substantially eliminate the presence of longitudinal ribs or features that cause preferential bending of the device in the inflated state, thereby ensuring a substantially circular working lumen.
It is yet another object of this invention to provide methods for manufacturing apparatus to access a body cavity that substantially eliminate the presence of welds or seals along the proximal peripheral edges of the device, thereby reducing the risk of patient discomfort.
In accordance with the principles of the present invention, apparatus is provided for accessing a body cavity that comprises an inflatable body formed from a single sheet of material that is everted upon itself and sealed along its distal edge (nearest the physician), thereby eliminating the presence of a distal seal or weld zone and providing an atraumatic proximal end. The inflatable body is inserted into the body cavity in a deflated configuration and then inflated to an expanded configuration, thereby expanding the walls of the body cavity. The inflatable body includes at a plurality of contact points arranged in a substantially uniform pattern to permit substantially uniform pressure distribution within the inflatable body during expansion. In accordance with the principles of the present invention, the contact areas are arranged so as not to create substantially longitudinal features, but instead provides a substantially circular central lumen when the inflatable body is inflated under load.
The inflatable body is coupled to an inflation device, such as a bulb or pump, via a length of relatively stiff tubing that extends into and terminates within the inflatable body. The tubing is sufficiently rigid to permit the clinician to exert a force of the inflatable body, in the contracted delivery configuration, to drive the inflatable body into the patient's orifice. In addition, a retractable, pre-lubricated sheath may be disposed on the exterior of the inflatable body to assist in inserting the device into the patient's orifice.
Optionally, the apparatus includes an internal support member that may be inserted within the central lumen of the inflatable body after inflation. The support member preferably comprises an inexpensive plastic component that is mounted on a dilator, and then placed within the speculum to enhance the radial strength of the apparatus, and to prevent the proximal end of the inflatable body from collapsing. This optional support member may be particularly advantageous for use in obese patients.
In some embodiments, the inflatable body may include one or more pockets disposed within the central lumen of the inflatable body to permit a fiber-optic light or other instrument to be retained within the lumen. Alternatively, the inflatable body may include additional lengths of tubing that extend to a position near the proximal end of the apparatus to permit the evacuation of smoke generated during treatment of the organ, e.g., such as during leep-conization.
In accordance with other aspects of the present invention, the apparatus may be used to facilitate drug delivery within an organ or cavity. In some embodiments, the exterior surface of the inflatable body may be coated with one or more drugs that elute into the patient's tissue when the apparatus is disposed within the body or organ. In other embodiments, the inflatable body defines a receptacle that accepts a cylinder having one or more drug-filled chambers configured to fit within a lumen of the inflated inflatable body and provide a predetermined profile for release of the drugs.
In still further alternative embodiments, the apparatus includes a handle assembly that may be attached to the inflatable body to facilitate insertion of the inflatable body into the body cavity, or to re-orient the field of view accessible through the central lumen of the inflatable body.
Methods of manufacturing the apparatus of the present invention also are provided.
The above and other objects and advantages of the present invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
In the expanded configuration, inflatable body 11 forms annular main body portion 17 defining central lumen 18 that provides the physician with access to the interior of the body organ or lumen. In accordance with one aspect of the present invention, inflation tube 13 is bendable but is otherwise relatively stiff, so that force applied to the inflation tube may be used to push the inflatable body into a patient's orifice. Inflation tube 13 communicates with the interior of main body portion 17 to permit inflatable body 11 to be inflated and deflated.
Valve 15 preferably is a one-way valve that retains pressure within main body portion 17, but does not require that bulb 14 remain pressurized. Valve 15 may be selectively actuated to deflate main body portion 17. Bulb 14 and valve 15 preferably are coupled to inflation tube via a conventional luer fitting, so that these items may be uncoupled from inflatable body 11 and inflation tube 13 for subsequent reuse. Bulb 14 and valve 15 preferably are disposed within shield 16, e.g., a plastic bag, to prevent contamination with the patient's body fluids.
Insertion sheath 12 comprises a light-weight plastic sheath that restrains in inflatable body 11 in a contracted position to facilitate insertion in the patient's organ or lumen. Sheath 12 includes a split bullet-nosed atraumatic shape that assists in insertion of the device, and is retracted distally over inflation tube 13 during deployment of the inflatable body.
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In accordance with the principles of the present invention, distributing the rows of contact areas 22 in an axially offset or staggered arrangement avoids the creation of longitudinal features on the inflatable body. Such features, which are present in the previously known devices, lead to preferential bending of the device under load, and permit the central lumen to become distorted into a narrow elipse. The offset grid pattern illustrated in
With respect to
Insertion sheath 12 preferably is lubricated with a biocompatible lubricant and then inserted into a patient's body cavity, e.g., the vagina. In accordance with one aspect of the present invention, inflation tube 13 is sufficiently rigid that it permits the clinician to hold the inflatable body stationary within the body cavity with one hand, while retracting the insertion sheath from the inflatable body in a distal direction with the other hand. The insertion sheath is then removed over the luer at the distal end of inflation tube 13, and valve 15, bulb 14 and shield 16 then are coupled to the luer to permit the inflatable body to be inflated.
Referring now to
An illustrative use of the apparatus of
With respect to
Referring now to
At step 54 a seal or weld is formed at the distal end of double-walled annular tube, thereby forming closed tube. As described hereinabove, having the weld only at the distal end of the inflatable body provides a smooth, atraumatic proximal end to the inflatable body. At step 55 a pattern of contact areas are formed along length and circumference of double-walled annular tube to form the inflatable body. As also described above, the contact areas are axially offset or staggered, so that when the inflatable body is inflated, no predominantly longitudinal features form that preferentially permit bending or partial collapse of the tube, as in previously known designs.
At step 56, shield 16 may be applied to the inflation tube, and at step 57, the luer termination may be applied to the distal end of the inflation tube. Alternatively, the luer termination may be applied, and the shield separately applied at a later time, e.g., after the insertion tube has been removed. Once the inflatable member is completed, at step 57, it may be rolled into an S-shaped configuration, as described above with respect to
With respect to
To facilitate delivery of the drug, gene or protein, features or patterns may be provided on the exterior wall. Alternatively, coating 61 may be lubricious and become slippery when exposed to water, thus reducing friction encountered during insertion of the device. As a further alternative, the apparatus may be pre-soaked in warm water prior to insertion to reduce patient discomfort, as the inflatable body is expected to retain some of the heat from the warm water.
In a further alternative embodiment depicted in
With respect to the embodiments of
In some embodiments gripping portion 72 includes thumb rest 74 designed to promote comfortable gripping of gripping portion 72 during a procedure. Thumb rest 74 is disposed generally on an anterior surface 72 a of gripping portion 72 near the junction of the gripping and tongue portions. Thumb rest 74 preferably comprises a material, e.g., rubber, that permits the handle assembly to be gripped securely while enhancing the tactile sensation of the user.
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Similar to the previous embodiment, handle assembly 90 facilitates insertion of the deflated device and manipulation of the internal anatomy of the vagina. Tongue portion 91 includes tip 99 configured to engage the end of a patient's vaginal canal so that the cervix may be manipulated and viewed. The tongue portion provides for the manipulation of the patient's cervix by engaging the junction of the vaginal canal. Both the tongue and gripping portions preferably comprise hollow plastic pieces fabricated, e.g., using an injection molding process. Alternatively, the tongue and gripping portions may comprise other materials, such as metal or wood.
Sheath 101 is employed to facilitate insertion of the tongue portion and inflatable body. Sheath 101 is adapted to hold the inflatable body against the tongue portion during insertion. Additionally, sheath 101 is adapted to split open during expansion of inflatable body 100. Sheath 101 may include a series of perforations to facilitate splitting open during inflation. Sheath 101 may be removed by the physician after the procedure or, alternatively, may be configured to dissolve within the vaginal canal.
In another alternative embodiment depicted in
Preferably, a patient will be given the option of inserting the speculum by herself. Advantageously, it is easier for a patient to insert the tongue portion once the handle portion has been removed. As shown in
Tongue portion 91 is designed to be thick enough to be usable as a lever without breaking, yet thin enough to provide comfort for the patient. Additionally, tongue portion 91 preferably is available in varying sizes for the treatment of different patients. Preferably, the tongue portion has a diameter of approximately 10 mm to 15 mm. Of course, as would be understood to those of ordinary skill in the art, the tongue portion may have a diameter other than 10 mm to 15 mm without departing from the scope of the present invention.
Inflatable body of the present invention preferably comes in multiple sizes, including a small size designed for young women and atrophic postmenopausal women, a medium size designed for “normal” women, and a large size designed for obese women. The small size preferably has a length of about 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 are capable of effectively absorbing certain drugs into the venous system. Currently, there exist hormone devices that are placed into the vagina to allow continuous administration of one or more drugs. However, such devices are difficult and often painful to insert. Additionally, several devices of varying sizes may have to be installed before finding a good fit, and some patients may be between sizes such that a good fit is unattainable.
Referring again to
With continued reference to
Drugs that have fast absorption properties are particularly suitable for delivery using cylinder 112 since the target tissue area where the drug is absorbed will be very close in proximity to the area where the drug is delivered. Drugs that may be delivered using cylinder 112 include, but are not limited to: antihypertensives, such as atenolol, diltiazem, enalapril, metoprolol and nifedipine; antibiotics; chronically administered drugs such as chemo; oral hypoglycemics such as glyburide, paclitaxol, abraxene and prep drug chremophor; drugs used to treat yeast infections such as terazol, diflucan, monistat and gynazole; and drugs used to treat bacterial infections such as flagy and cleocin.
According to one exemplary embodiment, chamber 120 is filled with chremophor and chamber 122 is filled with paclitaxol. The timing mechanism within pump 120 a is configured to deliver a controlled amount of chremophor onto a target treatment area at specific time intervals, for example once every 3 days. Likewise, the timing mechanism within pump 122 a is configured to deliver a controlled amount of paclitaxol onto the target treatment area at specific time intervals, for example once every 6 days. Alternatively, pumps 120 a, 122 b may be configured to continuously deliver chremophor and paclitaxol to the target treatment area.
According to another exemplary embodiment, designed to implement hormone replacement therapy in post-menopausal women or women who have had a hysterectomy, chamber 120 is filled with estrogen, chamber 122 is filled with progestin and chamber 124 is filled with water. The timing mechanism within pumps 120 a, 122 a are configured to deliver a controlled amount of estrogen and progestin, respectively, onto a target treatment area every week for three consecutive weeks. In the fourth week, the timing mechanism within pump 124 a is configured to deliver a controlled amount of water to the target treatment area. This drug delivery schedule (i.e., three weeks of drugs followed by a week of water) preferably is repeated indefinitely until one of the chambers requires refilling by a physician.
The chambers in the cylinder are adapted to be filled periodically by a doctor or pharmacist. For example, a pharmacist may fill a prescription of multiple drugs into the chambers, wherein the prescription will last for a predetermined amount of time. Advantageously, being able to fill the chambers will multiple drugs provides a tremendous convenience for many patients, particularly older women. Additionally, the continuous administration of drugs by absorption provides less variability than taking oral doses.
Vaginal prolapse occurs when the vagina stretches such that its front or back wall bulges. In addition, prolapse can occur from the bladder, urethra, rectum, or uterus. Prolapse is managed in different ways depending upon the severity of the prolapse and the age of the patient. On one hand, younger patients commonly opt for a surgical solution, which is necessary because most younger patients are sexually active and a device in the vagina would be prohibitive. On the other hand, elderly patients are usually not sexually active. Therefore, the insertion of a device is typically preferred.
In general, insertable devices have not been very successful since they suffer from a number of drawbacks. As noted above, sexually active patients typically opt for surgery to avoid interruption of their sex life. Further, the devices are very uncomfortable to insert and remove and may cause infections. Thus, even for the elderly population, surgery is often the chosen solution. However, many of these patients are not excellent operative candidates. Prolapse frequently causes bulges or areas of prolapse in the vaginal wall. These areas of prolapse often exert a significant amount of pressure on the intra-vaginal device and tend to push conventional devices out of the vagina altogether.
According to some embodiments, the central lumen of the inflatable body remains patent such that it allows normal fluid to flow out. Advantageously, this inhibits infection and reduces odor from the build-up of old discharge. A waste reservoir may be provided to collect the fluid discharge. Referring to
Leep conization is a common procedure for women having pre-cancer of the cervix. The procedure employs a metal wire having a cauterizing current flowing through it, which is used to cut through the cervix and yield a specimen. In order to be usable for such procedures, conventional metal speculums must be manufactured with an electrically non-conductive coating, which makes such specula very expensive.
Still referring to
Once electrode 143 has been positioned in contact with cervix C, metal wire 140 is rotated using handle 141, thereby causing electrode 143 to excise a layer of cervical tissue. The metal wire then is retracted distally and the tissue sample is removed for processing. When the procedure is completed, the inflatable body is allowed to deflate automatically by the force exerted by the vaginal cavity.
As described hereinabove with respect to the embodiment of
Intracavitary radiation devices exist for treatment of gynecologic cancers. One type of intracavitary radiation device comprises an oblong donut including a narrow central cylindrical opening. The radiation medium may be supplied as seeds and loaded into the device prior to placement of the device into the vagina. Such conventional intracavitary radiation devices must come in multiple sizes due to the large variation in vaginal cavity sizes. However, the conventional pre-sized devices do not often yield a comfortable fit for most patients.
Radiation seeds 160 are delivered to a diseased tissue area using elongated cylinder 162, which comprises distal end 162 a and proximal end 162 b and lumen 164 dimensioned for the passage of radiation seeds 160. Elongated cylinder 162 preferably further comprises a handle 166 disposed at distal end 162 a. A physician uses handle 166 to manipulate proximal end 162 b into position adjacent a diseased tissue area, for example the tissue surrounding cervix C. Once proximal end 162 b has been properly positioned, push rod 168 is urged proximally within lumen 164 by the physician, thereby ejecting a radiation seed 160 from proximal end 162 b. When the procedure is completed, the inflatable body is allowed to deflate automatically by the force exerted by the vaginal cavity. Advantageously, inflatable body 100 may be inflated to varying levels depending on the size of vagina V, thereby providing a comfortable fit for most patients.
Although preferred illustrative embodiments of the present invention are described above, it will be evident to one skilled in the art that various changes and modifications may be made without departing from the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.