Patent ID: 12201277

DETAILED DESCRIPTION

Hysteroscopy may be invaluable for diagnosing and treating the intrauterine cavity. Hysteroscopic procedures may be performed using an endoscope, with or without an attached integrated video imaging system, with the use of media suitable for distending the uterus. Examples of fluid media used to distend the uterus include, but are not limited to, liquids such as water or certain aqueous solutions (for example, a saline solution or Ringer's lactate solution) and gases. One exemplary method of distending the uterus using an appropriate gaseous medium involves insufflation with carbon dioxide (CO2). Upon the distension of the uterus, the surgical procedure carried out may relate to hysteroscopic tissue removal such as the removal of uterine fibroids or other abnormal gynecological tissues.

Referring toFIG.1, a gynecological cavity is shown and designated generally by the reference number10. The gynecological cavity10includes the uterus12defining the uterine cavity14, access to which is generally through the vaginal canal16and the cervix18. The fallopian tubes20extend from an upper portion of the uterus12and terminate in fimbriated and funnel-shaped openings that wrap partway around the ovaries22(shown inFIG.2).

It may be desirable in various situations for medical personnel to perform diagnostic and/or therapeutic procedures within the gynecological cavity10. For example, as shown inFIG.1, a surgeon may wish to detect, visualize, and/or treat conditions including, but not limited to, various tissue abnormalities such as fibroids24, polyps26, tumors, adhesions, or other tissue abnormalities within the uterus12. Types of fibroids24include, but are not limited to, intramural fibroids24a, pedunculated submucosal fibroids24b, pedunculated subserosal fibroids24c, submucosal fibroids24d, subserosal fibroids24e, and the like. The surgeon may also wish to treat endometriosis or other abnormal bleeding or fertility issues. To facilitate the visualization, detection, and/or treatment of the above and like conditions, ample space may be needed within the gynecological cavity10for the procedure to be performed. Unfortunately, however, in those instances in which the gynecological cavity10is the uterine cavity14, adequate space does not typically exist naturally. This is because the uterus12is a flaccid organ. As such, the walls of the uterus12are typically in contact with one another when in a relaxed state (similar to the walls of a deflated balloon). Consequently, active steps are generally taken to create a working space within the uterine cavity14. One technique for creating such a working space is to administer a fluid medium to the uterine cavity14, trans-cervically, under sufficient pressure to cause the uterus12to become distended.

Fluid media administered to the uterus12can be of low or high viscosity and of low or high molecular weight. The fluid media can also be either electrically conductive or nonconductive based upon the presence or absence of electrolytes in the fluid media. In terms of gaseous fluid media, it is generally accepted that CO2can be used as a distending medium for diagnostic hysteroscopy only as it may not be suitable for operative hysteroscopy or diagnostic procedures due to possible bleeding and the collection of blood and tissue debris, which may obscure the optical field of a viewing apparatus.

Referring now toFIG.2, the fluid medium, shown generally at30, may be introduced into the uterus12to cause the distension. While useful for the performance of hysteroscopy and hysteroscopically directed procedures, the distending fluid medium30, if absorbed systemically in sufficient amounts, may have adverse effects on a patient. Consequently, understanding the physical properties and the potential risks associated with the use of the various fluid media used for distending the uterus12is beneficial for the safe performance of hysteroscopic procedures. For example, because the fluid medium30is administered under pressure (which pressure may be as great as 80-100 millimeters (mm) Hg or greater), there may be a risk of intravasation. Intravasation during hysteroscopy procedures is the absorption of the uterine distension media through the uterine vasculature, thus resulting in such fluids leaking through open uterine channels such as the ostium of the uterine tube or the fallopian tubes20where the fluid is then spilled to the peritoneal or abdominal cavity. The methods as described herein allow for the minimization of fluid spillage and absorption in the patient's body. Factors influencing the amount of intravasation can include, but are not limited to, intrauterine pressure; number and size of the vascular openings in the uterus; duration of the procedure; and the condition of the patient. In other cases, the principal mechanism of systemic absorption of the distending fluid medium30may be directly related to surgical disruption of the integrity of the venous sinuses in the deep endometrium32and the myometrium34. Whether due to intravasation or surgical disruption, when these vessels or sinuses are transected, the fluid medium30is provided an opportunity to access the systemic circulation if the uterine pressure is greater than the patient's mean arterial pressure (MAP). Fluid overload in the patient can cause pulmonary edema or other undesirable effects. In terms of large amounts of CO2absorption, CO2is highly soluble in blood and if sufficiently high amounts reach the systemic circulation of the heart, CO2embolism may present, which may result in cardiorespiratory collapse.

To minimize the opportunities for the fluid medium to access the systemic circulation, intrauterine pressure should be controlled (for example, by close monitoring of the fluids administered) to maintain a balance between too much pressure, which increases the opportunity for intravasation, and too little pressure, which decreases the visibility of the uterine cavity. The intrauterine pressure should remain below the patient's MAP. The MAP is the average pressure within an artery over a complete cycle of one heartbeat. Monitoring equipment in a hospital setting usually provides an automatic calculation of the MAP for the anesthesia personnel who can then report the reading to the operative team. In a physician's office, it may be necessary for medical personnel to manually calculate the patient's MAP using data from an automatic blood pressure monitor.

The AAGL (American Association of Gynecologic Laparoscopists) Practice Report Practice Guidelines for Management of Hysteroscopic Distending Media states:

“a. For healthy patients, the maximum fluid deficit of 1000 mL is suggested when using hypotonic solutions. This is based on a decrease in serum sodium of 10 mmol, with absorbed volume of around 1000 mL. The maximum limit for isotonic solution is unclear, but 2500 mL has been advocated in the previous AAGL Guidelines. Individualization and an opinion from an anesthesiologist should be obtained.

b. When high-viscosity distending media are used, the maximum infused volume should not exceed 500 mL, and in the elderly and those with cardiopulmonary compromise should not exceed 300 mL.”

There are cases where hysteroscopic procedures are aborted due to a large fibroid24that needs to be removed but the fluid deficit was reached. The fluid deficit is characterized by the difference between the volume of distension fluid instilled into the uterine cavity14and the volume of, fluid removed through the out-flow channel of a hysteroscope, plus fluid collected from the drapes or inadvertently lost in drapes and surrounding area of the operative table. The deficit closely represents the amount of fluid that may have been absorbed into the patient's vasculature.

Referring now toFIG.3, a uterine cavity biocompatible seal is designated generally by the reference number40and is hereinafter referred to as “seal40.” The seal40is generally applied via an access sheath60using an endoscope such as a hysteroscope42in a hysteroscopic procedure, the access sheath60providing access to the seal40and access to the distal end of the hysteroscope42being through a working channel44. The access sheath60may also operate to dilate the cervical canal. The seal40may be positionable in a uterine cavity in a deflated condition and subsequently inflated by distension fluid or gas instilled into the seal40. As shown, the seal40is a biocompatible member fabricated of a material capable of being broken down and not requiring mechanical removal from the uterine cavity14(like sutures and chlorhexhidine chips). In some embodiments, the biocompatible member may be fabricated of a material that is bioresorbable, thus allowing the material to be resorbed into the patient's body. In the alternative, the material of the biocompatible member may be mechanically removable from the uterine cavity14, either by piecewise extraction or by being dissolved (for example, based on pH, enzymes, or temperature). Materials from which the biocompatible member may be fabricated include, but are not limited to, chitosan, cellulose, collagen, elastin, gelatin, keratin, polyethylene glycol (PEG), polyvinyl alcohol (PVA), combinations of the foregoing, and the like. Procedures used for the manufacture of the biocompatible member as the seal40include, but are not limited to, lyophilization, injection molding, UV crosslinking, chemical crosslinking (acid/base), and the like.

When deflated, the seal40is received over a distal end of the access sheath60on the hysteroscope42, which comprises the working channel44through which the hysteroscopic procedures may be carried out. The seal40comprises a forward inflation/expansion zone46at a forward end and is configured to be sealed to the access sheath60proximate a rearward end using a sealing member48. Upon initiation of, for example, a hysteroscopic procedure involving the removal of a fibroid24or polyp26, the access sheath60is inserted into uterine cavity14trans-cervically, and the seal40is insufflated with CO2or other appropriate gaseous medium. The inflation/expansion zone46, while deflated, can be used to dilate the cervix during initial insertion.

Referring now toFIG.4, the material of the biocompatible member is sufficiently elastic to allow the seal40to begin to inflate upon infusion of the distension fluid (fluid medium30). Expansion of the seal40allows the outer surface to expand and coat or otherwise engage inside surfaces of the uterine cavity14with minimal pressure equivalent to or below the patient's MAP that will provide suitable distension to allow for visualization of the uterine cavity14. As the seal40begins to inflate, a portion50of the seal40at the external os of the cervix18may expand.

Referring toFIG.5, infusion of the fluid medium30may be through a number of distension fluid/gas runners52that extend along an outer surface of the access sheath60. Although four distension fluid/gas runners52are shown, any suitable number of distension fluid/gas runners52may be used.

Referring toFIG.6, once expanded, the material of the seal40follows the contours of the walls of the uterine cavity14and expands around any protrusions from abnormalities such as submucosal fibroids24and polyps26while blocking pathways through the fallopian tubes20. Once expanded, the material of the seal40has surface friction with the walls of the uterine cavity14. The thickness of the material of the seal40is such that the seal40is transparent or minimally translucent to visually reveal abnormal tissue desired for resection by a tissue removal device54inserted through the working channel44.

Still referring toFIG.6, the tissue removal device54penetrates the material of the seal40before resecting the fibroids24and/or polyps26. Once the material of the seal40is breached, adjacent surfaces of the material (which is elastic) recede due to contraction (reverse expansion) and overcome the friction between the seal40and the walls of the uterine cavity14, thereby exposing the tissue abnormality for further resection while maintaining a seal around the exposed portion of the tissue to be resected. The breached material of the seal40may be extracted via a suction path of the tissue removal device54through the working channel44. Upon completion of the hysteroscopic procedure, the fluid medium30is extracted through the working channel44, the uterine cavity14is thereby deflated, and the hysteroscope42and (optionally) remaining biocompatible material of the seal40is removed. The access sheath60is also removed.

Referring toFIGS.7A through7D, the component parts and assembly method are illustrated. As shown inFIG.7A, material of the seal40in the inflation/expansion zone46may be thicker than the material at other portions (such as a rearward end58) of the seal40.

As shown inFIG.7B, an elongated tubular member may define the access sheath60as having a forward opening62through which the fluid medium30may be expelled to inflate the seal40. The access sheath60may also have a rearward end64on which an end cap66may be attached to clamp the seal40. The access sheath may be an extruded non-metallic tube and may also include fluid exit ports68through which the fluid medium30may be expelled to expand middle portions of the seal40(for example, at the external os of the cervix). The attachment of the end cap66to the access sheath60may be via a glued joint or an ultrasonic weld on an outer surface of the access sheath60. The end cap66may include a groove70machined on an inner surface thereof to accommodate an O-ring72to provide a seal point between the end cap66and a portion of the hysteroscope42extending rearward to the surgeon.

As shown inFIG.7C, ribs76may be located on an inner surface of the access sheath60. Ribs76may operate to center the hysteroscope42in the access sheath60and may provide annular areas78for the flow of the fluid medium30.

As shown inFIG.7D, the seal40may be received over the forward opening62of the access sheath60. Three heat shrink tubes80may be positioned over the seal40on the access sheath60after assembly to maintain the seal40in place on the access sheath60. The two rearward heat shrink tubes80may be spaced sufficiently to define the portion50, which is positioned at the cervical end of the vaginal tract and expands accordingly. The rearmost end of the seal40is maintained on the access sheath60via the end cap66.

Referring toFIG.8, a flow of one exemplary method of using the seal40and the access sheath60in conjunction with a hysterocope42and also in conjunction with, for example, a tissue removal device54is shown generally at90and is hereinafter referred to as “method90.” In the method90, the seal40and the access sheath60are installed onto the hysteroscope42and inserted into the uterine cavity14, in a step92. After insertion, the fluid medium30may be introduced, in a step94, through the working channel44of the hysteroscope42to inflate the seal40. Instruments that also may be introduced include, but are not limited to, viewing instruments such as cameras and lighting equipment having working channels for the introduction of further instruments such as tissue removal device blades, fluid flow devices, and the like. After inserting the instruments, tissue may be resected in a resection step96. In a removal step98, the resected tissue may be removed through a suction path of the tissue removal device blade. Following removal of the resected tissue, the instruments may be retracted in a retraction step100.

Any of the foregoing step may be carried out using a robot or robotic apparatus and controlled using a controller110having a processor112and a memory114, the memory114having software116. Although the resection step96is shown as being controlled using the controller110, it should be understood that any of the described steps could be carried out robotically and using the controller110.

Referring to all the Figures, the proposed invention provides a seal in the uterine cavity by implementing a coating or lining on the wall of the uterine cavity to block the pathway into the fallopian tubes to prevent saline (or other fluid) spillage to the abdominal cavity. The seal also minimizes the uterine cavity exposure to saline or fluids (such as gases or other distending media) thereby minimizing the extravasation/intravasation of fluids or gas during a hysteroscopic procedure. Furthermore, the seeding of other structures with cancerous or precancerous cells may be avoided. Additionally, accidental perforation of the uterine endometrium wall may be prevented.

Below are provided further descriptions of various non-limiting, exemplary embodiments. The below-described exemplary embodiments may be practiced in conjunction with one or more other aspects or exemplary embodiments. That is, the exemplary embodiments of the invention, such as those described below, may be implemented, practiced, or utilized in any combination (for example, any combination that is suitable, practicable, and/or feasible) and are not limited only to those combinations described herein and/or included in the appended claims.

In one exemplary embodiment, a device comprises: an access sheath comprising a tubular member; an inflatable member coupled to the access sheath; and an endoscope having a working channel, the endoscope being configured to be positioned through the access sheath. The inflatable member is configured to be received into a body cavity, such as a uterine cavity, by insertion of the access sheath into the uterine cavity, and the inflatable member is configured to expand to cover a contour of the uterine cavity upon inflation and to internally seal the uterine cavity.

The inflatable member may comprise a biocompatible member. The biocompatible member may be fabricated from one or more of chitosan, cellulose, collagen, elastin, gelatin, keratin, and polyethylene glycol. The inflatable member, once expanded to cover a contour of the uterine cavity, may be one of transparent and translucent to allow an abnormality to be viewed therethrough. The endoscope may be a hysteroscope.

In another exemplary embodiment, a method comprises: delivering a biodegradable expandable member into a uterine cavity of a patient; insufflating the biodegradable expandable member in the uterine cavity to expand the uterine cavity; sealing the biodegradable expandable member against an inner wall of the uterine cavity to seal the uterine cavity internally; and delivering an endoscope into the uterine cavity.

Delivering a biodegradable expandable member into a uterine cavity may comprise inserting an access sheath and the biodegradable expandable member into the uterine cavity from the endoscope. Insufflating the biodegradable expandable member in the uterine cavity may comprise inflating the biodegradable expandable member in the uterine cavity with a gas. The method may further comprise maintaining a mean arterial pressure of the patient lower than a pressure of the gas. The method may further comprise breaching the biodegradable expandable member and resecting an abnormality of the uterine cavity. The method may further comprise allowing at least a portion of the biodegradable expandable member to resorb into the uterine cavity of the patient. The method may further comprise removing at least a portion of the biodegradable expandable member from the uterine cavity.

In another exemplary embodiment, a method of treating a uterine abnormality of a patient comprises: inserting an access sheath having an inflatable member into a uterine cavity while installed to an endoscope, the endoscope having a working channel for fluid inflow; inflating the inflatable member to expand the inflatable member and to cover a contour of the uterine cavity; and operating a medical device through the working channel of the endoscope to treat the uterine abnormality of the patient.

Inserting an access sheath having an inflatable member into a uterine cavity may further comprise dilating an opening into the uterine cavity. Inflating the inflatable member to expand the inflatable member may comprise instilling a fluid medium into the inflatable member. Instilling a fluid medium into the inflatable member may comprise maintaining a pressure of the fluid medium below a mean arterial pressure of the patient. Inflating the inflatable member to expand the inflatable member and to cover a contour of the uterine cavity may comprise sealing the uterine cavity from an interior thereof. Operating a medical device, for example a tissue removal device blade, through the working channel of the endoscope may comprise breaching the inflated inflatable member covering a contour of the uterine cavity and resecting tissue of the uterine abnormality. Breaching the inflated inflatable member at the uterine abnormality may cause the breached inflatable member to recede from around the uterine abnormality to expose the uterine abnormality. The method may further comprise allowing at least a portion of the inflatable member to resorb into the patient.

It should be understood that the foregoing description is only illustrative of the invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the invention. Accordingly, the invention is intended to embrace all such alternatives, modifications, and variances which fall within the scope of the appended claims.