Patent Application
20070066990
The treatment of tissue masses (e.g., fibroids and tumors) often involves the destruction of tissue. For example, local ablation of a tissue mass may be carried out by inserting a therapeutic device thereinto to destroy targeted cells. Electrical energy may be applied to the tissue mass via one or more electrodes inserted into the tissue mass or fluids with appropriate properties may be injected into the vicinity of the tissue mass to chemically necrose selected portions of the tissue mass.
A number of diagnostic and therapeutic procedures requiring access to the uterus often involve dilation of the cervix to facilitate the introduction instruments therethrough into the uterus. However, when the cervix is over dilated or patulated or, when a device accessing the uterus is manipulated during a procedure, fluid or gas may leak from the cervix. The ablation of uterine tissue may involve the application of intracavity pressure while introducing fluids into the uterus. For example, this may be done when using the Hydro Therm Ablator (HTA®) uterine endometrial ablation system or similar uterine ablation systems, when using an RF uterine ablation system or when utilizing an alternate method of treating the endometrial lining. Injuries may occur during procedures involving the application of heated fluids (e.g., to ablate the endometrium) if these fluids escape from the uterus.
Although the cervical muscle is strong and effectively creates a seal at the opening of the uterus, procedures such as these may require mechanically enhancing the seal of the cervix to prevent fluid leakage therefrom. This may also be required where the cervix is over dilated, weak or subject to significant stress from movement of a device within the cervical os.
Currently, the cervix most often seals itself, but can be enhanced by compressing the cervix with a tenaculum clamped externally therearound. Conventional tenaculums include scissor-like clamps that generate significant compression around the cervix. However, multiple clamps may be required to effectively seal the cervix around its entire circumference and placing these tenacula requires more time which may still not result in an adequate seal. Clamps placed externally to the cervix may also increase trauma and patient discomfort.
The present invention is directed to a device for accessing a hollow organ comprising an elongated body sized for insertion into an opening into a hollow organ, the elongated body including a working channel extending therethrough from a proximal opening which, when the seal is in an operative position, is located proximally of the opening to a distal opening which, when the seal is in the operative position, opens into the hollow organ and a seal extending around a portion of the elongated body between the proximal and distal openings, the seal expanding from an insertion configuration to a sealing configuration.
The present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present invention is related to medical devices used to access hollow organs (e.g., the uterus) for medical treatment. In particular, the present invention relates to devices for reinforcing the fluid tight seal formed by an opening to the hollow organ (e.g., the cervix) around a medical instrument introduced into the organ therethrough.
Endometrial ablation procedures are often performed to treat menhorrhagia, or excessive uterine bleeding. As described above, ablation may be done using radio frequency (RF) methods, microwave heating or through the application of heated liquids. The heated liquids are either free flowing within the uterus or contained within a balloon or other constraining device. The Hydro Therm Ablator (HTA) circulates heated saline solution within the uterine cavity via a probe or sheath inserted into the uterus through the cervical canal. As described above, it is imperative that a fluid tight seal between the cervical canal and the HTA probe be maintained to prevent the escape of the heated fluid therefrom.
There are a wide variety of procedures carried out wherein it is desirable to maintain a fluid tight seal around an instrument inserted into a hollow organ (e.g., in the gastrointestinal tract). Such a seal may be useful in any case where a seal provided by a natural sphincter, restriction or passage into the cavity is not sufficient to provide a fluid-tight seal when a therapeutic device is inserted therethrough. A fluid tight seal may also be useful for bladder treatments. Thus, although the following description is principally directed to a cervical sealing device, those of skill in the art will understand that such description is illustrative only and that embodiments of the device may be used in procedures performed on a variety of other organs.
A device according to an exemplary embodiment of the present invention includes a seal comprising an elongated body adapted for insertion through the opening of the hollow organ (e.g., the cervix) and a plurality of elements connected to the elongated body to maintain a fluid-tight seal of the passage. The seal may also include a working channel extending therethrough, to permit a therapeutic instrument to be inserted into the hollow organ therethrough.
In one embodiment, the foam element 112 includes a protective skin 116 formed of a more resilient and non-absorbent material. For example, the skin layer 116 may form a sheath placed over the entire length of the foam element 112 or a selected portion thereof during insertion into the body. Then, after the seal 100 has been properly positioned within the cervix 102, the skin layer 116 is withdrawn to expose the surface of the foam layer 116. Thus, the skin layer 116 helps to prevent hydration of the foam element 112 before reaching the desired location. In one exemplary embodiment, the foam element 112 is formed of a PVA foam. However, those skilled in the art will understand that any of a wide variety of bio-compatible, fluid-absorbing materials may be used for the foam element 112. The material of the foam element 112 is preferably selected to have mechanical properties enabling it to return to an original shape and dimension after being compressed, for example during insertion through the cervix 102.
In a similar embodiment, the foam element 112 is formed of an expanding weave of material adding a mechanically interlocking function to the material, as the tissue of the cervix 102 works its way into interstices of the weave. This exemplary embodiment of the invention more securely seats the seal 100 within the cervix 102 during the procedure.
A shaft 108 extending from the elongated body 106 of the seal 100 is used to manipulate and position the elongated body 106 and its associated elements within the cervix 102. A working channel 110 extends longitudinally within the shaft 108 and the elongated body 106 between a proximal opening 111 which, when the seal 100 is in position, remains outside the body to a distal opening 113 which opens to the uterus 104. The working channel 110 preferably extends substantially along an axis of the seal 100, to provide a passage into the uterus 104. For example, medical instruments and therapeutic devices may be inserted into the uterus 104 through the working channel 110 while the cervix remains sealed around the seal 100. In a specific exemplary embodiment, devices for carrying out endometrial ablation (e.g., using heated saline solution or other ablating fluids) may be inserted though the working channel 110 into the uterus 104.
A further exemplary embodiment according to the present invention is shown in
The seal 150 is inserted, while in configuration (a) into a naturally occurring body orifice to the proximal opening of a hollow organ and, when located in a desired position, the tab 156 is pushed distally while maintaining the position of the elongated member 157 substantially constant, to expand the flexible member 152 against the wall of the organ sealing the opening thereto. For example, the seal 150 may be inserted into the cervix 102 in configuration (a) (
Those skilled in the art will understand that the flexible element 152 is preferably formed of a material which exhibits significant radial expansion when compressed longitudinally. Alternatively, the flexible element 152 may be formed as a flexible membrane which bends to form a convex surface when longitudinally compressed. The material may also be sponge-like with at least portions being absorbent to help stop or absorb fluids with which it comes in contact. For example, a polymeric material may be used to form the flexible element 152 with a shape selected to mechanically facilitate its radial expansion. For example, the flexible element 152 may include a convex inner surface which, when longitudinally compressed by the rod 154, urges the outer surface of the flexible element 152 to bow outward to form a convex shape. The flexible element 152 may also include a sub-structure of mesh, ribs and/or reinforcements to further control the shape of the radially deployed flexible element 152, so that the outer surface 158 takes a preselected shape conforming to the shape of the internal os.
A seal 200 according to a further embodiment of the invention may also include a membrane which extends from the elongated body to close off the cervical opening. For example, as shown in
As shown in
The shape of the deployed membrane 204 is preferably selected to match a shape of the internal os of the uterus 104. For example, the dimensions of the membrane 204 are preferably selected to match the deployed shape to the size and shape of the internal os of the uterus 104. Resilient elements such as rings 214, ribs and other structures may also be included in the membrane 204 to ensure that the deployed configuration sufficiently seals against the cervix 102.
As shown in
A seal obtained between the elongated shaft 252 and the inner walls of the cervix 102 by expanding an inflatable element 256 which may, for example, be formed as a balloon. The inflatable element 256 is preferably placed near the distal tip of the seal 250, so that it is located near the inner os 158 of the uterus 104. It will be apparent to those of skill in the art, that the exact location of the inflatable element 256 along the length of the cervix 102 may be selected to achieve a desired level of resistance to the passage of fluids therepast. In one exemplary embodiment, the inflatable element 256 is connected to a source of inflation fluid via a conduit 254. The source of inflating fluid (not shown) may include, for example, a simple hand-syringe, a compressor, a pump, a pressure storage device, or any other means to provide a fluid under pressure to the conduit 254. A control for the supply of inflation fluid is preferably provided so that the operator of the device can inflate the inflatable element at a desired time (e.g., when the seal 250 has been properly positioned within the cervix 102. The inflating fluid is preferably selected to be non-toxic and biocompatible (e.g., compressed air or saline solution) so that a leak will not cause injury.
To further enhance the sealing of the cervix 102, additional inflatable elements may be employed. For example, as shown in
In the exemplary embodiments shown in
When there is no longer a need for the barrier provided by the seal 250, 300, the inflatable elements are retracted by deflating them and withdrawing the seal 250, 300 from the body. For example, after an ablation procedure has been completed and the ablating fluid has been drained from the uterus, the inflating fluid may be removed from the inflatable elements 256, 304 and 306, so that they will collapse to the insertion configuration. The seal 250, 300 may then be removed from the body.
As described above, an exemplary seal according to the present invention may be inserted trans-cervically so that distal end thereof is located within the uterus 104. A seal is then established preventing the migration of fluids from the uterus 104 through the cervix 102 (e.g., by deploying sealing elements therefrom) and medical devices are introduced into the uterus 104 through the working channel of the seal to carry out a medical procedure (e.g., endometrial ablation) while preventing fluids, such as heated saline solution, introduced into the uterus for the procedure from escaping through the cervix 102 and damaging non-targeted tissue. After the procedure has been completed, the seal is withdrawn (e.g., after retracting sealing elements thereof).
The present invention was described with reference to specific exemplary embodiments. Those skilled in the art will understand that changes may be made in details, particularly in matters of shape, size, material and arrangement of parts. Accordingly, various modifications and changes may be made to the embodiments. For example, the exemplary devices described may be used to provide a fluid seal to openings of bodily cavities or hollow organs other than the cervix. The specifications and drawings are, therefore, to be regarded in an illustrative rather than a restrictive sense.
