The present disclosure relates to medical devices and more specifically to endometrial tissue ablation.
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
Menorrhagia is an ailment characterized by excessive and/or extended menstrual bleeding. Menorrhagia can be caused by a variety of factors, such as structural abnormalities, bleeding disorders, or cancer. Various methods have been used to treat the condition such as oral contraceptives, hormone therapy, hysterectomies, drug releasing intrauterine devices, or endometrial tissue ablation. Endometrial tissue ablation is a procedure that results in the surgical destruction of the endometrial lining tissue of the uterus. Destruction of the lining tissues of the uterus may result in a significant decrease in menstrual bleeding.
A number of different methods are used to perform endometrial tissue ablation including by burning or freezing the uterine lining. For example, radio frequency energy, microwave energy, electrical energy, cryoablation, and use of a heated saline solution have all been used with varying levels of success. However, these methods have various drawbacks, including high operating costs.
Thus, it is desirable to provide an endometrial tissue ablation device and procedure that is cheap to manufacture, effective in reducing menstrual bleeding, and easy to use.
In one form of the present disclosure, a tissue ablation device is provided. The tissue ablation device comprises an inflatable balloon comprising a cavity. The device also comprises a catheter comprising a lumen in fluid communication with the cavity of the inflatable balloon, the catheter configured to deliver a fluid to the cavity thereby causing the inflatable balloon to inflate. The device further comprises a heating element connected to the balloon, wherein the heating element is further connected to an electrical source, the heating element configured to receive an electrical current from the electrical source. Additionally, the heating element is configured to raise the temperature of the inflatable balloon and the fluid when an electrical current is passed through the heating element.
Further, the tissue ablation device may have the heating element integrally attached to the balloon. The heating element may comprise printed ink that may comprise a conductive, elastomeric material. Also, the heating element may comprise an etched-foil pattern. The tissue ablation device may also further comprise a heating pad, wherein the heating element is integrally attached to the heating pad, the heating pad engageable with an outer surface of the balloon. The tissue ablation device may further comprise first and second electrical leads connected at respective first ends to the heating element, and a control box, the control box connected to the second ends of the first and second leads, the control box further connected to the electrical source, wherein the control box is configured to control the electrical current that is transferred from the electrical source through the first and second electrical leads and into the heating element. The device may also comprise a delivery sheath, wherein at least a portion of the balloon is removably disposed within a lumen of the delivery sheath.
In another embodiment, a method for ablating tissue is provided. The method comprises providing a tissue ablation device comprising an inflatable balloon comprising a cavity, a catheter comprising a lumen in fluid communication with the cavity of the inflatable balloon, and a heating element connected to the balloon. The method further comprises inserting the balloon into the patient's uterus and inflating the balloon by inserting a fluid through the catheter and into the cavity of the balloon. The method also comprises applying an electrical current through the heating element, thereby raising the temperature of the fluid and the inflatable balloon.
The method may further include the electrical current being applied through the heating element for a predetermined period of time. Further, the predetermined period of time may range from 60 seconds to 900 seconds. Also, the fluid may remain within the balloon for the predetermined period of time. The method may also include the heating element heating the balloon and the fluid to a predetermined temperature, the predetermined temperature ranging from 50 degrees Celsius to 99 degrees Celsius. The method may further comprise maintaining the balloon within the patient's uterus for a length of time after the predetermined period of time has elapsed, the length of time ranging from 12 hours to 120 hours.
The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.
The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. It should also be understood that various cross-hatching patterns used in the drawings are not intended to limit the specific materials that may be employed with the present disclosure. The cross-hatching patterns are merely exemplary of preferable materials or are used to distinguish between adjacent or mating components illustrated within the drawings for purposes of clarity.
Referring to FIG, 1, a tissue ablation device 10 is provided. The tissue ablation device 10 may have a balloon 12 that may form a substantially triangular cross-section that conforms to the general shape of a uterus. The balloon 12 may have a fluid tight seal with the exception of an opening 14 that may provide fluid communication from a cavity 16 within the balloon 12 to a point external the balloon 12. The balloon 12 may be inflated with a fluid, such as saline, water, or air, through the opening 14. The balloon 12 may have a flexible surface 15 that is made of an elastic material that may stretch and expand to the shape of the uterus when the balloon 12 is inflated. Silicone may be a preferable material for the balloon 12 due to its elastic as well as thermal conductive characteristics. Other potential materials for the balloon 12 include, but are not limited to: polyurethane, polyethylene, polyamide, or other biocompatible elastomeric materials. The balloon 12 may further include a heating element 18 embedded into, etched onto, or otherwise attached to the flexible surface 15 of the balloon 12, such as with adhesive. The heating element 18 may be made of an electrically conductive material such as a biocompatible metal wire that can be attached to the surface 15 of the tissue ablation device 10. While
Further, while
In one non-limiting example, an etched-foil design may be used for the heating element 18. In this example, the heating element 18 may be made from a metal foil 40, such as nichrome, stainless steel, or thin-film nitinol, that is patterned and etched onto the surface of the balloon 12 using photolithography. To achieve the final etched-foil design, a sheet of metal foil 40 may first be adhered to the material to be used for the balloon 12, such as silicone (
In one non-limiting example, the heating element 18 may be printed directly onto the balloon 12 of the tissue ablation device 10 using an elastomeric conductive ink. The ink may be silver or carbon based and can be applied using a printing method directly to the balloon 12. A screen printing process may be used to apply the liquid ink to the balloon 12 where it eventually dries into a solid, conductive piece of material that makes up the heating element 18. Alternatively, printing methods other than screen printing may be used to achieve the same results. The elastomeric properties of the ink may allow the heating element 18 to flex easily during insertion of the device 10 into the patient's uterus and expand easily during inflation of the balloon 12 while still maintaining strong conductive properties.
The balloon 12 may be made up of multiple layers. For example.
In use, the tissue ablation device 10 may have an insertion state as shown in
The delivery sheath 52 may then be withdrawn proximally while the balloon 12 remains stationary within the uterus U, thus causing the balloon 12 to be released from the constraints of the delivery sheath 52. As shown in
If the tissue ablation device 10 was inserted into the patients body while the control box 30 was detached, the electrical leads 26, 28 may be attached to the control box 30 once the delivery sheath 52 has been proximally withdrawn from the patients body. As the balloon 12 is maintained in an inflated position, an electrical current may be applied by the control box's 30 power source 34 through the electrical leads 26, 28 and to the heating element 18. This electrical current may cause the heating element 18 to rise in temperature, which therefore may raise the temperature of the balloon 12 as well as the fluid within the balloon 12. Once the temperature of the balloon 12 reaches a certain threshold, the tissue on the walls of the uterus U may began to burn, which may result in removal of the uterine lining.
The temperature of the heating element 18 as well as the length of time the heating element 18 is activated during the procedure may be varied as desired. In one embodiment, the temperature of the heating element 18 may vary from 50 degrees Celsius to 99 degrees Celsius. Also, the activation time of the heating element 18 may vary from 60 seconds to 900 seconds. These are merely exemplary ranges, and the temperature and time may be varied further as desired. Further, the temperatures of the heating element 18 may be monitored by a thermistor (not shown) or other temperature sensing device either embedded directly into the balloon 12 or heating element 18. The thermistor may include separate electrical leads (not shown) that connect the thermistor to the control box 30, thereby allowing the user to regulate the temperature of the balloon 12 and heating element 18.
After the tissue ablation has been completed, the control box 30 may be turned off and disconnected from the electrical leads 26, 28. At this point, the stop valve 55 may be opened and the fluid may be drained from the balloon 12 to allow the balloon 12 to deflate and then be removed from the patient's body. One way to remove the tissue ablation device 10 is to reinsert the delivery sheath 52 over the catheter 22 and the balloon 12, thus reconstraining the balloon 12 into the delivery configuration. The delivery sheath 52 along with the tissue ablation device 10 may then be proximally withdrawn from the patient's body.
Alternatively, rather than immediately removing the tissue ablation device 10 after the ablation procedure has been completed, the tissue ablation device 10 may remain within the uterus while the uterine wall heals. The balloon 12 may remain inflated for a day or a period of several days to provide a protective layer over the now damaged uterine wall. The protective layer provided by the balloon 12 may help prevent or limit infection, improper or uneven healing of the uterine wall, and other potential complications during the healing process.
In another embodiment, as shown in
As shown in
As shown in
The tissue ablation device 100 may be operated in substantially the same manner as described above and shown in
While the embodiments described herein are described in reference to a tissue ablation device and process to be used to ablate the uterine lining, the embodiments are not so limited to this use. Any other ablation method, including fibroid ablation, polyablation, myometrium ablation, adenomyosis treatment, hemorrhage cauterization, and other uterine conditions, are contemplated in these embodiments.
The description of the disclosure is merely exemplary in nature and, thus, variations that do not depart from the substance of the disclosure are intended to be within the scope of the disclosure. Such variations are not to be regarded as a departure from the spirit and scope of the disclosure.
This application claims priority from PCT/US2017/027022, filed on Apr. 11, 2017, which claimed the benefit of the filing date under 35 U.S.C. § 119(e) of Provisional U.S. Patent Application Ser. No. 62/321,950 filed Apr. 13, 2016, the entirety of which are each incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2017/027022 | 4/11/2017 | WO | 00 |
Number | Date | Country | |
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62321950 | Apr 2016 | US |