MODIFIED ENDOMETRIAL ABLATION
20190314076 ยท 2019-10-17
Inventors
Cpc classification
A61B18/1485
HUMAN NECESSITIES
A61B2018/044
HUMAN NECESSITIES
A61B18/00
HUMAN NECESSITIES
A61B2018/0016
HUMAN NECESSITIES
A61B2018/0212
HUMAN NECESSITIES
A61B2018/00023
HUMAN NECESSITIES
A61B2018/00214
HUMAN NECESSITIES
A61B2018/1861
HUMAN NECESSITIES
International classification
A61B18/00
HUMAN NECESSITIES
Abstract
An endometrial ablation tool is configured for modified endometrial ablation, rather than global endometrial ablation. The tool can work according to various different methodologies including ablation by thermal energy (hot or cold), ablation by RF energy, ablation by microwave energy, ablation by plasma gas heating or ablation by other endometrial contact methodologies for ablation thereof. The ablation tool is shaped so that it avoids ablation in cornual areas. In one embodiment, the tool is configured with a unique posterior and anterior portion, with only one such portion configured to perform ablation, so that ablation occurs only with the anterior endometrium or only the posterior endometrium.
Claims
1: A method for performing modified endometrial ablation, including the steps of: placing a modified endometrial ablation tool into a uterus, the modified endometrial ablation tool having a configuration which keeps ablating portions thereof spaced away from cornual areas of the uterus; activating the modified endometrial ablation tool to ablate at least portions of walls of the endometrium spaced away from the cornual areas; and removing the modified endometrial ablation tool from the uterus.
2: The method of claim 1 wherein said placing step includes a shape of the modified endometrial ablation tool causing cornual areas to be avoided.
3: The method of claim 1 wherein said placing step includes a size of the modified endometrial ablation tool causing cornual areas to be avoided.
4: The method of claim 1 wherein said activating step includes the tool delivering radio frequency radiation therefrom.
5: The method of claim 1 wherein said activating step includes the tool delivering freezing temperature structures for ablation of endometrial tissues by freezing.
6: The method of claim 1 wherein said activating step includes the tool delivering microwave energy radiation therefrom.
7: The method of claim 1 wherein said activating step includes the tool delivering hot temperature fluid for ablation of endometrial tissues by burning.
8: A modified endometrial ablation tool, comprising in combination: at least one ablation surface taken from the group of surfaces including an anterior surface and a posterior surface; an ablation energy supply coupled to said ablation surface; and said ablation surface having a configuration which avoids cornual areas when placed within a uterus.
9: The tool of claim 8 wherein said ablation surface is shaped to avoid cornual areas.
10: The tool of claim 8 wherein said ablation surface is sized to avoid cornual areas.
11: The tool of claim 8 wherein said ablation energy supply includes a source of radio frequency radiation energy.
12: The tool of claim 8 wherein said ablation energy supply includes a below 0 C. temperature heat sink, sufficiently cold to ablate endometrial tissues by freezing.
13: The tool of claim 8 wherein said ablation energy supply includes a source of microwave radiation energy.
14: The tool of claim 8 wherein said ablation energy supply includes a source of hot fluid sufficiently hot to ablate endometrial tissues by burning.
15: The tool of claim 8 wherein only one of said anterior surface and said posterior surface is configured as an ablation surface.
16: A method for performing a modified endometrial ablation procedure, the method including the steps of: placing a modified endometrial ablation tool into a uterus, the modified endometrial ablation tool having a configuration which keeps ablating portions thereof spaced away from cornual areas of the uterus; activating the modified endometrial ablation tool to ablate at least portions of walls of the endometrium spaced away from the cornual areas; removing the modified endometrial ablation tool from the uterus; wherein the tool includes an anterior surface and a posterior surface, only one of the surfaces being at least part of the ablating portions of the tool; and wherein said activating step ablates the endometrium on only a posterior portion or an anterior portion of the uterus.
17: The method of claim 16 where said placing step includes the tool delivering radio frequency radiation therefrom.
18: The method of claim 16 wherein said activating step includes the tool delivering freezing temperature structures for ablation of endometrial tissues by freezing.
19: The method of claim 16 wherein said activating step includes the tool delivering microwave energy radiation therefrom.
20: The method of claim 16 wherein said activating step includes the tool delivering hot temperature fluid for ablation of endometrial tissues by burning.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DESCRIPTION OF THE PREFERRED EMBODIMENT
[0033] Referring to the drawings, wherein like reference numerals represent like parts throughout the various drawing figures, reference 10 (
[0034] In essence, and with particular reference to
[0035] With reference to
[0036] More specifically, and with particular reference to
[0037] As discussed in detail above, various complications can result from such total ablation of the endometrial tissues E-M, and most if not all therapeutic benefits can be provided by limiting ablation of the endometrial tissues E-M to being partial, and particularly to keeping the cornual areas C (and potentially also the lateral fundal wall areas L) free from ablation thereof. In other prior art embodiments, a prior art wire mesh 6 is delivered from a prior art delivery tube 8 and has a shape similar to that of the prior art balloon 2, but is configured to utilize RF energy for ablation of the entire endometrial tissues E-M (or near total (or global) ablation). Such prior art RF energy ablation tools with an associated wire mesh 6 are similarly configured with protuberances particularly to extend into cornual areas C for ablation of the endometrial tissues E-M adjacent thereto.
[0038] With this invention, the balloon 20 (generally including a flexible liner and/or a stretchable silicone (or other material) membrane) is particularly configured to leave the cornual areas C (and preferably also the upper lateral fundal wall areas L) free from ablation. Most preferably, the balloon 20 is configured with a shape that keeps the balloon 20 from extending into the cornual areas C. As an alternative, the balloon 20 can be sized smaller to achieve avoidance of contact with an entry into the cornual areas C. As a further alternative, the balloon 20 could extend into the cornual areas C, but a septum or other barrier could be provided within the balloon 20 to keep hot or cold ablation fluids from passing into such protuberances extending into the cornual areas C, so that ablation is limited to active portions of the balloon 20 which are truncated operationally to not extend ablation energy into the cornual areas C.
[0039] In the embodiment depicted herein (
[0040] The balloon 20 preferably has a shape which is generally triangular with truncated corners when viewed posteriorly or anteriorly. When viewed laterally (i.e. for instance
[0041] The delivery tube 14 also acts in placement of the balloon 20 within the uterus U. In particular, the balloon 20 is typically initially entirely retracted into an interior of the delivery tube 14 and on a proximal side of the entry port 12. The delivery tube 14 is then passed through the vagina and up into the uterus U. Once the entry port 12 extends into the uterus U, the delivery tube 14 is manipulated so that the balloon 20 is advanced distally from the delivery tube 14 (along arrow B) and into the uterus U. Such advancement typically continues until the upper surface 30 of the balloon 20 is adjacent to the fundal wall F of the uterus U. The balloon 20 is then inflated, such as with a fluid (typically liquid) until the balloon 20 has fully expanded, such as to the configuration depicted in
[0042] Once fully inflated, the upper surface 30 of the balloon 20 is adjacent to the fundal wall E Truncated surfaces 30 will have expanded laterally during expansion of the balloon 20, but stop short of passing into the cornual areas C, and preferably also stop short of coming into contact with or expanding beyond the upper lateral fundal wall L. Junctions between the upper surface 30 and the two truncated surfaces 40 are defined by a left lateral corner 32 and right lateral corner 34. Most preferably, these corners 32, 34 are spaced apart by a distance which is less than the spacing between the cornual areas C of the uterus U. Most preferably, the spacing between the corners 32, 34 is also sufficiently short that at least portions of the upper lateral fundal wall L are also left spaced from the truncated surfaces 40 of the balloon 20.
[0043] Lower lateral surfaces 50 of the balloon 20 extend from the truncated surfaces 40 back to the entry port 12. The lower lateral surfaces 50 taper toward each other as they extend from a left upper corner 52 adjacent to a left one of the truncated surfaces 40 and from a right upper corner 54 adjacent to a right one of the truncated surfaces 40. A lower edge 56 of the lower lateral surfaces 50 is generally cylindrically shaped and adjacent to the entry port 12. The lower lateral surfaces 50 have a tapering final shape so that when the balloon 20 is expanded, the lower lateral surfaces 50 generally maintain contact with the endometrial tissues E-M at middle portions of the uterus U. Preferably, the lower lateral surfaces 50 stop short of coming into contact with the cervix at the proximal end of the uterus U, leaving the cervix substantially unaffected by the ablation procedure.
[0044] After full placement and expansion of the balloon 20, extreme temperature fluid flow from the extreme temperature fluid source 11 is caused to occur (along arrows D and D) into and out of the balloon 20. An extreme temperature of the fluid is sufficient to cause heat transfer either out of the fluid and into the endometrial tissues E-M or out of the endometrial tissues E-M and into the fluid (in the case of an extreme low temperature fluid). Heat transfer is at a sufficiently higher rate that it causes ablation of the endometrial tissues E-M. Such ablation is to some extent a function of time and to some extent a function of the particular temperature of the extreme temperature fluid. Through appropriate experimentation or other design techniques, an optimal combination of temperature and time can be selected to optimize the ablation procedure.
[0045] After the ablation procedure is completed, the fluid is removed from the balloon 20 (at least partially), along the delivery tube 14. The balloon 20 can then be retracted into the delivery tube 14 through the entry port 12 (in a direction opposite that of arrow B) and the delivery tube 14 (along with the balloon 20 contained therein), can be translated proximally and removed from the uterus U. As an alternative, the balloon 20 can remain deployed from the entry port 12, but at least partially deflated by at least partial removal of fluid from an interior of the balloon 20, and retracted proximally to remove the delivery tube 14 and balloon 20 simultaneously from the uterus U without (or with only partial) retraction.
[0046] With particular reference to
[0047] The web mesh 120 is formed of sufficiently electrically conductive materials that the wire 115 from the alternative energy source 111 causes heating of the web mesh 120 when appropriate electric power and RF energy is supplied through the wire 115 from the RF energy source 111 to the web mesh 120. Such heating of the web mesh 120 is sufficiently great that portions of the endometrial tissues E-M of the uterus U adjacent to the web mesh 120 are caused to undergo ablation.
[0048] The web mesh is configured (either through a particular shape or a particular size or both) to avoid ablation of cornual areas C, and preferably also to avoid ablation of the endometrial tissues E-M adjacent to the upper lateral fundal wall L adjacent to each of the cornual areas C. In this particular embodiment, the web mesh 120 is shaped to avoid delivery of RF energy at a sufficiently high level to cause ablation within the cornual areas C. In particular, the web mesh 120 includes an upper surface 130 configured to be placed adjacent to the fundal wall F of the uterus U. A pair of truncated surfaces 140 extend diagonally both laterally and proximally from the upper surface 130. A lower lateral surface 150 extends from the truncated surfaces 140 back proximally to a lower edge 156 adjacent to the entry port 112 of the delivery tube 114.
[0049] In this particular embodiment, the web mesh 120 is provided with the desired shape by utilizing a central rib 125 along with a left lateral rib 122 and a right lateral rib 124, and with the left mid rib 126 between the left lateral rib 122 and the central rib 125. A right mid rib 128 is provided between the right lateral rib 124 in the central rib 125. The web mesh 120 both includes these ribs 122, 124, 125, 126, 128 and also preferably also includes smaller wires spanning between these ribs 122, 124, 125, 126, 128. These ribs can be formed of electrically conductive material or can merely be provided as structural elements, with only the mesh wiring supported by the ribs being electrically conductive.
[0050] Most preferably each of the ribs 122, 124, 125, 126, 128 is formed of a material which has a shape memory but is also flexible to an extent short of an elastic limit of the material. Thus, these ribs can flex to cause the ribs to come together within the delivery tube 114. However, when the web mesh 120 is advanced out of the delivery tube 114 (along arrow B of
[0051] While each of these ribs is shown as a singular rib, if desired, each of the singular ribs depicted in
[0052] The upper surface 130 of the wire mesh 120 preferably extends laterally until it terminates at a left lateral corner 132 and a right lateral corner 134. These lateral corners 132, 134 are preferably spaced apart by sufficiently short distance that the upper lateral fundal wall L is left free from contact with the web mesh 120. Most preferably, the mid ribs 126, 128 have a shape memory which causes them to extend to these lateral corners 132, 134.
[0053] Proximal portions of the truncated surfaces 140 transition into the lower lateral surfaces 150 through a left upper corner 152 and right upper corner 154. Remaining portions of the lower lateral surfaces 150 extend somewhat as a funnel shape down to the lower edge 156 where the lower lateral surfaces 150 can together be generally cylindrical in form directly adjacent to the entry port 112.
[0054] With the shape configuration described above, the RF energy tool 110 can be activated and have RF energy 111 delivered along the wire 115 to the web mesh 120, causing portions of the endometrial tissues E-M adjacent to the web mesh 120 to be ablated. Importantly, the cornual areas C, and preferably also portions of the upper lateral fundal wall L, are not ablated because the web mesh 120 is not adjacent thereto. Ablation is achieved by a combination of an appropriate amount of RF energy delivered by the RF energy tool 110, as well as an amount of time that the RF energy tool 110 is in operation. The RF energy level and time can be increased or decreased to optimize extent of ablation which occurs to the endometrial tissues E-M, and to otherwise achieve optimal results. Thereafter, the RF energy tool 110 can be removed from the uterus U by translation proximally, either with or without first retracting the wire mesh 120 back into the delivery tube 114 (in a direction opposite arrow B).
[0055] With particular reference to
[0056] A pair of divider walls 216 are provided within the delivery tube 214 to split the delivery tube 214 into a pair of first conduits 215 and a pair of second conduits 217. Alternatively, four separate conduits 215, 217 can be nested within the delivery tube 214 (or some sub-combination thereof can be provided). The goal of the conduits 215, 217 and the divider walls 216 is for delivery of an extreme temperature fluid and for return of the extreme temperature fluid relative to the extreme temperature fluid source 211, and to separately allow for flow of a normal temperature fluid from the normal temperature fluid source 213 into and out of a separate half of the balloon 220.
[0057] A septum 230 or other barrier wall is provided within the balloon 220 which divides an interior of the balloon 220 into an anterior half and a posterior half. The balloon 220 has an anterior surface 240 opposite a posterior surface 250. One of these surfaces is active for ablation, and an operator can select, in a preferred embodiment, which of these surfaces 240, 250 is the active ablation surface. The active ablation surface would have the extreme temperature fluid from the extreme temperature fluid source 211 passing thereinto and returning therefrom (along arrows D, D). On the opposite side of the septum 230, normal temperature fluid is circulated, also shown on arrows D, D. Thus, the normal temperature fluid causes one of the surfaces 240, 250 to have no ablation occur while the other surfaces 240, 250 are in contact with the extreme temperature fluid from the extreme temperature fluid source 211 and causes ablation of the endometrial tissues E-M on either the anterior or posterior side of the uterus U. In
[0058] With particular reference to
[0059] The web mesh 320 preferably has a shape similar to that of the web mesh 120 of the RF energy tool 110 described in detail above. However, an insulating liner 330 is provided upon an anterior surface 340 of the web mesh 320 or upon the posterior surface 350 of the web mesh 320. This insulating liner 330 has sufficient insulating characteristics to keep energy such as RF energy and/or heat from passing therethrough with sufficient magnitude to cause ablation. Rather, the insulating liner 330 abuts a posterior or anterior side of the uterus U which does not undergo any ablation. The anterior surface 340 or posterior surface 350 opposite the insulating liner 330 is provided with the web mesh 320 coupled to the RF energy source 311, to cause ablation of an adjacent anterior or posterior wall of the uterus U.
[0060] In one embodiment, the same semi-ablation RF energy tool 310 can be provided for either anterior surface ablation or posterior surface ablation, by reversing the tool 310 before insertion. As an alternative, the tool 310 can be optimized, such as with appropriate curvature, so that a separate tool 310 would be provided for anterior surface 340 ablation by RF energy delivery from the wire mesh 320, or posterior surface 350 ablation by passage of RF energy to the wire mesh 320 adjacent to the posterior surface 350 of the tool 310. Other details of the semi-ablation RF energy tool 310, including the contour and configuration of the semi-ablation RF energy tool 310, can be similar to that described above with respect to the RF energy tool 110 (
[0061] Various embodiments have been provided to illustrate how modified endometrial ablation can occur through utilization of a particularly configured ablation tool, and particularly a tool which avoids cornual areas C of the uterus U, and optionally to preferably also avoiding upper lateral fundal wall L portions of the uterus U. In addition, and as an option, modified endometrial ablation can be provided by utilizing a semi-ablation tool 210, 310 which is only active at an anterior wall or posterior wall of the uterus U, for ablation of only a portion of the endometrial tissues E-M, either on the anterior wall or the posterior wall of the uterus U. With such a semi-ablation tool 210, 310, the configuration of the tools 210, 310 is still sufficiently limited so that it avoids ablation within the cornual areas C, and preferably also avoids ablation at the upper lateral fundal wall L adjacent to the cornual areas C.
[0062] The principles embodied in these above described embodiments can also be extended to other endometrial ablation technologies. For instance, in one such system argon gas or some other easily ionizable gas is provided within a balloon or other membrane and an electric current is applied to this gas, causing the gas to turn into a plasma and to heat the balloon or other membrane sufficiently to cause thermal ablation to occur. Such a plasma ablation system could be provided within a balloon which has a shape configured to avoid cornual areas C, according to this invention. In other embodiments where microwave energy is utilized, a tool delivering the microwave energy can be provided with appropriate spacers which prevent movement of the microwave energy wand from extending laterally into the cornual areas. Furthermore, a shape of the tool and/or usage techniques can be provided to concentrate microwave radiation energy nearest a center of the uterus U, so that ablation energy does not extend into the cornual areas.
[0063] This disclosure is provided to reveal a preferred embodiment of the invention and a best mode for practicing the invention. Having thus described the invention in this way, it should be apparent that various different modifications can be made to the preferred embodiment without departing from the scope and spirit of this invention disclosure. When embodiments are referred to as exemplary or preferred this term is meant to indicate one example of the invention, and does not exclude other possible embodiments. When structures are identified as a means to perform a function, the identification is intended to include all structures which can perform the function specified. When structures of this invention are identified as being coupled together, such language should be interpreted broadly to include the structures being coupled directly together or coupled together through intervening structures. Such coupling could be permanent or temporary and either in a rigid fashion or in a fashion which allows pivoting, sliding or other relative motion while still providing some form of attachment, unless specifically restricted.