| US20210030585A1 | 2021-02-04 | |||
| US3706307A | 1972-12-19 | |||
| GB2305609A | 1997-04-16 | |||
| US20150335700A1 | 2015-11-26 | |||
| US20030229373A1 | 2003-12-11 | |||
| US20050187561A1 | 2005-08-25 | |||
| US20200368492A1 | 2020-11-26 | |||
| US20200009277A1 | 2020-01-09 |
| Claims 1) An applicator for high dose rate brachytherapy for cervical cancer, that has two parts, wherein, the first part is an intrauterine channel, and the second part is a fixation, wherein the fixation part, can be in an insertion/expulsion mode when it has small dimensions, or in fixation mode when it has larger dimensions that fills part of the uterine cavity, and hold the channel anchored to the uterus, as it is larger from the cervical canal. This part can have a stopper added to the outer part to prevent the movement of the device superiorly into the uterine cavity. 2) An applicator in claim 1, wherein the fixation part is wing or umbrella like, that can be closed or open, and wherein when the affixation part is close, it allows insertion or removal of the device into the uterus, and when it open once in the uterus, it affixes the device to the uterus. 3) An applicator in claim 1, wherein the fixation part is a balloon that can be inflated with air, water or any other material. The applicator is inserted into the uterus when it in the balloon is deflated, and once in the upper part of the uterine cavity it is inflated, and gently retracted inferiorly, so the balloon get in touch with the part of the uterine cavity that is similar to its diameter, and once in that position a stopper is added to the external part of the applicator that bulges out of the cervix uteri. 4) An applicator in claims 1-3, wherein radiopaque markers or MRI markers are attached to the channel to allow its visualization under x-rays and MRI, respectively. 5) An applicator in claims 1-4, wherein a fixation method is used similar to fixation methods used for fixation of birth control devices. 6) An applicator in claims 1-5, wherein an additional channel is provided around the cervix to treat the lateral part of the cervix and the parametria. 7) An applicator in claims 1-6 wherein the additional channel is in the shape of vaginal ring, that is fixated to the applicator intra-uterine channel. 8) An applicator in claims 1-7 wherein two or more channels are provided around the cervix to treat the lateral part of the cervix and the parametria. 9) An applicator in claims 1-8, wherein the channels around the cervix can include channels that can be nailed to tumor parts in the parametria or the cervix to allow interstitial brachytherapy. 10) An applicator in claims 1-9 wherein the applicator can be used for one or multiple treatments. 11) An applicator in claims 1-10 where in the additional channel that is deposited around the cervix and near the parametria, has unique markers on specific locations indicating distance between specific numbers of dwells, wherein fixed distances exist between increasing number of circles/markers, that allow visualization of the markers under x ray, CT, MRI or ultrasound, to determine the direction of the channel, and the location of the dwells in relation to the tumor, for HDR brachytherapy planning. 12) An applicator in claims 1-11 wherein the applicator is used for 2D, 3D or 4D planning brachytherapy, and uses X-ray, ultrasound or MRI imaging. 13) An applicator for high dose rate brachytherapy for cervical cancer, that has an intrauterine channel that has wings that can be closed or open. The wings can be housed in an “Inserter”, during the insertion, a guide wire is inserted into the HDR channel. After inserting the channel with the wings housed in the inserter, into the uterus, the inserter is retracted to allow the wings to open, then the channel is pushed to the uterus fundus by the guidewire that part of it in the HDR channel and the other part out of it. The inserter is then removed totally, then the guide wire is removed totally. 14) A method in claim 13 wherein the HDR channel can be soft, flexible or hard. For hard channels, the vaginal end can be covered by a rubber cover to prevent injury to the vagina. 15) A ring in claim 6-11, wherein an inflatable additional lumen is included, so that the ring can be inflated by air after its insertion to increase the distance between the cervix and the parametria, or to increase the distance between the HDR catheters and the bladder or rectum, or to decrease the distance between the HDR catheter and the cervical tumor. 16) A Ring is claim 15, with wholes that allow an insertion of interstitial needles. 17) An IUD for contraception that has an intrauterine channel that has wings that can be closed or open. The wings can be housed in an “Inserter”, during the insertion a guide wire is inserted into a channel. After inserting the channel with the wings housed in the inserter, into the uterus, the inserter is retracted to allow the wings to open, then the channel is pushed to the uterus fundus by the guidewire that in the channel. The inserter is then removed totally, then the guide wire is removed totally. The channel is blocked by a tying it, closing it with a cover. 18) An applicator for high dose rate brachytherapy for uterine cancer, that has two intrauterine channels that bends at its uterine end to form wing shapes, wherein the bended parts are positioned in the uterine horns. The bent parts are forces into an “Inserter”, during the insertion two guide wires are inserted into the two HDR channels. After inserting into the uterus, the inserter is retracted to allow the uterine end of the HDR channels to return to its bent position. The inserter is then removed totally, then the guide wire is removed totally. 19) An IUD for contraception that has an intrauterine channel that has an inflatable balloon around it. The IUD is inserted when the balloon is deflated, and once it inside the uterus the balloon is inflated to allow fixation of the device inside the uterus. After inserting the channel with the wings housed in the inserter, into the uterus, the inserter is retracted to allow the wings to open, then the channel is pushed to the uterus fundus by the guidewire that in the channel. The inserter is then removed totally, then the guide wire is removed totally. The channel is blocked by a tying it, closing it with a cover. Before removing the device, the inflation channel is cut above the plug, allowing emptying the inflation balloon and retrieval of the device. 20) An IUD device in claims 17 and 19, that can be made from copper, and had a reservoir that continuously discharge hormonal contraceptives. |
BACKGROUND INFORMATION
Cervical cancer took the lives of 4138 women in the USA in 2018; this is the equivalent of 11 women per day, one-half of whom were aged <58 years at death. It also continues to be the second leading cause of cancer death in women aged 20 to 39 years [1], Cervical cancer death rates, are 2 times higher in high-poverty versus low-poverty areas [1], Cervical cancer incidence and mortality currently vary 2-fold to 3-fold, with incidence rates ranging from <5 per 100,000 in Vermont and New Hampshire, to 10 per 100,000 in Arkansas and Kentucky, and 13 per
100,000 in Puerto Rico, and 7.6 per 100,000 on average for the United States [1]. The American
Cancer Society's estimates that 14,480 new cases of cervical cancer will be diagnosed in the
United States and about 4,290 women will die from it during 2021 [2], Worldwide cervical cancer is the fourth most common malignancy in women, with an estimated 570,000 women were diagnosed with cervical cancer in 2018 worldwide and about 311,000 women died from the disease [3],
While very early-stage cervical cancer can be cured with surgery, locally advanced disease needs definitive treatment with chemotherapy and radiation. Radiation therapy for cervical cancer in the definitive setting is delivered by combining external beam radiation, and brachytherapy.
Brachytherapy help provide very high doses of radiation to the cervix and uterus, while sparing nearby organs from radiation and is crucial to cure of this disease.
Brachytherapy for cervical cancer is a procedure that is done under general or spinal anesthesia.
After cleaning the genitalia, the cervix is grabbed with a tenaculum and serial dilatations are performed starting with a thin, low Hegar number rod and progressing gradually to larger numbers. At the end of the process a Smith Sleeve is inserted into the cervical canal, and stitched to it.
After the patient recovers, she comes to 4 -5 sessions of treatment during which tandem is inserted into the smith sleeve to allow delivery of radiation into the tandem channel, and ovoids or ring are introduced to treat the cervix and tissues immediately near it.
While brachytherapy using current applicators is highly effective. The procedure is very painful to the patients. Surgical dilatation of the cervix needs operative room, high expertise in the procedure to prevent rupture of the uterus, and time and experience for stitching the cervical smith sleeve. The treatment days, in which the insertion of tandem and ovoids are done, are usually performed with pain killers or sedation, but without general or local anesthesia, a procedure that is associated with discomfort and pain, in most instances.
While the applicators that are used now days to treat cervical cancer were designed for the two- dimensional imaging era, that historically used low dose rate brachytherapy, same applicators are still used for the 3D, CT and MRI while using high dose rate brachytherapy, that uses a source with very small dimentions.
The current invention is an applicator for delivery of high dose rate brachytherapy for cervical cancer, that can be inserted bed-side similar to Intrauterine Device (IUD) and vaginal ring, without general or spinal anesthesia. The device makes MRI imaging much easier to the patient and treatment planning much more accurate.
SUMMARY OF EXEMPLARY EMBODIMENTS An exemplary system and method are described in which the uterine and cervical canal is accessed by introducing an intrauterine HDR channel that get fixed to the uterus with a T shaped wings. The Device is inserted bedside. After its insertion, a cover that houses the wings is removed, which results is opening the wings, and attaching the device to the uterus. The HDR channel exits through the cervix and stays in the vagina. A vaginal ring is inserted then by the physician or the patient, so that the ring is near or hugs the cervix, the ring has a HDR channel in it, that is attached only to one side of the rubber vaginal ring, this allows the vaginal ring to be stretched without changing the length of the HDR channel in the ring. The vagina is then packed with wet pads or air balloons to increase the space between the cervix and the rectum and bladder. After that imaging is performed with MRI (preferably) or CT scan. Then the target volumes are drawn, as well as organs at risk. A brachytherapy plan is then generated. The patient is taken then to the HDR room, and the intrauterine HDR channel and vaginal ring HDR channel are connected to the HDR afterloader, and treatment delivered.
The device can be kept in its location for few weeks until completion of 4-5 fractions of brachytherapy, after which it can be removed. Alternatively, it can be removed after each fraction. If 3D planning is not available, the current invention can be used for classical planning using point A and point B.
Another applicator for high dose rate brachytherapy for uterine cancer is described, that has two intrauterine channels that bends at its uterine end to form wing shapes, wherein the bended parts are positioned in the uterine horns. The bent parts are forces into an “Inserter” before insertion into the uterus. During the insertion two guide wires are inserted into the two HDR channels.
After inserting into the uterus, the inserter is retracted to allow the uterine end of the HDR channels to return to its bent position. The inserter is then removed totally, then the guide wires are removed totally.
Another applicator for high dose rate brachytherapy for uterine cancer is described (Figure 14), that has (A) a channel that has an inflation unit. Inside the channel a HDR channel can be inserted. The channel with a deflated inflation unit is inserted into the uterus, and then the inflation unit is inflated. This anchors the channel to the uterus. A stopper is then attached to the outer side of the channel. F. Then an HDR channel is inserted inside the channel and is advance to the uterine fundus, and then locked in its location. Then, a ring with holes for interstitial brachytherapy is attached to the main HDR channel, as that described in Figure 14.
Using the same structure of the high dose rate brachytherapy for uterine cancer described in
Figure 14, an intrauterine device for contraception is described in Figure 15. The device can contain hormonal reservoir and can be made from copper or any other material. This device has a thickness of about 2 mm, about half of that of IUDs in market, making it easier to insert the device.
References
1. Siegel, R.L; Miller, K.D.; Fuchs, H.E.; Jemal, A. Cancer Statistics, 2021. CA: A Cancer Journal for
Clinicians 2021, 71, 7-33, doi:https://doi.org/10.3322/caac.21654.
2. Key Statistics for Cervical Cancer. Availabe online: https://www.cancer.org/cancer/cervical- cancer/about/key-statistics.html (accessed on 5/6/2021).
3. Cervical cancer. Availabe online: https://www.who.int/health-topics/cervical-cancer#tab=tab 1
(accessed on 5/6/2021).
BRIEF DESCRIPTION OF THE FIGURES Figure 1. HDR intra uterine device. (1) Uterus, (2) Ovary, (3) Fallopian tube, (4) Vagina, (5)
Cervix, (6) HDR intra uterine device
Figure 2. Intrauterine HDR Device A. Closed, B. cylindrical housing that keeps the wings in close state is partially (113) removed, note wings (112) open, C. HDR intra uterine device is fully open
Figure 3. Another iteration of the IUD HDR applicator part, (3000); the device has a stopper
(3001), an inserter (3002) and wings (3003). Before insertion, the wings are folded into the inserter. After the device is introduced into the uterus, the inserter is removed allowing unfolding of the wings, that anchor the device to the uterus, and allows delivery of radiation through the
HDR channel (3004).
Figure 4. A schematic drawing of the vaginal ring with one channel (200). A vaginal with HDR channel in it (201), that is attached only to one side of the rubber vaginal ring anchor (202), this allows the vaginal ring to be stretched without changing the length of the HDR channel (203) in the ring.
Figure 5. A schematic drawing of the vaginal ring with two channels (200) that allow easier motion of the source in the channels (201). The vaginal HDR channels are attached from one side to the vaginal ring anchor (202), this allows the vaginal ring to be stretched without changing the length of the HDR channels (203).
Figure 6. Another iteration of the IUD HDR applicator part of the channel that is deposited around the cervix and near the parametria. The applicator has HDR Chanell (601) that has unique markers on specific locations indicating distance between specific numbers of dwells (602), wherein fixed distances exist between increasing number of circles/markers, that allow visualization of the markers under x ray, CT, MRI or ultrasound, to determine the direction of the channel, and the location of the dwells to the tumor for HDR brachytherapy planning.
Figure 7. HDR intra uterine device (700) inserted into uterus (701) A. The wings (712) are forced into the inserter (713) before insertion, the guidewire (703) is introduced into the HDR channel (709) before insertion into the uterus. B. After insertion into the uterus, cylindrical inserter that keeps the wings in close state (713) is partially removed, C. which results in opening of the wings (712), C. The device is then pushed to the uterine fundus, and D-E. The inserter
(713) is removed; F. The guidewire (703) is removed.
Figure 8. HDR inside uterus. (801) Uterus, (802) Ovary, (803) Fallopian tube, (804) Vagina,
(805) Cervix, (806) HDR intra uterine device A. HDR intra uterine device inserted into uterus and in place, and HDR cervical ring (807) being inserted. B. HDR intra uterine device (806) inserted into uterus and in place, and HDR cervical ring (807) in place. C. HDR intra uterine device inserted into uterus and in place connected to HDR afterloader (808) with HDR channel
(810), and HDR cervical ring (807) in place and connected to HDR afterloader (808) with a different HDR channel (809).
Figure 9. HDR intra uterine device. An applicator for high dose rate brachytherapy for cervical cancer, that has an intrauterine channel (1003) that has wings (1002) that can be closed (A.) or open (B-D). The wings (1002) can be housed in an “Inserter” (1001) (A.), during the insertion a guide wire (1004) is inserted into the HDR channel (A-C). After inserting the channel with the wings (1002) housed in the inserter (1001) (A.), into the uterus, the inserter (1001) is retracted to allow the wings (1002) to open (B), then the channel is pushed to the uterus fundus by the guidewire (1004) (C), the inserter (1001) and the guide wire (1004) are then removed totally (D). Figure 10. An applicator for high dose rate brachytherapy for cervical cancer, that has an intrauterine channel (1003) that has wings (1002) that can be closed (A.) or open (B-E). The wings (1002) can be housed in an “Inserter” (1001), as in A; or out of it (B-E). During the insertion (A-D), a guide wire (1004) is inserted into the HDR channel (1003). After inserting the channel with the wings housed in the inserter (A), into the uterus (1010), the inserter (1001) is retracted to allow the wings (1002) to open (B-C). The inserter (1001) is then removed totally
(D), then the guide wire (1004) is removed totally (E).
Figure 11. Cervical ring, with right (1411) and left (1412) HDR channels, without (1400) or with (1401) balloons and interstitial brachytherapy holes. Balloon at the anterior part of the ring that increases the distance between the radioactive source and the bladder once inflated (1402).
Balloon at the posterior part of the ring that increases the distance between the radioactive source and the rectum once inflated (1403). Inner ring with HDR channel (1410). Marked holes for insertion of needles for interstitial brachytherapy (1415).
Figure 12. A sleeve shaped applicator (1500) with a proximal and distal ring with HDR channels in them (1501), as well as HDR channels vertical to the rings, and parallel to the cervix, within the sleeve (1502).
Figure 13. A double tandem uterine applicator for providing curative treatment for patients with uterine cancer who are not a surgical candidate. A double tandem uterine applicator within an inserter (1600), before insertion guide wires are introduced into the HDR channels (not shown).
The applicator has two HDR channels (1602), the channels have the part, at the innermost part of the uterus, in a bent shape. Before insertion, the bent shaped part is forced into the inserter
(1600), and once in the uterus, the inserter is removed, which opens the bent part of the HDR applicator (1602) and positions each of the HDR channels in the lateral horns of the uterus, allowing its fixation in place. This allows delivery of radiation to the center of the uterus and to the uterine horns (1610).
Figure 14. A. A channel that has an inflation unit. Inside the channel a HDR channel can be inserted. B. Uterus without any device. C. A channel with a deflated inflation unit is inserted into the uterus. D. The inflation unit is inflated. E. Once the inflation unit is inflated, the channel is gently drawn inferiorly, so the inflation unit anchor the channel to the uterus. A stopper is then attached to the outer side of the channel (not shown). F. Then an HDR channel is inserted inside the channel and is advance to the uterine fundus.
Figure 15. Intrauterine device for contraception. A. Schematic description of the device
(1801) hormonal formulation, (1802) hormonal reservoir, (1803) inserter channel with inflation balloon around it, (1804) channel for inflating the balloon, (1805) inserter rod, (1806) plug to block the inflating channel. B. Device inserted into the uterus. C. Balloon inflated. D. Inserter removed. E. Inflating channel plugged.