This invention relates to radiotherapies, and more particularly, to surgical cavity sizers for determining the appropriate radiation applicators to be used during brachytherapy or intraoperative radiation therapy, as well as containers for individually packaging radiation applicators.
Brachytherapy is a form of radiotherapy where a radiation source is placed internally either inside or next to the area requiring treatment. Intraoperative Radiation Therapy (IORT) is an in situ ionizing radiation treatment of the surgical cavity in which a radiation treatment is provided to an area adjacent to a tumor which has been excised (e.g., a surgical cavity or a tumor bed). IORT can be delivered using kV X-rays emitted by a miniature, probe-type X-ray unit, placed inside an applicator (e.g., a radiation applicator). After the tumor has been excised from the patient, a radiation applicator is introduced in the vicinity of the excised area and is associated with a radiation therapy system to provide radiation therapy. In order to achieve acceptable therapeutic results, it is important that the radiation therapy be applied in close contact with the tumor bed. The radiation application must therefore closely match the volume and area of the surgical cavity.
Prior to delivery of radiation, the size of the natural or surgical cavity thus needs to be determined so that the radiation delivery is optimally performed. This is currently done by trial and error using the same sterilized radiation applicators as those used during the radiation delivery. With this techniques, the radiation applicators which are not selected to deliver radiation must go through a significant number of sterilization cycles, which is needlessly large. Furthermore, the maximum number of allowed sterilizations can be quickly attained, after which new applicators need to be acquired.
Another technique consists of taking approximate measurements of the natural or surgical cavity using a length measurement device (e.g., a ruler), which is then used to select the final radiation applicator for the radiation treatment. This technique relies on the experience of the individual surgeon, and may introduce inconsistency in the selection of the most appropriate radiation applicator.
In accordance with an aspect, there is provided a device for intraoperative radiation therapy and brachytherapy, comprising: a surgical cavity sizer for a radiation applicator having a distal end to be located in a surgical cavity and allowing radiation emission therethrough, said surgical cavity sizer including a head portion having a shape and a size identical to the distal end of the radiation applicator, and a handle portion projecting from the head portion and permitting manipulation of the surgical cavity sizer, the handle portion being integrally formed with the head portion to form a monolithic structure composed of a biocompatible and sterilizable material.
According to another aspect, there is provided a container for a device for intraoperative radiation therapy and brachytherapy, the device including a surgical cavity sizer or a radiation applicator, said container comprising a pivoting engagement mechanism retaining the device, the pivoting engagement mechanism operable to pivot the device between a storage position, wherein a longitudinal axis of the device disposed fully within the container, and a releasable position, wherein the device is in an angled, partially upright, position and the distal end is at least partially out of the container.
According to yet another aspect, there is provided a method of selecting a radiation applicator for performing brachytherapy or intraoperative radiation therapy in a natural or surgical cavity, the method comprising: providing a plurality of radiation applicators, each having a distal end having a different size and/or shape; providing a plurality of surgical cavity sizers each having a head portion of different size and/or shape matching the size and/or shape of the distal end of respective ones of the radiation applicators; determining, from the surgical cavity sizers, the surgical cavity sizer conforming to the size and/or shape of the natural or surgical cavity, thereby providing a selected surgical cavity sizer; and selecting the radiation applicator having the distal end with the same size and/or shape as the head portion of the selected surgical cavity sizer to perform brachytherapy or intraoperative radiation therapy.
According to yet another aspect, there is provided a kit for selecting an appropriately sized radiation applicator for providing brachytherapy or intraoperative radiation therapy, said kit comprising a plurality of the devices as defined above, wherein the head portion of each of the surgical cavity sizers has a different size and/or shape.
According to yet another aspect, there is provided a kit for selecting an appropriately sized radiation applicator amongst a plurality of radiation applicators to provide brachytherapy or intraoperative radiation therapy, said kit comprising a plurality of the devices as defined above, wherein the head portion of each of the surgical cavity sizers is identical in shape and/or size to a corresponding distal end of one of the radiation applicators.
Reference is now made to the accompanying figures in which:
As noted above, in the past, the radiation applicators themselves (i.e. the applicator end, used to deliver the radiation therapy) have been used to size the surgical cavity/tumor bed. To reduce the number of times the radiation applicators are contaminated without providing radiation therapy and are thus subjected to non-useful and potentially detrimental sterilization, separate surgical cavity sizers (i.e. distinct from the radiation applicators) are disclosed herein.
At least one section of the peripheral surface of the first distal end 010 can be composed of a material which allows the transmission of ionizing radiation to the surrounding tissue. The distal end 010 is connected to the shaft 020 of the radiation applicator 008, which may be hollow and fit over the central tube 050. The shaft 020 may have a tapered section 040 extending between the proximal end 030 (i.e. the end 030 manipulated by the user) of the shaft 020 and the distal end 010. The shaft 020 of the radiation applicator 008 is configured for receiving and, in some instances, holding in place a source of ionizing radiation having the tube 050 and the tip 060. The tube 050 is disposed in operable connection with a brachytherapy or IORT system. As such, the shaft 020 of the radiation applicator 008 is at least partially hollow to allow the insertion and removal of the tube 050 and the tip 060 of the radiation emitter of the brachytherapy/IORT system. Although
The surgical cavity sizer 065 has a head portion 070 and a handle portion 080 which are monolithic (i.e. they are integrally formed of the same material) in that they form a monolithic structure 072. A plurality of such surgical cavity sizers 065 can be provided, as will be described in further detail below, and the head portion 070 of each of the surgical cavity sizers 065 matches the size and/or shape of the distal end of a corresponding radiation applicator susceptible to be used to provide brachytherapy/IORT. The surgical cavity sizers 065 are thus used to determine if the corresponding radiation applicator will fit in the natural or surgical cavity, and/or to select the most appropriate size and/or shape of the radiation applicator.
The monolithic structure 072 formed by the head portion 070 and the handle portion 080 is composed of a single material, which is different from the material of the radiation applicator 008. More particularly, the monolithic structure 072 is composed of a biocompatible material (e.g., a material considered safe for human use). For example, the surgical cavity sizer 065 can be composed of a high-performance medical grade plastic. In one embodiment, this material selected for monolithic structure 072 may include an amorphous thermoplastic such as polyphenylsulfone (PPSU). When compared to the material of the radiation applicator 008, the material of the surgical cavity sizer 065 may be capable of sustaining additional rounds of sterilization (such as, for example hot steam, ethylene oxide, plasma and gamma rays) without substantially being deformed or degraded.
In some embodiments, the surface of the monolithic structure 072 is smooth to facilitate the cleaning of the surgical cavity sizer 065 as well as its insertion in the surgical cavity. Additionally, while the head 070 of the surgical cavity sizer 065 is depicted as being substantially spherical in shape, it is to be understood that the head 070 may alternately be formed having a different shape in order to better suit the surgical cavity within which the head 070 is to be inserted or in order to be consistent with a differently shaped radiation applicator used in the radiation delivery. When spherical in shape, the head 070 of the surgical cavity sizer 065 may have a diameter of between about 1.5 cm and about 5.0 cm. When a plurality of such surgical cavity sizers 065 are provided, as a kit for example, the spherical heads 070 of each of the surgical cavity sizers 065 may have diameters of about 1.5 cm, about 2.0 cm, about 2.5 cm, about 3.0 cm, about 3.5 cm, about 4.0 cm, about 4.5 cm and about 5.0 cm. Other sizes and/or combination of sizes are of course also possible, as may be required depending on the size and type of surgical cavity.
The handle 080 of the surgical cavity sizer 065 is intended to facilitate handling of the instrument and may be of a cylindrical shape, as shown. Regardless, the handle 080 is sized and shaped such that it can be manipulated by the surgeon or user of the surgical cavity sizer 065, as may be required in order to insert the head 070 into place within the surgical cavity. In some embodiments, the handle portion 080 of the surgical cavity sizer 065 has a shape and/or size which is substantially similar to the shaft 020 of the radiation applicator. However, it is contemplated that other types of handle portions 080 can also be used.
Depending on the intended use and the type of surgical cavity being treated, the surgical cavity sizer 065 can be a rigid monolithic structure 072 or a flexible monolithic structure 072. In the latter instance, it is to be understood that when a flexible surgical cavity sizer 065 is used, its structure 072 does not allow the deformation of the size and/or shape of the head portion 070, but, for example, can allow for bending the handle portion 080 and/or the connector portion 090. In another embodiment, the head 070 may be formed separately from the handle 080 (i.e. they are not integrally formed or monolithic), provided that the entire surgical cavity sizer 065 remains able to be similarly sterilized as required.
Referring to
Each of the surgical cavity sizers 065 may be releasably attached to the internal bottom surface of the tray 092 by a pair of retention devices 093, which engage the surgical cavity sizers 065 at opposite ends of the handle portion 080 in order to secure the surgical cavity sizers 065 in place. The retention devices 093 may include, for example, clamps, latches, U-shaped resilient holders, and the like. One or more of these retention devices 093 may be provided for each of the surgical cavity sizers 065, or, alternately, a single retention device 093 may retain all of the plurality of sizers 065 in spaced-apart position within the tray 092. In the embodiment of
A kit is disclosed herein which comprises one or more surgical cavity sizers 065, and which may also have one or more corresponding matching radiation applicators within separate containers. In this embodiment, it is understood that the surgical cavity sizer(s) 065 be provided in a sterile container 075 which is distinct from the sterile container of the corresponding matching radiation applicator(s). It is also understood that, in the kit, for each radiation applicator susceptible of being used to provide brachytherapy/IORT, corresponding surgical cavity sizers 065 having the same size and/or shaped head portions 070 as the distal ends of the radiation applicators are provided.
The container 099 includes an outer casing 094 and a removable lid 089 which is fastenable to the box or casing 094 in a sealed manner. A removable inner tray 095 fits within the cavity of the casing 094, to which a radiation applicator 008 is removably engaged by a pivoting engagement mechanism 101. The pivoting engagement mechanism 101 includes a first, fixed, engaging element 096 and a second, pivoting, hinged engagement element 097.
The fixed engaging element 096 can be similar to the retention devices of the sterile container for the surgical cavity sizers discussed above. More particularly, the fixed engaging element 096 may include, for example, clamps, latches, U-shaped resilient holders, and the like. One or more of these fixed engaging elements 096 may be provided for the radiation applicator 008, or, alternately, a fixed engaging element 096 may retain the radiation applicator 008 within the sterile container 099. The fixed engaging element 096 does not allow the distal end 010 of the radiation applicator 008 to pivot at the point of engagement, and is instead intended to secure the radiation applicator 008 in place within the container 099.
As shown in
As seen in
The hinged engagement element 097 allows the radiation applicator 008 to pivot about a point located on the hinged engagement element 097 so that at least the distal end 010 of the radiation applicator 008 can be moved outside the container 099, as shown in
In the embodiment of
It will be appreciated that the pivoting engagement mechanism 101 described above can also be used in the sterile container 075 housing one or more surgical cavity sizers 065.
A method for selecting a radiation applicator for performing brachytherapy or intraoperative radiation therapy in a natural or surgical cavity is also disclosed. In typical IORT practice, the patient is first anesthetized and the cancerous tumor and surrounding tissues are excised until the wall of the excision (i.e. surgical) or natural cavity has a clear margin. In order to determine if a clear margin has been removed, the excised tissue is sent to pathology. If the surgeon decides the excised tissue exhibits a clear margin, then a radiation treatment plan is prescribed and undertaken.
The total radiation treatment is given in one session or dose. In the context of the present disclosure, at least one dose of radiation therapy is provided, optionally during the surgery, using a radiation applicator of an IORT or a brachytherapy system. Once a radiation applicator has been determined to be of the appropriate size and/or shape for providing brachytherapy/IORT, an X-ray source is inserted in the radiation applicator and the latter is inserted in the natural or surgical cavity. The X-ray source can emit at least radially uniformly, if not totally isotropically, to provide the brachytherapy/IORT. After the brachytherapy/IORT, the wound is closed and the patient is allowed to recover.
The method can be used, for example, to increase the accuracy in selecting the appropriate radiation applicator when compared to the accuracy obtained by using some conventional techniques (i.e. rulers or simply eyeballing). The method also helps to reduce the contamination (and ultimately the re-sterilization) of radiation applicators which have a size and/or a shape which does not fit appropriately in the surgical cavity.
Referring to
The method 100 also includes providing more than one surgical cavity sizers. Each surgical cavity sizer has a head portion which differs from the size and/or shape of the head portions of the other surgical cavity sizers. The head portions match the size and/or shape of the distal end of at least one of the radiation applicators.
The method 100 also includes determining, from the provided surgical cavity sizers, which one fits in the surgical cavity. In order to do so, the head portion of at least one surgical cavity sizer is inserted into the natural or surgical cavity and the fit between the surgical cavity sizer and the cavity is determined. More particularly, the surgical cavity sizer conforming to the size and/or shape of the cavity determines the fit between that surgical cavity sizer and the cavity.
Providing surgical cavity sizers can be repeated with a plurality of surgical cavity sizers until the appropriate fit is obtained. This generally occurs by inserting the head portions of the surgical cavity sizers into the natural or surgical cavity before any radiation applicators are inserted in the cavity. Once it is determined which of the surgical cavity sizers fits appropriately the surgical cavity, the radiation applicator whose first distal end corresponds to size and/or shape of the head portion of the surgical cavity sizer whose fit was considered the most appropriate is selected for brachytherapy/IORT. The selected radiation applicator will therefore also provide an appropriate fit in the cavity for providing brachytherapy/IORT.
However, if at decision node 110, it is determined that the first surgical cavity sizer does not fit the cavity (because, for example, it is too big to enter the cavity, too small to fill the excised area or its shape does not match the excised area), at 140, the first surgical cavity sizer is removed from the cavity and another surgical cavity sizer having a different head size and/or shape is inserted in the cavity. For example, if it was determined that the first surgical cavity sizer was too small to fit in the cavity, a second surgical cavity sizer having a larger head than the first one can be inserted in the cavity. Once the subsequent surgical cavity sizer has been inserted in the cavity, it is again determined, at decision node 110, if the further surgical cavity sizer fits in the cavity, i.e. if it is capable of entering the cavity and if it fills the area which has been optionally excised during surgery. Action 140 and decision node 110 can be repeated more than once to determine if alternative surgical cavity sizers (having different head size and/or shape) fit more appropriately in the cavity.
In the method 100 described herein, a plurality of surgical cavity sizers each having a head portion of different shape and/or sizes are provided. In some embodiments, the method includes providing enough different surgical cavity sizers for matching the first distal end of the each of the plurality of the radiation applicators. When a plurality of surgical cavity sizers are provided, it is not necessary to insert all of the surgical cavity sizers in the surgical cavity to make the determination of an appropriate fit between the sizer and the surgical cavity. For example, it is possible to exclude some surgical cavity sizers before inserting them in the surgical cavity because they are clearly too big to enter the cavity, too small to fill the cavity or their shape is too dissimilar from the shape of the cavity.
Similarly, it is not always necessary to use at least two surgical cavity sizers. If it is determined that a single surgical cavity sizer fits appropriately in the surgical cavity, then it is not necessary to insert another surgical cavity sizer, to select the appropriate radiation applicator. However, in some embodiments, to confirm that a specific surgical cavity sizer is of the appropriate fit, the method can include introducing at least one more surgical cavity sizer in the cavity and comparing the fit obtained with the fit obtained by inserting the first surgical cavity sizer in the cavity. Based on this comparison, the surgical cavity sizer having the most appropriate fit is determined and the matching radiation applicator is selected for providing brachytherapy/IORT.
The method described herein can be used for selecting a radiation applicator and providing brachytherapy/IORT to various patients whose cancerous tumors have been excised. As it is known in the art, brachytherapy/IORT is commonly used as an effective treatment for cervical, prostate, breast and skin cancer and can also be used to treat tumors in many other body sites. Brachytherapy/IORT can be used alone or in combination with other therapies such as surgery, external beam radiotherapy (EBRT) and chemotherapy.
In light of the preceding, it can be appreciated that the invention disclosed herein provides alternative methods or means for selecting the type of radiation applicators for brachytherapy or IORT, as well as for reducing the unnecessary sterilization of radiation applicators. Such methods/means should preferably limit the inconsistency observed with rulers and/or limit the contamination of radiation applicators which are not being used for the delivery of radiation therapy.
While the invention has been described in connection with specific embodiments thereof, it will be understood that the scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.
This application claims the benefit of U.S. provisional patent application 61/901,667 filed Nov. 8, 2013, the entire contents of which are hereby incorporated by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/CA2014/051075 | 11/7/2014 | WO | 00 |
Number | Date | Country | |
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61901667 | Nov 2013 | US |