WO2016073596A1

WO2016073596A1 - Balloons for brachytherapy applicators

Info

Publication number: WO2016073596A1
Application number: PCT/US2015/059022
Authority: WO
Inventors: Gary A. Lamoureux; Juan-Carlos Diaz
Original assignee: Lamoureux Gary A
Priority date: 2014-11-04
Filing date: 2015-11-04
Publication date: 2016-05-12

Abstract

Balloon assemblies are selectively mountable to a brachytherapy applicator, such as a tandem and ring applicator. The balloon assembly may include a balloon, an inflation port configured to selectively introduce and remove inflation fluid from an interior of the balloon, and a clamp assembly configured to support the balloon and to selectively mount the balloon assembly to the brachytherapy applicator.

Description

BALLOONS FOR BRACHYTHERAPY APPLICATORS

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of and priority to U.S. Provisional Application Serial No. 62/074,809 filed November 4, 2014, the entire contents of which are incorporated herein by reference.

BACKGROUND

Technical Field

This disclosure relates to applicators for use in brachytherapy. More specifically, this disclosure relates to balloons selectively mountable onto a tube of a brachytherapy applicator to positionally stabilize the applicator in a patient and reduce harm to healthy tissue during brachytherapy, such as high dose rate brachytherapy.

Description of the Art

Brachytherapy is frequently used to treat cancer, such as endometrial malignancies, either pre-operatively, as adjuvant therapy after surgery, as primary therapy for patients unable to tolerate surgery, or to treat recurrences following surgery. High dose rate (HDR) brachytherapy delivers a high dose (usually >0.4 Gy/min) of radiation, significantly reducing the duration of exposure and patient immobilization to minutes, and eliminating the need for prolonged hospitalization. To avoid harm to healthy tissue resulting from the high dose of radiation delivered to a tumor during HDR brachytherapy, shielding and/or radiation attenuating apparatus may be used. One such radiation attenuating apparatus employs balloons to create a distance between the healthy tissue and the radiation source. Where the balloons are filled with a radiation attenuating fluid, the balloons may also provide shielding.

There remains room for improvement in the design of balloons for use with a brachytherapy applicator.

SUMMARY

Balloon assemblies in accordance with the present disclosure are selectively mountable to and removable from a brachytherapy applicator.

In embodiments, a balloon assembly in accordance with an exemplary embodiment of the present disclosure includes a balloon, an inflation port configured to selectively introduce and remove inflation fluid from an interior of the balloon, a ring assembly configured to support the balloon, and a clamp associated with the ring assembly. The clamp is configured to selectively mount the balloon assembly to a brachytherapy applicator. In some embodiments, the clamp is positioned on an arm extending beyond the balloon. In other embodiments, the clamp is positioned on an interior circumference of the ring assembly. At least one ring retaining structure is defined on an interior circumference of the ring assembly to pivotally receive the ring of a ring and tandem brachytherapy applicator. The ring assembly may include an upper ring, a middle ring, and a bottom ring which, when assembled, secure edges of the balloon in a fluid tight manner. In embodiments, the balloon is substantially C-shaped. In other exemplary embodiments in accordance with the present disclosure, a balloon assembly includes a balloon, an inflation port configured to selectively introduce and remove inflation fluid from an interior of the balloon, and a clamp assembly configured to support the balloon and to selectively mount the balloon assembly to a brachytherapy applicator. The clamp assembly may include an inner balloon retainer and an outer balloon retainer, a proximal end ring, and a distal end ring, with the inner and outer balloon retainers being configured to snap fit together to secure edges of the balloon in a fluid tight manner. In embodiments, the inflation port is formed on the proximal end ring of the clamp assembly and the balloon is substantially C-shaped in cross section.

In another aspect, the present disclosure relates to a brachytherapy delivery system including a tandem and ring applicator including a tandem tube and a tube having a ring at a distal end thereof and a balloon assembly selectively mountable to and removable from the tube having a ring.

In yet another aspect, the present disclosure relates to a kit containing a plurality of balloon assemblies presented in a common package. In embodiments, the kit includes a package, and a plurality of balloon assemblies contained within the package, each balloon assembly of the plurality of balloon assemblies selectively mountable to a brachytherapy applicator. In embodiments, at least one balloon assembly of the plurality of balloon assemblies includes a balloon, an inflation port configured to selectively introduce and remove inflation fluid from an interior of the balloon, a ring assembly configured to support the balloon, and a clamp associated with the ring assembly, the clamp configured to selectively mount the balloon assembly to a brachytherapy applicator. In embodiments, at least one balloon assembly of the plurality of balloon assemblies includes a balloon, an inflation port configured to selectively introduce and remove inflation fluid from an interior of the balloon, and a clamp assembly configured to support the balloon and to selectively mount the balloon assembly to a brachytherapy applicator.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:

Fig. 1 is a top perspective view of a conventional tandem and ring applicator;

Fig. 2 is a side view of the applicator of FIG. 1;

Fig. 3 is a side perspective view of a balloon assembly in accordance with an exemplary embodiment of the present disclosure;

Fig. 4 is an exploded view of the balloon assembly of Fig. 3;

Fig. 5 is a partial cross sectional side view of the balloon assembly of Fig. 3 in the process of being positioned on the applicator of Fig. 1;

Figs. 6A and 6B illustrate the process for mounting the balloon assembly of Fig. 3 on the applicator of Fig. 1;

Fig. 6C shows the balloon assembly of Fig. 3 mounted on the applicator of Fig.

1; Fig. 7 is a side view of the device of Fig. 6C showing the mounting of additional balloon assemblies thereon in accordance with another exemplary embodiment of the present disclosure;

Fig. 8 is a cross sectional perspective view showing the structure of a balloon assembly in accordance with another exemplary embodiment of the present disclosure;

Figs. 9A and 9B are a top perspective view and side view, respectively of an applicator having three balloon assemblies mounted thereon in accordance with an exemplary embodiment of the present disclosure;

Fig. 10 is a side elevation of the exemplary embodiment of embodiment of Figs. 9A and 9B with all three balloon assemblies inflated;

Fig. 11 is a side perspective view of a balloon assembly in accordance with another exemplary embodiment of the present disclosure;

Fig. 12 is an exploded view of the balloon assembly of Fig. 11;

Fig. 13 is a partial cross sectional side view of the balloon assembly of Fig. 11 in the process of being positioned on the applicator of Fig. 1;

Figs. 14A and 14B illustrate the process for mounting the balloon assembly of Fig. 11 on the applicator of Fig. 1;

Fig. 15 shows the balloon assembly of Fig. 11 mounted on the applicator of Fig. 1 and showing the mounting of additional balloon assemblies thereon in accordance with another exemplary embodiment of the present disclosure; and

Fig. 16 shows a kit in accordance with an exemplary embodiment of the present disclosure. The figures depict specific embodiments of the present disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles described herein.

DETAILED DESCRIPTION

Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary. Therefore, specific structural and functional details described herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the presently disclosed concepts in virtually any appropriately detailed structure.

Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term "proximal" refers to the end of the apparatus which is closer to the user and the term "distal" refers to the end of the apparatus which is farther away from the user. The term "clinician" refers to any medical professional (e.g., doctor, surgeon, nurse, or the like) performing a medical procedure involving the use of embodiments described herein. The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. The word "example" may be used interchangeably with the term "exemplary."

Figs. 1 and 2 illustrate an embodiment of one type of conventional cervical applicator 10 often referred to as a tandem and ring set, including a tandem tube 20 with a distal projection portion 21, a tube 30 with a distal ring 31, and a bridge 40.

Tandem tube 20 may be a hollow, rigid, tube having a length sufficient to extend through the entire vaginal canal, through the exterior os, the cervix, the interior os, and project a select distance (determined by the particular physiology of the patient) into the uterine cavity. The distal end of tandem tube 20 defines projection portion 21 which is typically (but not necessarily) angled from tandem tube 20 to facilitate insertion of projection portion 21 through the cervix. The selection of the angle is dictated by particular physiology of the patient and the ability to allow for translation of a radioactive source through the entire length of tandem tube 20 to projection portion 21. Tandem tube 20 is formed from any suitable rigid, medical grade material and may have a circular cross-section.

Tube 30 is also formed from any suitable rigid, medical grade material, may have a circular cross-section, and may be solid or hollow. In the hollow form, tube 30 effectively qualifies as a second tandem tube, thereby providing a dual tandem arrangement allowing introduction via tube 30 of a selected element, such as instrumentation (e.g., a thermometer or a radiation dose/rate monitor) or a radiation source. Ring 31 located on the distal end of the tube 30 may be formed integrally with tube 30 or may be an affixable attachment. Ring 31 may be in line with, or at an angle to tube 30 as seen in Fig. 2.

Tandem tube 20 and tube 30 are maintained in a space-apart relation by bridge 40 during introduction of applicator 10. Bridge 40 may be fixed or adjustable. Bridge 40 may be formed integrally with or fixedly attached to tube 30 proximally of ring 31 and selectively attachable to tandem tube 20. Alternatively, bridge 40 may be a bracket of selectable length that is selectively attachable to both of the tubes 20 and 30 proximally of ring 31 and projection portion 21. Multiple bridges of the same or different types may be employed along tubes 20, 30.

A balloon assembly 50 is selectively attachable to and removable from tube 30. As seen in Fig. 3, balloon assembly 50 includes a balloon 55 and a ring assembly 60. Ring assembly 60 includes an inflation port 63, ring retaining structure 68, and a tube retainer 70.

Balloon 55 may be made of any biocompatible material capable of inflation. For example, balloon 55 may be made of any material conventionally used for inflatable balloons for medical purposes and may be a single layer or may be a laminate material. In embodiments, balloon 55 is constructed from an elastic material. Those skilled in the art will readily envision suitable materials for use in making balloon 55. In embodiments, balloon 55 possesses adequate strength to physically displace muscular tissues (e.g., the vaginal walls), upon inflation without risk of rupture. In the exemplary embodiment shown in Figs. 2-7 the balloon is substantially C-shaped. As seen in Fig. 4, ring assembly 60 includes a top ring 62, a center ring 64, and a bottom ring 66. Top ring 62, center ring 64, and bottom ring 66 may be molded of any suitable semi-rigid resilient plastic, such as, for example, thermoplastic and thermosetting polymers including, but not limited to acrylic polymers such as poly(methyl methacrylate) (PMMA), nylon, polyethylene, polypropylene, polystyrene, polyvinyl chloride (PVC), Teflon, polyurethane polymers, polyimides, polyester resins, epoxy resins and the like.

Inflation port 63 and tube retainer 70 are integrally formed on top ring 62. To assemble balloon assembly 50, edges 56 and 57 of balloon 55 are positioned adjacent inner portion of center ring 64. Top ring 62 and bottom ring 66 are then snap fit together to form ring assembly 60 and secure balloon 55. In embodiments, top ring 62 and bottom ring 66 include latch structures 67a, 67b which snap into groove 65 on center ring 64 as seen in Fig. 5. When assembled, top ring 62 and bottom ring 66 cooperate to define ring one or more retaining structures 68 configured to pivotally receive and releasably retain ring 31 when balloon assembly 50 is mounted to tube 30.

Upon assembly of ring assembly 60, inflation port 63 is in fluid communication with the interior of balloon 55 for introduction of fluid into, and withdrawal of fluid out of balloon 55. Fluid may be provided to inflation port 63 via supply line (not shown). Inflation fluid may be any suitable fluid, either a gas or a liquid, and is typically inert. The inflation fluid, where a gas, may be, for example, air, nitrogen, carbon dioxide or other gas. Suitable liquid inflation fluids include, for example, water, saline, mineral oil, or other liquid. In embodiments, an inflation fluid may be effective to absorb radiation to, for example, shield, moderate or adjust a dosage of radiation delivered to a patient's tissue from radioactive treatment material contained within tandem tube 20 and/or tube 30. Water provides good radiation attenuation and is also transparent/semi-transparent to certain radiation forms thereby permitting monitoring during brachytherapy. Other fluids, such as barium salt solutions provide excellent radiation attenuation but are also essentially radio-opaque, potentially obscuring monitoring during treatment.

Tube retainer 70 includes an arm 72 extending beyond the balloon 55 and having a clamp 75 at a proximal end thereof. Clamp 75 includes a channel 74 and tabs 76. Arm 72 extends a sufficient distance from top ring 62 to allow attachment of tube retainer 70 to a straight portion of tube 30, proximal of ring 31. Channel 74 is configured to have a diameter adapted to snugly accommodate tube 30, and an opening smaller than the diameter of tube 30. In this manner, when clamp 75 is pressed against tube 30, the walls defining channel 74 flex outwardly to receive tube 30 and then once past the widest part of tube 30, snap back to the original dimension of the opening to retain tube 30 within channel 74. Tabs 76 allow a clinician to easily expand the opening of channel 74 to facilitate removal or repositioning of tube retainer 70.

Positioning of the balloon assembly 50 on applicator 10 is dictated by the intended use. If the clinician's objective is to protect the rectum, the balloon may advantageously positioned on tandem tube 20 because it is closer to the rectum. Thus, the balloon 55 pushes against the posterior wall of the vagina when in an inflated state. If it is desired to primarily protect the bladder from radiation, balloon assembly 50 may instead be installed on the tube 30 (as shown), which is closer to the bladder to push against the anterior wall of the vagina when in an inflated state. Where both areas are to be protected, multiple balloons may be installed on tubes 20 and 30, as described hereinbelow.

Figs. 6A and 6B illustrate mounting of balloon assembly 50 onto tube 30. Initially, balloon assembly 50 is positioned over ring 31 so that ring 31 is within ring retaining structure 68. Then the balloon assembly 50 is rotated in the direction of arrow "A" as seen in Fig. 6A, so that tube 30 passes through gap 52 in ring assembly 60. Balloon assembly 50 is attached to tube 30 distally of bridge 40 by clamp 75 of tube retainer 70 as shown in Fig. 6B. Tandem tube 20 can then be positioned with projection portion 21 extending through ring 31 and balloon assembly 50, and secured in proper orientation by bridge 40 as shown in Fig. 6C.

The cervical applicator 10 with balloon assembly 50 installed can be used in much the same way as a conventional cervical applicator. Applicator 10 (with balloon 55 in a deflated state) is inserted into a patient's body, with ring 31 of tube 30 located in the vaginal vault in the vicinity of the cervix and projection portion 21 of tandem tube 20 extending into the cervix. Balloon 55 is inflated by a supply of inflating fluid provided through inflation port 63. As balloon 55 is filled with a fluid, it expands radially outwardly under pressure until it presses the posterior and/or anterior wall of the vagina away from tube 30 to increase the distance of the rectum and/or the bladder from ring 31. By retaining the inflating pressure within the balloon, the outer wall of balloon 55 retains its expanded position. An intended treatment is then introduced into tandem tube 20 and, if it is hollow, optionally tube 30. Inflation of balloon 55 is maintained throughout administration of the treatment.

Tandem tube 20 (and optionally tube 30) can be used to deliver an intended treatment to a tissue site to be treated. In embodiments, tandem tube 20 and/or tube 30 can be used to deliver radiotherapy, such as, for example brachytherapy, to tissue to be treated. As those skilled in the art will appreciate, there are two defined brachytherapy categories: low dose rate (LDR) brachytherapy and high dose rate (HDR) brachytherapy. The two categories differ in dose rates of radioisotopes and treatment strategies. Common radioisotopes for LDR brachytherapy include iodine- 125 (1251) and palladium-103 (103Pd), whereas gold-198 (198Au) and iridium-192 (192Ir) are among the common radioisotopes for HDR treatment. Those skilled in the art reading the present disclosure will readily envision other therapies that can be delivered using an applicator in accordance with the present disclosure.

Exemplary applicator 10 can be designed such that any radiation source can be inserted into tandem tube 20 and/or tube 30, including multiple radiations sources at a time. The radiation source can be positioned in tandem tube 20 and/or tube 30 and balloon 55 inflated such that a radiation dose can be maximally applied to the internal tissue disorder, and yet minimally applied to the surrounding area, thus limiting exposure of the patient's healthy tissue to radiation, and any possible collateral side effects. A radiation source may be positioned within tandem tube 20 and/or tube 30 using any suitable technique, including but not limited to manual or remote afterloading. As those skilled in the art will appreciate, remote afterloading systems provide protection from radiation exposure to healthcare professionals by securing the radiation source in a shielded safe. Once the applicator is correctly positioned in the patient, the applicator is connected to a commercially available 'afterloader' machine (containing the radioactive sources) through tandem tube 20 and/or tube 30. A treatment plan is programmed into the afterloader, which then controls the delivery of the radiation source along the tandem tube 20 and/or tube 30 into the pre-specified position within the applicator. The radiation source remains in place for a pre-specified length of time, again following the treatment plan, following which the radiation source is returned along tandem tube 20 and/or tube 30 to the afterloader.

Once the radiation source is removed from the applicator 10, balloon 55 is deflated by allowing inflating fluid to flow out through inflation port 63, and the applicator 10 is withdrawn from the patient's body. Balloon assembly 50 can then be removed from applicator 10 and discarded, while the tubes 20, 30 and other portions of the applicator 10 can be sterilized for reuse.

As noted above, in embodiments, more than one balloon can be mounted to applicator 10. For example, balloons may be mounted onto one or both of tubes 20 and 30. As seen in Fig. 7, in addition to balloon assembly 50, balloon assemblies 80 and 90 may be mounted to tube 30 and tandem tube 20, respectively.

Balloon assembly 80 is elongate and generally C-shaped in cross section so it can be snapped onto tandem tube 20. Balloon assembly 80 includes balloon 85, and a clamp assembly including inner and outer balloon retainers 82, 84, proximal end ring 81 and distal end ring 86. An inflation port 83 that is in fluid communication with the interior of balloon 85 is formed on proximal end ring 81. Inflating fluid is provided to inflation port 83 via a supply line (not shown) attached to inflation port 83. Inner and outer balloon retainers 82, 84 extend the length of balloon assembly 80 and balloon 85 is secured therebetween by snap-fitting outer retainer 84 onto inner retainer 82. Optionally, a medical grade adhesive may be applied to the portion of balloon 85 secured between inner and outer balloon retainers 82, 84. To hold balloon assembly 80 together, proximal end ring 81 is snap fit over the proximal ends of inner and outer balloon retainers 82, 84 (see Fig. 8) and distal end ring 86 is snap fit over the distal ends of inner and outer balloon retainers 82, 84.

Balloon assembly 80 can be mounted at any desired position on tube 30, such as immediately proximal of the position of tube retainer 70 of balloon assembly 50 as shown in Fig. 7. Because of the generally C-shape of balloon assembly 80, it can be positioned so as to span bridge 40. Bridge 40 prevents balloon assembly 80 from rotating completely around tube 30.

Balloon assembly 90 is also elongate and generally C-shaped in cross section so it can be snapped onto tandem tube 20. Balloon assembly 90 is similar in structure to balloon assembly 80, and includes balloon 95, inner and outer balloon retainers (not shown), proximal end ring 91 and distal end ring 96. An inflation port 93 that is in fluid communication with the interior of balloon 95 is formed on proximal end ring 91. Inflating fluid is provided to inflation port 93 via a supply line (not shown) attached to inflation port 93. As with balloon assembly 80, proximal end ring 91 and distal end ring 96 are placed over the proximal and distal ends, respectively of inner and outer balloon retainers (not shown) to hold balloon assembly 90 together. Balloon assembly 90 can be mounted at any desired position on tandem tube 20, such as a position directly across from balloon assembly 80 as shown in Fig. 7. Because of the generally C-shape of balloon assembly 90, it can be positioned so as to span bridge 40. Bridge 40 prevents balloon assembly 90 from rotating completely around tandem tube 20.

Balloon assemblies 80 and 90 may be mounted to applicator 10 after balloon assembly 50 is mounted onto tube 30 as described above, simply by snapping balloon assemblies 80 and 90 onto tube 30 and tandem tube 20, respectively. Figs. 9A and 9B show applicator 10 with all three balloon assemblies 50, 80, 90 positioned thereon.

In the case of multiple balloons, there is no requirement that balloons 55, 85, 95 be of identical shape or elasticity or even that the balloons be inflated with the same fluid. Balloons 55, 85, 95 may incorporate various inflated configurations and may even be segmented, to provide differing degrees of attenuation along selected profiles. For example, if the primary internal organ to be protected against radiation is the rectum, balloon 55 may be shaped to expand more towards the posterior wall of the vagina than towards the anterior wall. Consequently, balloons 55, 85, 95 may define any number of inflated configurations so long as they are able to push against the vaginal wall and physically dilate the cavity in a desired manner.

For example, as seen in the exemplary embodiment of Fig. 9, the distance between proximal end ring 81 and distal end ring 86 is shorter than the distance between proximal end ring 91 and distal end ring 96. As shown in Fig. 10, once inflated, balloon 85 can be seen to include a main portion 87 located between proximal end ring 81 and distal end ring 86 and a nose portion 89, which extends distally of distal end ring 86. Balloon 95 can be seen in its inflated state to include a main portion 97 located between proximal end ring 91 and distal end ring 96 and a nose portion 99, which extends distally of distal end ring 96. While main portion 87 of balloon 85 is longer than main portion 97 of balloon 95, nose portion 89 of balloon 85 is shorter than nose portion 99 of balloon 95. Thus, when inflated, nose portions 89, 99 of balloons 85 and 95 can reach and fill in the gap between ends 55a, 55b of balloon 55 despite the different positions at which balloon assemblies 80, 90 are mounted on tubes 30, 20, respectively.

Fig. 11 illustrates a balloon assembly 150 in accordance with another exemplary embodiment that is selectively attachable to and removable from tube 30. As seen in Fig. 11, balloon assembly 150 includes a balloon 155 and a ring assembly 160. Ring assembly 160 includes an inflation port 163, ring retaining structure 168, and a ring clamp 175 located on an interior circumference of ring assembly 160.

Balloon 155 may be made of any material described above with respect to balloon 55.

As seen in Fig. 12, ring assembly 160 includes a top ring 162, a center ring 164, and a bottom ring 166. Rings 162, 164 and 166 may be made of any material described above with respect to rings 62, 64 and 66.

Inflation port 163 and ring clamp 175are integrally formed on top ring 162. To assemble balloon assembly 150, the edges of balloon 155 are positioned adjacent inner portion of center ring 164. Top ring 162 and bottom ring 166 are then snap fit together to form ring assembly 160 and secure balloon 155. In embodiments, top ring 162 and bottom ring 166 include latch structures 167a, 167b which snap into groove 165 on center ring 164 as seen in Fig. 13. When assembled, top ring 162 and bottom ring 166 cooperate to define one or more ring retaining structures 168 configured to pivotally receive and releasably retain ring 31 when balloon assembly 150 is mounted to tube 30.

Upon assembly of ring assembly 160, inflation port 163 is in fluid communication with the interior of balloon 155 for introduction of fluid into, and withdrawal of fluid out of balloon 155. Fluid may be provided to inflation port 63 via supply line (not shown). The inflating fluid may be any suitable fluid described above.

Ring clamp 175 includes a channel 174 and tab 176. Channel 174 is configured to have a diameter adapted to snugly accommodate ring 31 of tube 30, and an opening smaller than the diameter of ring 31. In this manner, when ring clamp 175 is pressed against ring 31, the wall defining channel 174 flexes towards the center of ring assembly 160 to receive ring 3 land then once past the widest part of ring 31, snaps back to the original dimension of the opening to retain ring 31 within channel 174. Tab 176 allows a clinician to easily expand the opening of channel 174 to facilitate removal or re-positioning of ring clamp 175. It should of course be understood that more than one ring clamp may be provided on the interior circumference of ring assembly 160. It is also contemplated in embodiments, two different types of clamps may be provided on the ring assembly; namely one or more ring clamps may be provided on an interior circumference of ring assembly 160 and an additional clamp may be provided on an arm extending from the ring assembly as shown in Figs 3-7.

Figs. 14A and 14B illustrate mounting of balloon assembly 150 onto ring 31. Initially, balloon assembly 150 is positioned over ring 31 so that ring 31 is within ring retaining structure 168. Then the balloon assembly 150 is rotated in the direction of arrow "A" as seen in Fig. 14A, so that tube 30 passes through gap 152 in ring assembly 160. Balloon assembly 150 is attached to ring 31 by ring clamp 175 as shown in Fig. 14B. Tandem tube 20 can then be positioned with projection portion 21 extending through ring 31 and balloon assembly 150, and secured in proper orientation by bridge 40. Optionally, additional balloon assemblies 180 may be mounted to tube 30 and/or tandem tube 20 as shown in Fig. 15. In this exemplary embodiment, additional balloon assemblies 180 (which can be structurally the same as balloon assemblies 80, 90 described above) are identical in configuration and size, reducing the number of unique parts that need to be manufactured.

It is further contemplated that kits containing a plurality of balloon assemblies presented in a common package may be provided in accordance with the present disclosure. In embodiments, the kit further includes a brachytherapy applicator, such as the components of the tandem and ring application illustrated in Fig. 1.

In an exemplary embodiment shown in Fig. 16, the kit 500 has a package that includes a thermoformed tray 510 defining a predetermined area that contains a plurality of balloon assemblies 150, 180. In embodiments, each balloon assembly of the plurality of balloon assemblies is received within a corresponding recess formed in the tray. Thermoformed tray 510 can be made from any suitable material, such as, for example, polyethylene terephthlate(PETE), polyvinyl chloride (PVC), polypropylene(PP) and polystyrene(PS) and the like. Foam inserts (not explicitly shown) may be provided adjacent to each balloon assembly to provide cushioning and insure a secure fit of the balloon assemblies within the tray. In addition, an outer cardboard box (not explicitly shown) may be provided that includes appropriate labeling (product description, expiration date, etc.).

The balloon assemblies contained in the kit may be the same or may be different. For example, the plurality of balloon assemblies may all be of the structure of balloon assembly 50 or 150 described above, either of the same or different sizes. Alternatively, the plurality of balloon assemblies may include one balloon assembly of the structure of balloon assembly 50 or 150 described above, and one or more balloon assemblies of the structure of balloon assembly 80, 90, 180, or 190 described above. It should be understood that the plurality of balloon assemblies may include more than one balloon assembly of the structure of balloon assembly 80, 90, 180, or 190 described above with each such balloon assembly being of the same or of different sizes and configurations.

While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of presently disclosed embodiments. Thus the scope of the embodiments should be determined by the appended claims and their legal equivalents, rather than by the examples given.

Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non- limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. As well, one skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

It should be understood that the foregoing description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached drawing figs, are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.

Claims

What is claimed is:

1. A balloon assembly comprising:

a balloon;

an inflation port configured to selectively introduce and remove inflation fluid from an interior of the balloon;

a ring assembly configured to support the balloon; and

a clamp associated with the ring assembly, the clamp configured to selectively mount the balloon assembly to a brachytherapy applicator.

2. The balloon assembly of claim 1 wherein the clamp is positioned on an arm extending beyond the balloon.

3. The balloon assembly of claim 1 wherein the clamp is positioned on an interior circumference of the ring assembly.

4. The balloon assembly of claim 1 further comprising ring retaining structure defined on an interior circumference of the ring assembly, the ring retaining structure configured to pivotally receive a ring of a ring and tandem brachytherapy applicator.

5. The balloon assembly of claim 1 wherein the ring assembly includes an upper ring, a middle ring, and a bottom ring which, when assembled, secure edges of the balloon in a fluid tight manner.

6. The balloon assembly of claim 1 wherein the balloon is substantially C-shaped.

7. A balloon assembly comprising:

a balloon;

a clamp assembly configured to support the balloon and to selectively mount the balloon assembly to a brachytherapy applicator.

8. The balloon assembly of claim 7 wherein the clamp assembly includes an inner balloon retainer and an outer balloon retainer, a proximal end ring, and a distal end ring, the inner and outer balloon retainers configured to snap fit together to secure edges of the balloon in a fluid tight manner.

9. The balloon assembly of claim 7 wherein the inflation port is formed on the proximal end ring.

10. The balloon assembly of claim 7 wherein the balloon is substantially C-shaped in cross section.

11. A brachytherapy delivery system comprising:

a tandem and ring applicator including a tandem tube and a tube having a ring at a distal end thereof;

a balloon assembly including:

a balloon;

a ring assembly configured to support the balloon; and a clamp associated with the ring assembly, the clamp configured to selectively mount the balloon assembly to the ring of the brachytherapy applicator.

12. The brachytherapy delivery system of claim 11 further comprising: an elongate balloon assembly selectively mountable to the tandem tube, the balloon assembly including:

an elongate balloon;

an inflation port configured to selectively introduce and remove inflation fluid from an interior of the balloon; and

a clamp assembly configured to support the balloon, the clamp assembly including an inner balloon retainer and an outer balloon retainer, a proximal end ring, and a distal end ring, the inner and outer balloon retainers configured to snap fit together to secure edges of the balloon in a fluid tight manner.

13. The brachytherapy delivery system of claim 12 wherein the tandem and ring applicator further includes a bridge connecting the tandem tube and the tube having a ring at a distal end, the bridge preventing the elongate balloon assembly from rotating completely around the tandem tube.

14. The brachytherapy delivery system of claim 12 further comprising: an elongate balloon assembly selectively mountable to the tube having a ring at a distal end thereof proximally of the ring, the balloon assembly including:

an elongate balloon;

15. The brachytherapy delivery system of claim 14 wherein the tandem and ring applicator further includes a bridge connecting the tandem tube and the tube having a ring at a distal end, the bridge preventing the elongate balloon assembly from rotating completely around the tandem tube.

16. A kit comprising:

a package; and

a plurality of balloon assemblies contained within the package, each balloon assembly of the plurality of balloon assemblies selectively mountable to a brachytherapy applicator.

17. The kit of claim 16 wherein at least one balloon assembly of the plurality of balloon assemblies includes:

a balloon;

a ring assembly configured to support the balloon; and

18. The kit of claim 16 wherein at least one balloon assembly of the plurality of balloon assemblies includes:

a balloon;