Brachytherapy device for facilitating asymmetrical irradiation of a body cavity

Information

  • Patent Grant
  • 10413750
  • Patent Number
    10,413,750
  • Date Filed
    Friday, August 12, 2016
    7 years ago
  • Date Issued
    Tuesday, September 17, 2019
    4 years ago
Abstract
The disclosure describes devices and methods for asymmetrical irradiation at a body cavity or site, such as after removal of tissue, e.g. biopsy or cancer. One device includes a lumen which is off-set or off-settable from a longitudinal axis to increase the intensity of radiation received from a radiation source by a first tissue portion surrounding the body cavity and to reduce or minimize radiation received by a second tissue portion (e.g. healthy tissue) surrounding the body cavity.
Description
FIELD OF THE INVENTION

This invention relates generally to the fields of medical treatment devices and methods. In particular, the invention relates to devices and methods for treating tissue surrounding a body cavity, such as a site from which cancerous, pre-cancerous, or other tissue has been removed.


BACKGROUND OF THE INVENTION

In diagnosing and treating certain medical conditions, it is often desirable to perform a biopsy, in which a specimen or sample of tissue is removed for pathological examination, tests and analysis. A biopsy typically results in a biopsy cavity occupying the space formerly occupied by the tissue that was removed. As is known, obtaining a tissue sample by biopsy and the subsequent examination are typically employed in the diagnosis of cancers and other malignant tumors, or to confirm that a suspected lesion or tumor is not malignant. Treatment of cancers identified by biopsy may include subsequent removal of tissue surrounding the biopsy site, leaving an enlarged cavity in the patient's body. Cancerous tissue is often treated by application of radiation, by chemotherapy, or by thermal treatment (e.g., local heating, cryogenic therapy, and other treatments to heat, cool, or freeze tissue).


Cancer treatment may be directed to a natural cavity, or to a cavity in a patient's body from which tissue has been removed, typically following removal of cancerous tissue during a biopsy or surgical procedure. For example, U.S. Pat. No. 6,923,754 to Lubock and U.S. patent application Ser. No. 10/849,410 to Lubock, the disclosures of which are all hereby incorporated by reference in their entireties, describe devices for implantation into a cavity resulting from the removal of cancerous tissue which can be used to deliver cancer treatments to surrounding tissue. One form of radiation treatment used to treat cancer near a body cavity remaining following removal of tissue is “brachytherapy” in which a source of radiation is placed near to the site to be treated.


Lubock above describes implantable devices for treating tissue surrounding a cavity left by surgical removal of cancerous or other tissue that includes an inflatable balloon constructed for placement in the cavity. Such devices may be used to apply one or more of radiation therapy, chemotherapy, and thermal therapy to the tissue surrounding the cavity from which the tissue was removed. The delivery lumen of the device may receive a solid or a liquid radiation source. Radiation treatment is applied to tissue adjacent the balloon of the device by placing radioactive material such as radioactive “seeds” in a delivery lumen. Such treatments may be repeated if desired.


For example, a “MammoSite® Radiation Therapy System” (MammoSite® RTS, Proxima Therapeutics, Inc., Alpharetta, Ga. 30005 USA) includes a balloon catheter with a radiation source that can be placed within a tumor resection cavity in a breast after a lumpectomy. It can deliver a prescribed dose of radiation from inside the tumor resection cavity to the tissue surrounding the original tumor. The radiation source is typically a solid radiation source; however, a liquid radiation source may also be used with a balloon catheter placed within a body cavity (e.g., Lotrex®, Proxima Therapeutics, Inc.). A radiation source such as a miniature or micro-miniature x-ray tube may also be used (e.g. U.S. Pat. No. 6,319,188). The x-ray tubes are small, flexible and are believed to be maneuverable enough to reach the desired treatment location within a patient's body. The radiation source is to be removed following each treatment session, or remains in place as long as the balloon remains within the body cavity. Inflatable treatment delivery devices and systems, such as the MammoSite® RTS and similar devices and systems (e.g., GliaSite® RTS (Proxima Therapeutics, Inc.)), are useful to treat cancer in tissue adjacent a body cavity.


However, radiation, chemotherapy, thermal treatment, and other cancer treatments often have deleterious effects on healthy tissue in addition to the desired effects on cancerous tissue. In such treatments, care must be taken to direct the maximum treatment effects to diseased tissue while minimizing its delivery or effects on healthy tissue. For example, radiation treatment may be most effective when only the portion of tissue requiring treatment receives the radiation and where surrounding healthy tissue is unaffected. Tissue cavities typically are not uniform or regular in their sizes and shapes, so that differences in dosages applied to different regions of surrounding tissue, including “hot spots” and regions of relatively low dosage, often result from radiation treatment.


A treatment delivery device for treating tissue adjacent a body cavity has been disclosed in U.S. Pat. No. 6,923,754. This device applies a partial-vacuum or suction to bring tissue towards a radiation source and allows for uniform application of radiation to tissue surrounding a body cavity. An advantage of the present invention is that it allows for the protection of healthy tissue within that body cavity and provides a seal in the passageway leading to the body cavity while treating the desired tissue.


SUMMARY OF THE INVENTION

This invention is generally directed to treating a patient's body cavity or other intracorporeal site (hereinafter collectively referred to as a body cavity) and devices and methods for such treatments. The invention is particularly suitable for treating tissue adjacent to a body cavity formed by the removal of tissue such as in a biopsy or lumpectomy.


More specifically, a device embodying features of the invention has a distal portion with a treatment location which is configured to be asymmetrically deployed within the body cavity so as to be closer to a first portion of tissue surrounding the cavity than a second portion of tissue surrounding the cavity opposite the first tissue portion. The treatment location of the distal portion which includes or is configured to receive a radiation source such as a brachytherapy seed or other irradiating agent for irradiating the first portion of tissue surrounding the body cavity more intensely that the second portion of tissue surrounding the body cavity opposed to the first portion of tissue due to the radiation source being closer to the first tissue portion than to the second tissue portion.


In one embodiment the treatment location having a radiation source is offset or capable of being offset within the body cavity so that tissue of the first portion of the cavity receives more intense radiation treatment than the tissue of the second portion.


This invention is generally directed to treating a patient's body cavity or other intracorporeal site and devices and methods for such treatments. The invention is particularly suitable for treating tissue adjacent to a body cavity such as a cavity formed by the removal of tissue.


More specifically, a device embodying features of the invention has a distal portion with a treatment location which is configured to be asymmetrically deployed within the body cavity and which is configured to receive or which includes a brachytherapy or other irradiating agent for treating tissue surrounding the cavity or other site.


In one embodiment the treatment location having a radiation source is offset or capable of being offset from the central location within the body cavity so that tissue of one portion of the cavity receives more intense radiation treatment than the tissue of an opposing portion.


The invention is generally directed to treating a patient's body cavity by irradiation, and devices and methods for such treatments. The invention is particularly suitable for treating tissue adjacent a patient's body cavity, such as that formed by removal of tissue for a biopsy.


More specifically, a device embodying features of the invention includes a treatment location at a distal portion of the device which is configured to receive or which includes a brachytherapy agent, such as a radiation source and which has a centrally located longitudinal axis. The distal portion of the shaft with the treatment location is deployable within the body cavity so as to provide asymmetrical treatment such as irradiation thereto to tissue surrounding the cavity and is or is capable of being deployed away from the longitudinal axis and closer to one portion of the cavity than an opposed portion.


In one embodiment the distal portion of the device has at least one delivery lumen which is configured to receive a radiation source and which is off-set or capable of being off-set from a central longitudinal axis so that the radiation source is closer to the tissue of the first portion of the body cavity than the tissue of the second portion of the cavity at an opposing side resulting in greater levels of radiation being received by the first tissue portion of the cavity. In this embodiment the device may also have one or more radiation shielding components that provide further control of the radiation emitted from the radiation source, such as described in application Ser. No. 11/593,952 (now U.S. Pat. No. 7,407,476), entitled Tissue Irradiation With Shielding. Off-setting the lumen in which the radiation source is deployed places the radiation source closer to a first tissue portion surrounding the body cavity to provide greater levels of radiation thereto and further away from the second tissue portion surrounding the body cavity at other locations to reduce the level of radiation thereto. The radiation received by the tissue surrounding the body cavity is a function of inverse of the distance (R) from the radiation source squared (1/R2), so even small changes in the location of the radiation source within a body cavity can make a significant impact on the amount of radiation received by tissue in the body cavity or site. In this embodiment the shaft having the distal portion with the treatment location may be deformed to deflect the radiation lumen to an off set location with respect to the central longitudinal axis. An alternative is to provide an asymmetrical cavity filling member that holds the distal portion of the shaft with the treatment location at a desired position within the cavity or body site to provide asymmetrical irradiation to the tissue surrounding the cavity or site. This may be accomplished with a cavity filling member that is asymmetrical, is mounted asymmetrically on the shaft or is configured to be inflated to an asymmetrical shape. The cavity filling member may have separate chambers which are independently inflated to different sizes so as to develop an asymmetrical shape that results in an off-set of the radiation source.


In another embodiment the device has an outer sheath with an inner lumen and an inner cannula or catheter which is rotatably disposed within the inner lumen of the outer sheath. The cannula or catheter has an inner lumen which is configured to receive a radiation source. The inner lumen receiving the radiation source is off set from a central longitudinal axis of the catheter or cannula, so that rotation of the cannula or catheter within the inner lumen of the outer sheath will adjust the position of a radiation source within the body cavity or site to provide the desired asymmetrical irradiation dose within the cavity.


The elongated shaft may also have one or more radiation shielding components designed to reduce or minimize damaging irradiation of healthy tissue surrounding the body cavity while treating nearby areas having diseased tissue with radiation emitted from the radiation source. The radiation shielding components include one or more radiation shields disposed about a delivery shaft containing the radiation source. Suitable radiation shielding components are described in application Ser. No. 11/593,952 (now U.S. Pat. No. 7,407,476), entitled Tissue Irradiation With Shielding.


A device embodying features of the invention preferably has an enlarged or enlargeable cavity filling member at the treatment location which at least in part fills the body cavity. Preferably, the cavity filling member is inflatable member such as a balloon. The elongated shaft has an inner inflation lumen for directing inflation fluid to the interior of the cavity filling member for its inflation.


The device may also include an inner lumen configured to be in fluid communication with a proximal vacuum source and one or more vacuum ports preferably proximal and or distal to the cavity filling member such as described in U.S. Pat. No. 6,923,754 and application Ser. No. 10/849,410 filed on May 19, 2004, (now U.S. Pat. No. 6,955,641), both of which are assigned to the present assignee. Application of a vacuum within the inner lumen aspirates fluid in the cavity through one or more vacuum ports and the vacuum within the body cavity pulls tissue defining the cavity onto the exterior of the cavity filling member deployed within the cavity. The application of a vacuum may also be employed to aspirate fluids from the cavity or site.


A method for treating a body cavity or other intracorporeal site of a patient includes delivering a treatment agent such as a radiation source to a body cavity to treat the desired tissue while minimizing damaging irradiation of healthy tissues. More specifically, a method for treating a body cavity or intracorporeal site includes providing a device having an elongate shaft with a proximal end, a distal end, and a treatment location in a distal portion of the shaft. The method further includes providing a radiation source configured to be deposited in the treatment location and a radiation shielding component partially encircling the treatment location which is configured to control at least in part the emission of radiation emitted from the treatment location. The device is advanced within the patient until the treatment location of the device is deployed within the body cavity or site and the radiation source is positioned within the treatment location. The radiation shielding component is positioned to shield portions of the body cavity from radiation emitted from the radiation source.


A patient's skin is susceptible to damage from radiation delivered by isotopes (e.g. seeds) or x-ray catheters in a lumen of a radiation balloon catheter if the radiation source is too close to the skin. Generally, radiation treatments using a radiation balloon catheter is usually not performed on patients where the body cavity (e.g. from a lumpectomy) is less than 5 mm, sometimes less than 7 mm from the patient's skin. Additionally, over inflation of the balloon can thin and stretch the skin. The application of a vacuum to the body cavity can help by pulling the tissue to the balloon and increased cavity to skin surface distances would result. However, in some instances it would still be too thin to treat. The number of potential patient's which are suitable candidates for treatments with the present device is significantly increased due to reducing the potential for skin tissue damage.


Placing patterns of radiation absorbing materials on the surface or within the wall of the balloon would aid in shielding the skin or in other cases, sensitive organs (e.g., heart, lung, ribs, etc.) from unnecessary radiation. Examples include—Mylar with aluminum, balloon coatings with gold, lead, titanium barium and barium sulfate or silver ions incorporated within the balloon wall.


The surface (inside or outside) of the balloon or within the balloon wall may be provided with indicator marks for location or orientation detection during the procedures. For example, dots or lines to help place balloon in appropriate position under CT, x-ray or fluoroscopy. The indicator marks may be radiopaque. Alternatively, or additionally, ultrasound indicators or MRI and direct visual indicators could be incorporated. The indicator marks may extend along the catheter shaft to help with placement of the catheter device during the treatment procedure and the orientation of the off set lumen and shield.


In other embodiments having features of the invention, the radiation shield may be secured to a control rod or band within the catheter device so that the location of the shield may be adjusted. Alternatively, the radiation shield may be secured within or onto the catheter device.


These and other advantages of the present invention are described in more detail in the following written description and the accompanying exemplary drawings.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a schematic view, partially in section, of a brachytherapy device embodying features of the invention including a cavity filling member.



FIG. 2 is a transverse cross sectional view of the device shown in FIG. 1 taken along lines 2-2 which illustrates the device with two inner lumens.



FIG. 3 is a transverse cross sectional view of an alternative device similar to the device shown in FIG. 1 having three lumens.



FIG. 4 is a transverse cross sectional view of an alternative device similar to the device shown in FIG. 1 having 5 lumens.



FIG. 5 is a transverse cross-sectional view of an alternative device having three lumens having circular transverse cross-sections and a pair of opposed arcuate inner lumens for radiation shielding component.



FIG. 6 is a transverse cross-sectional view of a device similar to that shown in FIG. 1 which has a plurality of arcuate lumens with enlarged central portions which allow for the deployment of a radiation shield or a radiation source within the lumens.



FIG. 7 is an elevational view, partially in section, of a distal portion of an alternative design for a brachytherapy device wherein the shaft within the cavity filing member is deformed to place the radiation source closer to one side of the cavity filling member than an opposed site.



FIG. 7A is an enlarged longitudinal cross-section of the deformed shaft within the cavity filling member.



FIG. 8 is a transverse cross-sectional view of the device shown in FIG. 7 taken along the lines 8-8.



FIG. 9 is an elevational view of a distal portion of an alternative design for a brachytherapy device wherein the cavity filling member is asymmetric, or inflated to an asymmetric configuration to place the radiation source closer to one side of the body cavity or site.



FIG. 10 is a transverse cross-sectional view of the brachytherapy device shown in FIG. 9 taken along the lines 10-10.



FIG. 11 is a transverse cross-sectional view similar to that shown in FIG. 10 in which the interior of the cavity filling member is separated into two chambers by a membrane so that each chamber may be inflated, e.g. to different sizes.



FIG. 12 illustrates a shaft formed of a plurality of elongated elements with at least one of the elongated elements having an inner lumen configured to receive a radiation source.



FIGS. 13A-B illustrate another embodiment having features of the invention which has an outer catheter with a cavity filling member and an inner catheter with an inner lumen which is off set or off settable from a longitudinal axis.



FIG. 14A is a perspective view, partially in section, of an alternative device which has a plurality of radially extending tubular members for delivery of radiation sources.



FIG. 14B is a transverse cross-sectional view of the device shown in FIG. 14A taken along the lines 14B-14B.



FIG. 14C is a perspective view of a compartmented support member and tubular members which extend through an inflatable member.



FIG. 14D is a transverse cross-sectional view of the device shown in FIG. 14A taken along the lines 14D-14D.





DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to devices and methods for treatment of a patient's body cavity, particularly to deliver asymmetrical radiation into a biopsy cavity or into a cavity left after removal of tissue from the patient's body. Other body sites may also be treated.



FIGS. 1 and 2 illustrate a brachytherapy device 10 embodying features of the invention which has an elongated shaft 11 with a treatment location 12 in a distal portion 13 of the elongated shaft 11. The elongated shaft 11 has a first lumen 14 which is off set from central longitudinal axis 15 and which is configured to receive a radiation source 16. The radiation source 16 is disposed at the distal end of pusher rod 17 to facilitate deployment within the treatment location 12. The elongated shaft 11 also has a second lumen 18 for delivery of inflation fluid to the interior of the cavity filling member 19 through inflation port 20. The elongated shaft 11 may also have a third lumen 21 shown in phantom to provide a vacuum to a desired location such as vacuum ports 22 and 23 also shown in phantom which are proximal and/or distal to the cavity filling member 19 as described in U.S. Pat. No. 6,923,641 (assigned to the present assignee). The third lumen may also be utilized as an off-set lumen to receive a radiation source in the event the first lumen 14 is not in a desired location when the distal end of the device is placed in the patient and the physician does not wish to rotate the device 10. The proximal end of the elongated shaft 11 has a multi-arm adapter 24 for delivery of a vacuum, inflation fluid and radiation source as shown. The device 10 may also have one or more radiation shielding components (not shown) to further reduce radiation to tissue which is not to be treated. Suitable radiation shielding components are described in application Ser. No. 11/593,952 (now U.S. Pat. No. 7,407,476), entitled Tissue Irradiation With Shielding which has been assigned to the present assignee.


A body cavity within a patient may be treated with the device 10 by inserting the distal shaft portion 13 into the desired body cavity with the off-set first lumen 14 configured to receive the radiation source 16 being closer to a first tissue portion surrounding the cavity to be treated and farther away from a second tissue portion surrounding the cavity which needs to be protected. A radiation source 16 is advanced within the first lumen 14 until the radiation source is properly positioned within the treatment location 12 (or prepositioned therein). Inflation fluid is delivered to the interior of the cavity filling member 19 so as to at least partially fill the body cavity. A vacuum may be generated about the cavity filling member 19 through vacuum ports 22 and 23 to conform the tissue surrounding the cavity to the exterior of the cavity filling member. The radiation source 16 is maintained at the treatment location 12 for a prescribe period of time, usually less than 30 minutes and typically a few (5-10) minutes. At the end of the treatment time the radiation source may be removed from device 10 or the entire device may be withdrawn from the patient. Preferably, the device is left in place so that further radiation treatments may be performed.



FIG. 3 illustrates an elongated shaft 11a of an alternative brachytherapy device which has three off-set lumens 25, 26 and 27 that are equally disposed about the longitudinal axis 28. The first off-set lumen 25 may be used as the radiation delivery lumen such as described above for first lumen 14. The second and third off-set lumens 26 and 27 may be utilized for delivery of inflation fluid to the interior of a cavity filling member (not shown) or for delivery of a vacuum to vacuum ports (not shown) proximal or distal to the cavity filling member as described above. Additionally, a centrally located fourth lumen 29 (shown in phantom) may be provided as an alternative lumen for radiation delivery in the event an off-set location is not needed. The fourth lumen may also be employed as an inflation or vacuum lumen as described above, leaving one of the off-set lumens 26 and 27 to deliver a radiation source in the event the first off-set lumen is not in a desirable location when the device is deployed within the patient's body cavity.



FIG. 4 illustrates an elongated shaft 11b of another alternative design of device 10 which has four off set lumens 30-33, one central lumen 34 which is axially aligned with longitudinal axis 35. The off set lumens 30-33 and central lumen 34 may be utilized as in the prior embodiments. This embodiment provides additional alternative lumens for delivery of a radiation source (not shown) as described above.



FIG. 5 illustrates yet another elongated shaft 11c of an alternative design which has two off set lumens 36 and 37 and a central lumen 38 which have circular transverse cross-sections as shown. The off set and central lumens 36, 37 and 38 may be utilized as described above. Additionally, at least one arcuate lumen 39 may be provided to facilitate placement of a radiation shield 40 as described in application Ser. No. 11/593,952 (now U.S. Pat. No. 7,407,476) entitled Tissue Irradiation With Shielding. A second arcuate lumen 41 at an opposed position within the shaft 11c (shown in phantom) for delivery of a radiation shield in the event the device is not placed in a desired orientation and the physician does not want to rotate the device.



FIG. 6 depicts another elongated shaft 11d for an alternative brachytherapy device 10 which has a first arcuate lumen 42 with an enlarged central portion 43. This first arcuate lumen 42 is design to slidably receive a radiation shielding member 44 and the enlarged central portion 43 is designed to slidably receive a radiation source 45 such as shown in second arcuate lumen 46 with enlarged central portion 47. A central lumen 48 is axially disposed about the longitudinal axis 49 and may be utilized for delivery of inflation fluid or a vacuum to the distal portion of the device. This design allows for the flexibility of placing either a radiation source or a radiation shielding member on either side of the device. The central lumen 48 may alternatively be positioned off-set within the shaft 11d. Other off-set lumens may be provided as described above with respect to the other embodiments.



FIGS. 7, 7A and 8 depict an alternative brachytherapy device 50 which has an elongated shaft 51 with a treatment location 52 in a distal portion 53 thereof. The shaft 51 is deformable within the treatment location 52. The elongated shaft 51 has a first lumen 54 which is configured to receive a radiation source 55 to position a radiation source off set from the longitudinal axis 56. The radiation source 55 has a standard pusher rod 57 to facilitate placement of the radiation source at the treatment location 52 within the first lumen 54. The distal shaft portion 53 is deformed, i.e. radially deflected, by pull-wire 58 so that the treatment location 52 is off-set or further off set from the longitudinal axis 56. The distal end of the pull-wire 58 has an enlarged hub which secures the distal end of the pull-wire within the shaft. The deformation of the distal shaft portion 53 places the radiation source 55 closer to one side of the cavity filling member 60 thereby reducing the radiation to tissue of the opposing side of the cavity. While only one pull-wire 58 is illustrated, multiple pull-wires may be employed about the longitudinal axis 56 to facilitate deformation of the distal shaft portion 53 in multiple directions. Other mechanical structures, may be provided to radially deflect the distal shaft portion 53 away from longitudinal axis 56. Off-set lumen 61 leads to inflation port 62 for directing inflation fluid to the interior of the cavity filling member 60. Off-set lumen 63 leads to vacuum port 64 (shown in phantom) proximal to the cavity filling member 60 to generate a vacuum within the body cavity to aspirate fluids and/or to conform surrounding tissue of the body cavity to the exterior of the cavity filling member 60.



FIGS. 9 and 10 illustrate another brachytherapy device 70 embodying features of the invention. The device 70 has an elongated shaft 71, a treatment location 72 in distal shaft portion 73, a first lumen 74 configured to receive radiation source 76, a second lumen 77 and a third lumen 78 and an asymmetrical cavity filling member 80. The first lumen 74 is closest to the smaller side 81 of the cavity filling member 80 so that radiation through the smaller side 81 of the cavity filling member 80 to adjacent tissue is greater than the radiation through the larger side 82 to adjacent tissue. The larger side 82 of the cavity filling member 80 is placed next to tissue in which the radiation dose is to be minimized, whereas the smaller side 81 is positioned adjacent to tissue which is to receive a higher dose of radiation. The second and third lumens 77 and 78 may be utilized for vacuum and inflation fluid as discussed above with respect to other embodiments.



FIG. 11 shows an alternative brachytherapy device 90 which has an elongated shaft 91 with three inner lumens. Off set lumens 92 and 93 and centrally disposed lumen 94. The first off set lumen 92 is for receiving a radiation source as previously described. The second off set lumen 93 may be for vacuum, inflation fluid or as an alternative lumen for a radiation source. The central lumen 94 may be employed for vacuum, inflation fluid or alternatively a radiation source. The device 90 has a cavity filling member 95 which has inner membranes 96 and 97 which separate the interior of the cavity filling member into separate chambers 98 and 99. Each chamber has separate sources (lumens) for inflation fluid so that one side 100 of the cavity filling member 95 may be inflated to one or more different sizes than an adjacent side 101. As shown in phantom, the side 100 may be inflated to a smaller size 100a or a larger size 100b. Adjusting the sizes controls the location of the radiation source within a lumen. With a smaller size 100a, the tissue to be treated adjacent to side 100 receives a higher radiation dose than tissue adjacent to side 101 which should be protected and given a smaller radiation dose. Alternatively, when chamber 98 is inflated so that side 100 is of a larger size, the tissue adjacent to side 100 will receive more radiation.



FIG. 12 depicts an elongate shaft 11e of an alternative device which comprises a plurality of elongated tubular elements 110, 111, 112 and 113. At least one of the elongated elements 110 has a first inner lumen 114 configured for receiving a radiation source such as described above for the other embodiments. The other elongated elements may also have inner lumens 115-117 for delivery of inflation fluid to a cavity filling member (not shown) on a distal portion of the shaft, for delivery of a vacuum to a vacuum port proximal or distal to the cavity filling member or an additional lumen for receiving a radiation source. The plurality of elements 110-113 may be bundled together by one or more outer straps or bands or by an outer sheath or by a suitable adhesive. The plurality of elongated elements of the shaft may be twisted or braided together. Tubular element 110 (as well as 111-113) may be radially deflected as depicted in FIG. 7 to position the first inner lumen closer to the first tissue portion surrounding the body cavity than the second tissue portion.



FIGS. 13A-B illustrate a brachytherapy device 120 which has an outer catheter 121 with an inner lumen 122 and an inner catheter 123 which is configured to be rotatably disposed within the inner lumen 122. The outer catheter 121 has an inflatable cavity filling member 124 on a distal portion 125 of shaft 126. The wall of shaft 126 has at least one lumen 127 for directing inflation fluid to the interior of the cavity filling member 124. The outer catheter 121 also has vacuum ports 128 and 129 proximal and distal to the cavity filling member 124. The wall 130 of shaft 126 has at least one lumen 131 which is in fluid communication with a vacuum port and preferably two lumens. The inner catheter 123 has an elongated shaft 132 with an off-set lumen 133 and may also have a central lumen 134 configured for receiving a radiation source to provide an asymmetrical radiation dose about longitudinal axis 135.



FIGS. 14A-14D illustrate an alternative device 140 which has an elongated shaft 141, a cavity filling balloon 142 on the distal portion of the shaft and an adapter 143 on the proximal end of shaft 141. A plurality of tubes 144-148 extend into the adapter 143 and are in fluid communication with lumens 150-154 respectively within the shaft 141 which are configured to receive radiation sources (not shown) such as those previously described. The device 140 also has an inflation tube 149 which is in fluid communication with lumen 155 that extends to and is in fluid communication with the interior of the balloon 142 to facilitate delivery of inflation fluid thereto. The adapter 143 has a vacuum arm 156 that is in fluid communication with lumens 157 and 158. Lumen 158 is in fluid communication with proximal vacuum port 160 and lumen 157 is in fluid communication with tubular member 161 which in turn is in fluid communication with distal vacuum port 162. Radiation delivery tubes 163-167 are in fluid communication with lumens 150-154. Radiation tube 163 and 164 are radially extended within the interior of balloon 142 in order to be closer to a first tissue portion surrounding a body cavity as previously described. While tubes 163 and 164 are shown as being radially extended within the balloon 142, one radiation delivery tube or more than two radiation delivery tubes may radially extend within the balloon 142 depending upon the need for a particular treatment.


A compartmented support element 168 extends between the proximal and distal ends of the balloon 142. The support element 168 shown has nine compartments 170-174 which are designed to receive tubular radiation delivery members 163-167 respectively. The device 140 may be assembled with the radial extension of radiation delivery tubes 144 and 145 fixed as shown or they may be slidable within the catheter shaft 141 so that the radial extension of these delivery tube be effected during the procedure. The radial extension of the radiation delivery tubes will not usually extend to contact the interior surface of the inflated balloon 142.


The radiation delivery tubes 144-148, which extend into the adapter 143, may extend through the lumens in shaft 141 and may form tubes 163-167 which are received by the support member 163.


All of the radiation delivery tubes which extend through the interior of the balloon 142 would not necessarily be used in a procedure and in fact would probable not be used. However, they would be available for use by the physician if needed, e.g. when the catheter is not in a desired position and rotation of the catheter is not appropriate or desirable. The shaft 141 is shown as a solid shaft having a plurality of passageways. However, the shaft 141 may be made more flexible by utilizing a plurality of tubes which are bundled together form the shaft as shown in FIG. 12.


The radiation source 16 for the brachytherapy device 10 can include a solid or liquid radiation source. Suitable liquid radiation sources include, for example, a liquid containing a radioactive iodine isotope (e.g., I125 or I131), a slurry of a solid isotope, for example, 198Au or 169Yb or a gel containing a radioactive isotope. Liquid radiation sources are commercially available (e.g., Lotrex®, Proxima Therapeutics, Inc., Alpharetta, Ga.). The radiation source 16 preferably includes brachytherapy seeds or other solid radiation sources used in radiation therapy, for example, a radioactive microsphere available from 3M Company of St. Paul, Minn. Microminiature x-ray source may also be utilized. The radiation source 16 may be either preloaded into the device 10 at the time of manufacture or may be loaded into the device 10 before or after placement into a body cavity or other site of a patient. Solid radionuclides suitable for use with a device 10 embodying features of the present invention are currently generally available as brachytherapy radiation sources (e.g., I-Plant™ Med-Tec, Orange City, Iowa.). Radiation may also be delivered by a device such as the x-ray tube of U.S. Pat. No. 6,319,188. The x-ray tubes are small, flexible and are believed to be capable of being maneuverable enough to reach the desired location within a patient's body.


The brachytherapy device 10 having features of the invention can be provided with a lubricious coating, such as a hydrophilic material. The lubricious coating preferably is applied to the elongate shaft 12 or to the cavity filling member, if one is present, or both to reduce sticking and friction during insertion of a device 10. Hydrophilic coatings such as those provided by AST, Surmodics, TUA Systems, Hydromer, or STS Biopolymers are suitable.


A device 10 having features of the invention may also include an antimicrobial coating that covers all or a portion of the device 10 to minimize the risk of introducing of an infection during extended treatments. The antimicrobial coating preferably is comprised of silver ions impregnated into a hydrophilic carrier. Alternatively the silver ions are implanted onto the surface of the device 10 by ion beam deposition. The antimicrobial coating preferably is comprised of an antiseptic or disinfectant such as chlorhexadiene, benzyl chloride or other suitable biocompatible antimicrobial materials impregnated into hydrophilic coatings. Antimicrobial coatings such as those provided by Spire, AST, Algon, Surfacine, Ion Fusion, or Bacterin International would be suitable. Alternatively a cuff member covered with the antimicrobial coating is provided on the elongated shaft of the delivery device 10 at the point where the device 10 enters the skin.


While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention. Some details of the brachytherapy devices have not been disclosed. To the extent not otherwise disclosed herein, materials and structure may be of conventional design.


Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is therefore intended that this invention be defined by the scope of the appended claims as broadly as the prior art will permit.


Terms such as “element”, “member”, “component”, “device”, “means”, “portion”, “section”, “steps” and words of similar import when used herein shall not be construed as invoking the provisions of 35 U.S.C. § 112(6) unless the following claims expressly use the terms “means for” or “step for” followed by a particular function without reference to a specific structure or a specific action. All patents and all patent applications referred to above in this application as filed are hereby incorporated by reference in their entirety.

Claims
  • 1. A method of treating tissue adjacent a body cavity comprising: inserting at least partially into the body cavity a device comprising a shaft and an inflatable member disposed about a portion of the shaft;inflating the inflatable member such that at least a portion of the inflatable member at least partially contacts tissue that defines the body cavity;expanding away from an axis of the shaft, spaced apart from but within the inflatable member, a radiation delivery tube; andinserting a radiation source into the radiation delivery tube.
  • 2. The method of claim 1, wherein expanding the radiation delivery tube comprises not contacting an inner surface of the inflated inflatable member.
  • 3. The method of claim 1, wherein the radiation tube is disposed in the shaft and wherein the shaft is deflectable away from the axis.
  • 4. The method of claim 3, further comprising pulling a pull wire so as to expand the radiation delivery tube.
  • 5. The method of claim 1, further comprising pushing the radiation delivery tube into a lumen so as to expand the radiation delivery tube.
  • 6. The method of claim 1, wherein the radiation delivery tube is at least partially disposed in a compartmented support element that extends between a proximal end and a distal end of the inflatable member along the axis of the shaft, and wherein expanding the radiation delivery tube comprises extending the radiation delivery tube away from the compartmented support element.
  • 7. The method of claim 6, wherein the compartmented support element defines a compartment that is configured to receive at least a portion of the radiation delivery tube and extends longitudinally along the compartmented support element, and wherein extending the radiation delivery tube comprises radially extending the radiation delivery tube out of the compartment.
  • 8. A brachytherapy method comprising: inserting at least a portion of a brachytherapy device having an inflatable member into a body cavity;inflating the inflatable member within the body cavity; andradially expanding from a first position to a second position, a radiation delivery tube within the inflatable member, wherein radial expansion of the radiation delivery tube occurs separate from inflation of the inflatable member.
  • 9. The method of claim 8, wherein when in the first position, the radiation delivery tube is disposed in a support element within an interior of the inflatable member, and when in the second position, the radiation delivery tube extends from the support element, and wherein radially expanding the radiation delivery tube comprises extending the radiation delivery tube at least partially out of the support element.
  • 10. The method of claim 9, wherein extending the radiation delivery tube at least partially out of the support element comprises positioning the radiation delivery tube in a substantially curved configuration relative to the support element.
  • 11. The method of claim 8, further comprising restricting contact between the radiation delivery tube and an inner surface of the inflatable member when in the second position.
  • 12. The method of claim 8, wherein radially expanding the radiation delivery tube comprising sliding the radiation delivery tube within the brachytherapy device.
  • 13. The method of claim 8, wherein inflating the inflatable member comprises delivering inflation fluid into the brachytherapy device.
  • 14. The method of claim 8, further comprising inserting a radiation source into the radiation delivery tube.
  • 15. A brachytherapy method comprising: inserting a brachytherapy device into a body cavity, wherein the brachytherapy device comprises an inflatable element, at least one radiation delivery tube, and a support element wherein the support element is disposed at least partially within the inflatable element and defines a plurality of compartments, and wherein each compartment of the plurality of compartments is configured to receive a radiation delivery tube of the at least one radiation delivery tube;inflating the inflatable element so as to contact the body cavity; andextending the at least one radiation delivery tube out of the corresponding compartment.
  • 16. The method of claim 15, wherein the plurality of compartments extend longitudinally along the support element, and wherein extending the at least one radiation delivery tube comprises radially extending the at least one radiation delivery tube out of the corresponding compartment and within the inflatable element.
  • 17. The method of claim 15, wherein extending the at least one radiation delivery tube comprises expanding the at least one radiation delivery tube in a substantially curved configuration from the support element.
  • 18. The method of claim 17, wherein the at least one radiation delivery tube comprises a plurality of radiation delivery tubes, each received in corresponding compartments of the support element, and wherein extending the at least one radiation delivery tube comprises extending two or more radiation delivery tubes of the plurality of radiation delivery tubes out of the corresponding compartments.
  • 19. The method of claim 18, further comprising individually extending the two or more radiation delivery tubes out of the corresponding compartments.
  • 20. The method of claim 15, wherein the at least one radiation delivery tube comprises a plurality of radiation delivery tubes, each received in corresponding compartment of the support element, and wherein extending the at least one radiation delivery tube comprises extending one or more radiation delivery tubes of the plurality of radiation delivery tubes out of the corresponding compartment and fixing one or more radiation delivery tubes of the plurality of radiation delivery tubes at least partially within the corresponding compartment.
CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 13/299,376, filed Nov. 18, 2011, now U.S. Pat. No. 9,415,239, which is a continuation of application Ser. No. 11/593,784, filed Nov. 6, 2006, now U.S. Pat. No. 8,079,946, which is a continuation-in-part of application Ser. No. 11/283,236, filed Nov. 18, 2005, now U.S. Pat. No. 7,413,539, and which also is related to provisional application Ser. No. 60/819,919 filed on Jul. 11, 2006, entitled Radiation Device For A Body Cavity, all from which priority is claimed and which are incorporated herein by reference in their entireties

US Referenced Citations (438)
Number Name Date Kind
3324847 Zoumboulis Jun 1967 A
3502878 Stewart Mar 1970 A
3863073 Wagner Jan 1975 A
3872856 Clayton Mar 1975 A
3971950 Evans et al. Jul 1976 A
3975350 Hudgin et al. Aug 1976 A
4119094 Micklus et al. Oct 1978 A
4160906 Daniels et al. Jul 1979 A
4310766 Finkenzeller et al. Jan 1982 A
4350169 Dutcher et al. Sep 1982 A
4417576 Baran Nov 1983 A
4454106 Gansow et al. Jun 1984 A
4496557 Malen et al. Jan 1985 A
4559641 Caugant et al. Dec 1985 A
4571241 Christopher Feb 1986 A
4690677 Erb Sep 1987 A
4706269 Reina et al. Nov 1987 A
4706652 Horowitz Nov 1987 A
4744099 Huettenrauch et al. May 1988 A
4754745 Horowitz Jul 1988 A
4763642 Horowitz Aug 1988 A
4773086 Fujita et al. Sep 1988 A
4773087 Plewes Sep 1988 A
4819258 Kleinman et al. Apr 1989 A
4821725 Azam et al. Apr 1989 A
4821727 Levene et al. Apr 1989 A
4867741 Portnoy Sep 1989 A
4929470 Rittenhouse et al. May 1990 A
4969174 Scheid et al. Nov 1990 A
4989227 Tirelli et al. Jan 1991 A
4998917 Geiser_ et al. Mar 1991 A
4998930 Lundahl Mar 1991 A
5015247 Michaelson May 1991 A
5018176 Romeas et al. May 1991 A
RE33634 Yanaki Jul 1991 E
5029193 Saffer Jul 1991 A
5051904 Griffith Sep 1991 A
5059166 Fischell et al. Oct 1991 A
5078142 Siczek et al. Jan 1992 A
5084001 Vant Hooft et al. Jan 1992 A
5084015 Moriuchi Jan 1992 A
5084022 Claude Jan 1992 A
5106360 Ishiwara et al. Apr 1992 A
5112303 Pudenz et al. May 1992 A
5152747 Olivier Oct 1992 A
5163075 Lubinsky et al. Nov 1992 A
5164976 Scheid et al. Nov 1992 A
5167622 Muto Dec 1992 A
5199056 Darrah Mar 1993 A
5199939 Dake et al. Apr 1993 A
5227969 Waggener et al. Jul 1993 A
5236410 Granov et al. Aug 1993 A
5240011 Assa Aug 1993 A
5259847 Trambert Nov 1993 A
5289520 Pellegrino et al. Feb 1994 A
5302168 Hess Apr 1994 A
5312356 Engelson et al. May 1994 A
5314518 Ito et al. May 1994 A
5336178 Kaplan et al. Aug 1994 A
5342305 Shonk Aug 1994 A
5359637 Webber Oct 1994 A
5365562 Toker Nov 1994 A
5381504 Novack et al. Jan 1995 A
5411466 Hess May 1995 A
5415169 Siczek et al. May 1995 A
5417687 Nardella et al. May 1995 A
5422926 Smith et al. Jun 1995 A
5426685 Pellegrino et al. Jun 1995 A
5428658 Oettingger et al. Jun 1995 A
5429582 Williams Jul 1995 A
5452367 Bick et al. Sep 1995 A
5465733 Hinohara Nov 1995 A
5484384 Fearnot Jan 1996 A
5503613 Weinberger Apr 1996 A
5506877 Niklason et al. Apr 1996 A
5520646 D'Andrea May 1996 A
5526394 Siczek et al. Jun 1996 A
5535817 Dunne Jul 1996 A
5539797 Heidsieck et al. Jul 1996 A
5553111 Moore et al. Sep 1996 A
5562594 Weeks Oct 1996 A
5566221 Smith et al. Oct 1996 A
5592562 Rooks Jan 1997 A
5594769 Pellegrino et al. Jan 1997 A
5596200 Sharma et al. Jan 1997 A
5598454 Franetzke et al. Jan 1997 A
5603991 Kupiecki et al. Feb 1997 A
5609152 Pellegrino et al. Mar 1997 A
5611767 Williams Mar 1997 A
5616114 Thornton et al. Apr 1997 A
5621780 Smith et al. Apr 1997 A
5624395 Mikhail et al. Apr 1997 A
5627869 Andrew et al. May 1997 A
5653683 D'Andrea Aug 1997 A
5657362 Giger et al. Aug 1997 A
5662580 Bradshaw et al. Sep 1997 A
5668889 Hara Sep 1997 A
5704926 Sutton Jan 1998 A
5706327 Adamkowski et al. Jan 1998 A
5719952 Rooks Feb 1998 A
5720717 D'Andrea Feb 1998 A
5724400 Swerdloff et al. Mar 1998 A
5735264 Siczek et al. Apr 1998 A
5741253 Michaelson Apr 1998 A
5759173 Preissman et al. Jun 1998 A
5769086 Ritchart et al. Jun 1998 A
5782742 Crocker et al. Jul 1998 A
5800333 Liprie Sep 1998 A
5803895 Kronholz et al. Sep 1998 A
5803912 Siczek et al. Sep 1998 A
5818898 Tsukamoto et al. Oct 1998 A
5820594 Fontirroche et al. Oct 1998 A
5820717 Siegenthaler Oct 1998 A
5828722 Ploetz et al. Oct 1998 A
5851182 Sahadevan Dec 1998 A
5863284 Klein Jan 1999 A
5863285 Coletti Jan 1999 A
5872828 Niklason et al. Feb 1999 A
5878104 Ploetz Mar 1999 A
5896437 Ploetz Apr 1999 A
5899882 Waksman et al. May 1999 A
5908406 Ostapchenko et al. Jun 1999 A
5913813 Williams et al. Jun 1999 A
5916143 Apple et al. Jun 1999 A
5919473 Elkhoury Jul 1999 A
5924973 Weinberger Jul 1999 A
5931774 Willaims et al. Aug 1999 A
5935098 Blaisdell et al. Aug 1999 A
5986662 Argiro et al. Nov 1999 A
5993972 Reich et al. Nov 1999 A
6005907 Ploetz Dec 1999 A
6013038 Pflueger Jan 2000 A
6022308 Williams Feb 2000 A
6022325 Siczek et al. Feb 2000 A
6033357 Ciezki et al. Mar 2000 A
6036631 McGrath et al. Mar 2000 A
6050930 Teirstein Apr 2000 A
6056702 Lorenzo May 2000 A
6075879 Roehrig et al. Jun 2000 A
6083148 Williams Jul 2000 A
6086970 Ren Jul 2000 A
6091841 Rogers et al. Jul 2000 A
6093142 Ciamacco, Jr. Jul 2000 A
6095966 Chomenky et al. Aug 2000 A
6137527 Abdel-Malek et al. Oct 2000 A
6141398 He et al. Oct 2000 A
6143013 Samson et al. Nov 2000 A
6149301 Kautzer et al. Nov 2000 A
6175117 Komardin et al. Jan 2001 B1
6196715 Nambu et al. Mar 2001 B1
6200257 Winkler Mar 2001 B1
6216540 Nelson et al. Apr 2001 B1
6217565 Cohen Apr 2001 B1
6219059 Argiro Apr 2001 B1
6233473 Shepherd et al. May 2001 B1
6234952 Liprie May 2001 B1
6243441 Zur Jun 2001 B1
6248122 Klumb et al. Jun 2001 B1
6251059 Apple et al. Jun 2001 B1
6256370 Yavuz Jul 2001 B1
6256529 Holupka et al. Jul 2001 B1
6267775 Clerc et al. Jul 2001 B1
6272207 Tang Aug 2001 B1
6282142 Miyawaki Aug 2001 B1
6289235 Webber et al. Sep 2001 B1
6292530 Yavus et al. Sep 2001 B1
6306074 Waksman et al. Oct 2001 B1
6319188 Lovoi Nov 2001 B1
6327336 Gingold et al. Dec 2001 B1
6341156 Baetz et al. Jan 2002 B1
6375352 Hewes et al. Apr 2002 B1
6378137 Hassan et al. Apr 2002 B1
6390967 Forman et al. May 2002 B1
6390968 Harmon May 2002 B1
6390992 Morris et al. May 2002 B1
6398708 Hastings et al. Jun 2002 B1
6411836 Patel et al. Jun 2002 B1
6413203 Sahatjian Jul 2002 B1
6413204 Winkler et al. Jul 2002 B1
6415015 Nicolas et al. Jul 2002 B2
6416457 Urick et al. Jul 2002 B1
6416492 Nielson Jul 2002 B1
6442288 Haerer et al. Aug 2002 B1
6443912 Mazzola et al. Sep 2002 B1
6458069 Tam et al. Oct 2002 B1
6458070 Waksman et al. Oct 2002 B1
6459925 Nields et al. Oct 2002 B1
6482142 Winkler et al. Nov 2002 B1
6501819 Unger et al. Dec 2002 B2
6512942 Burdette et al. Jan 2003 B1
6527693 Munro, III et al. Mar 2003 B2
6540655 Chin et al. Apr 2003 B1
6556655 Chichereau et al. Apr 2003 B1
6558390 Cragg May 2003 B2
6579221 Peterson Jun 2003 B1
6597762 Ferrant et al. Jul 2003 B1
6605030 Weinberger Aug 2003 B2
6606515 Windheuser Aug 2003 B1
6607477 Longton et al. Aug 2003 B1
6610013 Fenster et al. Aug 2003 B1
6611575 Alyassin et al. Aug 2003 B1
6615070 Lee Sep 2003 B2
6616629 Verin et al. Sep 2003 B1
6620111 Stephens et al. Sep 2003 B2
6626849 Huitema et al. Sep 2003 B2
6633674 Barnes et al. Oct 2003 B1
6638235 Miller et al. Oct 2003 B2
6647092 Eberhard et al. Nov 2003 B2
6652441 Weinberger et al. Nov 2003 B2
6673006 Winkler Jan 2004 B2
6685618 Tam et al. Feb 2004 B2
6706014 Banik et al. Mar 2004 B2
6723052 Mills Apr 2004 B2
6744848 Stanton et al. Jun 2004 B2
6746392 Stiger et al. Jun 2004 B2
6748044 Sabol et al. Jun 2004 B2
6749555 Winkler et al. Jun 2004 B1
6749595 Murphy Jun 2004 B1
6751285 Eberhard et al. Jun 2004 B2
6752752 Geitz Jun 2004 B2
6758824 Miller et al. Jul 2004 B1
6770058 Liprie Aug 2004 B1
6813334 Koppe et al. Nov 2004 B2
6882700 Wang et al. Apr 2005 B2
6885724 Li et al. Apr 2005 B2
6912319 Barnes et al. Jun 2005 B1
6913600 Valley et al. Jul 2005 B2
6923754 Lubock Aug 2005 B2
6940943 Claus et al. Sep 2005 B2
6955641 Lubock Oct 2005 B2
6970531 Eberhard et al. Nov 2005 B2
6978040 Berestov Dec 2005 B2
6983754 Anderson et al. Jan 2006 B1
6987831 Ning Jan 2006 B2
6999554 Mertelmeier Feb 2006 B2
7098463 Adamovics Aug 2006 B2
7107089 Lee Sep 2006 B2
7110490 Eberhard et al. Sep 2006 B2
7110502 Tsuji Sep 2006 B2
7123684 Jing et al. Oct 2006 B2
7127091 Op De Beek et al. Oct 2006 B2
7142633 Eberhard et al. Nov 2006 B2
7171255 Holupka et al. Jan 2007 B2
7201715 Burdette et al. Apr 2007 B2
7214178 Lubock May 2007 B2
7245694 Jing et al. Jul 2007 B2
7315607 Ramsauer Jan 2008 B2
7319735 Defreitas Jan 2008 B2
7322929 Lovoi Jan 2008 B2
7323692 Rowlands et al. Jan 2008 B2
7404791 Linares et al. Jul 2008 B2
7407476 Lubock et al. Aug 2008 B2
7413539 Lubock et al. Aug 2008 B2
7430272 Jing et al. Sep 2008 B2
7443949 Defreitas et al. Oct 2008 B2
7465268 Lubock Dec 2008 B2
7476235 Diederich et al. Jan 2009 B2
7497819 White et al. Mar 2009 B2
7497820 White et al. Mar 2009 B2
7513861 Klein et al. Apr 2009 B2
7517310 Lubock et al. Apr 2009 B2
7609806 Defreitas et al. Oct 2009 B2
7630533 Ruth et al. Dec 2009 B2
7662082 White et al. Feb 2010 B2
7697660 Ning Apr 2010 B2
7783006 Stewart et al. Aug 2010 B2
7792245 Hitzke et al. Sep 2010 B2
7869563 Defreitas et al. Jan 2011 B2
7885382 Stewart et al. Feb 2011 B2
7887476 Hermann et al. Feb 2011 B2
7955246 Lubock et al. Jun 2011 B2
8075469 Lubock et al. Dec 2011 B2
8079946 Lubock Dec 2011 B2
8123722 Change et al. Feb 2012 B2
8137256 Cutrer et al. Mar 2012 B2
8192344 Lubock et al. Jun 2012 B2
8277370 Quick Oct 2012 B2
8287442 Quick Oct 2012 B2
8565374 Defreitas et al. Oct 2013 B2
9180312 Lubock Nov 2015 B2
9248311 Damarati Feb 2016 B2
9352172 Benson May 2016 B2
9415239 Lubock Aug 2016 B2
9579524 Damarati Feb 2017 B2
9623260 White Apr 2017 B2
20010016725 Valley et al. Aug 2001 A1
20010038681 Stanton et al. Nov 2001 A1
20010038861 Hsu et al. Nov 2001 A1
20010049464 Ganz Dec 2001 A1
20010051669 McGhee Dec 2001 A1
20020012450 Tsujii Jan 2002 A1
20020026090 Kaplan et al. Feb 2002 A1
20020045893 Lane et al. Apr 2002 A1
20020050986 Inouc et al. May 2002 A1
20020055666 Hunter et al. May 2002 A1
20020075997 Unger et al. Jun 2002 A1
20020095114 Palasis Jul 2002 A1
20020156342 Burton et al. Oct 2002 A1
20020177804 Saab Nov 2002 A1
20020177870 Sepetka Nov 2002 A1
20030018272 Treado et al. Jan 2003 A1
20030073895 Nields et al. Apr 2003 A1
20030095624 Eberhard May 2003 A1
20030144570 Hunter et al. Jul 2003 A1
20030153803 Harmon Aug 2003 A1
20030191491 Duane et al. Oct 2003 A1
20030194050 Eberhard Oct 2003 A1
20030194051 Wang et al. Oct 2003 A1
20030194121 Eberhard et al. Oct 2003 A1
20030210254 Doan et al. Nov 2003 A1
20030212373 Hall Nov 2003 A1
20030215120 Uppaluri et al. Nov 2003 A1
20040015193 Lamson Jan 2004 A1
20040039437 Sparer et al. Feb 2004 A1
20040054366 Davison et al. Mar 2004 A1
20040066884 Hermann Claus et al. Apr 2004 A1
20040066904 Eberhard et al. Apr 2004 A1
20040087827 Lubock May 2004 A1
20040094167 Brady et al. May 2004 A1
20040101095 Jing et al. May 2004 A1
20040109529 Eberhard et al. Jun 2004 A1
20040116767 Lebovic et al. Jun 2004 A1
20040147800 Barber et al. Jul 2004 A1
20040171986 Tremaglio, Jr. et al. Sep 2004 A1
20040215048 Lubock Oct 2004 A1
20040260142 Lovoi Dec 2004 A1
20040267157 Miller et al. Dec 2004 A1
20050016771 Mayes et al. Jan 2005 A1
20050049521 Miller et al. Mar 2005 A1
20050059990 Ayala et al. Mar 2005 A1
20050061771 Murphy Mar 2005 A1
20050063509 DeFreitas et al. Mar 2005 A1
20050078797 Danielsson et al. Apr 2005 A1
20050080313 Stewart et al. Apr 2005 A1
20050101823 Linares et al. May 2005 A1
20050105679 Wu et al. May 2005 A1
20050113681 DeFreitas May 2005 A1
20050113715 Schwindt et al. May 2005 A1
20050124843 Singh Jun 2005 A1
20050129172 Mertelmeier Jun 2005 A1
20050135555 Claus et al. Jun 2005 A1
20050135664 Kaufhold et al. Jun 2005 A1
20050182286 Lubock Aug 2005 A1
20050226375 Eberhard et al. Oct 2005 A1
20050240073 Apffelstaedt et al. Oct 2005 A1
20050240074 Lubock Oct 2005 A1
20050267320 Barber et al. Dec 2005 A1
20050277577 Hunter et al. Dec 2005 A1
20060014997 Kindlein et al. Jan 2006 A1
20060020156 Shukla Jan 2006 A1
20060020256 Bell et al. Jan 2006 A1
20060030784 Miller et al. Feb 2006 A1
20060074288 Kelly Apr 2006 A1
20060098855 Gkanatsios May 2006 A1
20060100475 White et al. May 2006 A1
20060116546 Eng Jun 2006 A1
20060129062 Nicoson et al. Jun 2006 A1
20060136051 Furst et al. Jun 2006 A1
20060149186 Wantink Jul 2006 A1
20060155209 Miller et al. Jul 2006 A1
20060167416 Mathis et al. Jul 2006 A1
20060173233 Lovoi Aug 2006 A1
20060173235 Lim et al. Aug 2006 A1
20060205992 Lubock et al. Sep 2006 A1
20060291618 Eberhard et al. Dec 2006 A1
20070005003 Patterson et al. Jan 2007 A1
20070030949 Jing et al. Feb 2007 A1
20070036265 Jing et al. Feb 2007 A1
20070055144 Neustadter et al. Mar 2007 A1
20070076844 Defreitas et al. Apr 2007 A1
20070106108 Hermann et al. May 2007 A1
20070142694 Cutrer et al. Jun 2007 A1
20070142779 Duane et al. Jun 2007 A1
20070167665 Hermann et al. Jul 2007 A1
20070167666 Lubock et al. Jul 2007 A1
20070191667 Lubock et al. Aug 2007 A1
20070223651 Wagenaar et al. Sep 2007 A1
20070225600 Weibrecht Sep 2007 A1
20070242800 Jing Oct 2007 A1
20070270627 Cutrer et al. Nov 2007 A1
20080009659 Smith et al. Jan 2008 A1
20080019581 Gkanatsios Jan 2008 A1
20080045833 Defreitas Feb 2008 A1
20080057298 Finley Mar 2008 A1
20080064915 Lubock Mar 2008 A1
20080071212 Lubock et al. Mar 2008 A1
20080086083 Towler Apr 2008 A1
20080091055 Nguyen et al. Apr 2008 A1
20080101537 Sendai May 2008 A1
20080112534 DeFreitas et al. May 2008 A1
20080130979 Ren Jun 2008 A1
20080177127 Allan et al. Jul 2008 A1
20080188705 Lubock et al. Aug 2008 A1
20080221384 Chi Sing et al. Sep 2008 A1
20080221444 Ritchie et al. Sep 2008 A1
20080228023 Jones et al. Sep 2008 A1
20080228024 Jones et al. Sep 2008 A1
20080228025 Quick Sep 2008 A1
20080228150 Jones et al. Sep 2008 A1
20080281142 Lubock et al. Nov 2008 A1
20080281143 Lubock et al. Nov 2008 A1
20080287801 Magnin et al. Nov 2008 A1
20090003519 DeFreitas Jan 2009 A1
20090010384 Jing Jan 2009 A1
20090030259 Quick Jan 2009 A1
20090080594 Brooks Mar 2009 A1
20090080602 Brooks Mar 2009 A1
20090093821 Edmundson Apr 2009 A1
20090124845 Lubock et al. May 2009 A1
20090135997 Defreitas May 2009 A1
20090156880 Allan et al. Jun 2009 A1
20090156882 Chi Sing et al. Jun 2009 A1
20090171157 Diedrich et al. Jul 2009 A1
20090188098 Acosta et al. Jul 2009 A1
20090198095 Acosta et al. Aug 2009 A1
20090213987 Stein et al. Aug 2009 A1
20090268865 Ren Oct 2009 A1
20090296882 Gkanatsios Dec 2009 A1
20090304147 Jing et al. Dec 2009 A1
20100048977 Sing et al. Feb 2010 A1
20100054400 Ren Mar 2010 A1
20100069878 Parsai et al. Mar 2010 A1
20100086188 Ruth Apr 2010 A1
20100150306 Defreitas et al. Jun 2010 A1
20100195882 Ren Aug 2010 A1
20100204534 Damarati Aug 2010 A1
20100204535 Damarati Aug 2010 A1
20100226475 Smith Sep 2010 A1
20100268029 Phan Oct 2010 A1
20100286465 Benson Nov 2010 A1
20100290585 Eliasson Nov 2010 A1
20110069809 Defreitas et al. Mar 2011 A1
20120046647 Matsukuma et al. Feb 2012 A1
20120071705 Lubock et al. Mar 2012 A1
20120083646 Benson Apr 2012 A1
20120178983 Benson Jul 2012 A1
20130225902 White Aug 2013 A1
20160287902 Benson Oct 2016 A1
Foreign Referenced Citations (55)
Number Date Country
2539553 Mar 1977 DE
0340881 Oct 1992 EP
0536440 Apr 1993 EP
0642766 Mar 1995 EP
0693293 Jan 1996 EP
0719571 Jul 1996 EP
775467 May 1997 EP
0853957 Jul 1998 EP
0867200 Sep 1998 EP
0982001 Mar 2000 EP
1051990 Nov 2000 EP
1070514 Jan 2001 EP
1402922 Mar 2004 EP
1428473 Jun 2004 EP
1541188 Jun 2005 EP
1618924 Jan 2006 EP
1759637 Mar 2007 EP
10137250 May 1998 JP
2001120561 May 2001 JP
2177350 Dec 2001 RU
WO 9005485 May 1990 WO
WO 9210932 Jul 1992 WO
WO 9309724 May 1993 WO
WO 9520241 Jul 1995 WO
WO 9712540 Apr 1997 WO
WO 9719723 Jun 1997 WO
WO 9745053 Dec 1997 WO
WO 9816903 Apr 1998 WO
WO 9815315 Apr 1998 WO
WO 9911325 Mar 1999 WO
WO 9933515 Jul 1999 WO
WO 9934869 Jul 1999 WO
WO 9942163 Aug 1999 WO
WO 0051484 Sep 2000 WO
WO 0114011 Mar 2001 WO
WO 0143826 Jun 2001 WO
WO 0158346 Aug 2001 WO
WO 0209599 Feb 2002 WO
WO 02069862 Sep 2002 WO
WO 03020114 Mar 2003 WO
WO 2004043531 May 2004 WO
WO 2004043535 May 2004 WO
WO 2005037363 Apr 2005 WO
WO 2005039655 May 2005 WO
WO 2005039665 May 2005 WO
WO 2005051197 Jun 2005 WO
WO 2005067442 Jul 2005 WO
WO 2005110230 Nov 2005 WO
WO 2005112767 Dec 2005 WO
WO 2006055830 May 2006 WO
WO 2006058160 Jun 2006 WO
WO 2007027831 Mar 2007 WO
WO 2007143560 Dec 2007 WO
WO 2008067557 Jun 2008 WO
WO 09079170 Jun 2009 WO
Non-Patent Literature Citations (97)
Entry
“DuPont Teflon PFA HP Plus”, XP007904995:retrieved from the Internet: URL: http://www2.dupont.com/Teflon_Industrial/en_US/assets/downloads/ h88800.pdf; retrieved on Jun. 19, 2008, by Authorized Officer in International Application PCT/US2008/003364, 4 pgs.
“Essentials for life: Senographe Essential Full-Field Digital Mammography system”, GE Health-care Brochure, MM-0132-05.06-EN-US, 2006, 12 pgs.
“Filtered Back Projection,” (NYGREN) published May 8, 2007; URL: http://web.archive.org/web/19991010131715/http://www.owlnet.rice.edu/-.about.e1ec539/Projects97/cult/node2.html, 2 pgs.
“Lorad Selenia” Document B-BI-SEO US/Intl (May 2006), copyright Hologic 2006, 12 pgs.
“Variable shield for radiation-therapy sourcewire and centering catheter”, Research disclosure, Mason Publications, Hampshire, GB, vol. 438, No. 48, Oct. 2000, XP007126916, 1 page.
Abstracts of the 11th International Conference on Brain tumor Research and Therapy Oct. 31-Nov. 3, 1995, Silverad Country Club and Resort, Napa, California, Journal of Neuro-Oncology 28, p. 72, 1996, 2 pages all together.
Akagi, Y, et al.,“Optimum Fractionation for High-Dose-Rate Endoesophageal Brachytherapy Following External Irradiation of Early State Esophageal Cancer”, Int. J. Radiation Oncology Biol. Phys., vol. 43, 1999, pp. 525-530, Elsevier Science, Inc.
Ashpole et al., “A New Technique of Brachytherapy for Malignant Gliomas with Caesium-137: A New Method Utilizing a Remote Afterloading System,” Clinical Oncology, 1990, vol. 2, pp. 333-337.
Astrahan, Melvin A., PhD et al., “Optimization of Mammosite therapy”, Int. J. Radiation Oncology Biol. Phys, vol. 58, No. 1, pp. 220-232, 2004.
Bowsher. W. G., et al., “Update on Urology-Prostate Cancer. 4-Treatment of Local Disease”. European Journal of Surgical Oncology. 1995 pp. 679-682. vol. 21. No. 6.
Chan, Heang-Ping et al., “ROC study of the effect of stereoscopic imaging on assessment of breast lesions”, Medica Physics, vol. 32, No. 4, Apr. 2005, 7 pgs.
Cole, Elodia, et al., “The Effects of Gray Scale Image Processing on Digital Mammography Interpretation Performance”, Academic Radiology, vol. 12, No. 5, pp. 585-595, May 2005.
Cuttino, L. W., et al.,“CT-Guided Multi-Catheter Insertion Technique for Partial Breast Brachytherapy: Reliable Target Coverage and Dose Homogeneity”, Brachy1herapy 4, 2005, pp. 10-17, Elsevier.
Das, R. K., et al., “3D-CT-Based High-Dose-Rate Breast Brachytherapy Implants: Treatment Planning and Quality Assurance”, Int. J. Radiation Oncology Biol. Phys. 2004, pp. 1224-1228, vol. 59, No. 4, Elsevier Inc.
Debicki, M. P., et al., “Localized Current Field Hyperthermia in Carcinoma of the Cervix: 3-D Computer Simulation of SAR Distribution”. International Journal of Hyperthermia. 1999. pp. 427-440. vol. 15. No. 5.
Demanes, D. J . et al., “The Use and Advantages of a Multichannel Vaginal Cylinder in High-Dose-Rate Brachytherapy”. Int. J. Radiation Oncology Biol. Phys. (1999). pp. 211-219. vol. 44. No. 1. Elsevier Science Inc.
Dempsey, J. F. et al., “Dosimetric Properties of a Novel Brachytherapy Balloon Applicator for the Treatment of Malignant Brain-Tumor Resection-Cavity Margins”, Int. J. Radiation Oncology Biol. Phys., May 1998, pp. 421-429, vol. 42. No. 2. Elsevier.
Devic et al., “Advantages of Inflatable Multichannel Endorectal Applicator in the Neo-Adjuvant Treatment of Patients With Locally Advanced Rectal Cancer With HOR Brachytherapy”, Journal of Applied Clinical Medical Physics, Spring 2005, pp. 44-49, vol. 6, No. 2.
Digital Clinical Reports, Tomosynthesis, GE Brochure 98-5493, Nov. 1998, 8 pgs.
Edmundson,Gregory K. et al., “Dosimetric Characteristics of the Mammosite RTS, a New Breast Brachytherapy Applicator”, Int. J. Radiation Oncology Biol. Phys., vol. 52, No. 4, pp. 1132-1139, 2002.
Federica Pediconi et al., “Color-coded automated signal intensity-curve for detection and characterization of breast lesions: Preliminary evaluation of a new software for MR-based breast imaging”, International Congress Series 1281 (2005) 1081-1086.
Fowler, J. E., “Brief Summary of Radiobiological Principles in Fractionated Radiotherapy”, Seminars in Radiation Oncology, Jan. 1992, pp. 16-21, vol. 2, No. 1, W. B. Saunders Company.
Friedman, M, et al., “A New Technic for the Radium Treatment of Carcinoma of the Bladder”, Presented at the Thirty-fourth Annual Meeting of the Radiological Society of North America, Dec. 5-10, 1948, pp. 342-362.
Friedman, M, et al., “Irradiation of Carcinoma of the Bladder by a Central Intracavitary Radium or Cobalt 60 Source (The Walter Reed Technique)”, Presented at the Annual Meeting of the American Radium Society, 1955, pp. 6-31.
Garipagaoglu, M. et al., “Geometric and Dosimetric Variations of ICRU Bladder and Rectum Reference Points in Vaginal Cuff Brachytherapy Using Ovoids”, Int. J. Radiation Oncology Biol. Phys. 2004, pp. 1607-1615. Elsevier Inc.
Gaspar, L. E., et al., “Esophageal Brachytherapy”, Principles and Practice of Brachytherapy, 1997, pp. 305-321, Futrua Publishing Company, Inc., Armouk, New York.
Glasgow, G. P., et al. “Remote Afterloading Technology”, AAPM Report No. 41, 1993, pp. i-vi and 1-107, American Institute of Physics, Inc., 116 pgs.
Gutin, P.H. et al., “A coaxial catheter system for afterloading radioactive sources for the interstitial irradiation of brain tumors”, J. Neurosur, vol. 56, pp. 734-735, 1982.
Hall, J. W., et al., “ Histologic Changes in Squamous-Cell Carcinoma of the Mouth and Oropharynx Produced by Fractionated External Roentgen Irradiation”, Radiological Society of North America, 1948, pp. 318-350, Mar. 3, 1950.
Harada, T, et al.,“Transcystoscopic Intracavitary irradiation for Carcinoma of the Bladder: Technique and Preliminary Clinical Results”, The Journal of Urology, Oct. 1987, pp. 771-774, vol. 138, No. 4, The Williams & Wilkins Co.
Harper, Paul V., “Some Therapeutic Applications of Radioisotopes”, Journal of the Mississippi State Medical Association, Oct. 1966, vol. VII, pp. 526-533.
Hewitt, C. B., et al., “Intracavitary Radiation in the Treatment of Bladder Tumors”, The Journal of Urology, vol. 107, Apr. 1972, pp. 603-606, The Williams & Wilkins Co.
Hewitt, C. B., et al., “Update on Intracavitary Radiation in the Treatment of Bladder Tumors”, The Journal of Urology; Official Journal of the American Urological Association, Inc., 1981, pp. 323-325, vol. 126 September, The Williams & Wilkins Co.
Hieshima,G. B., et al. “A Detachable Balloon for Therapeutic Transcatheter Occlusions 1”, Technical Notes, Jan. 1981, pp. 227-228, vol. 138.
Hine, G. J., et al., “Isodose Measurements of Linear Radium Sources in Air and Water by Means of an Automatic Isodose Recorder”, The American Journal of Roentgenology and Radium Therapy, 1950, pp. 989-998, vol. 64, No. 6, The Societies.
Hologic, Inc., Cytec Corp., and Hologic L.P. v. Senorx, Inc., Norhtern District of California, San Jose Division, Case No. 08-CV-0133 RMW, Defendant Senorx, Inc.'s Notice of Motion and Motion for Summary Judgment of Invalidity ('142 Patent, Claims 1 & 8) and Non-Infringement ('813 Patent, Claims 11 & 12; '204 Patent, Claims 4 & 17), filed May 20, 2009, pp. 7-22, discussing Ashpole, et al., “A New Technique of Brachytherapy for Malignant Gliomas with Caesium-137: A New Method for Utilizing a . . .”, 60 pgs.
Hoshino, T., “Brain Tumor Research Center”, Abstracts of the 11th Conference on Brain Tumor Research and Therapy, Journal of Neuro-Oncology 28, 1996, pp. 31-113.
International Search Report for PCT/US2006/043891 dated Sep. 25, 2007, 7 pgs.
Johannesen, T.B. et al, “Intracavity Fractioned Balloon Brachytherapy in Glioblastoma”, Acta Neurochir (Wien) (1999) 141: 127-133.
Kaufman, N., “Remote Afterloading Intraluminal Brachytherapy in the Treatment of Rectal, Rectosigmoid, and Anal Cancer: A Feasibility Study”, International Journal of Radiation Oncology, Biology, Physics, Sep. 1989, pp. 663-668, vol. 17, Issue 3, Pergamon Press pic.
Kita et al., “Correspondence between different view breast X-rays using simulation of breast deformation”, Proceedings 1998 IEE Computer Society Conference on Computer Vision and Pattern Recognition, Santa Barbara, CA, Jun. 23-25, 1998, pp. 700-707.
Kolotas., C. et al., “CT Guided Interstitial High Dose Rate Brachytherapy for Recurrent Malignant Gliomas”. The British Journal of Radiology. 72. (1999), pp. 805-808.
Kuettel, M. R. et al._ “Treatment of Female Urethral Carcinoma in Medically Inoperable Patients Using External Beam Irradiation and High Dose Rate Intracavitary Brachytherapy”, The Journal of Urology. May 1997, pp. 1669-1671, vol. 157, The American Urological Association, Inc.
Lewis, J, et al., “Intracranial Brachytherapy Using a High Dose Rate Microselectron”, Northern Centre for Cancer Treatment, Dept. of Neurosciences, Regional Medical Physics Department, Newcastle General Hospital, Newcastle Upon Tyne, UK, Radiation and Oncology, vol. 39, Supplement 1, May 1996, pp. 45-45, 1 page, p. 179.
Low-Beer, B. V. A., “Radioisotope Therapy”, “The Clinical Use of Radioactive Isotopes”, 1950, pp. 284-349, Charles C. Thomas, Publisher, Springfield, Illinois, U.S.A., See pp. 343-349.
Low-Beer, B. V. A., “The Therapeutic Use of Radioactive Isotopes”, “Practical Therapeutics”, Dec. 1954, pp. 69-87, vol. X, No. 6.
Mammographic Accreditation Phantom, http://www.cirsinc.com/pdfs/015cp.pdf, (2006), 2 pgs.
Marshall V. F., et al., “Current Clinical Problems Regarding Bladder Tumors”, Symposium on Bladder Tumors, 1956, pp. 543-550, 9/3/May-Jun., J.B. Lippincott Co, Etc.
Micheletti, E., et al., “High-Dose-Rate Brachytherapy for Poor-Prognosis, High-Grade Glioma: (Phase II) Preliminary Results”, Tumori, 1996, pp. 339-344.
Muller, J. H., “Radiotherapy of Bladder Cancer by Means of Rubber Balloons Filled In Situ With solutions of a Radioactive Isotope (Co60)”, Cancer, A Journal of the American Cancer Society, Jul.-Aug. 1955, pp. 1035-1043, vol. 8, No. 4, J.B. Lippincott Company, Philadelphia.
Nag, S, “Modem Techniques of Radiation Therapy for Endometrial Cancer”, Clinical Obstetrics and Gynecology, Sep. 1996, pp. 728-744, vol. 39, No. 3, Lippincott-Raven Publishers.
Nag, S., et al., “Perineal Template Interstitial Barchytherapy Salvage for Recurrent Endometrial Adenocarcinoma Metastatic to the Vagina”, Necologic Oncology 66, 1997, pp. 16-19, Article No. G0974722, Academic Press.
Nag, S., et al., “Remote Controlled High Dose Rate Brachytherapy” , Critical Reviews in Oncology/Hematology 22, 1996, pp. 127-150, Elsevier Science Ireland Ltd.
Nag, S., et al., “The Future of High Dose Rate Brachytherapy”, High Dose Rate Brachytherapy: A Textbook, 1994, pp. 447-453, Futura Publishing Company, Inc. , Armonk, New York 10504.
Nath, Ph.D. et al., “Development of an 241 Am Applicator for Intracavitary Irradiation of Gynecologic Cancers”, I.J. Radiation Oncology Biol. Phys., May 1988, vol. 14, p. 969-978.
Office Action dated Jun. 11, 2013 in U.S. App. No. 13/861,195 issued by the United States Patent and Trademark Office.
PCT International Preliminary Report on Patentability for PCT/US03/33775 dated Oct. 10, 2007.
PCT International Preliminary Report on Patentability for PCT/U52006/043891 dated Jan. 12, 2008, 3 pgs.
PCT International Preliminary Report on Patentability for PCT/US2006/044067 dated Oct. 2, 2009.
PCT International Preliminary Report on Patentability for PCT/US2008/003217 dated Mar. 21, 2011, 6 pgs.
PCT International Preliminary Report on Patentability for PCT/US2008/003364 dated Aug. 3, 2010, 11 pgs.
PCT International Search Report for PCT/US03/33775 dated Jun. 21, 2004, 5 pgs.
PCT International Search Report for PCT/US2006/044067 dated Dec. 18, 2007, 3 pgs.
PCT International Search Report for PCT/US2008/003217 dated Aug. 12, 2008, 3 pgs.
PCT International Search Report for PCT/US2008/003364 dated Aug. 27, 2008, 6 pgs.
PCT Written Opinion of the International Searching Authority for PCT/US2006/043891 dated May 18, 2008, 12 pgs.
PCT Written Opinion of the International Searching Authority for PCT/US2006/044067 dated Jan. 11, 2009, 8 pgs.
PCT Written Opinion of the International Searching Authority for PCT/US2008/003217 dated Sep. 12, 2009, 6 pgs.
PCT Written Opinion of the International Searching Authority for PCT/US2008/003364 dated Sep. 15, 2009, 10 pgs.
Pernot, M., “Combined Surgery and Brachytherapy in the Treatment of Some Cancers of the Bladder (Partial Cystectomy and Interstitial Iridium—192)”, Radiotherapy & Oncology, 1996, pp. 115-120, Elsevier Science Ireland Ltd.
Rotman, M., et al., “The Intracavitary Applicator in Relation to Complications of Pelvic Radiation—The Ernst System”, Int. J. Radiation Oncology Biol. Phys., 1978, pp. 951-956, vol. 4, Pergamon Press Inc.
Russel, A.H., et al, “Intracavitary Irradiation for Carcinoma of the Urinary Bladder: Rationale, Technique, and Preliminary Results”, Int. J. Radiation Oncology. Phys., 1984, pp. 215-219, vol. 10, Pergamon Press Ltd.
Senographe 700 & 800T (GE); 2-page download on Jun. 22, 2006 from www.gehealthcare.com/inen/rad/whe/products/mswh800t.html.; Figures 1-7 on 4 sheets re lateral shift compression paddle, 2 pgs.
SenoRX, Inc.v. Hologic, Inc.; District Court for the District of Delaware, Case No. 1 :12-cv-00173-LPS-CJB, Complaint filed Feb. 10, 2012, 7 pgs.
SenoRX, Inc. v. Hologic, Inc.; District Court for the District of Delaware, Case No. 1 :12-cv-00173-LPS-CJB, Hologic, Inc.'s Answer to Complaint and Counterclaim filed on May 23, 2012, 10 pgs.
SenoRX, Inc. v. Hologic, Inc.; District Court for the District of Delaware, Case No. 1 :12-cv-00173-LPS-CJB, Joint Claim Construction Chart, filed Nov. 16, 2012, 7 pgs.
SenoRX, Inc. v. Hologic, Inc.; District Court for the District of Delaware, Case No. 1 :12-cv-00173-LPS-CJB, SenoRX's Answer to Counterclaim filed on Jun. 18, 2012, 6 pgs.
Slevin. N. J. et al., “Intracavitary Radiotherapy Boosting for Nasopharynx Cancer”, The British Journal of Radiology, 70, Apr. 1997, pp. 412-414.
Smith, A., “Fundamentals of Breast Tomosynthesis”, White Paper, Hologic Inc., WP-00007, Jun. 2008, 8 pgs.
SNEED. P. K. et al., “Interstitial Brachytherapy Procedures for Brain Tumors”, Seminars in Surgical Oncology 1997; 13: 157-166. Wiley-Liss. Inc.
Stubbs, J.B., et al.,“Preclinical Evaluation of a Novel Device for Delivering Brachytherapy to the Margins of Resected Brain Tumor Cavities”, J. Neurosurg 96, Feb. 2002, pp. 335-343, vol. 96.
Sylvester, J., et al., “Interstitial Implantation Techniques in Prostate Cancer”, Journal of Surgical Oncology 1997; 66: 65-75. Wiley-Liss. Inc.
Symon et al., “Individual Fraction Optimization vs. First Fraction Optimization for Multichannel Applicator Vaginal Cuff High-Dose-Rate Brachytherapy”, pp. 211-215, Brachytherapy 5 (2006), Elsevier.
Tan, L. T. et al., “Radical Radiotherapy for Carcinoma of the Uterine Cervix Using External Beam Radiotherapy and a Single Line Source Brachytherapy Technique: The Clatterbridge Technique”, The British Journal of Radiology, 70, Dec. 1997, pp. 1252-1258.
Tanderup et al. “Multi-Channel Intracavitary Vaginal Brachytherapy Using Three-Dimensional Optimization of Source Geometry”, Radiation & Oncology Journal of the European Society for Therapeutic Radiology and Oncology, 2004, pp. 81-85, Radiotherapy and Oncology 70 (2004), Elsevier Ireland Ltd.
U.S. Appl. No. 13/571,495, Office Action dated Feb. 1, 2013, 7 pgs.
U.S. Appl. No. 13/649,668, Office Action dated Mar. 13, 2013, 16 pgs.
Vicini, F. A., et al, “Dose-Volume Analysis for Quality Assurance of Interstitial Brachytherapy for Breast Cancer”, Int. J. Radiation Oncology Biol. Phys., vol. 45, 1999, pp. 803-810, Elsevier Science Inc.
Voung, T, et al., “High-Dose-Rate Endorectal Brachytherapy in the Treatment of Loacally Advanced Rectal Carcinoma: Technical Aspects”, Brachytherapy 4, 2005, pp. 230-235, Elsevier.
Walton, R. J., “Therapeutic Uses of Radioactive Isotopes in the Royal Cancer Hospital”, The British Journal of Radiology, 1950, pp. 559-599, William Heinemann, Publisher.
Walton, R. J., et al., Radioactive Solution (24Na and 82 Br) In the Treatment of Carcinoma of the Bladder:, British Medical Bulletin, 1952, pp. 158-165, Medical Dept., The British Council.
Wang, C. C., “Carcinoma of the Nasopharynx”, Radiation Therapy of Head and Neck Neoplasms, 1997, pp. 257-280, Chapter 10, Wiley-Liss, Inc.
Wheeler, F.W. et al. (2006), “Micro-Calcification Detection in Digital Tomosynthesis Mammography”, Proceedings of SPIE, Conf-Physics of Semiconductor Devices, Dec. 11, 2001 to Dec. 15, 2001, Delhi, SPIE, US, vol. 6144, Feb. 13, 2006, 12 pgs.
Wolf, C. D., et al., “A Unique Nasopharynx Brachytherapy Technique”, Official Journal of the American Association of Medical Dosimetrists, 1990, pp. 133-136, vol. 15, Issue No. 3., Pergamon Press.
Wu, Tao et al., “Tomographic mammography using a limited number of low-dose cone-beam images”, Medical Physics, AIP, Melville, NY, vol. 30, No. 3, Mar. 1, 2003, pp. 365-380.
Xu, Z., et al., “Calculation of Dose Distribution Near an Innovative Concentric Balloon Catheter for Endovascular Brachytherapy”, Cardiovascular Radiation Medicine 2, 2000, pp. 26-31, Elsevier Science Inc.
Yin, W., “Brachytherapy of Carcinoma of the Esophagus in China, 1970-1974 and 1982-1984”, Brachytherapy HOR and LOR, May 4-6, 1989, pp. 52-56.
Related Publications (1)
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20170080252 A1 Mar 2017 US
Provisional Applications (1)
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60819919 Jul 2006 US
Continuations (2)
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Parent 13299376 Nov 2011 US
Child 15236265 US
Parent 11593784 Nov 2006 US
Child 13299376 US
Continuation in Parts (1)
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Parent 11283236 Nov 2005 US
Child 11593784 US