WO2018190851A1 - Système amélioré de traitement par curiethérapie - Google Patents

Système amélioré de traitement par curiethérapie Download PDF

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Publication number
WO2018190851A1
WO2018190851A1 PCT/US2017/027478 US2017027478W WO2018190851A1 WO 2018190851 A1 WO2018190851 A1 WO 2018190851A1 US 2017027478 W US2017027478 W US 2017027478W WO 2018190851 A1 WO2018190851 A1 WO 2018190851A1
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WO
WIPO (PCT)
Prior art keywords
locating
recited
locating member
radiation source
distal
Prior art date
Application number
PCT/US2017/027478
Other languages
English (en)
Inventor
Scott D. COEN
Original Assignee
Coen Scott D
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Coen Scott D filed Critical Coen Scott D
Priority to PCT/US2017/027478 priority Critical patent/WO2018190851A1/fr
Publication of WO2018190851A1 publication Critical patent/WO2018190851A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1014—Intracavitary radiation therapy
    • A61N5/1016—Gynaecological radiation therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007—Arrangements or means for the introduction of sources into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048—Monitoring, verifying, controlling systems and methods
    • A61N5/1049—Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007—Arrangements or means for the introduction of sources into the body
    • A61N2005/1008—Apparatus for temporary insertion of sources, e.g. afterloaders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048—Monitoring, verifying, controlling systems and methods
    • A61N5/1049—Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam
    • A61N2005/1061—Monitoring, verifying, controlling systems and methods for verifying the position of the patient with respect to the radiation beam using an x-ray imaging system having a separate imaging source

Definitions

  • the present disclosure relates to improved brachytherapy treatment systems and methods for treating cancer, and more particularly, for treating cervical and/or uterine cancers.
  • Brachytherapy is a form of radiotherapy in which a radiation source is located proximal to a target tissue volume (e.g. a volume that encompasses a tumor) to deliver a desired dose of ionizing radiation thereto, while minimizing radiation delivery to healthy tissue outside of the target volume.
  • Brachytherapy may be utilized alone or in conjunction with external means of radiotherapy, chemotherapy and/or other forms of cancer treatment.
  • brachytherapy treatment has typically entailed the advancement of a radiation source from an afterloader in to a tandem of an applicator positioned in a patient, typically with a Smit Sleeve pre-positioned in and sutured to the patient's cervix.
  • the afterloader may be controlled to position the radiation source in one or more predetermined locations for predetermined time periods to deliver the desired radiation dose.
  • Known applicators for intracavitary applications include Fletcher-Suite type devices. Such applicators typically entail the separate positioning, assembly and interconnection of a tandem and multiple additional components at the brachytherapy treatment site, thereby entailing a time consuming set-up procedure, multiple medical personnel and attendant patient discomfort. Further, such devices typically entail the manual positioning of gauze packing or other packing material around the applicator assembly to engage vaginal tissue and thereby displace the bladder and/or rectum of a patient to minimize radiation delivery thereto. Such manual packing entails further time and patient discomfort, and often entails an iterative process to ensure that the applicator assembly remains positioned in a desired location for radiation dose delivery.
  • the positioning of such packing invariably deviates from treatment to treatment for a given patient, thereby presenting challenges to medical personnel in relation to achieving delivery of the desired radiation dose to the desired tissue volume on a repeatable basis, as prescribed in a given patient's multiple treatment plan.
  • the applicator assembly may be sutured in to position for the duration of multiple treatments over a period of several days, thereby entailing additional patient discomfort.
  • Embodiments of improved brachytherapy treatment systems and methods are disclosed herein that address the above-noted drawbacks of known devices, and that otherwise offer additional advantages.
  • a brachytherapy treatment system may comprise an access member having a proximal end and a distal portion extending away from the proximal end to define a guideway, wherein the distal portion of the access member is at least partially positionable within a body cavity of a patient (e.g. within the cervix).
  • the brachytherapy treatment system may further include a locating member adapted to locate a radiation source relative thereto (e.g. for radiation treatment of target a tissue volume), and having a distal portion for positioning in the guideway of the access member from the proximal end thereof.
  • the distal portions of the access member and the locating member may be adapted to advantageously establish a fixed relative position therebetween when the distal portion of the locating member is positioned in the guideway of the access member.
  • enhanced positioning of a radiation source relative to a target tissue volume may be realized.
  • the distal portions of the access member and the locating member may be provided with complimentary features for selective locking engagement and disengagement.
  • the brachytherapy treatment system may include an inflatable member (e.g. a first inflatable member) supportably interconnected to the distal portion of the locating member and inflatable to engage the distal portion of the access member to establish a fixed relative position therebetween.
  • the guideway of the access member may include an enlarged portion, located distally from the proximal end of the access member, for retainably receiving at least a portion of the inflatable member therein upon inflation of the inflatable member.
  • the inflatable member may encircle a segment of the distal portion of the locating member and the distal portion of the access member may be of a tubular configuration, wherein an annular enlarged portion of the distal portion of the access member may retainably receive a corresponding annular portion of the inflatable member upon inflation.
  • the distal portion of the locating member may be tubular.
  • the system may include an inflation lumen having a distal end fluidly interconnected to the inflatable member and extending proximally therefrom along and within the tubular distal portion of the locating member, thereby yielding compactness and ease-of- positioning advantages.
  • a proximal end of the inflation lumen may be fluidly interconnectable to and disconnectable from a fluid delivery device (e.g. a hand-held syringe) for selective and convenient inflation and deflation of the inflatable member.
  • the guideway of the access member and the distal portion of the locating member may comprise complimentary portions configured to require positioning of a locating member in a predetermined orientation relative to the access member for insertion thereof in the guideway of the access member. Further, the complimentary portions may be further configured to guide the distal portion of the locating member along a predetermined path upon insertion and advancement in the guideway of the access member. In turn, enhanced positioning of the locating member in a desired location may be realized, thereby facilitating desired positioning of a radiation source relative to the locating member for enhanced radiation dose delivery during a brachytherapy treatment procedure.
  • At least one of the complimentary members may be configured to limit advancement of the distal portion of the locating member in the guideway of the access member at a predetermined relative position (e.g. at a single predetermined relative position or within a predetermined range of relative positions), wherein when the locating member is located in the guideway of the access member at the predetermined relative position, the inflatable member is inflatable so that at least a portion thereof is received in an enlarged portion of the guideway.
  • a predetermined relative position e.g. at a single predetermined relative position or within a predetermined range of relative positions
  • the complimentary portions of the guideway of the access member and the distal portion of the locating member may include a projecting male member extending along at least a portion of the distal portion of one of the access member and locating member, and a complimentary female recess extending along at least a portion of the distal portion of the other one of the access member and locating member.
  • the distal portion of the locating member may include a spline to define the male member
  • the guideway of the distal portion of the access member may be tubular with a key way to define the complimentary female recess.
  • one or a plurality of imaging marker(s) may be interconnected to the access member and/or the locating member, wherein such imaging marker(s) are identifiable in image data generated by one or more imaging modality.
  • image data may be employed to confirm desired positioning of the access member and/or of the locating member and/or of the locating member relative to the access member.
  • at least one imaging marker(s) may be interconnected to each of the distal portions of the access member and locating member, wherein image data may be generated/reviewed after positioning of the distal portion of the access member in a patient cervix (e.g.
  • the positions and/or relative positions of the imaging markers may be identified and assessed in relation to predetermined acceptable or otherwise desired positions and relative positions of such imaging markers. If such positions and/or relative positions are not acceptable, the brachytherapy system facilitates ready repositioning of the access member and/or locating member.
  • the image data obtained in relation to a given radiation therapy treatment may be recorded in a brachytherapy treatment plan for the corresponding patient, wherein the positions and/or relative positions of the imaging markers in the recorded image data may be utilized in conjunction with one or more subsequent radiation therapy treatments of the patient.
  • the recorded positions and/or relative positions of the imaging markers may be utilized to replicate or as a basis to modify the positioning of the access member and/or locating member in a subsequent radiation treatment of the patient.
  • the brachytherapy treatment system may further include a collar member interconnected to and extending about and laterally away from the locating member at a proximal end of the distal portion thereof.
  • the collar member may be advantageously located for engagement with the proximal end of the access member when the distal portion of the locating member is advanced in the guideway of the access member, thereby yielding further enhanced positioning of the locating member in a desired location.
  • the collar member may be pivotable relative to the locating member to advantageously facilitate adapted positioning for engagement with the proximal end of the access member and thereby accommodate a range of different anatomical configurations (e.g. different vaginal canal cervix orientations).
  • the collar member may be pivotable about a first pivot axis that is fixed relative to and extends transverse to the locating member.
  • the collar member may be pivotable about the first pivot axis through an angular range of at least about 30°, and in some implementations at least about 60°.
  • at least a peripheral portion of the collar member may be elastically deformable, thereby advantageously facilitating advancement of the locating member during use of the device (e.g. advancement through an internal volume of a speculum positioned within a patient).
  • a tubular locating member (e.g. having a catheter-like configuration) may comprise a tubular distal portion, a tubular proximal portion, and a tubular intermediate portion interconnected therebetween.
  • the intermediate portion may include a proximal end portion adjoined to the proximal portion of the locating member, and a distal end portion adjoined to the distal portion of the locating member, wherein the proximal and distal end portions of the intermediate portion define an angle of between about 30° and 60° therebetween.
  • the intermediate portion may include an angled elbow member.
  • the distal and intermediate portions of the locating member may be of molded construction, wherein the distal portion may be at least semi-rigid.
  • the proximal portion of the locating member may be defined by a length of tubing that provides a degree of flexure along a length thereof, and that is stiff enough to be self-supporting (e.g. when the locating member is grasped by a user at the proximal end thereof) and/or to be advanceable into position during a brachytherapy procedure without kinking.
  • a stylet may be provided as part of and/or otherwise utilized with the brachytherapy treatment system during positioning of the locating member.
  • the stylet may comprise a slender, semi-rigid member initially inserted or otherwise provided for insertion in, and removable from, a proximal end of the tubular locating member, and having sufficient stiffness to prevent the proximal portion of the locating member from kinking during advancement and positioning of the locating member in conjunction with a brachytherapy treatment procedure.
  • the intermediate portion may be elastically deformable to advantageously allow the proximal and distal end portions thereof to pivot through an angular range of at least about 20°, and preferably at least about 30°, relative to one another about a second pivot axis that extends transverse to an adjoinment region of proximal and distal end portions.
  • first pivot axis of the collar member and the second pivot axis of the intermediate portion may be disposed substantially parallel one another.
  • the first pivot axis and second pivot axis may be disposed substantially normal to a longitudinal axis of the distal portion of the locating member.
  • the brachytherapy treatment system may further include a radiation source lumen having a distal end fixedly interconnected to the distal portion of the locating member and extending proximally within and/or proximally from the distal portion of the locating member.
  • the radiation lumen may guide a carrier member having a radiation source connected thereto during advancement and retraction of the carrier member within the radiation source lumen and distal portion of the locating member during a brachytherapy treatment procedure.
  • the brachytherapy treatment system may further comprise a collar member having one or more features described above, with a plurality of passageways extending across different corresponding portions of the collar member, wherein the plurality of passageways are provided to guide a carrier member having a radiation source interconnected thereto so as to locate the radiation source at different angular locations about and/or at different distances from a longitudinal axis of the distal portion of the locating member, thereby advantageously facilitating the delivery of a desired radiation dose to a predetermined target tissue volume (e.g. in accordance with a predetermined brachytherapy treatment plan for a given patient).
  • the plurality of passageways may be arranged in coincidental configurations (e.g. spiral and/or radially extending configurations), with at least a portion of each of the plurality of passageways extending radially inward from or radially outward from a longitudinal axis of the distal portion of the locating member.
  • the brachytherapy treatment system may further include a radiation source lumen having a distal end interconnected to the collar member at a first one of the plurality of passageways, and another radiation source lumen having a distal end interconnected to the collar member at a second one of the plurality of passageways, wherein each of such radiation source lumens include at least a corresponding portion that extends proximally along and within a tubular proximal portion of the locating member, thereby yielding compactness and ease-of-positioning advantages.
  • each of such radiation source lumens may be provided to guide a carrier member having a radiation source connected thereto during advancement and retraction of the carrier member within such radiation source lumen and along the corresponding interconnected passageway of the collar member to deliver a desired radiation dose to a predetermined, target tissue volume, e.g. in accordance with a predetermined brachytherapy treatment plan.
  • the brachytherapy treatment system may further include an inflatable member (e.g. a second inflatable member) supportably interconnected to the proximal portion of the locating member and inflatable to engage patient tissue (e.g. engagement with vaginal tissue of a patient to displace the rectum and/or bladder of the patient during a brachytherapy treatment procedure).
  • an inflatable member e.g. a second inflatable member
  • such inflatable member may also be disposed to advantageously engage a distal aspect of a collar member having one or more features described above, thereby facilitating enhanced stationary positioning of a pivotable collar member relative to and in engagement with the proximal end of the access member.
  • such inflatable member may encircle a segment of the distal portion of the locating member.
  • the brachy therapy treatment system may include an inflation lumen having a distal end fluidly interconnected to the inflatable member and extending proximally therefrom along and within at least a portion of the tubular proximal portion of the locating member, thereby yielding compactness and ease-of-positioning advantages, wherein a proximal end of such inflation lumen may be fluidly interconnected to a fluid delivery device (e.g. a hand-held syringe) for selective inflation and deflation of the inflatable member.
  • a fluid delivery device e.g. a hand-held syringe
  • the brachytherapy treatment system may include or otherwise be employed with an afterloader device comprising a programmable controller for providing control signals to a motor driven device for automated advancement and retraction of a carrier member having a radiation source supportably interconnected thereto (e.g. in accordance with a predetermined brachytherapy treatment plan for a given patient).
  • an afterloader device comprising a programmable controller for providing control signals to a motor driven device for automated advancement and retraction of a carrier member having a radiation source supportably interconnected thereto (e.g. in accordance with a predetermined brachytherapy treatment plan for a given patient).
  • proximal ends of radiation lumens described herein may be selectively interconnected to different ones of a plurality of ports presented by the afterloader.
  • the afterloader may be preprogrammed to sequentially advance/retract the carrier member and interconnected radiation source in to/out of different ones of the radiation lumens via different corresponding afterloader ports to deliver the desired radiation dose to the desired tissue volume (e.g. in accordance with a predetermined brachytherapy treatment plan for a given patient).
  • the carrier member and interconnected radiation source may be advanced in a first radiation lumen in to a distal portion of the locating member (e.g. within the distal portion of the access member), then retracted therefrom to deliver a desired radiation dose.
  • the carrier member and interconnected radiation source may be sequentially advanced in to and retracted from at least second and third radiation lumens, and along corresponding, interconnected passageways of a collar member, as described herein, to deliver a desired radiation dose.
  • a method for use in brachytherapy treatment may comprise the steps of locating a distal portion of an access member at least partially within a patient body cavity, and positioning a distal end of a locating member in a guideway defined by the distal portion of the access member, wherein the locating member is adapted to locate a radiation source relative thereto (e.g. for radiation treatment of a target tissue volume).
  • the method may further include the step of establishing, after the locating and positioning steps, a fixed relative position between the distal portions of the access member and locating member, as described herein.
  • at least one imaging marker may be interconnected to at least one of the access member and the locating member.
  • the method may further include the step of generating image data, after the locating, positioning and establishing steps, wherein the imaging markers are identifiable in the image data. Further, the method may include the step of employing the image data, after the generating step, to confirm desired positioning of at least one of the access member and the locating member.
  • the establishing step may include first inflating a first inflatable member supportably interconnected to the distal portion of the locating member so as to engage the distal portion of the access member to establish the fixed relative position therebetween.
  • the inflating may include flowing a fluid into a proximal end of a first inflation lumen having a distal end fluidly interconnected to the inflatable member to inflate the first inflatable member and thereby establish the fixed relative position.
  • a hand-held syringe may be employed to flow fluid in to the first inflation lumen to the first inflatable member.
  • the method may further include the recording of a first volume of the fluid flowed in to the proximal end of the first inflation lumen during the flowing (e.g. via observation/notation of starting/ending fluid volumes in a hand-held syringe as indicated by gradations thereof).
  • the method may include utilizing the recorded first volume in a brachytherapy treatment plan for the patient.
  • the recorded first volume may be replicated or used as a basis for determination of an adjusted volume of fluid to be delivered to the first inflatable member in a subsequent brachytherapy treatment of the given patient.
  • positioning of the locating member relative to the access member may include contacting a proximal end of the access member with a collar member that is interconnected to and extends about and laterally away from the locating member, as described herein.
  • contacting may entail pivoting the collar member relative to the locating member.
  • the contacting may further and/or alternately include the pivoting of the distal portion of the locating member relative to a proximal portion of the locating member.
  • the locating member may include an elastically deformable intermediate portion interconnected between the distal portion and proximal portion of the locating member, wherein the intermediate portion may flex during placement of the locating member in a brachytherapy treatment procedure, as described herein.
  • the method may further include inflating a second inflatable member, supportably interconnected to the proximal portion of the locating member, to engage a proximal aspect of the collar member.
  • the second inflatable member may contact and thereby displace patient tissue in a predetermined manner, as otherwise described herein.
  • the second inflating may include flowing a fluid into a proximal end of a second inflation lumen having a distal end fluidly interconnected to the second inflatable member to inflate the second inflatable member.
  • a hand-held syringe may be employed to flow fluid in to and through the second inflation lumen to the second inflatable member.
  • the second inflating may include the recording of a second volume of fluid flowed in the proximal end of the second inflation lumen during the flowing step (e.g. via observation/notation of starting/ending fluid volumes in a hand-held syringe as indicated by gradations thereof), and utilizing the recorded second volume in a brachytherapy treatment plan for a given patient.
  • the recorded second volume may be replicated or used as a basis for determination of an adjusted volume of fluid to be delivered to the second inflatable member in a subsequent brachytherapy treatment of the given patient.
  • the method may include advancing a carrier member and interconnected radiation source along and retracting the carrier member and interconnected radiation source from a preselected one or more of a plurality of passageways extending across different corresponding portions of the collar member, wherein the plurality of passageways are provided to guide a carrier member and interconnected radiation source so as to locate the radiation source at different angular locations about and/or at different distances from a longitudinal axis of the distal portion of the locating member.
  • Such advancing/retracting may further include advancing the carrier member and interconnected radiation source along and retracting the carrier member and interconnected radiation source from the distal portion of the locating member, as described herein.
  • Fig. 1 illustrates an embodiment of a brachytherapy treatment system, including embodiments of a locating member and an access member thereof.
  • Fig. 2 illustrates the brachytherapy treatment system embodiment of Fig. 1, with a distal portion of the access member located within the cervix of a patient and a distal portion of the locating member positioned for advancement into a guideway defined by the access member.
  • Fig. 3 illustrates the brachytherapy treatment system embodiment of Fig. 1, including a cross-sectional view of the distal portion of the access member located within the cervix of a patient, and the distal portion of the locating member positioned in fixed relation thereto via inflation of an inflatable member.
  • Fig. 4 illustrates the brachytherapy treatment system embodiment of Fig. 1, with a pivotable collar member thereof located in engagement with a proximal end of the access member.
  • Fig. 5 illustrates the brachytherapy treatment system embodiment of Fig. 1, with the distal portions of the locating member and access member in the fixed relative position shown in Fig. 3 and with another inflatable member inflated to engage vaginal tissue of a patient and a proximal aspect of the proximal end of the access member.
  • Fig. 1 illustrates an embodiment of a brachytherapy treatment system 1 adapted for cervical applications.
  • the brachytherapy treatment system 1 may include an access member 100 having a distal portion 110 extending distally away from a proximal end 120 to define a guideway 130, and at least partially positionable within the cervix of a patient.
  • the guideway 130 extends distally at an aperture of the proximal end 120 into a tubular volume of the distal portion 110 of the access member 100.
  • the brachytherapy treatment system 1 may further comprise a locating member 10 adapted to locate a radiation source relative thereto, and having a distal portion 12 for positioning within the guideway 130 of the access member 100.
  • the brachytherapy treatment system 1 may comprise a first inflatable member 20 (shown in deflated state) supportably interconnected to and encircling a segment of the distal portion 12 of the locating member 10, wherein after positioning of the distal portion 12 of the locating member 10 in the guideway 130 of the access member 100, the first inflatable member 20 may be selectively inflated to engage an internal surface of the distal portion 110 of the access member 100 to establish a fixed relative position therebetween.
  • fixed relative positioning of the distal portion 12 of the locating member 10 and the distal portion 1 10 of the access member 100 may be provided utilizing one or more spring-loaded member(s) at the distal portion 12 or distal portion 110 and/or utilizing complimentary advance and rotate-to-lock surfaces at the distal portion 12 or distal portion 110.
  • the locating member 10 may be of a tubular construction and may comprise the distal portion 12, a proximal portion 16 and an intermediate portion 14 interconnected therebetween. As shown, the intermediate portion 14 may include an angled elbow member as will be further described.
  • the provision of a tubular locating member 10 allows for the positioning of various additional components therewithin so as to facilitate handling and compactness of the brachytherapy treatment system 1.
  • the system 1 may include a first inflation lumen 22 having a distal end fluidly interconnected to the first inflatable member 20 and extending proximally therefrom, along and within the distal portion 12, the intermediate portion member 14 and the proximal portion 16 of the locating member 10, wherein a proximal end of the first inflation lumen 22 may extend out of a first port 18a of a hub 18 provided at a proximal end of locating member 10.
  • the proximal end of the first inflation member 22 may be fluidly interconnectable with a fluid delivery device, e.g. a hand-held syringe S I for selective manual inflation and deflation of the first inflatable member 20 with a liquid (e.g. a sterile solution).
  • a proximal end of the first inflation lumen 22 may be provided with a lure connector 24 for ready interconnection to and disconnection from a lure tip provided on the hand-held syringe S I .
  • a flow control member 26 e.g. a stop-cock valve
  • first flow control member 26 may be provided along a length of tubing fluidly interconnected or interconnectable at opposing ends to lure connector 24 and hand-held syringe S I .
  • the first flow control member 26 may be manipulated from an open position to a closed position so as to maintain the inflated state of the first inflation lumen 22, free from continued handling of the hand-held syringe S I by a user.
  • the brachytherapy treatment system 1 may further include a collar member 50 interconnected to and extending about and laterally away from the locating member 10 at a proximal end of the distal portion 12 thereof.
  • the collar member 50 may be provided for contact engagement with the proximal end 120 of the access member 100 during positioning of the locating member 10, thereby facilitating the positioning of the distal portion 12 of the locating member 10 at a desired location relative to the distal portion 110 of the access member 100, and stabilizing the interface between the locating member 10 and access member 100.
  • the collar member 50 may be pivotable relative to the locating member 10, thereby yielding enhanced anatomical adaptability, i.e. by allowing the collar member 50 to pivot in to an optimal position for face-to-face engagement with the proximal end 120 of access member 100.
  • the collar member 50 may be pivotable about a first axis AA extending transverse to the locating member 10.
  • the collar member may be pivotably interconnected to a hub 54 that is fixedly interconnected to the locating member 10 at a distal end of the distal portion 12 thereof.
  • the collar member 50 may be pivotably interconnected to the hub 54 via one or a plurality of elastically deformable yolk-like members interconnected therebetween (not shown).
  • the collar member 50 may be pivotably interconnected to a pair of pin projections that extend away from opposite sides of the hub 54 along first axis AA and are received in apertures of the collar member 50.
  • at least a peripheral portion of the collar member 50 may be elastically deformable to facilitate positioning of the locating member 10, as will be further described.
  • collar member 50 has an annular, ring-shaped configuration. In other embodiments, collar member 50 may have a non-symmetric configuration.
  • the brachytherapy treatment system 1 may also include a second inflatable member 30 (shown in deflated state) supportably interconnected to and encircling a segment of the proximal portion 16 of the locating member 10.
  • the second inflatable member 30 may be selectively inflated to engage patient tissue (e.g. vaginal tissue of a patient) to displace the rectum and/or bladder of the patient to reduce radiation delivery thereto during treatment, and/or to retain the locating member 10 in a desired position relative to the patient tissue, and/or to supportably engage a proximal aspect of the collar member 50.
  • the brachytherapy treatment system 1 may include a second inflation lumen 32 having a distal end fluidly interconnected to the second inflatable member 30 and extending proximally therefrom, along and within the tubular proximal portion of the locating member 10, wherein a proximal end of the second inflation lumen 32 may extend out of the first port 18a of the hub 18.
  • the proximal end of the second inflation lumen 32 may be fluidly interconnectable with a fluid delivery device, e.g. a hand-held syringe S2, for selective inflation and deflation of the second inflatable member 30 with a liquid (e.g. a sterile solution).
  • a proximal end of the second inflation lumen 32 may be provided with a second lure connector 34 for ready interconnection to and disconnection from a lure tip provided on the hand-held syringe S2.
  • a second flow control member 36 e.g. a stop-cock valve
  • second flow control member 36 may be provided along a proximal end portion of the second inflation lumen 32 to provide for the selective passage or blockage of fluid through the second inflation lumen 32.
  • second flow control member 36 may be provided along a length of tubing fluidly interconnected or interconnectable at opposing ends to lure connector 34 and hand-held syringe S2.
  • the second flow control member 36 may be manipulated from an open position to a closed positioned so as to maintain the inflated state of the second inflatable member 30, free from continued handling of the second hand-held syringe S2 by a user.
  • second flow control member 36 may be readily moved from a closed position to an open position and the second hand-held syringe S2 may be manipulated to withdraw fluid from the second inflatable member 30 through the second inflation lumen 32, wherein second inflatable member 30 may be deflated.
  • the locating member 10 may be adapted to locate a radiation source relative thereto during a brachytherapy treatment procedure.
  • the brachytherapy treatment system 1 may include a plurality of radiation source lumens 40, 42 and 44 that extend into the proximal portion 16 of the locating member 10 through a second port 18b of the hub 18 at the proximal end of the locating member 10.
  • the second port 18b of hub 18 may be aligned with a longitudinal axis of the proximal portion 16 of the locating member 10.
  • the proximal end of each of the plurality of radiation lumens 40, 42 and 44 may be utilized to receive a carrier member CM having a radiation source RS interconnected thereto (e.g.
  • each of the plurality of radiation lumens 40, 42 and 44 may guide the carrier member CM when advanced/retracted therein so as to locate the radiation source RS at desired locations for the delivery of radiation therapy.
  • the proximal ends of the plurality of radiation lumens 40, 42 and 44 may be interconnected to different ones of a plurality of ports 202 provided by an afterloader device 200.
  • the afterloader device 200 may be adapted for automated advancement and retraction of a carrier member CM through one or more predetermined ports 202, and the corresponding interconnected radiation lumen(s) 40, 42 and/or 44, for positioning of the radiation source RS at predetermined locations along the interconnected radiation lumens 40, 42 and/or 44.
  • the afterloader device 200 may comprise a programmable controller for providing control signals (e.g. a computer processor configurable by one or more software modules comprising executable instructions stored in non-transitory memory), and a motor-driven device responsive to the control signals for automated advancement/retraction of the carrier member CM.
  • the programmable controller may be configured to provide control signals in accordance with a patient radiation treatment plan selectively established by a user (e.g. established at a user interface for a given patient and stored in a computer-readable medium accessible by the programmable controller).
  • a user e.g. established at a user interface for a given patient and stored in a computer-readable medium accessible by the programmable controller.
  • the afterloader device 200 may be provided to sequentially advance and retract the carrier member CM in radiation lumens 40, 42 and/or 44 to locate radiation source RS at predetermined locations for predetermined dwell times for the delivery of a desired radiation dose to a targeted tissue volume(s) of a patient.
  • radiation lumen 40 may extend distally from the proximal end of the locating member 10 via second port 18b of the hub 18 through the proximal portion 16, intermediate portion 14 and distal portion 12 of the tubular locating member 10, wherein a distal end of the radiation lumen 40 may be fixedly interconnected within the distal portion 12 of the locating member 10.
  • the carrier member CM may be advanced through the radiation lumen 40 and in to the distal portion 12 of the locating member 10, then retracted therefrom, so as to deliver a predetermined radiation dose to a patient from the interconnected radiation source RS, e.g. according to the predetermined patient treatment plan as described above.
  • radiation lumen 42 and radiation lumen 44 may extend distally from the proximal end of the locating member 10 via the second port 18b of the hub 18 through at least a portion of the proximal portion 16 of the locating member 10 to corresponding exit locations proximal to the intermediate portion 14 of the locating member 10.
  • distal ends of the radiation lumens 42 and 44 may be interconnected to different ones of passageways 52a, 52b defined by the collar member 50.
  • passageways 52a, 52b may be disposed to extend across different corresponding portions of the collar member 50, wherein the passageways 52a, 52b are provided to guide the carrier member CM so as to locate the radiation source RS interconnected thereto at different angular locations about and/or at different distances from a longitudinal axis BB of the distal portion 12 of the locating member 10 to deliver a predetermined radiation dose to a patient, e.g. according to a predetermined patient treatment plan as described above.
  • the passageways 52a, 52b may be arranged in coincidental configurations, with at least a portion of each of the plurality of passageways extending radially inward or outward (e.g. toward or away from a longitudinal axis BB of the distal portion of the locating member 10).
  • all or portions of each of the passageways 52a, 52b may spiral about a longitudinal axis BB of the distal portion 12 of the locating member 10 or may otherwise be arranged in a spoke-like pattern about a longitudinal axis BB of the distal portion 12 of the locating member 10.
  • Fig. 2 illustrates further features of the brachytherapy treatment system 1 in relation to an embodiment of a brachytherapy treatment method.
  • the access member 100 may be positioned relative to the cervix C of a patient, with the distal portion 110 thereof extending into the cervix C.
  • the proximal end 120 of the access member 100 may be fixedly engaged with the cervix C and fixedly interconnected, or anchored, to the cervix C, e.g. a plurality of sutures SS at different ones of a plurality of suture ports 122 provided at the proximal end 120 of the access member 100.
  • the guideway 130 of the access member 100 and the distal portion 12 of the locating member 10 may comprise complimentary portions configured to require positioning of the locating member 10 in a desired, predetermined orientation relative to the access member 100 for insertion of the distal portion 12 in the guideway 130 of the access member 100. More particularly, such complimentary portions may include a projecting male member 12b in the form of a spline extending along a portion of a length of the distal portion 12 of the locating member 10, and a complimentary female recess 132 in the form of a key way extending along a portion of the access member 100 from the proximal end 120 thereof.
  • the male member 12b and female recess 132 may be configured to guide the distal portion 12 of the locating member 10 along a predetermined path (e.g. a line or path) upon insertion and advancement in the guideway 130 of the access member 100.
  • a predetermined path e.g. a line or path
  • a speculum 300 may be inserted into the vagina of a patient and thereby externally engage vaginal tissue VT to define an access volume therewithin.
  • the intermediate portion 14 of the locating member 10 and/or the collar member 50 may be provided to facilitate insertion and advancement of the locating member 10 within the speculum 300.
  • at least a peripheral portion of the collar member 50 may be elastically deformable to facilitate deformation (e.g.
  • the intermediate portion 14 of the locating member 10 may be elastically deformable to facilitate a degree of relative movement between a distal end of the distal portion 12 and a proximal end of the proximal portion 16 of the locating member 10.
  • distal and proximal portions of the intermediate portion 14 may be pivotable through an angular range of at least about 20° relative to one another, and in some embodiments, at least about 30° relative to one another.
  • collar member 50 may include an aperture 56 (e.g. extending about at least a portion of hub 54), thereby providing a porthole for visual viewing of the distal portion 12 of locating member 10 during advancement of the distal portion 12 within speculum S and in to and along guideway 130 of access member 100.
  • the collar member 50 may have a scalloped, peripheral portion, thereby providing a porthole for visual viewing of the distal portion 12.
  • one or more imaging marker(s) 60 may be interconnected to the distal portion 1 10 of the access member 100, and one or more imaging marker(s) 62 may be interconnected to the distal portion 12 of the locating member 10.
  • imaging markers 60, 62 may be identifiable in image data generated by at least one imaging modality, wherein such image data may be employable to confirm desired positioning of the access member 100 and/or desired positioning of locating member 10.
  • the imaging markers 60, 62 may be disposed on distal portions 110 and 12, wherein when the distal portions 1 10 and 12 are located in desired, predetermined relative positions, the imaging markers 60, 62 will be located in correspondingly desired, predetermined relative positions that are identifiable in the image data (e.g.
  • the imaging markers 60, 62 may be radio opaque markers that may be readily identifiable in x-ray image data generated via x-ray imaging during positioning of the distal portion 12 of the locating member 10 relative to the access member 100.
  • FIG. 3 which illustrates advanced positioning of the locating member 10 at a desired location relative to access member 100 within a patient, with a distal aspect of the collar member 50 engaged with at least a portion of a proximal aspect of the proximal end 120 of the access member 100, and with the speculum 300 shown in Fig. 2 removed from the patient.
  • the distal aspect of the collar member 50 may be optionally provided with a recess configured to receive and thereby locate at least a portion of the proximal end 120 of access member 100 therewithin.
  • the first inflatable member 20 has been inflated via the delivery of fluid from hand-held syringe S I through first lure connector 24, first flow control member 26 and first inflation lumen 22 to the first inflatable member 20 so as to establish a fixed relative position between the distal portion 12 of the locating member 10 and the distal portion 1 10 of the access member 100.
  • the first flow control member 26 may be selectively closed, as shown in Fig. 3.
  • the access member 100 and/or locating member 10 may be provided with one or more locking features.
  • the guideway 130 of the distal portion 110 of the access member 100 may be tubular and may include an enlarged portion 134 for receiving at least a portion of the first inflatable member 20 upon inflation thereof.
  • a distal end portion of the guideway 130 may be stepped out from a first diameter to a greater second diameter for receipt of a portion of the inflatable member 20 therein.
  • enlarged portion 134 provides for abutting engagement with a portion of the first inflatable member 20 upon inflation, thereby enhancing the fixed interconnection therebetween.
  • the female recess 132 may be configured to limit advancement of the distal portion 12 of the locating member 10. That is, the female recess 132 may extend distally for a predetermined length from the proximal end 120, wherein an inwardly -proj ecting stop surface 136 is located for abutment with a distal end of the male member 12b provided on the distal portion 12 of locating member 10.
  • a distal aspect of the collar member 50 is shown in face- to-face engagement with a proximal aspect of the proximal end 120 of the access member 100, thereby yielding enhanced stabilization at the interface after inflation of the first inflatable member 20 to establish fixed relative positioning of the distal portions 12 and 110.
  • the collar member 50 may pivotable relative to the locating member 10 to facilitate the noted engagement with the proximal end 120 of the access member 100, while accommodating a range of anatomical configurations.
  • the collar member 50 is shown with the distal aspect thereof in face-to-face engagement with the proximal aspect of the proximal end 120 of the access member 100, and oriented substantially parallel to a cervical face plane represented by CP.
  • the collar member 50 may accommodate an angular range of differing cervical face plane CP orientations presented by patients having different anatomical configurations.
  • the collar member 50 may be pivotable through an angular range R, wherein R > 30°, and in some arrangements R > 60°.
  • Fig. 5 illustrates the brachytherapy treatment system 1 fully deployed and ready for the administration of a brachytherapy treatment to a patient.
  • the access member 100 is anchored in a desired position relative to the cervix C of a patient with the distal portion 1 10 thereof extending into the cervix C.
  • a distal aspect of the collar member 50 is shown in an engaged position with a proximal aspect of the proximal end 120 of the access member 100.
  • the distal aspect of the collar member 50 may be continuously engaged with the proximal aspect of proximal end 120 of the access member 100 about the longitudinal axis BB of the aligned distal portion 12 of the locating member 10 and distal portion 110 of the access member 100.
  • the first inflatable member 20 has been inflated to establish fixed positioning between the distal portion 12 of the locating member 10 and the distal portion 1 10 of access member 100, as described above in relation to Fig. 3.
  • hand-held syringe S I may be fluidly interconnected to the first lure connector 24 with fluid therefrom maintained within the first inflatable member 28 via closure of the first flow control member 26.
  • the second inflatable member 30 has been inflated from a deflated state to an inflated state to engage with the vaginal tissue VT of a patient to displace the rectum and/or bladder of the patient, to fixedly locate the intermediate portion 14 and at least a distal section of the proximal portion 16 of the locating member 10 relative to the patient, and to engage with a proximal aspect of the collar member 50, and thereby supportably locate the collar member 50 relative to the locating member 10, access member 100 and the patient.
  • the second hand-held syringe S2 has been interconnected to the second lure connector 34, with fluid therefrom having been delivered through the second lure connector 34 to the second inflatable member 30. Further, the second flow control member 36 has been closed to maintain inflation of the second inflatable member 30.
  • radiation treatment of the cervix C of the patient may be carried out in accordance with a predetermined patient treatment plan, as described above.
  • the carrier member CM with radiation source RS interconnected thereto may be sequentially advanced in to and retracted out of radiation lumens 40, 42 and/or 44 in a predetermined manner so as to deliver the desired dose of radiation from the radiation source RS at different predetermined locations and for corresponding, predetermined dwell times.
  • the second inflatable member 30 may be readily deflated via the opening of the second flow control member 36 and withdrawal of fluid from the second inflatable member 30 via manipulation of the second hand-held syringe S2 (e.g. via retraction of a plunger of the second syringe S2).
  • the first inflatable member 20 may be readily deflated via the opening of the first flow control member 26 and withdrawal of fluid from the first inflatable member 20 via manipulation of the first hand-held syringe SI (e.g. via retraction of a plunger of the first syringe SI).
  • the locating member 10 and various additional components interconnected thereto and supportably located therewithin may be readily withdrawn from the patient.
  • the access member 100 may be left in an initial anchored location relative to the cervix C, as described above in relation to Figs. 2-5.
  • the locating member 10 may be positioned relative to the access member 100, inflatable members 20 and 30 may be inflated, and carrier member CM and radiation source RS may be advanced/retracted in radiation lumens 40, 42 and/or 44 to administer radiation treatment, as described above.
  • a user may record the volumes of liquid utilized to inflate the inflatable members 20 and 30, and include such recorded volumes in the corresponding patient treatment plan.
  • a brachytherapy treatment system may include an access member 100, as described above, and a modified locating member having a distal portion 12 for positioning within and removal from the guideway 130 of the access member 100.
  • the distal portion 12 of the modified locating member may be configured to support and thereby locate a radiation source (e.g. a low-dose radiation source contained in a capsule) in a stationary position relative to the distal portion 12.
  • the system may further include a first inflatable member 20, as described above, and a corresponding inflation lumen to establish a fixed relative position between the access member and distal portion 12 of the modified locating member, as described above.
  • the modified locating member 40 and inflation lumen may be provided to proximally project a relatively small distance from the proximal end 120 of access member 100 during use, thereby facilitating in-situ positioning of the system over an extended time period.

Abstract

La présente invention concerne un système amélioré de traitement par curiethérapie comprenant un élément d'accès ayant une extrémité proximale et une partie distale s'étendant de manière distale à partir dudit élément d'accès pour définir une voie de guidage, la partie distale pouvant être positionnée à l'intérieur d'un patient, et un élément de positionnement conçu pour positionner une source de rayonnement par rapport à ce dernier et ayant une partie distale pouvant être positionnée dans la voie de guidage de l'élément d'accès depuis son extrémité proximale. Les parties distales de l'élément d'accès et de l'élément de positionnement peuvent être conçues pour établir une position relative fixe entre elles, par exemple par gonflage d'un élément gonflable interconnecté à la partie distale de l'élément de positionnement. L'élément d'accès et l'élément de positionnement peuvent comprendre des parties complémentaires conçues pour nécessiter le positionnement de l'élément de positionnement dans une orientation prédéterminée par rapport à l'élément d'accès pour une insertion dans la voie de guidage. Le système peut en outre comprendre un élément de collier pivotant interconnecté à l'élément de positionnement et s'étendant autour et latéralement à partir de ce dernier.
PCT/US2017/027478 2017-04-13 2017-04-13 Système amélioré de traitement par curiethérapie WO2018190851A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005120201A2 (fr) * 2004-06-07 2005-12-22 Henry Ford Health System Systeme de brachytherapie a rayons x modules par intensite et guides par image
US20070167664A1 (en) * 2005-10-31 2007-07-19 Hermann George D Brachytherapy apparatus and methods of using same
US20080221384A1 (en) * 2006-06-02 2008-09-11 Cianna Medical, Inc. Expandable brachytherapy apparatus and methods for using them
US20100048977A1 (en) * 2008-08-18 2010-02-25 Cianna Medical, Inc. Brachytherapy apparatus, systems, and methods for using them
CN201921324U (zh) * 2010-12-02 2011-08-10 西藏昌都惠恒发展有限公司 一种近距离治疗装置和系统

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005120201A2 (fr) * 2004-06-07 2005-12-22 Henry Ford Health System Systeme de brachytherapie a rayons x modules par intensite et guides par image
US20070167664A1 (en) * 2005-10-31 2007-07-19 Hermann George D Brachytherapy apparatus and methods of using same
US20080221384A1 (en) * 2006-06-02 2008-09-11 Cianna Medical, Inc. Expandable brachytherapy apparatus and methods for using them
US20100048977A1 (en) * 2008-08-18 2010-02-25 Cianna Medical, Inc. Brachytherapy apparatus, systems, and methods for using them
CN201921324U (zh) * 2010-12-02 2011-08-10 西藏昌都惠恒发展有限公司 一种近距离治疗装置和系统

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