CA2166915C - Intracavitary catheter for use in therapeutic radiation procedures - Google Patents
Intracavitary catheter for use in therapeutic radiation procedures Download PDFInfo
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- CA2166915C CA2166915C CA002166915A CA2166915A CA2166915C CA 2166915 C CA2166915 C CA 2166915C CA 002166915 A CA002166915 A CA 002166915A CA 2166915 A CA2166915 A CA 2166915A CA 2166915 C CA2166915 C CA 2166915C
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- balloon
- catheter
- primary
- body cavity
- primary balloon
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Classifications
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22068—Centering
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1047—Balloon catheters with special features or adapted for special applications having centering means, e.g. balloons having an appropriate shape
-
- 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
- A61N5/1002—Intraluminal radiation therapy
- A61N2005/1003—Intraluminal radiation therapy having means for centering a radioactive source within the lumen, e.g. balloons
-
- 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
- A61N2005/1012—Templates or grids for guiding the introduction of sources
-
- 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
- A61N2005/1018—Intracavitary radiation therapy with multiple channels for guiding radioactive sources
-
- 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
Abstract
The present invention is for radiation diagnosis and/or therapy in or near body cavities accessible through existing orifices. At least one balloon of a catheter and balloon assembly is inflated by fluid communication through the catheter. Several embodiments provide for diagnostic procedures or radiation therapy, at times in association with one or more of formation of seals, control of movement, nutrient passage and drainage. When radiation therapy is provided, rods or other radiotherapeutic items are secured, positioned or inserted along the contour of the surface of the balloon and are thus deployed to treatment position by balloon inflation.
Description
21669i~
PATENT
Case 800P002 INTRACAVITARY CAln~ K
FOR USE IN RADIATION PROCEDURES
Description Backqround of the Invention The present invention generally relates to diagnostic or therapeutic procedures and devices used during radiation diagnosis or therapy. This device generally consists of a catheter with a balloon positioned along at least a portion of its length. In some embodiments, radiotherapeutic members, tubes or elongated rods for containing radioactive material are engaged by and move with the balloon when it is expanded. These rods or the like may be inserted in elongated pockets of the balloon; they may also be secured to the balloon with loops attached to the inner or outer surfaces of the balloon, or they may be secured to a balloon surface with adhesive strips. The catheter and balloon assembly is intended to be inserted into living body cavities through existing body orifices. Once the catheter and its balloon are inserted in the prescribed manner into the body cavity, the balloon is inflated to mark the boundary of the body cavity during radiographic examination or to move and hold the radioactive material into desired radiation treatment position within the body cavity during radiation therapy. The inflated therapeutic balloon also may be used to move, push, reposition, hold or otherwise manipulate body tissue during the radiation diagnosis or therapy.
This invention is intended to have a plurality of functions. It may be used to identify the boundary of a body cavity or otherwise provide reference to assist the physician in identifying the appropriate treatment area.
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It may also be used to manipulate a body cavity to assist the physician in identifying the appropriate treatment area or to push tissues out of the treatment area. The invention permits the introduction of air or of various s diagnostic fluids free from risk that toxins or other contaminants could contact the patient. Also, the invention can be used in a variety of body cavities.
When the radiotherapeutic members are incorporated, this invention provides the physician with a new technique to treat cancers within the body. This invention is most useful to treat cancers inside or in the proximity of body cavities including the bladder, vagina, rectum, subglottic region, stomach, bronchial tubes, nasopharynx region, and the like. This invention permits radiation treatment within the human body without requiring interstitial insertion of radiotherapeutic rods or the like. Prior to this invention, application of radiotherapeutic rods typically required insertion of the rods through tissue. This invention provides an intracavitary alternative for radiating internal body tissues. Patient trauma and risk from infection, and other similar types of potential hazards of interstitial procedures are substantially reduced. Typically, this invention can lessen the training time and/or experience level required to perform internal radiation therapy where an interstitial procedure might ordinarily be employed in view of the elimination of more intensive procedures related to an interstitial insertion of the radiotherapeutic rods.
It is a general object of this invention to provide a significantly improved tool and procedure for diagnosis or radiation therapy in or near body cavities accessible through existing orifices.
Another object of this invention is to provide an improved apparatus and method to provide the physician with a view of the body cavity during radiographic viewing, such as X-ray radiography.
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Another object of this invention is to enable the physician to move, push or otherwise manipulate body tissue for the purpose of improved diagnoses or therapy.
Another object of this invention is to enable introduction of radiographic fluids or air into the body cavity of the patient without subjecting the patient to risk from those radiographic fluids.
Another object of the invention is to provide intracavitary radiation therapy at or nearer diseased tissues than possible with external radiation therapy.
Another object of the invention is to provide radiation therapy at or nearer diseased tissues without invasive or interstitial procedures and whether at a high dose rate during short treatment times of from 15 minutes to a few hours and up to 24 hours or at a low dose rate during longer treatment times of up to about 3 days or more.
Another object of the invention is to facilitate long-term, low dose rate radiation by enabling introduction of nutrients or air or evacuation of wastes through a therapeutic treatment device itself.
Another object of the invention is to utilize existing body cavities for radiation therapy in an intracavitary manner.
Another object of this invention is to provide a device and method suitable for use in the bladder by providing an elongated insertion catheter having drainage characteristics.
Another object of this invention is to provide an improved apparatus and method which allows the provision of radiopaque reference lines at desired locations within a variety of body cavities.
Another object of this invention is to permit the physician to tailor the size of a radiation treatment device to the particular diagnostic or therapeutic requirements of the body cavity being treated.
Another object of this invention is to maintain the position of a diagnostic or therapeutic device through the use of a smaller, secondary balloon located within a larger, therapeutic balloon.
Another object of this invention is to provide a device and method suitable for use in the rectum by providing a large diameter catheter having drainage characteristics.
Another object of this invention is to provide a device and method suitable for use in the vagina or rectum by providing a template which provides securement.
Another object of this invention is to provide a device and method suitable for use in the stomach by providing a catheter having inflow and outflow characteristics.
Another object of this invention is to provide a device and method suitable for use in the subglottic region by providing a catheter having inflow and outflow characteristics.
Another object of this invention is to provide a device and method suitable for use in the nasopharynx region by providing a catheter having inhalation and exhalation characteristics.
Another object of the invention is to provide a device and method that provide for inflow of nutrients and outflow of wastes to enable long-duration treatments.
These and other objects and advantages of the present invention will be apparent from the following description.
Summary of the Invention This invention utilizes a catheter for insertion into a body cavity. A large or primary balloon is secured to a tubular catheter body, the balloon being positioned and sized for insertion into a particular type of body cavity. The proximal end of the catheter has one or a plurality of passageways to enable fluid communication 216691~
through various channels in the catheter body, depending upon the embodiment. The passageways preferably utilize one- or two-way valves, regulators, hypodermic syringes, or the like for introduction, control, and/or withdrawal of fluids into and out of one or more balloons and/or body cavities.
The fluid with which the balloon may be filled can be a biocompatible gas, such as air, or a biocompatible liquid, such as saline solution. The balloon(s) of the catheter device may also be used to move, expand, or otherwise manipulate the body cavity by balloon inflation in order to provide more effective radiation diagnosis or treatment.
Radiation treatment members which can take the form of rods or tubes are associated with the balloon so as to be properly positioned by the balloon to effect the intracavitary treatment, typically by moving treatment rods toward and/or in contact with the walls of the body cavity. For example, the balloon can contain rod receiving members which are used to hold the radiation treatment rods. The rod receiving members may be elongated pockets within the balloon material or strips of elastomeric or adhesive material along the circumference of the balloon and into which the treatment rods are inserted. Typical treatment rods contain small radioactive pellets which irradiate diseased tissue. The size, dose rate and spacing of these pellets is prescribed by the physician and assembled prior to and/or during the procedure in which the catheter device is ready for insertion through the body cavity orifice and into the body cavity.
Different embodiments of this invention can utilize one or more different approaches to secure the catheter device during radiation diagnosis or therapy.
These include a secondary inner balloon, a secondary distal balloon, one or two secondary outer balloons and asæociated tether catheters, a template, and a catheter lead.
When provided, the secondary inner balloon which usually is substantially smaller than the large or primary balloon assists in holding the catheter device in place within the body cavity at the orifice and typically is located generally within and at the proximal end of the larger balloon. Upon inflation, the secondary balloon secures the catheter device within the body cavity by restricting movement of the device at the body orifice.
A secondary distal balloon, when included, is located distal of the larger balloon. When inflated, it anchors the catheter device at a location downstream of the larger balloon.
In one embodiment, this invention uses a slidable clip with which the physician can adjust the longitudinal size of the primary balloon. The physician premeasures the desired length of the primary balloon material and the desired catheter penetration length and secures the slidable clip over the primary balloon which is, as manufactured, sealed onto and over the catheter body at a proximal seal location. This movement of the slidable clip in effect adjusts the expansion size of the primary balloon by providing a variable proximal sealing location which can be selected by the physician to precisely tailor the primary balloon to the particular body cavity being subjected to diagnosis. For example, the clip and thus the approximate proximal end of the primary balloon can be positioned at the body cavity orifice or opening. This slidable clip has the features of easy accessibility and positive manipulability by the physician, minimal patient trauma, and an approximately circular overall shape so as to fit closely over the catheter body and balloon(s).
Some embodiments lend themselves to include a template to secure the catheter device at a location external of the body cavity orifice. Such a template may 216693 ~
be secured by one of two means: either by suturing the template to tissue in the vicinity of the orifice of the body cavity or by attaching secondary catheters which are secured in orifices near the treated body cavity.
Securement may also be provided by a distally extending catheter lead which anchors the catheter device by slipping the distal end lead through a narrow section of the body cavity, such as at the cervix or duodenum. One embodiment of this invention incorporates a Foley-type catheter for radiation therapy in the bladder, said Foley-type catheter enabling the necessary drainage of urine or the like during the therapeutic procedure without having to move or remove the catheter device.
Brief Description of the Drawings FIG. 1 is an elevation view of an embodiment of the invention, including the therapeutic balloon sealed to the catheter, inflation tube, and also radiation rods for following the contour of the balloon;
FIG. 2 demonstrates an embodiment of the invention in use within the vagina, shown in cross section;
FIG. 3 demonstrates an embodiment of the invention, shown principally in cross section, in use within the rectum, shown in cross section;
FIGS. 4-5 are cross-sectional views of the therapeutic balloon with radiation rods, demonstrating possible rod locations along the balloon contour;
FIG. 6 is a cross-sectional view showing the rod receiving members of the therapeutic balloon, demonstrating elongated pockets for therapeutic radiation rod insertion;
FIG. 7 demonstrates another embodiment of the invention, shown principally in cross section, in use within the bladder, shown in cross section;
FIG. 8 demonstrates another embodiment of the invention in use within the stomach, shown principally in cross section;
FIG. 9 demonstrates another embodiment of the invention in use within the subglottic region, shown principally in cross section;
FIGS. 10 and lOA demonstrate other embodiments of the invention in use within the nasopharynx, hypopharynx and/or subglottic region(s), shown principally in cross section;
FIG. 11 demonstrates another embodiment of the invention in use within the pyriform fossa, shown principally in cross section;
FIG. 12 is an elevation view of a further embodiment of the invention, including the primary or large balloon sealed to the catheter and also showing a fitting at its proximal end;
FIG. 13 is a plan view of an embodiment of a slidable adjustment clip, demonstrating its preferred characteristics;
FIG. 14 demonstrates an embodiment of the invention, shown principally in cross-section, in use within the rectum, shown in cross-section;
FIG. 15 demonstrates another embodiment of the invention, shown principally in cross-section, in use within a bladder, shown in cross-section; and FIG. 16 is a cross-sectional view along the line 16-16 of FIG. 15.
Description of the Preferred Embodiments FIG. 1 shows a balloon and catheter assembly, including a body or tube member 10, a therapeutic balloon 20, radiotherapeutic members such as the illustrated rods 50, and an inflation tube 60. The therapeutic balloon 20 is positioned over a distal end length portion of the catheter body member or cylinder 10. This distal end length portion and its therapeutic balloon 20 are intended 216691~
g to be inserted by the physician in an intracavitary manner through a naturally occurring body orifice of a patient and into a body cavity in order to carry out a therapeutic radiation procedure.
The therapeutic balloon 20 is typically made of a polymer material. Catheter or cylinder 10 is typically made of a polymeric material, a metallic material, or a combination of polymeric with metallic material, such as strands of metal imbedded in polymer in order to create the desired balance of flexibility and rigidity. In this particular embodiment, the catheter can be substantially rigid and is more in the nature of a plastic carrier.
The therapeutic balloon is inflated by means of the inflation tube 60 which opens into the balloon through an orifice 51 to inflate and deflate the balloon as desired. Inflation tube 60 may be inserted between the catheter and therapeutic balloon as illustrated in FIG. 2, or as shown in FIG. 1, it may be within the catheter or plastic carrier 10 and pass through its wall and into the balloon at S1. A proximal portion 21 of the annular inside surface of the balloon 20 is sealed about catheter or cylinder 14 at a distal annular portion 13. When an inflation tube exterior of the catheter is utilized, the seal must accommodate the profile of the tube. Fitting 61 connects with a pressurized fluid source and may include a valve or regulator. The pressurized fluid may be a biocompatible gas such as air or a biocompatible fluid such as saline solution. The means of pressurization may be a pressurized tank, an in-house line plumbed to the treatment room, a hypodermic syringe, or the like.
Typically, the radiotherapeutic rods 50 are rendered radiotherapeutic by being loaded with radioactive pellets, rice, seeds, wires or the like, as prescribed by the physician, either before or after insertion of the device into the body cavity. Any other suitable member for effecting radiotherapy may be used provided it can be moved into position by the therapeutic balloon.
Positioning of the rods may be aided by rod receiving members of the therapeutic balloon skin, described in more detail in connection with FIGS. 4-6. The device may be inserted through the living body orifice into the body cavity or vessel for the therapeutic radiation procedure either prior to or following insertion of the radiotherapeutic rods into the rod receiving members.
Once the assembly and radiotherapeutic rods are inserted into the cavity and secured, the balloon 20 is inflated to move the rods to the cavity or vessel wall, and radiation therapy of the diseased tissues is initiated and will continue for the prescribed duration, after which the balloon is deflated and the device removed.
FIG. 2 shows a modified form of the device of FIG. 1 in use in the vagina 80. This device further includes a template 70 and a distal end catheter tandem lead 12. The radiotherapeutic rods 50 are loaded with radioactive pellets and slipped through openings 75 in the template 70 into the rod receiving members of the therapeutic balloon 23. The device may be inserted through the vaginal opening into the vagina 80 for the treatment procedure either prior to or following insertion of the radiotherapeutic rods into the rod receiving members.
In this embodiment, the catheter is a substantially rigid cylinder 14 terminating in a substantially rigid, hemispherical section or dome 15.
When provided, the catheter rigid tandem lead 12 protrudes from the dome, in which event, the balloon will not have a closed distal end as generally shown in FIG. 1, but it will have an annular connection leg 22 by which it is sealed to the cylinder end of the catheter. The rigid cylinder may have a polymeric surface and may be hollow or have passageways for loading radioactive material thereinto. When in use, the template 70 is located just outside of the body orifice and is used to hold the treatment device in position during the therapy. The template 70 is made of a polymeric or metallic material chosen for its rigidity and bored with several holes for allowing passage therethrough of the catheter and balloon assembly, radiation rods, blind end needles, and/or selected securement arrangements.
The template may be sutured into nearby tissue through holes 71. The template 70 may also be secured with anchoring balloons 72 located in the bladder 85 and/or rectum 83. The anchoring balloons 72 are located on tether catheters 73 which guide the balloons through the urethra 84 into the bladder 85 and through the anus 82 into the rectum 83, respectively, these tether catheters permitting inflation of the anchoring balloon(s) by means of passageways extending longitudinally through the catheter to a port located between the proximal and distal ends of the anchoring balloon. Fittings (not shown) are attached to the proximal ends of the catheters 73 for connection with pressurized fluid sources. The pressurized fluid may be a biocompatible gas such as air or a biocompatible fluid such as saline solution. The means of pressurization may be a pressurized tank, an in-house line plumbed to the treatment room, a hypodermic syringe, or the like. When the balloons 72 are inflated and the tether catheters 73 are secured to the template 70 at holes 74, such as with clamps 76, the device is secured in the vagina 80 for treatment without re~uiring suturing.
Securement of the invention also may be achieved with rigid tandem or catheter lead 12 which is intended to be inserted through the cervix 81 of the patient. The tandem or catheter lead 12 is affixed to the distal end of the catheter or cylinder 14 and may be made of a metallic or polymeric material. The tandem or catheter lead 12 may itself accommodate radiotherapeutic member(s), rod(s) and/or pellets for prescribed radiation therapy.
Additional radiotherapeutic members may be loaded into internal catheter capsule 52 which can extend beyond the proximal end of the catheter or cylinder 14 as shown.
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FIG. 3 shows an embodiment for use in the rectum, including a catheter 110 which usually will be more flexible than the cylinder 14 of FIG. 2. A secondary balloon 30 is positioned within the therapeutic balloon 120 having radiotherapy members such as illustrated rods 150 and inflation tubes. A template 170 can also be included. The device is inserted through the anus 82 into the rectum 83.
The ~econ~ry balloon 30 is located within the therapeutic balloon 120, being sealingly affixed at its distal portion such as by leg 31. Balloons 30 and 120 may be inflated with the same inflation tube, or tube 160 for the secondary balloon 30 isolated from tube 164 for the therapeutic balloon 120 may be provided as shown. If two inflation tubes are used, each communicates through its length to a distal port, respectively 62, 162, each port permitting inflation and deflation of each balloon. If the same inflation tube inflates both balloons, the therapeutic balloon and secondary smaller balloon are inflated by means of an inflation tube which has two isolated channels for fluid communication to the therapeutic and secondary balloons through separate ports.
Fitting 161 connects with pressurized fluid sources as required. The securement or secondary balloon 30 is inflated until adequate securement is provided. Typically thereafter the therapeutic balloon 120 is inflated to move the rods 150 generally radially in an outward direction in order to bring the therapeutic radiation treatment as close as possible to the diseased tissue.
When provided, a template 170 is located just outside of the anus 82 and is used to hold the device in position during the therapy. The template 170 is bored with several holes for the catheter and balloon treatment device, for extra radiation rods, for suturing, and the like. This template arrangement may be used alone or in combination with the securement balloon, or the securement balloon alone may be used.
The catheter 110 has a hole 111 at its distal end which communicates longitudinally through the length of the catheter to an outlet 112 at the proximal end of the catheter, thereby permitting the flow of excrement from the intestines during the procedure. The hole 111, outlet 112 and the passageway with which they communicate are intended to be of cross section sufficiently large to enable flow of excrement. The opening of the hole 111 preferably is rounded to facilitate insertion in a non-traumatic fashion. The distal end of balloon 120 issealed near the distal end of catheter 110 such as at a leg 122. Proximal end portion or leg 125 of the therapeutic balloon and, when provided, proximal leg 32 of secondary balloon 30 are sealed in pressure-resistant fashion to the catheter 110 by known procedures.
FIGS. 4-6 show three manifestations of the manner by which the radiation rods can be associated with the large therapeutic balloon of the various embodiments so as to move with the balloon and generally follow its 20- contour when it is inflated and deflated. Arrangements for receiving the radiotherapeutic components may be provided, such as the elongated pockets 23 of the balloon 2Oa shown in FIG. 6. Rod receiving members may take the form of strips 24 about a portion or all of the circumference of the balloon, the strips being made of polymeric, elastomeric or adhesive material, or other arrangement such that the rod will follow the balloon movement. The objective of the radiotherapeutic component receiving members is to first restrict and then to effect movement of the radiotherapeutic components by positioning them by or onto the balloon during insertion through the orifice and into the body cavity and to bring the components or rods as near as possible to the cavity tissue. FIG. 4 shows radiotherapeutic rods located on the interior of the balloon. FIG. 5 shows radiotherapeutic rods located on the exterior of the balloon, which can avoid the need for any discrete receiving members because the rods will be pushed outwardly by the expanding balloon. FIG. 6 shows radiotherapeutic rods located within the balloon material itself. These designs provide radiation therapy along the contour of the balloon.
Inflation of the balloon within and to the body cavity locates the radiation rods at the surface of the body cavity tissue.
FIG. 7 shows an embodiment for use in the bladder, including a catheter 210, a therapeutic balloon 220, secondary balloon 230, radiation rods 250, and two inflation tubes 260 and 264. The radiotherapeutic rods 250 are loaded or preloaded with radioactive pellets, rice, seeds, wires or the like as prescribed by the physician and then slipped into the rod receiving members of the therapeutic balloon. The assembly is inserted through the urethra 84 and into the bladder 85.
The proximal ends of both the secondary balloon 230 and the therapeutic balloon 220 have approximately the same location on the catheter 210. The distal end of the secondary balloon is located significantly closer to the proximal end of the catheter than the distal end of the therapeutic balloon, the distal end of the therapeutic balloon being located very near the distal end of the catheter. The secondary balloon is located and sized to provide adequate securement of the invention within the bladder.
The therapeutic balloon 220 and secondary balloon 230 are inflated by means of the inflation tubes 260 and 264, or by a single tube which has two isolated channels for fluid communication to the therapeutic and secondary balloons. The secondary balloon 230 is inflated through outlets 261 until adequate securement is provided, and the therapeutic balloon 220 is inflated to bring the therapeutic radiation treatment as close as possible to the diseased tissue.
This embodiment of the invention utilizes a Foley-type catheter 210 to enable urine flow during the therapy. The Foley-type catheter features a hole at the distal end 211 which communicates through a passageway within the catheter to a drain tube 241 located at the proximate portion of the catheter. FIG. 7 shows the male bladder, but the device is also usable in the female bladder.
FIG. 8 shows an embodiment for use of the device in the stomach. It includes an elongated catheter 310, catheter lead 312, therapeutic balloon 320, radiotherapeutic rods 350, and an inflation tube 360. The radiotherapeutic rods 350 are preloaded with radioactive pellets and then slipped into the channels of the therapeutic balloon. Catheter lead 312 guides the catheter into the mouth or the nose 86, through the nasopharynx region 87, through the subglottic region 88 and into the stomach 89. Once inserted into the prescribed location, the catheter lead 312 may be inserted into a narrow region of the stomach, such as the duodenum.
The therapeutic balloon is inflated by means of the inflation tube 360. Inflation tube 360 may be inserted between the catheter 310 and the therapeutic balloon 320. Balloon 320 is sealed about catheter 310 over inflation tube 360 at leg portion 322. Fitting 361 is for connection to a pressurized fluid source in a manner generally discussed herein or as otherwise known.
FIG. 9 shows an embodiment for use in the subglottic region. This embodiment of the invention includes an elongated catheter 410, a therapeutic balloon 420, radiotherapeutic rods 450, and inflation tube 460.
The radiotherapeutic rods 450 are preloaded with radioactive pellets and then slipped into the rod receiving members of the therapeutic balloon. The assembly is inserted through the nose 86, through the nasopharynx region 87 and through the subglottic region 88 until the smaller secondary balloon 440 reaches the stomach 89.
21~6915 The smaller secondary balloon 440 is located distally of the therapeutic balloon 420 at the distal end of the catheter 410 and is intended to provide securement to the device by anchoring it in the stomach 89. This secondary balloon 440 is similar in function to the secondary balloons 130 and 230 shown in FIGS. 3 and 7, respectively, but this securement or secondary balloon 440 is located outside and distal of the therapeutic balloon.
The therapeutic balloon 420 and secondary smaller balloon 440 may be inflated, for example, by means of the inflation tube 460 which has two isolated channels for fluid communication to the therapeutic and secondary balloons. The secondary balloon 440 is inflated until adequate securement is provided and the therapeutic balloon 420 is inflated to bring the therapeutic radiation treatment as close as possible to the diseased tissue at the location of the subglottic region, for example.
The catheter 410 has a hole 411 at its distal end which communicates longitudinally through the length of the catheter. The elongated longitudinal passageway which is thus provided is intended to permit the flow of nutrients and/or wastes during the radiation therapy procedure which can take several hours or even days.
FIGS. 10 and lOA illustrate embodiments for use in the nasopharynx, hypopharynx, subglottic and/or superglottic regions. This assembly of FIG 10 includes the catheter 510, therapeutic balloon 520, secondary balloon 540, radiotherapeutic rods 550, and inflation tube 560. The radiotherapeutic rods 550 are preloaded with radioactive pellets, rice or the like and then slipped into the rod receiving members of the therapeutic balloon 520. The assembly is inserted through the mouth or nose 91 and through the nasopharynx region 87 and past the vocal chords 92 until the smaller secondary balloon 540 reaches the subglottic region 93 proximate to the esophagus 88. At this stage, the secondary balloon 540 can be inflated to secure the device in place. Inflation 2166~15 of the therapeutic balloon 520 moves the radiotherapy materials outwardly to treat the superglottic region 94.
The therapeutic balloon and secondary smaller balloon are inflated by means-of one or two inflation tubes 560. The secondary balloon 540 is inflated until adequate securement is provided by its engagement in the subglottic or esophagus areas 93, 88, and the therapeutic balloon S20 is inflated to bring the therapeutic radiation treatment as close as possible to the diseased tissue.
The catheter 510 has a hole 511 at its distal end which communicates longitudinally through the length of the catheter to provide a longitudinal passageway for permitting inhalation and exhalation during the radiation therapy procedure.
In the FIG. lOA embodiment, the therapeutic balloon 740 is sized, shaped and positioned for treatment of the subglottic region 740. While a secondary or securement balloon could be included for engagement in the superglottic region 94, such is typically not required because the therapeutic balloon 740 often will adequately anchor the device. Treatment tubes 750 can extend through the tubular catheter body 710 as shown. Alternatively, the therapeutic balloon 740 can be loaded with radiotherapeutic materials prior to deployment of the device. This feature is also optional in any of the other embodiments. It can be particularly useful where the catheter is of considerable length or must bend significantly when in use, for example in the embodiments of FIG. 7 through FIG. 11. Balloon 740 inflation is through passageway 760, and fluids can pass through the catheter 710 between its proximal end and the distal opening 711.
An embodiment for use in the hypopharynx is illustrated in FIG. 11. This device includes a catheter 610, a secondary balloon 640, radiotherapeutic tubes or rods 650, and an inflation tube 660. The therapeutic balloon 620 for this embodiment may be split at a generally proximal location into two chambers 665, 666 which inflate into each pyriform fossa. The radiotherapeutic rods 650 typically are preloaded with radioactive members or materials and then positioned for movement with the balloon 620 such as by being slipped into rod receiving members of the therapeutic balloon.
The therapeutic balloon is inserted into the hypopharynx 90. If needed the secondary balloon 640 can be inserted into the subglottic region. The therapeutic balloon 620 and secondary balloon 640 are inflated by means of one or two inflation tubes 660. A hole 611 and longitudinal passageway throughout the catheter 610 permit respiration during the course of the radiation therapy procedure.
FIG. 12 shows a diagnostic catheter, generally designated as 810, having a body or tube member 823. A
primary balloon 820, which is relatively large in relationship to the rest of the catheter and any other balloon(s) which may be included on the diagnostic catheter 810, is positioned over and sealed onto a distal end length or portion of the body member 823. This distal end length and its primary balloon 820 are intended to be inserted by the physician into the patient's body cavity during a diagnostic procedure.
In this embodiment, the length and profile of the primary balloon is adjustable by means of an adjustment member or assembly. Illustrated in this regard in this embodiment is a slidable clip 821. Although the balloon is necec-c~rily already sealed onto the body member 823 at its proximal end (as well as at its distal end in some embodiments), the adjustment member allows the physician to select a location for the proximal end of the primary balloon, such as by releasing the clip, manually moving it to the desired proximal end location of the balloon, and securing the clip at this desired location along the length of the primary balloon 820. In this manner, the balloon will inflate in the proximal direction only up until the location of this adjustment member 821.
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At its proximal end, body member 823 of the catheter 810 may juncture into a plurality of branches (two in the embodiment of FIG. 14 and three in the embodiment of FIG. 15). Each such branch contains a separate, isolated fluid line which communicates through the catheter and to appropriate openings such as the illustrated holes 811, 812.
The primary balloon is inflated through one or more holes 811. Each hole 811 communicates through the catheter tube member 823 to fitting 814. Fitting 814 connects with a pressurized fluid source, which may be a biocompatible gas such as air or a biocompatible-liquid such as saline solution. The fluid may also be radiopaque, if the physician determines that the diagnostic procedure requires its use. The means of pressurization may be a hypodermic syringe, such as that illustrated at 824, or other suitable means as discussed herein.
Slidable clip 821 secures the large or primary balloon 820 onto the catheter by clamping down the balloon onto the catheter body at the location inside of the clip or clamp. The physician locates the clip so that the desired amount of balloon material and depth of catheter penetration are achieved. The physician manipulates the slidable clip with his or her hand(s) and, once in place and secured, is free to use both hands for other subsequent steps of the diagnostic procedure. Slidable clip 821 is preferably made of a radiopaque material to mark its location, and the location of the body cavity orifice, during radiographic viewing.
FIG. 13 shows details of an exemplary embodiment of the slidable clamp or clip 821. Illustrated is the preferred functional features of this clip: accessibility to and manipulability by the physician, minimal patient trauma, and a substantially circular shape. The slidable clip may be made of a polymeric, an elastomeric or a metallic material. Slidable clip 821 preferably has a 2166~15 means for closure that is readily operated with the physician's thumb and fingers, such as by engaging the tab(s) 821A, 821B. Slidable clip 821 also preferably adjusts and holds its position with members such as the meshing teeth 82lC which are illustrated.
FIG. 14 shows a diagnostic catheter that incorporates a secondary or positioning balloon 830, which is considerably smaller than the primary balloon, as well as the slidable clip 821. Small or secondary balloon 830 may be made of polymeric materials suitable for medical device balloons, and preferably of an elastomeric material to enhance its holding effectiveness.
The distal portion of this catheter 810, including at least a portion of each of the primary balloon 820 and of the secondary balloon 830, is inserted into the patient's rectal cavity 40 in this embodiment.
Slidable clip 821 has been positioned on the catheter for imparting the desired profile and size of the primary balloon 820 and so as to be located at the patient's orifice. In the preferred embodiment, the slidable clip 821 is radiopaque to mark its location during radiographic viewing. Large or primary balloon is inflated through hole 811, expanding the rectal cavity for radiation diagnosis. Secondary balloon 830 is inflated through holes 812 to secure the catheter assembly.
The proximal and distal ends of the secondary balloon 830 are adhered to the tube of the catheter 810, and the slidable clip 821 may be secured anywhere along the length of the secondary balloon (with the primary balloon usually being positioned therebetween. Secondary balloon 830 may be inflated either proximally or distally of the clip location, or, as shown in FIG. 14, both proximally and distally of the slidable clip 821, preferably in an isolated manner.
FIG. 15 illustrates a catheter for diagnosis in a bladder 841. The particular illustrated bladder 841 is a male bladder; however, the invention is suitable for use ~16~91~
in female bladders as well. This diagnostic catheter includes a catheter tube or body 823A having a Foley-type catheter tube 823B with a detachable urine bag 823C. Also included are a primary balloon 820, a secondary balloon 830, and radiopaque reference line(s) 822. This diagnostic catheter is inserted through the urinary tract 842 into the bladder. A hole 819 at the distal tip of the body permits necessary urine flow during the procedure.
Urine flows through hole 819 into a separate isolated communication line 817A (FIG. 16) in the catheter tube and into a branch 817 having the Foley-type catheter tube 823B .
AS is the case for the FIG. 14 embodiment, the primary balloon 820 of this embodiment is inflated through one or more holes 811. Secondary balloon 830 is inflated through one or more holes 812. Both balloons are adhered to the catheter at their respective distal and proximal circumferential ends. The secondary balloon is located near the proximal end of the primary balloon. The distal end of the primary balloon is located just proximal of the distal tip of the catheter and includes the drainage hole 819. The illustrated primary balloon has radiopaque reference line(s) to provide a marking reference for the physician during radiographic viewing.
A branch 815 of the catheter tube 823A is at the proximal end of the fluid communication line for inflating the secondary balloon 830. A passageway 815A within the catheter tube 823A and branch 815 provides this fluid communication. The physician may attach any fitting, valve or regulator 816 to the branch which permits connection to and control of the source for inflation and deflation of the small balloon 830, such as the hypodermic syringe 824 shown in FIG. 12. Branch 812 is functionally similar to branch 815, except that it is used for isolated fluid communication with the primary balloon 820. A
passageway 812A within the catheter tube 823A and branch 21~6915 812 provides this fluid communication. Any fitting, valve or regulator 818 may be attached to this branch.
In the radiation diagnosis aspect of the invention, the physician selects the appropriate embodiment for the required diagnostic procedure, whether it includes one or more of the slidable clip and/or secondary balloon as an adjustable securement member, and/or a Foley-type catheter tube, and/or radiopaque reference line(s). The physician inserts the selected embodiment of the diagnostic catheter into and through the orifice of the body cavity to be diagnosed.
When the diagnostic catheter has a slidable clip, the physician inserts the desired amount of the primary balloon to the desired catheter penetration depth and then secures the clip at the body orifice by appropriate simplified manipulation of the clip. In those instances where a secondary balloon is included, the physician inflates this now by admitting the pressurized fluid through the appropriate branch at the proximal end of the catheter. When a Foley-type catheter is included, the drainage function of this device would operate as customary while the diagnosis is taking place with the primary balloon being inflated.
In the instance of a catheter as generally illustrated in FIG. 15, after initial insertion into the urinary tract, the physician inflates the small or secondary balloon to secure the assembly in place at the proximal end of the bladder. Next, the physician inflates the larger or primary balloon to thereby mark and/or manipulate the body cavity. When the radiopaque reference line(s) feature is included, the physician has a radiographic image of the boundary of the body cavity. If a radiographic inflating fluid is used to inflate the primary balloon, the physician also has a radiographic image of the internal walls of the body cavity when viewed in the usual manner of diagnosis. This allows the physician to see characteristics of the body cavity that 216691~
will be of great assistance in diagnosing disease, such as potentially cancerous areas that can be treated by radiation therapy.
It will be understood that variations of and modifications to the present invention may be made without departing from the spirit and scope of the invention.
PATENT
Case 800P002 INTRACAVITARY CAln~ K
FOR USE IN RADIATION PROCEDURES
Description Backqround of the Invention The present invention generally relates to diagnostic or therapeutic procedures and devices used during radiation diagnosis or therapy. This device generally consists of a catheter with a balloon positioned along at least a portion of its length. In some embodiments, radiotherapeutic members, tubes or elongated rods for containing radioactive material are engaged by and move with the balloon when it is expanded. These rods or the like may be inserted in elongated pockets of the balloon; they may also be secured to the balloon with loops attached to the inner or outer surfaces of the balloon, or they may be secured to a balloon surface with adhesive strips. The catheter and balloon assembly is intended to be inserted into living body cavities through existing body orifices. Once the catheter and its balloon are inserted in the prescribed manner into the body cavity, the balloon is inflated to mark the boundary of the body cavity during radiographic examination or to move and hold the radioactive material into desired radiation treatment position within the body cavity during radiation therapy. The inflated therapeutic balloon also may be used to move, push, reposition, hold or otherwise manipulate body tissue during the radiation diagnosis or therapy.
This invention is intended to have a plurality of functions. It may be used to identify the boundary of a body cavity or otherwise provide reference to assist the physician in identifying the appropriate treatment area.
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It may also be used to manipulate a body cavity to assist the physician in identifying the appropriate treatment area or to push tissues out of the treatment area. The invention permits the introduction of air or of various s diagnostic fluids free from risk that toxins or other contaminants could contact the patient. Also, the invention can be used in a variety of body cavities.
When the radiotherapeutic members are incorporated, this invention provides the physician with a new technique to treat cancers within the body. This invention is most useful to treat cancers inside or in the proximity of body cavities including the bladder, vagina, rectum, subglottic region, stomach, bronchial tubes, nasopharynx region, and the like. This invention permits radiation treatment within the human body without requiring interstitial insertion of radiotherapeutic rods or the like. Prior to this invention, application of radiotherapeutic rods typically required insertion of the rods through tissue. This invention provides an intracavitary alternative for radiating internal body tissues. Patient trauma and risk from infection, and other similar types of potential hazards of interstitial procedures are substantially reduced. Typically, this invention can lessen the training time and/or experience level required to perform internal radiation therapy where an interstitial procedure might ordinarily be employed in view of the elimination of more intensive procedures related to an interstitial insertion of the radiotherapeutic rods.
It is a general object of this invention to provide a significantly improved tool and procedure for diagnosis or radiation therapy in or near body cavities accessible through existing orifices.
Another object of this invention is to provide an improved apparatus and method to provide the physician with a view of the body cavity during radiographic viewing, such as X-ray radiography.
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Another object of this invention is to enable the physician to move, push or otherwise manipulate body tissue for the purpose of improved diagnoses or therapy.
Another object of this invention is to enable introduction of radiographic fluids or air into the body cavity of the patient without subjecting the patient to risk from those radiographic fluids.
Another object of the invention is to provide intracavitary radiation therapy at or nearer diseased tissues than possible with external radiation therapy.
Another object of the invention is to provide radiation therapy at or nearer diseased tissues without invasive or interstitial procedures and whether at a high dose rate during short treatment times of from 15 minutes to a few hours and up to 24 hours or at a low dose rate during longer treatment times of up to about 3 days or more.
Another object of the invention is to facilitate long-term, low dose rate radiation by enabling introduction of nutrients or air or evacuation of wastes through a therapeutic treatment device itself.
Another object of the invention is to utilize existing body cavities for radiation therapy in an intracavitary manner.
Another object of this invention is to provide a device and method suitable for use in the bladder by providing an elongated insertion catheter having drainage characteristics.
Another object of this invention is to provide an improved apparatus and method which allows the provision of radiopaque reference lines at desired locations within a variety of body cavities.
Another object of this invention is to permit the physician to tailor the size of a radiation treatment device to the particular diagnostic or therapeutic requirements of the body cavity being treated.
Another object of this invention is to maintain the position of a diagnostic or therapeutic device through the use of a smaller, secondary balloon located within a larger, therapeutic balloon.
Another object of this invention is to provide a device and method suitable for use in the rectum by providing a large diameter catheter having drainage characteristics.
Another object of this invention is to provide a device and method suitable for use in the vagina or rectum by providing a template which provides securement.
Another object of this invention is to provide a device and method suitable for use in the stomach by providing a catheter having inflow and outflow characteristics.
Another object of this invention is to provide a device and method suitable for use in the subglottic region by providing a catheter having inflow and outflow characteristics.
Another object of this invention is to provide a device and method suitable for use in the nasopharynx region by providing a catheter having inhalation and exhalation characteristics.
Another object of the invention is to provide a device and method that provide for inflow of nutrients and outflow of wastes to enable long-duration treatments.
These and other objects and advantages of the present invention will be apparent from the following description.
Summary of the Invention This invention utilizes a catheter for insertion into a body cavity. A large or primary balloon is secured to a tubular catheter body, the balloon being positioned and sized for insertion into a particular type of body cavity. The proximal end of the catheter has one or a plurality of passageways to enable fluid communication 216691~
through various channels in the catheter body, depending upon the embodiment. The passageways preferably utilize one- or two-way valves, regulators, hypodermic syringes, or the like for introduction, control, and/or withdrawal of fluids into and out of one or more balloons and/or body cavities.
The fluid with which the balloon may be filled can be a biocompatible gas, such as air, or a biocompatible liquid, such as saline solution. The balloon(s) of the catheter device may also be used to move, expand, or otherwise manipulate the body cavity by balloon inflation in order to provide more effective radiation diagnosis or treatment.
Radiation treatment members which can take the form of rods or tubes are associated with the balloon so as to be properly positioned by the balloon to effect the intracavitary treatment, typically by moving treatment rods toward and/or in contact with the walls of the body cavity. For example, the balloon can contain rod receiving members which are used to hold the radiation treatment rods. The rod receiving members may be elongated pockets within the balloon material or strips of elastomeric or adhesive material along the circumference of the balloon and into which the treatment rods are inserted. Typical treatment rods contain small radioactive pellets which irradiate diseased tissue. The size, dose rate and spacing of these pellets is prescribed by the physician and assembled prior to and/or during the procedure in which the catheter device is ready for insertion through the body cavity orifice and into the body cavity.
Different embodiments of this invention can utilize one or more different approaches to secure the catheter device during radiation diagnosis or therapy.
These include a secondary inner balloon, a secondary distal balloon, one or two secondary outer balloons and asæociated tether catheters, a template, and a catheter lead.
When provided, the secondary inner balloon which usually is substantially smaller than the large or primary balloon assists in holding the catheter device in place within the body cavity at the orifice and typically is located generally within and at the proximal end of the larger balloon. Upon inflation, the secondary balloon secures the catheter device within the body cavity by restricting movement of the device at the body orifice.
A secondary distal balloon, when included, is located distal of the larger balloon. When inflated, it anchors the catheter device at a location downstream of the larger balloon.
In one embodiment, this invention uses a slidable clip with which the physician can adjust the longitudinal size of the primary balloon. The physician premeasures the desired length of the primary balloon material and the desired catheter penetration length and secures the slidable clip over the primary balloon which is, as manufactured, sealed onto and over the catheter body at a proximal seal location. This movement of the slidable clip in effect adjusts the expansion size of the primary balloon by providing a variable proximal sealing location which can be selected by the physician to precisely tailor the primary balloon to the particular body cavity being subjected to diagnosis. For example, the clip and thus the approximate proximal end of the primary balloon can be positioned at the body cavity orifice or opening. This slidable clip has the features of easy accessibility and positive manipulability by the physician, minimal patient trauma, and an approximately circular overall shape so as to fit closely over the catheter body and balloon(s).
Some embodiments lend themselves to include a template to secure the catheter device at a location external of the body cavity orifice. Such a template may 216693 ~
be secured by one of two means: either by suturing the template to tissue in the vicinity of the orifice of the body cavity or by attaching secondary catheters which are secured in orifices near the treated body cavity.
Securement may also be provided by a distally extending catheter lead which anchors the catheter device by slipping the distal end lead through a narrow section of the body cavity, such as at the cervix or duodenum. One embodiment of this invention incorporates a Foley-type catheter for radiation therapy in the bladder, said Foley-type catheter enabling the necessary drainage of urine or the like during the therapeutic procedure without having to move or remove the catheter device.
Brief Description of the Drawings FIG. 1 is an elevation view of an embodiment of the invention, including the therapeutic balloon sealed to the catheter, inflation tube, and also radiation rods for following the contour of the balloon;
FIG. 2 demonstrates an embodiment of the invention in use within the vagina, shown in cross section;
FIG. 3 demonstrates an embodiment of the invention, shown principally in cross section, in use within the rectum, shown in cross section;
FIGS. 4-5 are cross-sectional views of the therapeutic balloon with radiation rods, demonstrating possible rod locations along the balloon contour;
FIG. 6 is a cross-sectional view showing the rod receiving members of the therapeutic balloon, demonstrating elongated pockets for therapeutic radiation rod insertion;
FIG. 7 demonstrates another embodiment of the invention, shown principally in cross section, in use within the bladder, shown in cross section;
FIG. 8 demonstrates another embodiment of the invention in use within the stomach, shown principally in cross section;
FIG. 9 demonstrates another embodiment of the invention in use within the subglottic region, shown principally in cross section;
FIGS. 10 and lOA demonstrate other embodiments of the invention in use within the nasopharynx, hypopharynx and/or subglottic region(s), shown principally in cross section;
FIG. 11 demonstrates another embodiment of the invention in use within the pyriform fossa, shown principally in cross section;
FIG. 12 is an elevation view of a further embodiment of the invention, including the primary or large balloon sealed to the catheter and also showing a fitting at its proximal end;
FIG. 13 is a plan view of an embodiment of a slidable adjustment clip, demonstrating its preferred characteristics;
FIG. 14 demonstrates an embodiment of the invention, shown principally in cross-section, in use within the rectum, shown in cross-section;
FIG. 15 demonstrates another embodiment of the invention, shown principally in cross-section, in use within a bladder, shown in cross-section; and FIG. 16 is a cross-sectional view along the line 16-16 of FIG. 15.
Description of the Preferred Embodiments FIG. 1 shows a balloon and catheter assembly, including a body or tube member 10, a therapeutic balloon 20, radiotherapeutic members such as the illustrated rods 50, and an inflation tube 60. The therapeutic balloon 20 is positioned over a distal end length portion of the catheter body member or cylinder 10. This distal end length portion and its therapeutic balloon 20 are intended 216691~
g to be inserted by the physician in an intracavitary manner through a naturally occurring body orifice of a patient and into a body cavity in order to carry out a therapeutic radiation procedure.
The therapeutic balloon 20 is typically made of a polymer material. Catheter or cylinder 10 is typically made of a polymeric material, a metallic material, or a combination of polymeric with metallic material, such as strands of metal imbedded in polymer in order to create the desired balance of flexibility and rigidity. In this particular embodiment, the catheter can be substantially rigid and is more in the nature of a plastic carrier.
The therapeutic balloon is inflated by means of the inflation tube 60 which opens into the balloon through an orifice 51 to inflate and deflate the balloon as desired. Inflation tube 60 may be inserted between the catheter and therapeutic balloon as illustrated in FIG. 2, or as shown in FIG. 1, it may be within the catheter or plastic carrier 10 and pass through its wall and into the balloon at S1. A proximal portion 21 of the annular inside surface of the balloon 20 is sealed about catheter or cylinder 14 at a distal annular portion 13. When an inflation tube exterior of the catheter is utilized, the seal must accommodate the profile of the tube. Fitting 61 connects with a pressurized fluid source and may include a valve or regulator. The pressurized fluid may be a biocompatible gas such as air or a biocompatible fluid such as saline solution. The means of pressurization may be a pressurized tank, an in-house line plumbed to the treatment room, a hypodermic syringe, or the like.
Typically, the radiotherapeutic rods 50 are rendered radiotherapeutic by being loaded with radioactive pellets, rice, seeds, wires or the like, as prescribed by the physician, either before or after insertion of the device into the body cavity. Any other suitable member for effecting radiotherapy may be used provided it can be moved into position by the therapeutic balloon.
Positioning of the rods may be aided by rod receiving members of the therapeutic balloon skin, described in more detail in connection with FIGS. 4-6. The device may be inserted through the living body orifice into the body cavity or vessel for the therapeutic radiation procedure either prior to or following insertion of the radiotherapeutic rods into the rod receiving members.
Once the assembly and radiotherapeutic rods are inserted into the cavity and secured, the balloon 20 is inflated to move the rods to the cavity or vessel wall, and radiation therapy of the diseased tissues is initiated and will continue for the prescribed duration, after which the balloon is deflated and the device removed.
FIG. 2 shows a modified form of the device of FIG. 1 in use in the vagina 80. This device further includes a template 70 and a distal end catheter tandem lead 12. The radiotherapeutic rods 50 are loaded with radioactive pellets and slipped through openings 75 in the template 70 into the rod receiving members of the therapeutic balloon 23. The device may be inserted through the vaginal opening into the vagina 80 for the treatment procedure either prior to or following insertion of the radiotherapeutic rods into the rod receiving members.
In this embodiment, the catheter is a substantially rigid cylinder 14 terminating in a substantially rigid, hemispherical section or dome 15.
When provided, the catheter rigid tandem lead 12 protrudes from the dome, in which event, the balloon will not have a closed distal end as generally shown in FIG. 1, but it will have an annular connection leg 22 by which it is sealed to the cylinder end of the catheter. The rigid cylinder may have a polymeric surface and may be hollow or have passageways for loading radioactive material thereinto. When in use, the template 70 is located just outside of the body orifice and is used to hold the treatment device in position during the therapy. The template 70 is made of a polymeric or metallic material chosen for its rigidity and bored with several holes for allowing passage therethrough of the catheter and balloon assembly, radiation rods, blind end needles, and/or selected securement arrangements.
The template may be sutured into nearby tissue through holes 71. The template 70 may also be secured with anchoring balloons 72 located in the bladder 85 and/or rectum 83. The anchoring balloons 72 are located on tether catheters 73 which guide the balloons through the urethra 84 into the bladder 85 and through the anus 82 into the rectum 83, respectively, these tether catheters permitting inflation of the anchoring balloon(s) by means of passageways extending longitudinally through the catheter to a port located between the proximal and distal ends of the anchoring balloon. Fittings (not shown) are attached to the proximal ends of the catheters 73 for connection with pressurized fluid sources. The pressurized fluid may be a biocompatible gas such as air or a biocompatible fluid such as saline solution. The means of pressurization may be a pressurized tank, an in-house line plumbed to the treatment room, a hypodermic syringe, or the like. When the balloons 72 are inflated and the tether catheters 73 are secured to the template 70 at holes 74, such as with clamps 76, the device is secured in the vagina 80 for treatment without re~uiring suturing.
Securement of the invention also may be achieved with rigid tandem or catheter lead 12 which is intended to be inserted through the cervix 81 of the patient. The tandem or catheter lead 12 is affixed to the distal end of the catheter or cylinder 14 and may be made of a metallic or polymeric material. The tandem or catheter lead 12 may itself accommodate radiotherapeutic member(s), rod(s) and/or pellets for prescribed radiation therapy.
Additional radiotherapeutic members may be loaded into internal catheter capsule 52 which can extend beyond the proximal end of the catheter or cylinder 14 as shown.
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FIG. 3 shows an embodiment for use in the rectum, including a catheter 110 which usually will be more flexible than the cylinder 14 of FIG. 2. A secondary balloon 30 is positioned within the therapeutic balloon 120 having radiotherapy members such as illustrated rods 150 and inflation tubes. A template 170 can also be included. The device is inserted through the anus 82 into the rectum 83.
The ~econ~ry balloon 30 is located within the therapeutic balloon 120, being sealingly affixed at its distal portion such as by leg 31. Balloons 30 and 120 may be inflated with the same inflation tube, or tube 160 for the secondary balloon 30 isolated from tube 164 for the therapeutic balloon 120 may be provided as shown. If two inflation tubes are used, each communicates through its length to a distal port, respectively 62, 162, each port permitting inflation and deflation of each balloon. If the same inflation tube inflates both balloons, the therapeutic balloon and secondary smaller balloon are inflated by means of an inflation tube which has two isolated channels for fluid communication to the therapeutic and secondary balloons through separate ports.
Fitting 161 connects with pressurized fluid sources as required. The securement or secondary balloon 30 is inflated until adequate securement is provided. Typically thereafter the therapeutic balloon 120 is inflated to move the rods 150 generally radially in an outward direction in order to bring the therapeutic radiation treatment as close as possible to the diseased tissue.
When provided, a template 170 is located just outside of the anus 82 and is used to hold the device in position during the therapy. The template 170 is bored with several holes for the catheter and balloon treatment device, for extra radiation rods, for suturing, and the like. This template arrangement may be used alone or in combination with the securement balloon, or the securement balloon alone may be used.
The catheter 110 has a hole 111 at its distal end which communicates longitudinally through the length of the catheter to an outlet 112 at the proximal end of the catheter, thereby permitting the flow of excrement from the intestines during the procedure. The hole 111, outlet 112 and the passageway with which they communicate are intended to be of cross section sufficiently large to enable flow of excrement. The opening of the hole 111 preferably is rounded to facilitate insertion in a non-traumatic fashion. The distal end of balloon 120 issealed near the distal end of catheter 110 such as at a leg 122. Proximal end portion or leg 125 of the therapeutic balloon and, when provided, proximal leg 32 of secondary balloon 30 are sealed in pressure-resistant fashion to the catheter 110 by known procedures.
FIGS. 4-6 show three manifestations of the manner by which the radiation rods can be associated with the large therapeutic balloon of the various embodiments so as to move with the balloon and generally follow its 20- contour when it is inflated and deflated. Arrangements for receiving the radiotherapeutic components may be provided, such as the elongated pockets 23 of the balloon 2Oa shown in FIG. 6. Rod receiving members may take the form of strips 24 about a portion or all of the circumference of the balloon, the strips being made of polymeric, elastomeric or adhesive material, or other arrangement such that the rod will follow the balloon movement. The objective of the radiotherapeutic component receiving members is to first restrict and then to effect movement of the radiotherapeutic components by positioning them by or onto the balloon during insertion through the orifice and into the body cavity and to bring the components or rods as near as possible to the cavity tissue. FIG. 4 shows radiotherapeutic rods located on the interior of the balloon. FIG. 5 shows radiotherapeutic rods located on the exterior of the balloon, which can avoid the need for any discrete receiving members because the rods will be pushed outwardly by the expanding balloon. FIG. 6 shows radiotherapeutic rods located within the balloon material itself. These designs provide radiation therapy along the contour of the balloon.
Inflation of the balloon within and to the body cavity locates the radiation rods at the surface of the body cavity tissue.
FIG. 7 shows an embodiment for use in the bladder, including a catheter 210, a therapeutic balloon 220, secondary balloon 230, radiation rods 250, and two inflation tubes 260 and 264. The radiotherapeutic rods 250 are loaded or preloaded with radioactive pellets, rice, seeds, wires or the like as prescribed by the physician and then slipped into the rod receiving members of the therapeutic balloon. The assembly is inserted through the urethra 84 and into the bladder 85.
The proximal ends of both the secondary balloon 230 and the therapeutic balloon 220 have approximately the same location on the catheter 210. The distal end of the secondary balloon is located significantly closer to the proximal end of the catheter than the distal end of the therapeutic balloon, the distal end of the therapeutic balloon being located very near the distal end of the catheter. The secondary balloon is located and sized to provide adequate securement of the invention within the bladder.
The therapeutic balloon 220 and secondary balloon 230 are inflated by means of the inflation tubes 260 and 264, or by a single tube which has two isolated channels for fluid communication to the therapeutic and secondary balloons. The secondary balloon 230 is inflated through outlets 261 until adequate securement is provided, and the therapeutic balloon 220 is inflated to bring the therapeutic radiation treatment as close as possible to the diseased tissue.
This embodiment of the invention utilizes a Foley-type catheter 210 to enable urine flow during the therapy. The Foley-type catheter features a hole at the distal end 211 which communicates through a passageway within the catheter to a drain tube 241 located at the proximate portion of the catheter. FIG. 7 shows the male bladder, but the device is also usable in the female bladder.
FIG. 8 shows an embodiment for use of the device in the stomach. It includes an elongated catheter 310, catheter lead 312, therapeutic balloon 320, radiotherapeutic rods 350, and an inflation tube 360. The radiotherapeutic rods 350 are preloaded with radioactive pellets and then slipped into the channels of the therapeutic balloon. Catheter lead 312 guides the catheter into the mouth or the nose 86, through the nasopharynx region 87, through the subglottic region 88 and into the stomach 89. Once inserted into the prescribed location, the catheter lead 312 may be inserted into a narrow region of the stomach, such as the duodenum.
The therapeutic balloon is inflated by means of the inflation tube 360. Inflation tube 360 may be inserted between the catheter 310 and the therapeutic balloon 320. Balloon 320 is sealed about catheter 310 over inflation tube 360 at leg portion 322. Fitting 361 is for connection to a pressurized fluid source in a manner generally discussed herein or as otherwise known.
FIG. 9 shows an embodiment for use in the subglottic region. This embodiment of the invention includes an elongated catheter 410, a therapeutic balloon 420, radiotherapeutic rods 450, and inflation tube 460.
The radiotherapeutic rods 450 are preloaded with radioactive pellets and then slipped into the rod receiving members of the therapeutic balloon. The assembly is inserted through the nose 86, through the nasopharynx region 87 and through the subglottic region 88 until the smaller secondary balloon 440 reaches the stomach 89.
21~6915 The smaller secondary balloon 440 is located distally of the therapeutic balloon 420 at the distal end of the catheter 410 and is intended to provide securement to the device by anchoring it in the stomach 89. This secondary balloon 440 is similar in function to the secondary balloons 130 and 230 shown in FIGS. 3 and 7, respectively, but this securement or secondary balloon 440 is located outside and distal of the therapeutic balloon.
The therapeutic balloon 420 and secondary smaller balloon 440 may be inflated, for example, by means of the inflation tube 460 which has two isolated channels for fluid communication to the therapeutic and secondary balloons. The secondary balloon 440 is inflated until adequate securement is provided and the therapeutic balloon 420 is inflated to bring the therapeutic radiation treatment as close as possible to the diseased tissue at the location of the subglottic region, for example.
The catheter 410 has a hole 411 at its distal end which communicates longitudinally through the length of the catheter. The elongated longitudinal passageway which is thus provided is intended to permit the flow of nutrients and/or wastes during the radiation therapy procedure which can take several hours or even days.
FIGS. 10 and lOA illustrate embodiments for use in the nasopharynx, hypopharynx, subglottic and/or superglottic regions. This assembly of FIG 10 includes the catheter 510, therapeutic balloon 520, secondary balloon 540, radiotherapeutic rods 550, and inflation tube 560. The radiotherapeutic rods 550 are preloaded with radioactive pellets, rice or the like and then slipped into the rod receiving members of the therapeutic balloon 520. The assembly is inserted through the mouth or nose 91 and through the nasopharynx region 87 and past the vocal chords 92 until the smaller secondary balloon 540 reaches the subglottic region 93 proximate to the esophagus 88. At this stage, the secondary balloon 540 can be inflated to secure the device in place. Inflation 2166~15 of the therapeutic balloon 520 moves the radiotherapy materials outwardly to treat the superglottic region 94.
The therapeutic balloon and secondary smaller balloon are inflated by means-of one or two inflation tubes 560. The secondary balloon 540 is inflated until adequate securement is provided by its engagement in the subglottic or esophagus areas 93, 88, and the therapeutic balloon S20 is inflated to bring the therapeutic radiation treatment as close as possible to the diseased tissue.
The catheter 510 has a hole 511 at its distal end which communicates longitudinally through the length of the catheter to provide a longitudinal passageway for permitting inhalation and exhalation during the radiation therapy procedure.
In the FIG. lOA embodiment, the therapeutic balloon 740 is sized, shaped and positioned for treatment of the subglottic region 740. While a secondary or securement balloon could be included for engagement in the superglottic region 94, such is typically not required because the therapeutic balloon 740 often will adequately anchor the device. Treatment tubes 750 can extend through the tubular catheter body 710 as shown. Alternatively, the therapeutic balloon 740 can be loaded with radiotherapeutic materials prior to deployment of the device. This feature is also optional in any of the other embodiments. It can be particularly useful where the catheter is of considerable length or must bend significantly when in use, for example in the embodiments of FIG. 7 through FIG. 11. Balloon 740 inflation is through passageway 760, and fluids can pass through the catheter 710 between its proximal end and the distal opening 711.
An embodiment for use in the hypopharynx is illustrated in FIG. 11. This device includes a catheter 610, a secondary balloon 640, radiotherapeutic tubes or rods 650, and an inflation tube 660. The therapeutic balloon 620 for this embodiment may be split at a generally proximal location into two chambers 665, 666 which inflate into each pyriform fossa. The radiotherapeutic rods 650 typically are preloaded with radioactive members or materials and then positioned for movement with the balloon 620 such as by being slipped into rod receiving members of the therapeutic balloon.
The therapeutic balloon is inserted into the hypopharynx 90. If needed the secondary balloon 640 can be inserted into the subglottic region. The therapeutic balloon 620 and secondary balloon 640 are inflated by means of one or two inflation tubes 660. A hole 611 and longitudinal passageway throughout the catheter 610 permit respiration during the course of the radiation therapy procedure.
FIG. 12 shows a diagnostic catheter, generally designated as 810, having a body or tube member 823. A
primary balloon 820, which is relatively large in relationship to the rest of the catheter and any other balloon(s) which may be included on the diagnostic catheter 810, is positioned over and sealed onto a distal end length or portion of the body member 823. This distal end length and its primary balloon 820 are intended to be inserted by the physician into the patient's body cavity during a diagnostic procedure.
In this embodiment, the length and profile of the primary balloon is adjustable by means of an adjustment member or assembly. Illustrated in this regard in this embodiment is a slidable clip 821. Although the balloon is necec-c~rily already sealed onto the body member 823 at its proximal end (as well as at its distal end in some embodiments), the adjustment member allows the physician to select a location for the proximal end of the primary balloon, such as by releasing the clip, manually moving it to the desired proximal end location of the balloon, and securing the clip at this desired location along the length of the primary balloon 820. In this manner, the balloon will inflate in the proximal direction only up until the location of this adjustment member 821.
216~91 ~
At its proximal end, body member 823 of the catheter 810 may juncture into a plurality of branches (two in the embodiment of FIG. 14 and three in the embodiment of FIG. 15). Each such branch contains a separate, isolated fluid line which communicates through the catheter and to appropriate openings such as the illustrated holes 811, 812.
The primary balloon is inflated through one or more holes 811. Each hole 811 communicates through the catheter tube member 823 to fitting 814. Fitting 814 connects with a pressurized fluid source, which may be a biocompatible gas such as air or a biocompatible-liquid such as saline solution. The fluid may also be radiopaque, if the physician determines that the diagnostic procedure requires its use. The means of pressurization may be a hypodermic syringe, such as that illustrated at 824, or other suitable means as discussed herein.
Slidable clip 821 secures the large or primary balloon 820 onto the catheter by clamping down the balloon onto the catheter body at the location inside of the clip or clamp. The physician locates the clip so that the desired amount of balloon material and depth of catheter penetration are achieved. The physician manipulates the slidable clip with his or her hand(s) and, once in place and secured, is free to use both hands for other subsequent steps of the diagnostic procedure. Slidable clip 821 is preferably made of a radiopaque material to mark its location, and the location of the body cavity orifice, during radiographic viewing.
FIG. 13 shows details of an exemplary embodiment of the slidable clamp or clip 821. Illustrated is the preferred functional features of this clip: accessibility to and manipulability by the physician, minimal patient trauma, and a substantially circular shape. The slidable clip may be made of a polymeric, an elastomeric or a metallic material. Slidable clip 821 preferably has a 2166~15 means for closure that is readily operated with the physician's thumb and fingers, such as by engaging the tab(s) 821A, 821B. Slidable clip 821 also preferably adjusts and holds its position with members such as the meshing teeth 82lC which are illustrated.
FIG. 14 shows a diagnostic catheter that incorporates a secondary or positioning balloon 830, which is considerably smaller than the primary balloon, as well as the slidable clip 821. Small or secondary balloon 830 may be made of polymeric materials suitable for medical device balloons, and preferably of an elastomeric material to enhance its holding effectiveness.
The distal portion of this catheter 810, including at least a portion of each of the primary balloon 820 and of the secondary balloon 830, is inserted into the patient's rectal cavity 40 in this embodiment.
Slidable clip 821 has been positioned on the catheter for imparting the desired profile and size of the primary balloon 820 and so as to be located at the patient's orifice. In the preferred embodiment, the slidable clip 821 is radiopaque to mark its location during radiographic viewing. Large or primary balloon is inflated through hole 811, expanding the rectal cavity for radiation diagnosis. Secondary balloon 830 is inflated through holes 812 to secure the catheter assembly.
The proximal and distal ends of the secondary balloon 830 are adhered to the tube of the catheter 810, and the slidable clip 821 may be secured anywhere along the length of the secondary balloon (with the primary balloon usually being positioned therebetween. Secondary balloon 830 may be inflated either proximally or distally of the clip location, or, as shown in FIG. 14, both proximally and distally of the slidable clip 821, preferably in an isolated manner.
FIG. 15 illustrates a catheter for diagnosis in a bladder 841. The particular illustrated bladder 841 is a male bladder; however, the invention is suitable for use ~16~91~
in female bladders as well. This diagnostic catheter includes a catheter tube or body 823A having a Foley-type catheter tube 823B with a detachable urine bag 823C. Also included are a primary balloon 820, a secondary balloon 830, and radiopaque reference line(s) 822. This diagnostic catheter is inserted through the urinary tract 842 into the bladder. A hole 819 at the distal tip of the body permits necessary urine flow during the procedure.
Urine flows through hole 819 into a separate isolated communication line 817A (FIG. 16) in the catheter tube and into a branch 817 having the Foley-type catheter tube 823B .
AS is the case for the FIG. 14 embodiment, the primary balloon 820 of this embodiment is inflated through one or more holes 811. Secondary balloon 830 is inflated through one or more holes 812. Both balloons are adhered to the catheter at their respective distal and proximal circumferential ends. The secondary balloon is located near the proximal end of the primary balloon. The distal end of the primary balloon is located just proximal of the distal tip of the catheter and includes the drainage hole 819. The illustrated primary balloon has radiopaque reference line(s) to provide a marking reference for the physician during radiographic viewing.
A branch 815 of the catheter tube 823A is at the proximal end of the fluid communication line for inflating the secondary balloon 830. A passageway 815A within the catheter tube 823A and branch 815 provides this fluid communication. The physician may attach any fitting, valve or regulator 816 to the branch which permits connection to and control of the source for inflation and deflation of the small balloon 830, such as the hypodermic syringe 824 shown in FIG. 12. Branch 812 is functionally similar to branch 815, except that it is used for isolated fluid communication with the primary balloon 820. A
passageway 812A within the catheter tube 823A and branch 21~6915 812 provides this fluid communication. Any fitting, valve or regulator 818 may be attached to this branch.
In the radiation diagnosis aspect of the invention, the physician selects the appropriate embodiment for the required diagnostic procedure, whether it includes one or more of the slidable clip and/or secondary balloon as an adjustable securement member, and/or a Foley-type catheter tube, and/or radiopaque reference line(s). The physician inserts the selected embodiment of the diagnostic catheter into and through the orifice of the body cavity to be diagnosed.
When the diagnostic catheter has a slidable clip, the physician inserts the desired amount of the primary balloon to the desired catheter penetration depth and then secures the clip at the body orifice by appropriate simplified manipulation of the clip. In those instances where a secondary balloon is included, the physician inflates this now by admitting the pressurized fluid through the appropriate branch at the proximal end of the catheter. When a Foley-type catheter is included, the drainage function of this device would operate as customary while the diagnosis is taking place with the primary balloon being inflated.
In the instance of a catheter as generally illustrated in FIG. 15, after initial insertion into the urinary tract, the physician inflates the small or secondary balloon to secure the assembly in place at the proximal end of the bladder. Next, the physician inflates the larger or primary balloon to thereby mark and/or manipulate the body cavity. When the radiopaque reference line(s) feature is included, the physician has a radiographic image of the boundary of the body cavity. If a radiographic inflating fluid is used to inflate the primary balloon, the physician also has a radiographic image of the internal walls of the body cavity when viewed in the usual manner of diagnosis. This allows the physician to see characteristics of the body cavity that 216691~
will be of great assistance in diagnosing disease, such as potentially cancerous areas that can be treated by radiation therapy.
It will be understood that variations of and modifications to the present invention may be made without departing from the spirit and scope of the invention.
Claims (27)
1. An intracavitary catheter for insertion into a body cavity to enable internal diagnosis in an intracavitary manner, the catheter comprising:
a tubular catheter body sized and shaped for insertion through a living body orifice and into an existing body cavity accessible through the orifice, said tubular catheter body having a proximal end portion and a distal end portion;
a primary balloon positioned over a portion of said tubular catheter body, said primary balloon having a proximal end and a distal end, said proximal end of the primary balloon being secured to said tubular catheter body;
an inflation passageway for communication of fluids into and out of said primary balloon so as to radially expand and contracts said primary balloon while same is within the body cavity;
a diagnostic member exhibiting radioactivity and extending generally along at least a portion of said primary balloon so as to move toward an internal wall of the body cavity when said primary balloon is radially expanded; and a receptor for engaging said diagnostic member, said receptor being on said primary balloon.
a tubular catheter body sized and shaped for insertion through a living body orifice and into an existing body cavity accessible through the orifice, said tubular catheter body having a proximal end portion and a distal end portion;
a primary balloon positioned over a portion of said tubular catheter body, said primary balloon having a proximal end and a distal end, said proximal end of the primary balloon being secured to said tubular catheter body;
an inflation passageway for communication of fluids into and out of said primary balloon so as to radially expand and contracts said primary balloon while same is within the body cavity;
a diagnostic member exhibiting radioactivity and extending generally along at least a portion of said primary balloon so as to move toward an internal wall of the body cavity when said primary balloon is radially expanded; and a receptor for engaging said diagnostic member, said receptor being on said primary balloon.
2. The catheter of claim 1, wherein said diagnostic member includes a radiotherapeutic rod and said receptor engages same.
3. The catheter of claim 1, wherein said primary balloon has a surface wall, and said receptor is an elongated pocket on said surface wall of said balloon.
4. The catheter of claim 1, wherein said receptor is a loop of material which substantially affixes the radiotherapeutic rod along the contour of said primary balloon.
5. The catheter of claim 1, further including a securement assembly to maintain the apparatus in the body cavity.
6. The catheter of claim 5, wherein said securement assembly includes a catheter lead extending distally from said distal end of the catheter body for insertion through a narrowed section within the body cavity.
7. The catheter of claim 5, wherein said securement assembly includes a template which is positioned at or near said proximal end of the balloon, said template having at least one hole therethrough, the catheter and balloon passing through said hole in the template.
8. The catheter of claim 5, wherein said securement assembly includes a template, and one or more tether catheters securable to the template, each said tether catheter having an anchoring member for positioning in an adjacent body cavity.
9. The catheter of claim 8, wherein said anchoring member is an anchoring balloon which inflates within the adjacent body cavity.
10. The catheter of claim 5, wherein said securement assembly includes a secondary balloon positioned within said primary balloon, said secondary balloon having an axial length which i.s substantially shorter than that of said primary balloon, said secondary balloon being secured to said tubular catheter body, further including another passageway in said tubular catheter body and which is isolated from said inflation passageway through the tubular catheter body, whereby a fluid passes from a fluid source, through said another passageway and into said secondary balloon.
11. The catheter of claim 5, wherein said securement assembly includes an anchoring balloon which is positioned distally of the primary balloon toward the distal end portion of the catheter, said anchoring balloon communicating with another passageway isolated from said inflation passageway through said tubular catheter body, whereby a fluid passes from a fluid source, through said another passageway and into said anchoring balloon.
12. The catheter of any one of claims 1-11, wherein said distal end portion of the primary balloon extends distally beyond and is unsealed to said tubular catheter body.
13. The catheter of any one of claims 1-11, wherein a distal tip portion of raid tubular catheter body extends distally out of and beyond said distal end portion of the primary balloon, and said distal end portion of the primary balloon is sealed to said tubular catheter body.
14. The catheter of claim 13, further including a distal opening in said distal tip portion of the tubular catheter body and a drainage passageway extending from said distal opening to a collection location external of the body cavity of the living patient.
15. The catheter of any one of claims 1-11 and 14, wherein said primary balloon has sufficient axial length and radial extendibility to generally fill the portion of the body cavity to be subjected to diagnosis when the balloon is inflated, and said balloon provides manipulation of the body cavity by expansive engagement between the balloon and the body cavity upon inflation of the balloon.
16. The catheter of claim 7, wherein said template has a plurality of holes therethrough, one of said holes receiving and thereby directing at least one radiotherapeutic rod into one of the rod receiving members of the therapeutic balloon.
17. The catheter of claim 7, further including suture holes in said template to suture the catheter to tissue surrounding the orifice in which the catheter is inserted to provide securement.
18. The catheter of claim 1, wherein said shape of the primary balloon is that of a generally concave ellipsoid.
19. The catheter of claim 1, wherein said primary balloon is substantially longer than wide, and said tubular catheter is elongated and includes a longitudinal passageway which communicates from the distal end portion to the proximal end portion of said tubular catheter body
20. The catheter of claim 1, wherein said primary balloon is bifurcate a into two sections each sized and shaped such that when inflated each said section engages internal tissue of a hypopharynx, nasopharynx, superglottic or subglottic region and such that one said section enters a first pyriform fossa and another said section enters a second pyriform fossa.
21. The catheter of claim 20, wherein each said bifurcated balloon section includes a radiotherapeutic member which moves with said balloon section when it expands into engagement with said internal tissue.
22. The catheter of claim 1, wherein said diagnostic member is to insert biocompatible or radiopaque fluids into said primary balloon to identify the position and shape of a body cavity of a living patient: during radiation diagnosis.
23. The catheter of claim 1 or 22, further including an adjustable securement assembly in engagement with said primary balloon for selectively defining said proximal end of the balloon at differing locations along said tubular catheter body.
24. The catheter of claim 23, wherein said adjustable securement assembly is a clip which is slidable along said tubular catheter body and over at least the proximal end portion of the primary balloon, which clip clamps over said primary balloon to prevent the fluid from flowing into and expanding the primary balloon at a location which is proximal of the clip.
25. The catheter of claim 24, wherein said slidable clip includes a plurality of oppositely disposed intermeshing teeth to adjust the circumference of the slidable clip.
26. The catheter of claim 1 or 22, wherein said inflation passageway opens at its proximal end into a hypodermic syringe which is a reservoir for biocompatible or radiopaque fluid.
27. The catheter of claim 1, wherein at least one radiopaque reference line is provided on the primary balloon for radiopaque viewing.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US395,865 | 1995-02-28 | ||
| US08/395,865 US5653683A (en) | 1995-02-28 | 1995-02-28 | Intracavitary catheter for use in therapeutic radiation procedures |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2166915A1 CA2166915A1 (en) | 1996-08-29 |
| CA2166915C true CA2166915C (en) | 2002-12-10 |
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ID=23564864
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002166915A Expired - Lifetime CA2166915C (en) | 1995-02-28 | 1996-01-10 | Intracavitary catheter for use in therapeutic radiation procedures |
Country Status (2)
| Country | Link |
|---|---|
| US (2) | US5653683A (en) |
| CA (1) | CA2166915C (en) |
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| US6582352B2 (en) | 1994-06-10 | 2003-06-24 | Schneider (Europe) A.G. | Medical appliance for treatment by ionizing radiation |
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Also Published As
| Publication number | Publication date |
|---|---|
| US5653683A (en) | 1997-08-05 |
| US5720717A (en) | 1998-02-24 |
| CA2166915A1 (en) | 1996-08-29 |
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