WO2007134126A2 - After-loader devices and kits and methods for their use - Google Patents

After-loader devices and kits and methods for their use Download PDF

Info

Publication number
WO2007134126A2
WO2007134126A2 PCT/US2007/068595 US2007068595W WO2007134126A2 WO 2007134126 A2 WO2007134126 A2 WO 2007134126A2 US 2007068595 W US2007068595 W US 2007068595W WO 2007134126 A2 WO2007134126 A2 WO 2007134126A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle
loader
loader device
bore
implant
Prior art date
Application number
PCT/US2007/068595
Other languages
French (fr)
Other versions
WO2007134126A3 (en
Inventor
Gary A. Lamoureux
Warren W. Johnston
Anthony Viselli
Paul Walker
Edward Bleich
Original Assignee
Worldwide Medical Technologies Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Worldwide Medical Technologies Llc filed Critical Worldwide Medical Technologies Llc
Publication of WO2007134126A2 publication Critical patent/WO2007134126A2/en
Publication of WO2007134126A3 publication Critical patent/WO2007134126A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007Arrangements or means for the introduction of sources into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0069Devices for implanting pellets, e.g. markers or solid medicaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007Arrangements or means for the introduction of sources into the body
    • A61N2005/1008Apparatus for temporary insertion of sources, e.g. afterloaders

Definitions

  • This invention relates to devices and methods that are used for transferring implants to needles used in hrachytherapy
  • Brachy therapy is a general term covering medical treatment which involves placement of radioactive sources near a diseased tissue and can involve the temporan or permanent im plantation or insertion of radioactive sources into the body of a patient
  • the radioactive sources are located in proximity to the area of the body which is being treated. A high dose of radiation can thereby be delivered to the treatment site with relatively low doses of radiation to surrounding or intervening healthy tissue
  • Exemplary radioactive sources include radioactive seeds, radioactive rods and radioactive coils.
  • Brachytherapy has been used or proposed for use in the treatment of a variety of conditions, including arthritis and cancer.
  • Exemplary cancers tSiat can be treated using brachytherapy include breast, brain, liver and ovarian cancer and especially prostate cancer in men.
  • treatment for prostate cancer can involve the temporary- implantation of radioactive sources (e.g., rods) for a calculated period, followed by the subsequent removal of the radioactive sources.
  • radioactive sources e.g., seeds
  • the use of temporary or permanent implantation depends on the isotope selected and the duration and intensity of treatment required.
  • Permanent implants for prostate treatment include radioisotopes with relatively short half lives and lower energies relative to temporary seeds
  • Exemplary permanently implantable sources include iodine- 125, palladium- 103 or cesium-131 as the radioisotope.
  • the radioisotope can be encapsulated in a biocompatible casing (e.g., a titanium casing) to form a "seed" which is then implanted.
  • Temporary implants for the treatment of prostate cancer may involve iridium-192 as the radioisotope. For temporary implants, radioactive rods are often used.
  • radioactive seeds are typically smooth sealed containers or capsules of a biocompatible material, e.g., titanium or stainless steel, containing a radioisotope within the sealed chamber that permits radiation to exit through the container/chamber walls.
  • Other types of implantable radioactive sources for use in radiotherapy are radioactive rods and radioactive coils, as mentioned above.
  • the implantation of radioactive sources for brachytherapy is carried out using minimally-invasive techniques such as, e.g., techniques involving hollow needles. It is possible to calculate a desired location for each radioactive source which will give the desired radiation dose profile.
  • the dimensions of tissues and organs within the body for use in such dosage calculations can be obtained prior to or during placement of the radioactive sources by using conventional diagnostic imaging techniques including X-iay imaging, magnetic resonance imaging (MRI ). computed tomography (C O imaging, fluoroscopy and ultrasound imaging
  • a surgeon can monitor the position of tissues such as the prostate gland using, c g , ultrasound imaging o ⁇ fluoroscopy techniques which offei the advantage of Sow risk and convenience to both patient and surgeon The surgeon can also monitor the position of the relatnely large needle used in implantation procedures using ultrasound or othe* imaging
  • brachvtherapy t ⁇ picali ⁇ employs hoi Sow needles that are insertab!e into a patient's body, often with the assistance of a template ⁇ typical template used to guide and/or inform the positioning of hollow needle* at a surgical site can provide access to more than one hundred locations The number of locations can be so numerous that a typical pitch between needle access points can include a pitch of 5 ram
  • a hollow needle as explained abov e, is used to implant radioactive sources and or other types of treatment elements into patient tissue at a desired location and to a des ⁇ ed depth
  • Such treatment elements which arc implantable using the hollow needle, shall be collective!
  • Such an implant can be an elongate treatment member, such as a strand that includes a plurality of radioactive sources (e g , seeds) spaced apart from one another within a bioabsorbabie materia!
  • an implant can be another type of treatment member that includes a plurality of radioactive sources spaced apart from one another, such as a member formed of seeds and spaceis that aie frictiona ⁇ ly or otherwise connected to one another (e g , as described in U S Patent Kos 6.010,446 and 6,450, ⁇ 39, which are incorporated herein by reference)
  • An elongate treatment member may also be made from a hollow tube that includes a plurality of seeds and spacers loaded within a bore of the tube, with the tube possibly heat shrunk around the seeds and spacers, or the ends of the tube otherwise closed Alternatively .
  • an implant can be a plurality of loose seeds and loose spacers axialiy aligned one behind the other H it> also possible that tiie implant be a smgie loose radioactive source
  • an implant can include one or more iadioactise rod or coil
  • An impSaiu can also include one or more seed that has anchoring mechanisms, exemplary details of which are provided m cornrnoniy assigned L S Patent Application Serial No 1 1/187,41 L entitled "Implants for Use in Brachs therapy and Other Radiation Therapy That Resist Migration and Rotation," filed July 22, 2005,
  • the implant can be or include some other object and need not be radioactive, e.g. a spacer, a marker, or a thermal seed that gives off heat.
  • FIGS. IA and SB A first type of needle, shown in FlG. 1 A, is often referred to as an applicator needle, and Is sometimes marketed under the trademark MICK* ' needle.
  • an applicator needle 102a is shown as including a hollow needle 104a (also referred to as a cannula) with a blunt or ⁇ n ⁇ sliarpened distal end 106a, and a huh 108a positioned at a proximal end.
  • the huh 108a as shown, has a generally simple cylindrical shape.
  • An exemplary length of the entire needle 102a including the hub is about 7 7/8 inches (about 20cm), with the hub 108a having a length of about 1 inch (about 2.5cm).
  • the hub 108a surrounds a proximal portion of the cannula 104a.
  • a bore UOa also referred to as a lumen extends through the applicator needle 102a.
  • An exemplar ⁇ ' diameter of the bore 1 10a i.e., the inner diameter of the cannula 104a
  • a sharp stylet (not shown) is inserted through the lumen HOa of the hollow needle, so that the sharp distal end of the sharp stylet (e.g., a trocar tip) extends past the blunt distal end 106a of the applicator needle 102a.
  • the needle 102a with the sharp stylet point extending out its biunt distal end 106a, can then be inserted into patient tissue at a desired location, including to a desired depth. Thereafter, the sharp stylet is removed, and an implant (e.g., a strand, seeds and spacers, or combinations thereof) is loaded into the needle through the proximal end of the needle.
  • an implant e.g., a strand, seeds and spacers, or combinations thereof
  • Tweezers or the like can be used to insert a strand or other treatment member, and/or loose seeds and spacers, into the proximal end of the needle.
  • a blunt ended stylet (not shown) can then be inserted into the proximal opening of the needle 102a, until the distal end of the stylet contacts the proximal end of the treatment member (or most proximal seed or spacer). The needle can then be retracted with the stylet held in position so that the implant is deposited at a desired location.
  • an applicator device such as a MICK* ' applicator
  • the applicator device can be used to dispose loose seeds (and optionally loose spacers) through the needle 102a and into patient tissue.
  • the MICK* applicator is available from Mick Radio-Nuclear Instruments, Inc., Mount Vernon, NY Details of the NUCIv* applicator a*e provided in U S Patent No S 860, ⁇ ) 09
  • a second type of needle 102b which shall be refe ⁇ ed to herein as a locking hub needle for reasons tlial will be apparent (and sometimes referred to as a prostate .seed needle, a .standard needle, or a seed lock needle), includes a cannula 104b, a sharpened distal end 106b (e g . a beveled end), and a hub 108b positioned at a proximal end
  • the bub 108b has an enlarged diameter with a funneled pioximai portion 112, and threads 1 14 on an outer circumference, that may be used, e g .
  • the funneled distal end 1 12 allows a moie forgiving tolerance foi inserting implants into a lumen 1 iOb of the cannula iO4b (if tweezers or the like axe used to insert a treatment member and/or l ⁇ ot>e seeds and spacers into the proximal end of the needle) Nevertheless, even though the proximal funneled opening of needle 102b is larger then the proximal opening of needle 102a, it can still be very difficult and time consuming to load an implant into the needle 102b Such needles 102b a?e typically plugged at the distal end with boncwax oi some olhei plugging material, and pre-loaded with a treatment member and/or loose seeds and spacers, prior to the needle 102b being inserted into patient tissue Alternatively, such needles 102b can be loaded ⁇ i e .
  • exemplary length of the entire needle 102b, including the hub is about 8 7/8 inches (about 22 5cm)
  • An exemplary length of the hub 108b is about 1 inch (about 2 5 inches)
  • only a portion of the hub 108a su ⁇ ounds a proximal portion of the cannula 104b, so that the funneled portion 1 12 can have a larger diameter than the diameter of the cannula 104b
  • An exemplary diameter of the bore HOb i e , the inner diameter of the cannula 1.04b is about 0 042 inches
  • Embodiments of the present invention relate to devices, referred to as after-loader devices, that are useful for loading an implant, into a hollow needle after the needle is inserted into patient tissue.
  • Embodiments of the present invention also relate to kits that include such after-loader devices, as well as methods for using after-loader devices.
  • an after-loader device is especially useful for a connecting to a hollow needle, known as an applicator needle, which has a simple cylindrical needle hub at the proximal end of the needle.
  • the after-loader includes an elongated body having a proximal end and a distal end, with a bore extending axialiy through the body between the proximal and distal ends.
  • a main portion of the bore has a first inner diameter that is approximately equal to the inner diameter of the hollow needle to which the after-loader attaches.
  • a distal portion of the bore has a second inner diameter that is larger than the outer diameter of the needle hub, with the distal portion of the bore being configured to connect to the cylindrical needle hub of the hollow needle,
  • a depth of the distal portion of the bore is sufficient to enable the body of the after-loader device to rigidly connect to the cylindrical needle hub of the hollow needle without requiring additional support.
  • a proximal portion of the bore can be tunneled to assist with inserting an implant and/or a stylet into the bore.
  • the after-loader device includes a radiation shield configured to slide over an outer circumferential surface of a main portion of the body, to thereby cover the main portion of the body.
  • the body of the after-loader can be translucent or transparent so that a user can observe an implant loaded into the bore, when the radiation shield is at least partially removed.
  • a distal portion of the body of the after- loader has an outer diameter that is greater than an outer diameter of the main portion of the body, and greater than an inner diameter of the radiation shield. Such distal portion of the body provides a stop for the radiation shield, and also accommodates the distal portion of the bore. Additionally, a tapered outer circumference, that extends between the distal portion of the body and the main portion of the body, can provide a friction fit between the body and the radiation shield.
  • the after-loader device includes a distal end plug to plug a distal opening of the bore, and a proximal end plug to plug a proximal opening of the bore.
  • the distal end plug and the proximal end plug when respectively plugged into the distal and proximal openings of the bore, prevent an implant loaded in the bore tYora falling out of the bore.
  • Such end plugs can each include a gripping portion and an insertion portion, and can be made from a radiation blocking material,
  • a tapered nose at the distal end of the body is configured to Ht into a hub of a second type of hollow needle, such as a locking hub needle.
  • the after-loader device includes an adapter for use in connecting the body of the after-loader device to a second type of hollow needle, such as a locking hub needle.
  • a second type of hollow needle such as a locking hub needle.
  • an adaptor can include a central portion, a distal hollow shaft and a proximal hollow shaft.
  • the distal hollow shaft is for insertion into a hub of the second type of needle and into a proximal most portion of a lumen of the second type of needle.
  • the proximal hollow shall if for insertion into the distal portion of the bore of the body of the after-loader device.
  • the central portion of the adaptor can includes inner threads, for engaging threads on the hub of the second type of needle.
  • kits can include a plurality of after-loader devices, each of which is useful for loading an implant into a hollow needle after the needle is inserted into patient tissue.
  • the kit can also include a plurality of treatment members, each member loaded into a bore of one of the after-loader devices, and maintained in the bore by end-plugs of the after-loader device.
  • Each such member e.g., a strand
  • an implant loaded into a bore can include a plurality of loose seeds separated from one another by spacers.
  • Each the after-loader device of the kit can include a radiation shield that surrounds at least, a main portion of the body of the after-loader device.
  • the kit can include at least one stylet having a length that is at least as Song as a total length of the after-loader device connected with a hollow needle, as well as at least one hollow needle.
  • the plurality of treatment members of the kit fulfill an entire predetermined treatment plan for a patient.
  • the kit can also include a tray holding the plurality of after-loader devices loaded with the plurality of treatment members, as well as a pouch housing the tray (which is holding the plurality of after- loader devices loaded with the plurality of treatment members).
  • the kit can also include at least one adaptor configured to connect the after-loader devices to hub of a locking hub hoi Sow needle.
  • Embodiments of the present Invention are also directed to methods for implanting implants into patient tissue.
  • a distal end of a hollow needle is inserted Into patient tissue at a desired location and to a desired depth.
  • a sharp end of a sharp stylet is extended beyond the distal end of the hoHovv needle, to assist with the insertion of the needle.
  • the needle has a sharpened distal end, such a sharpened stylet need not be used.
  • the after-loader device can be connected to the cylindrical needle hub by inserting at least a portion of the cylindrical needle hub into a distal portion of a bore of the after-loader, such that the after-loader is rigidly connected to the cylindrical needle hub of the hollow needle without requiring additional support, A stylet is inserted into an opening at a proximal end of the after-loader device, to urge an implant from the after-loader device into a lumen of the hollow needle.
  • Certain embodiments employ the use of a stylet having a length that is at least as long as a total length of the after-loader device connected with a hollow needle. Where such a stylet is available, the implant can be urged from the after-loader device, through a lumen of the hollow needle, to a distal end of the hollow needle, while the after-loader device is still connected to the needle. Thereafter, the hollow needle and the after-loader device are retracted, while the stylet is held in place, to thereby deposit the implant at the desired location and to the depth.
  • the implant can be loaded into the bore of the after-loader device, after the after-loader device is connected to the hollow needle, but before the stylet is inserted into the after-loader device. In other embodiments, the implant was already loaded into the bore of the after-loader device before the after-loader device is connected to the hollow needle.
  • the end plugs of the after-loader device which maintain the implant within a bore of the after- loader device, are removed prior to connecting the after-loader device to the hollow needle.
  • the implant is a treatment strand or other treatment member, which includes a plurality of radioactive sources spaced apart from one another Alternatively, or additional! ⁇ 1 , the implant can be a plurality of loose seeds and spacers.
  • Other implants are also possible, as described below.
  • the stylet to be employed is not as long as a total length of the after-loader device connected with a hollow needle
  • the stylet is used to urging an implant from the after-loader device, into a 1 uracil of the hollow needle.
  • the stylet is then retracted from the after-loader, and the after-loader is removed, i.e., disconnected from the hollow needle.
  • a stylet (the same or a different stylet) is inserted into an opening at a distal end of the hollow needle, and the stylet is used to urge the implant to a distal end of the hollow needle.
  • the hollow needle is retracted while the stylet is held in place, to thereby deposit the implant at the desired location and to the depth.
  • Methods of the present invention also include methods that used the adaptor mentioned above. For example, after a distal end of a hollow needle is inserted into patient tissue, a distal hollow shaft of an adaptor can be inserted through the needle hub and into a proximal portion of a lumen of the hollow needle, and an after-loader device can be connected to a proximal hollow shaft of the adaptor. It is also possible that the adaptor, just described, already be connected to the proximal portion of a hollow needle, when the distal end of the hollow needle is inserted into patient tissue, A stylet can then be inserted into an opening at a proximal end of the after-loader device.
  • the after-loader body and adaptor may be left in place during the remainder of the implant procedure, or may need to be removed before a stylet is used to urge the implant to the distal end of the hollow needle.
  • the hollow needle (and the after- loader device and adaptor, if still in place) are then retracted, while the stylet is held in place, to thereby deposit tlie implant at the desired location and to the depth.
  • FIG. IA is a side view of first type of hollow brachytherapy needle, often referred to as an applicator needle,
  • FIG. IB is a side view of a second type of hollow brachytherapy needle, sometime referred to as a seed lock needle, or a locking hub needle.
  • FIG. 2A Is a side view of an after-loader in accordance with an embodiment of the present invention, with its shield removed,
  • FSG. 2B is a side view of the after-loader device of FlG. 2A, with its shield in place.
  • FIG. 2C is a perspective view of the after-loader device of FKJS, 2A & 2B, with its shield removed.
  • FSG. 2D is a perspective view of the shield of the after-loader device.
  • FSG. 3 A is a cross- sectional side view of the after-loader of FlG. 2 A mated with. the needle of FIG. I A, and having a stylet disposed within the after-loader device and hollow needle,
  • FlG. 3B is a cross-sectional side view of the after-loader of FIG. 2A mated with the hollow needle of FIG. IB, and having a stylet disposed within the after-loader device and hollow needle.
  • FICJ. 4A IS a perspective view of an adaptor, according to an embodiment of the present invention, which can be used to help connect the after-Soader device of FIGS. 2A & 2B to the hollow needle of FIG. 1 B.
  • FIG. 4B is a cross-sectional view of the adaptor of FIG. 4A.
  • FIG. 4C is a cross-sectional side view of the after-loader device of FIG. 2A mated with the ho ⁇ ow needle of FlG. LB, using the adapter of FiGS. 4A and 4.B. and having a styiei disposed within the bore of the after-foader and adaptor and the hollow needle.
  • FlG. 5A is a side view of a distal end plug for an after-loader, in accordance with an embodiment of the present invention.
  • FIG. 5B is a side view of a proximal end plug for an after-loader, in accordance with an embodiment of the present invention
  • FlG. 5C is a side view of the after-loader of FIGS, 2A-2C (without its shield) with the distal and proximal end plugs of FIGS. 5 A and 5 B in place.
  • FIG. 6A is a. side view of a distal end plug for an after-loader, In accordance with another embodiment of the present invention,
  • FIG. 6B is a side view of a proximal end plug for an after-loader, in accordance with another embodiment of the present invention.
  • FIG. 7 shows a plurality of after-loaded devices within a tray.
  • FIG. 8 is a high level flow diagram that is used to summarize a method of using an after-loader, in accordance with an embodiment of the present invention.
  • FIG. 9 is a high levei flow diagram that is used to summarise a method of using an after-loader, in accordance with an alternative embodiment of the present invention.
  • embodiments of the present invention relate to devices, referred to as after-loader devices, that are useful for loading an implant into a hollow needle after the needle is inserted into patient tissue.
  • embodiments of the present invention also relate to kits that include such after-loader devices, as well as methods for using after-loader devices.
  • an after-loader of the present invention can simplify and/or expedite the loading of an implant into a hollow needle, especially after the needle has been inserted into patient tissue it is because such a device is useful in loading a hollow needle "after” the needle is inserted into patient tissue, that the device is referred to herein as an "after-loader". Nevertheless, the after-loader device can also be used to pre- ioad a needle (i.e., load an implant into a hollow needle before the needle is inserted into patient tissue), if desired.
  • FIG. 2A an after-loader device 202, according to an embodiment of the present invention, is shown
  • FlG. 2C shows a perspective view of the after-loader device 202, which is also referred to simply as an after-ioader 202.
  • the after-loader 202 can be used with the applicator needle 102a of F ⁇ G. IA (as shown in FIG. 3A), or alternatively with the locking hub needie 1.02b of FIG. IB (as shown in FIGS. 38 and 4C), providing flexibility in needle choice.
  • the after-loader 202 includes an elongated body 204 having a distal end 206, a proximal end 208, with a bore 210 extending therebetween.
  • the body 204 of the after-loader 202 is shown as having a generally cylindrical shape, however variations on this are possible.
  • the body 204 of the after-loader 202, or the after-loader 202 in general, includes a dista! portion 212, a main portion 214 and a proximal portion 216,
  • the main portion 214 of the after-loader 202 includes a generally constant outer diameter (e.g., 0.162 inches), and a generally constant inner diameter (e g., 0.055 inches), with the inner diameter being about the same as the inner diameter of the needle with which the after-loader 202 will interface (as mentioned abouve, the inner diameter of the cannula of the hollow needles 102a and 102b can be about 0,042 inches).
  • the diameter of the bore 210 that extends through the main portion 214 of the after-loader 202 should be slightly larger than the outer diameter of the implant (e.g., strand, seed(s) and/or spacer(s)) that is to be loaded into the after-loader 202.
  • the inner diameter of the bore 210 of the main portion 214 of the after- loader 202 can have one or more step., and/or have a taper (rather than having a constant inner diameter), such that the proximal end of the bore 210 within the main portion 214 has a slightly larger diameter than the distal end of the bore 2 K) within the main portion 214.
  • the distal portion 212 of the after-ioader 202 includes ati enlarged outer diameter (e.g., 0.188 inches), which tapers at each end. More specifically, at the proximal end of the distal portion, the distal portion 212 tapers at a small angle ⁇ (e.g., 5 degrees) until the diameter of the main portion 214 of the body 204 (e.g., 0.162 inches) is reached.
  • e.g., 5 degrees
  • the purpose of this taper 219 is to provide a friction fit for a shield 250 that slides over the rest of the after-loader 202, the friction fit being attributable to the increase in diameter toward the distal portion 210,
  • the shield 250 is positioned around the after-loader 202 to reduce or minify an amount of radiation that escapes from the after-loader 202 where implants placed in the after-loader 202 are radioactive
  • FIG. 2B shows the after-loader 202 with its shield 250 in place
  • F ⁇ G. ID shows
  • the taper at the distal end of the distal portion 212 forms a nose 218 of the after-loader 202, which is tapered at an angle ⁇ generally corresponding to an angle of the funnel ed proximal portion 1 12 of the Socking hub needle 102b.
  • an external angle of the nose 2i S can be approximately 15 degrees in angle, in an embodiment wherein a typical Socking hub needle 102b is to be accommodated.
  • the nose 218 of the after-loader 202 can be positioned within the funnel ed portion 1 12 of the locking hub needle 102b, so that the after-loader 202 is removably mated with the hub 108b of the locking hub needle 102b, as can be appreciated from FlG. 3B, discussed in more detail below. It is also possible that an after-loader 202 not include a tapered nose 218.
  • a funoeled portion 230 of the bore 210 of the after-loader 202 can be tunneled at an angle ⁇ to simplify insertion of an implant, and stylet into the bore 210 of the after- loader 202.
  • the funnel can cause an increase in diameter at a 5 to 10 degree angle, and specifically at an 8 degree angle.
  • Such funneled portion 230 of the bore 210 extends through the proximal portion 216 of the body 204.
  • the body 204 of the after-loader 202 can be made of a transparent or translucent material, such as a media! grade plastic, e.g., acrylic, polycarbonate or other plastic, that enables a user (e.g.. physician, clinician, physicist, etc.) to visually verify the contents (i.e., implant) loaded in the after-loader 202.
  • a media! grade plastic e.g., acrylic, polycarbonate or other plastic
  • the shield 250 is employed to reduce and preferably prevent leakage. As shown in FIG.
  • the shield 250 can be a hollow cylinder formed of a material (e.g., stainless steel) that sufficiently restricts the amount of radiation that escapes the shield 250.
  • the shield 250 can be slid back (i.e., toward the proximal end of the after-loader 202) to reveal the contents of the after-loader 202, for visual verification purposes.
  • the after- loader 202 itself can be made from a material more opaque to radiation, such as stainless steei, or a plastic impregnated with lead, or some other shielded plastic.
  • the enlarged outer diameter of the distal portion 212 of the after-loader 202 serves two purposes. First, it enables the diameter of a distal portion 220 of the bore 210 to be enlarged to accommodate the hub 108a of the applicator needle 102a, as discussed in more detail below. Further, it acts as a stop to hold the shield 250 in place at the proper location after the shield 250 has been slid over the proximal end 208 of the after-loader 202.
  • the inner diameter of the distal portion 212 of the after-loader 202 is larger than the inner diameter of the main portion 214 of the after- loader 202, so that the hub 108a of the applicator needle 102a can be accepted therein.
  • the diameter of the distal portion 220 of the bore 210 (which is the portion of the bore 210 within distal portion 212) is larger than the diameter of the main portion of the bore 210 (i.e., the portion of the bore 210 extending through the main portion 214 of the body 204).
  • the distal opening of the portion 220 of the bore 210 extending from the distal end 206 towards the proximal end 208 of the body 204, has a diameter that is slightly larger than the outer diameter of the hub 10Sa of the applicator needle 102a, so that the distal portion 220 of bore 210 is configured to receive, and thereby connect to, the huh 108a of the applicator needle i02a.
  • the diameter of the distal portion 220 of the bore 210 can be 0.099 inches, while the diameter of the main portion of the bore 210, which roughly corresponds to the inner diameter of a hollow needle, can be fro ⁇ i anywhere from about 0.042 to 0.055 inches,
  • the distal portion 220 of the bore 210 has a slight taper from its opening rearward (e.g., an opening diameter of 0.105 inches tapers to 0.985 inches), so that a slight friction fit can be provided between the distal portion 220 of the bore 210 and the hub 108a accepted therein (presuming the outer diameter of the hub 108a is less than 0.105 inches, but greater than 0.985 inches).
  • a depth d of the distal portion 220 of the bore 210 is preferably sufficient to enable the body 204 of the after-loader 202 to rigidly connect to the hub 108a of the needle 102a without requiring any additional support, e.g., from a user or some support structure (e.g., a support rod).
  • a depth d Preferably such depth d ⁇ % at least 14 inch, and more preferably about Vx inch.
  • other depths will work, and are within the scope of the present invention.
  • FIG. 3 A shows a cross-section of the after-loader 202 accepting the hub 108a of an applicator needle 102a.
  • FKl. 3 A also shows a stylet 302, including a handle 304 at its proximal end, inserted through the bore 210 of the after-loader 202 and the lumen 1 10a of the applicator needle 102a.
  • the diameter of the distal portion 220 of the bore 210 of the after-loader is slightly larger than the outer diameter of the hub 108a, so the hub 108a fits therein.
  • FIG. 3 B shows a cross-section of the after-loader 202 with its nose 2 18 within the tunneled portion. 1 12 of a locking hub needle 102b.
  • FlG. 3 A also shows a stylet 302, including a handle 304 at its proximal end, inserted through the bore 210 of the after- loader 202 and the lumen i JOb of the locking hub needle 102b,
  • the after-loader 202 may need to be supported by the user, to prevent the after-loader from disengaging from the hub 108b of the needle 102b.
  • an adaptor 402 of an embodiment of the present invention can be used, as will now be explained with reference to FIGS. 4A-4C.
  • FIG. 4A is a perspective view of the adaptor 402, in accordance with an embodiment of the present invention.
  • FIG. 4B is a cross-section of the adaptor 402.
  • the adaptor 402 includes a central portion 404, from which extends a distal hollow shaft 406 and a proximal hollow shall 408.
  • the hollow shafts 406 and 408 can be discontinuous (i.e , separate from one another), as shown in HG. 4B.
  • the distai and proximal shafts 406 and 408 can be parts of a continuous shaft that extends through the central portion 404.
  • a bore 4 iO extends axiaily through the entire adaptor 402, whether or not the shafts 406 and 4OS arc continuous.
  • the diameter of the bore 4!0 should be sufficient to allow an implant to pass there-through.
  • the diameter of the bore 410 can be similar to the diameter of the bores 1 1 Oa and 110b of needles 102a and 102b, which can be similar to the diameter of the major portion of the bore 210 of the after-loader 202 as discussed above.
  • the distai hollow shaft 406 of the adaptor 402 is intended to fit within the proximal end of hub 108b of locking hub needle 102b, and into a most proximal portion of the lumen S I Ob of the cannula 104b.
  • the central portion 404 can include inner threads 414 to engage the outer threads 1 14 of the hub 108b of the locking hub needle ⁇ 02b.
  • An outer circumference 412 of the central portion 404 can be textured, to make it easier for a user to turn the adaptor 402 so it screws onto threads 1 14 of the hub 108b
  • the proximal hollow shaft 408 is intended to fit in the enlarged distal portion 220 of the bore 210 of the after-loader 202.
  • One or more empty after-loader 202 can be provided to a user, so that the user can load each after-loader 202 with an implant and thereafter use the after-loader(s) 202 during an brachytherapy procedure.
  • one or more already loaded after- loader 202 i.e., a pre-loaded after-loader
  • a facility can load implants into a plurality of after-loaders 202, and provide such pre-loaded after-loaders to a user.
  • the pre-loaded after -loaders 202 can include all the implants that are necessary to fulfill a predetermined patient specific treatment plan, In specific embodiments, each after-loader is pre-loaded with a corresponding strand or other treatment member that has been manufactured to meet a. treatment plan. Such pre-loaded after-loaders 202 can be delivered in a tray having a unique number for each of the preloaded after-loaders 202, so that the user knows which strand or other member is located in which after-loader, and thus knows, where each strand or other member should be implanted. It is also possible that such numbers or similar designations are printed directly on the after -loaders 202.
  • each pre-loaded after-loader 202 is covered by its shield 250
  • the packaging that is used to store the plurality of pre-loaded after-loaders can include further shielding, e g , a lead plate can cover a row of pre-loaded after-ioadeis thai aie wilhm a tray
  • FIG 5 B shows a proximal end plug 512, according to an embodiment of the present invention
  • FIG ⁇ C shows a side view of a pre-loaded after-loadci 202, which is pre-loaded with a strand 502 lhe strand 522 includes a plurality of radioactive seeds. 524 that are spaced apart from one another, e g , in accoi dance with a treatment plan
  • a cut-a ⁇ wiy ⁇ icw of the shield 250 is provided, so that it can be seen that the strand 522 is within the bore 210 of the after-loader 202
  • the opening at the distal end 206 of the after-loader 202 is plugged with the distal end plug 502
  • the opening at the proximal end 208 of the afte* -loader 202 is plugged with the proximal end plug 512 ⁇ n addition Io preventing a treatment member (e g , strand) or other implant from falling out of the after-loader 202, the end plugs 502 and 512 can also be employed to block radiation from emitting from the
  • the distal end plug 502 includes a grip portion 504, that can be gripped to insert the insertion portion 506 of the distal end plug 502 into the opening at the dista! end 206 of the after-loader 202
  • the diameter of the grip portion 504 is greater than the diameter of the distal portion 220 of the bore 210
  • the dianietei of the insertion portion 506 of the distal end plug 502 is sized so that it fits within the distal portion 220 of the bore 210, ⁇ et creates a friction fit so the end plug 502 docs not inadve ⁇ e ⁇ t ⁇ y fall out
  • a length or depth of the insertion portion 506 of the distal end plug 502 is aboi ⁇ t the same as the depth of the distal portion 220 of the bore 210 This will keep the distal end of the Ueatment member (c g , strand) or other implant within the confines of the shield 2?0
  • the proximal end plug 512 includes a grip portion 514, that can be gripped to insert the insertion portion 516 of the proximal end plug 512 into the opening at the proximal end 208 of the a tie* -loader 202 T he diameter of the grip portion 514 is greater than the largest diameter of the funnel ed portion 230 of the bore 210.
  • the diameter of the insertion portion 516 of the proximal end plug 512 is sized so that it fits within the funneled portion 230 of the bore 210, yet creates a friction fit so the end plug 512 does not inadvertently fall out.
  • a length or depth of the insertion portion 516 of the proximal end plug 512 is about the same as the depth from the proximal end 208 to the most distal point of the funnel 230, This will keep the proximal end of the treatment member (e.g., strand) or other implant within the confines of the shield 250.
  • the end plugs 502 and 512 need not be shaped as shown in FiGS. 5A and 5B. The end plugs need only he shaped so as to function to maintain the implant within the after-loader 202. For example, where radiation emission from the implant is not a concern, the end plug need not function to block radiation. Alternative designs for the end plugs are shown in FIGS.
  • an elongate treatment member (that is loaded within the bore 210 of the after-loader 202) can include one or more bumps, rings, wings, polymeric hairs or other protrusions that f ⁇ ctionally maintains the member within the bore 210, until the member is urged out using a stylet.
  • FIGS. 4 A, 5B, 6A and 6B illustrate exemplary embodiments of end plugs for use with after-loaders 202.
  • some other style of end plugs can be employed to retain an implant with an after-loader 202.
  • end plugs for use with the after-loader of the present invention can be integral!' formed with an implant housed within the after -loader,
  • FlG. 7 shows a plurality of pre-loaded after-loaded devices 202 within a tray 702, according to an embodiment of the present invention.
  • the tray 702 is shown as including a plurality of grooves 704, that are configured to f ⁇ ctionally hold fifteen after-loaders 202.
  • the tray 702 can be configured to hold less or more after-loaders 202
  • a further radiation shield 706, which provides for some additional radiation shielding is also shown (in dashed line)
  • Such a tray 702 can be part of a kit of the present invention, and may also have a cover (not shown), both of which can be placed in a pouch 720.
  • Such a pouch 720 e.g., made of TyvekTM, can keep the contents of the tray 702 sterile until they are ready for use, and the pouch is opened to reveal its contents.
  • Methods for using the after-loader 202 shall now be described with reference to FiGS 8 and * ⁇ ) Steps that ate common to each method are numbered in the same manner, to a ⁇ oici replication of the discussion
  • the hollow needle is positioned at the desited location, e g , with the assistance of a template
  • the hub of the ho! low needle is mated with the distal end 206 of the after-loader 202, either b ⁇ way the enlarged distal portion 220 of the bore 210, the tapered nose 218, or b ⁇ using the adaptor 402
  • a stylet 302 is inserted into the opening at the proximal end 20S of the after-loader 202
  • a stylet 302 for use with the after-loader 202 can be sufficient in length to accommodate both the needle 102 and the aiter-loader 202 Where that is the case, at step 808.
  • the implant is urged toward the distal end of the needle until the implant is positioned at the desired location and depth J hen, the stylet K)2 is held in place while the needle and after-loader are retracted, so that the implant is deposited at a desired location, as indicated at step 810
  • a stylet of less than sufficient length to accommodate both the needle and the after-loader 202 can be employed
  • the stylet can be used urge the implant from the after-loader 202 to the hollow needle, as indicated at step 806
  • the stylet can then be removed, and the after-loader 202 disconnected, as indicated at step ⁇ 08 in FIG 9
  • a stylet (the same, or a different stylet) can then be inserted (e g , reinserted) to urge the implant to the desired location and depth, at step 910 At step ⁇ 12.
  • the needle can then be retracted with the stylet held in position so that the implant is deposited at the desired location and depth
  • each after-l ⁇ adcr 202 can be employed for use with one or more radioactive or other treatment seed, one or more treatment member ⁇ e g , strand), radioactive iod. radioactive coil, market; or some other implant
  • a strand (also referred to as a treatment strand) can include a plurality of radioactive sources spaced apart from one another, e g in accordance with a treatment plan
  • a strand likely includes a bi ⁇ absotbable materia! within which treatment sources (e g , radioactive seeds) arc encapsulated, and spaced apart from one another, e g , in accordance with a treatment plan
  • the after-loaders 202 can be pre-loaded with strands, or other implants so that the pre-loaded after-loaders can be provided to a physician
  • Pre- conllgured strands OJ another implant can be loaded into the after-loader 202 off-site and fitted with end plugs at the distal and proximal ends 206 and 208 of the after-loader, and then shipped to the user for a specific patient.
  • the proper treatment can be determined as part of a pre-plan.
  • the after-loader preferably would include its shield 250 securely fitted to the outside surface of the after-loader 202.
  • Such pre-loaded after-loaders can simplify and expedite the implantation process. Further, such pre-loaded after-loaders 202 offer benefits to hospitals or clinics that strhe to minify the amount of handling of the implants performed by staff
  • a physician can load strands into the after-loaders 202 The physician can do this prior to inserting any needles into patient tissue Alternatively, after needles are inserted into patient tissue, the physician can connect an after-loader 202 to a needle, and then insert the implant into the after-loader 202. Thereafter, the physician would urge the implant from the after-loader 202 into the needle, using a stylet. Other variations are also possible, as would be understood from the description herein.
  • the after-loaders 202 can be longer or shorter in length as needed
  • the after-loader 202 can include an outer diameter that at a maximum, does not exceed 5 mm in size to generally match the pitch of a typical template.
  • the after-loader 202 can be larger or smaller in diameter.

Abstract

After-loader devices, kits, and methods for using the same are provided. Such after-loader devices are useful for loading implants into hollow needles, especially after the needles are inserted into patient tissue. The after-loader devices can be pre-loaded with implants, before the after-loaders are connected to hubs of hollow needles, or loaded thereafter.

Description

AFTER-LX)ADB-R DEVICES AND IvFIS AND ME iI lODS FOR THEiIR USE
Inventors:
Gary A Lamoureux Warren W. Johnston
Anthony Vi sell i
Paul Walker Edward Bleieh
Priority Ci aim
This application claims priority to the following U.S. Applications, each of which is incorporated herein by reference"
U.S. Patent Application No. 1 !/74! ,65S, filed April 27, 2007, and entitled METHODS FOR USING AFTER-LOADERS;
U.S. Patent Application No. I l /741 ,652, filed April 27, 2007, and entitled AFTER- LOADER DEVICES AND KITS;
U.S Patent Application No 1 1/592,90Q, filed November 3, 2006, and entitled AFTER-LOADER FOR POSI TIONING IMPLANTS FOR NEEDLE DELfVERY IN BRACI IYTHERAPY AND OTHER RADIATION THERAPY,
U S. Provisional Patent Application No. 60/847,834. filed September 28, 2006. and entitled AFTER-LOADER FOR POSITIONING IMPLANTS FOR NEEDLE DELIVERY IN BRAC H YTHERAP Y AND OTHER RADIATION THERAPY; and
U.S Provisional Patent Application No. 60/799,16 !, filed May 9, 2006. and entitled AFTER-LOADER FOR POSITIONING IMPLANTS FOR NEEDLE. DELIVERY IN BRACHYTHERAPY AND OTHER RADIATION THERAPY
Field of the Invention
This invention relates to devices and methods that are used for transferring implants to needles used in hrachytherapy
BACKGROUND
Brachy therapy is a general term covering medical treatment which involves placement of radioactive sources near a diseased tissue and can involve the temporan or permanent im plantation or insertion of radioactive sources into the body of a patient The radioactive sources are located in proximity to the area of the body which is being treated. A high dose of radiation can thereby be delivered to the treatment site with relatively low doses of radiation to surrounding or intervening healthy tissue, Exemplary radioactive sources include radioactive seeds, radioactive rods and radioactive coils.
Brachytherapy has been used or proposed for use in the treatment of a variety of conditions, including arthritis and cancer. Exemplary cancers tSiat can be treated using brachytherapy include breast, brain, liver and ovarian cancer and especially prostate cancer in men. For a specific example, treatment for prostate cancer can involve the temporary- implantation of radioactive sources (e.g., rods) for a calculated period, followed by the subsequent removal of the radioactive sources. Alternatively, radioactive sources (e.g., seeds) can be permanently implanted in the patient and left to decay to an inert state over a predictable time. The use of temporary or permanent implantation depends on the isotope selected and the duration and intensity of treatment required.
Permanent implants for prostate treatment include radioisotopes with relatively short half lives and lower energies relative to temporary seeds Exemplary permanently implantable sources include iodine- 125, palladium- 103 or cesium-131 as the radioisotope. The radioisotope can be encapsulated in a biocompatible casing (e.g., a titanium casing) to form a "seed" which is then implanted. Temporary implants for the treatment of prostate cancer may involve iridium-192 as the radioisotope. For temporary implants, radioactive rods are often used. Conventional radioactive seeds are typically smooth sealed containers or capsules of a biocompatible material, e.g., titanium or stainless steel, containing a radioisotope within the sealed chamber that permits radiation to exit through the container/chamber walls. Other types of implantable radioactive sources for use in radiotherapy are radioactive rods and radioactive coils, as mentioned above. Preferably, the implantation of radioactive sources for brachytherapy is carried out using minimally-invasive techniques such as, e.g., techniques involving hollow needles. It is possible to calculate a desired location for each radioactive source which will give the desired radiation dose profile. This cars be done using knowledge of the radioisotope content of each source, the dimensions of the source, accurate knowledge of the dimensions of the tissue or tissues in relation to which the source is to be placed, plus knowledge of the position of the tissue relative to a reference point. The dimensions of tissues and organs within the body for use in such dosage calculations can be obtained prior to or during placement of the radioactive sources by using conventional diagnostic imaging techniques including X-iay imaging, magnetic resonance imaging (MRI ). computed tomography (C O imaging, fluoroscopy and ultrasound imaging
During the placement of the radioactive sources into position, a surgeon can monitor the position of tissues such as the prostate gland using, c g , ultrasound imaging oτ fluoroscopy techniques which offei the advantage of Sow risk and convenience to both patient and surgeon The surgeon can also monitor the position of the relatnely large needle used in implantation procedures using ultrasound or othe* imaging
As mentioned above, brachvtherapy t\ picali\ employs hoi Sow needles that are insertab!e into a patient's body, often with the assistance of a template \ typical template used to guide and/or inform the positioning of hollow needle* at a surgical site can provide access to more than one hundred locations The number of locations can be so numerous that a typical pitch between needle access points can include a pitch of 5 ram
A hollow needle, as explained abov e, is used to implant radioactive sources and or other types of treatment elements into patient tissue at a desired location and to a desύed depth Such treatment elements, which arc implantable using the hollow needle, shall be collective! v refer* ed to as an implant Such an implant can be an elongate treatment member, such as a strand that includes a plurality of radioactive sources (e g , seeds) spaced apart from one another within a bioabsorbabie materia! Besides a strand, an implant can be another type of treatment member that includes a plurality of radioactive sources spaced apart from one another, such as a member formed of seeds and spaceis that aie frictionaϊly or otherwise connected to one another (e g , as described in U S Patent Kos 6.010,446 and 6,450,^39, which are incorporated herein by reference) An elongate treatment member may also be made from a hollow tube that includes a plurality of seeds and spacers loaded within a bore of the tube, with the tube possibly heat shrunk around the seeds and spacers, or the ends of the tube otherwise closed Alternatively . an implant can be a plurality of loose seeds and loose spacers axialiy aligned one behind the other H it> also possible that tiie implant be a smgie loose radioactive source Other possibilities also exist, as would be appreciated by one of ordinary skill in the art For example, an implant can include one or more iadioactise rod or coil An impSaiu can also include one or more seed that has anchoring mechanisms, exemplary details of which are provided m cornrnoniy assigned L S Patent Application Serial No 1 1/187,41 L entitled "Implants for Use in Brachs therapy and Other Radiation Therapy That Resist Migration and Rotation," filed July 22, 2005, Alternatively, the implant can be or include some other object and need not be radioactive, e.g. a spacer, a marker, or a thermal seed that gives off heat.
Various types of hollow needles can be used in brachy therapy, examples of which are shown in FIGS. IA and SB. A first type of needle, shown in FlG. 1 A, is often referred to as an applicator needle, and Is sometimes marketed under the trademark MICK*' needle. Referring to FIG. IA, an applicator needle 102a is shown as including a hollow needle 104a (also referred to as a cannula) with a blunt or υn~sliarpened distal end 106a, and a huh 108a positioned at a proximal end. The huh 108a, as shown, has a generally simple cylindrical shape. An exemplary length of the entire needle 102a including the hub is about 7 7/8 inches (about 20cm), with the hub 108a having a length of about 1 inch (about 2.5cm). As shown in FIG. IA5 the hub 108a surrounds a proximal portion of the cannula 104a. A bore UOa (also referred to as a lumen) extends through the applicator needle 102a. An exemplar}' diameter of the bore 1 10a (i.e., the inner diameter of the cannula 104a) is about 0.042 Inches. When an applicator needle 102a is used in brachytherapy, a sharp stylet (not shown) is inserted through the lumen HOa of the hollow needle, so that the sharp distal end of the sharp stylet (e.g., a trocar tip) extends past the blunt distal end 106a of the applicator needle 102a. The needle 102a, with the sharp stylet point extending out its biunt distal end 106a, can then be inserted into patient tissue at a desired location, including to a desired depth. Thereafter, the sharp stylet is removed, and an implant (e.g., a strand, seeds and spacers, or combinations thereof) is loaded into the needle through the proximal end of the needle. Tweezers or the like can be used to insert a strand or other treatment member, and/or loose seeds and spacers, into the proximal end of the needle. However, this can be very difficult and time consuming due to the small inner diameter of the hollow needle. A blunt ended stylet (not shown) can then be inserted into the proximal opening of the needle 102a, until the distal end of the stylet contacts the proximal end of the treatment member (or most proximal seed or spacer). The needle can then be retracted with the stylet held in position so that the implant is deposited at a desired location.
Alternatively, an applicator device, such as a MICK*' applicator, can be attached to the proximal end of the applicator needle 102a, and the applicator device can be used to dispose loose seeds (and optionally loose spacers) through the needle 102a and into patient tissue. The MICK* applicator is available from Mick Radio-Nuclear Instruments, Inc., Mount Vernon, NY Details of the NUCIv* applicator a*e provided in U S Patent No S 860,^)09
Referring now to FIG I B, a second type of needle 102b. which shall be refeπed to herein as a locking hub needle for reasons tlial will be apparent (and sometimes referred to as a prostate .seed needle, a .standard needle, or a seed lock needle), includes a cannula 104b, a sharpened distal end 106b (e g . a beveled end), and a hub 108b positioned at a proximal end The bub 108b has an enlarged diameter with a funneled pioximai portion 112, and threads 1 14 on an outer circumference, that may be used, e g . to connect the hub 108b to a syringe The funneled distal end 1 12 allows a moie forgiving tolerance foi inserting implants into a lumen 1 iOb of the cannula iO4b (if tweezers or the like axe used to insert a treatment member and/or lαot>e seeds and spacers into the proximal end of the needle) Nevertheless, even though the proximal funneled opening of needle 102b is larger then the proximal opening of needle 102a, it can still be very difficult and time consuming to load an implant into the needle 102b Such needles 102b a?e typically plugged at the distal end with boncwax oi some olhei plugging material, and pre-loaded with a treatment member and/or loose seeds and spacers, prior to the needle 102b being inserted into patient tissue Alternatively, such needles 102b can be loaded {i e . after-loaded) with a treatment member and/or loose seeds and spacers after the needle 102b is inserted into patient tissue \n exemplary length of the entire needle 102b, including the hub, is about 8 7/8 inches (about 22 5cm) An exemplary length of the hub 108b is about 1 inch (about 2 5 inches) Here, only a portion of the hub 108a suπounds a proximal portion of the cannula 104b, so that the funneled portion 1 12 can have a larger diameter than the diameter of the cannula 104b An exemplary diameter of the bore HOb (i e , the inner diameter of the cannula 1.04b) is about 0 042 inches
It has genet ail) been difficult and time consuming for physicians to load a hollow needle (e g , 102a or 102b) with a treatment member and'or loose seed*, and spacer, especially after the needle has been inserted into patient tissue It would be beneficial if devices and methods weie provided for simplifying and expediting ^uch proceduies
SUMMARY OF EMBODIMENTS OF THE INVENTION Embodiments of the present invention relate to devices, referred to as after-loader devices, that are useful for loading an implant, into a hollow needle after the needle is inserted into patient tissue. Embodiments of the present invention also relate to kits that include such after-loader devices, as well as methods for using after-loader devices. Sn accordance with specific embodiments, an after-loader device is especially useful for a connecting to a hollow needle, known as an applicator needle, which has a simple cylindrical needle hub at the proximal end of the needle. The after-loader includes an elongated body having a proximal end and a distal end, with a bore extending axialiy through the body between the proximal and distal ends. A main portion of the bore has a first inner diameter that is approximately equal to the inner diameter of the hollow needle to which the after-loader attaches. A distal portion of the bore has a second inner diameter that is larger than the outer diameter of the needle hub, with the distal portion of the bore being configured to connect to the cylindrical needle hub of the hollow needle, In accordance with an embodiment, a depth of the distal portion of the bore is sufficient to enable the body of the after-loader device to rigidly connect to the cylindrical needle hub of the hollow needle without requiring additional support. A proximal portion of the bore can be tunneled to assist with inserting an implant and/or a stylet into the bore.
Sn accordance with specific embodiments, the after-loader device includes a radiation shield configured to slide over an outer circumferential surface of a main portion of the body, to thereby cover the main portion of the body. The body of the after-loader can be translucent or transparent so that a user can observe an implant loaded into the bore, when the radiation shield is at least partially removed.
In accordance with specific embodiments, a distal portion of the body of the after- loader has an outer diameter that is greater than an outer diameter of the main portion of the body, and greater than an inner diameter of the radiation shield. Such distal portion of the body provides a stop for the radiation shield, and also accommodates the distal portion of the bore. Additionally, a tapered outer circumference, that extends between the distal portion of the body and the main portion of the body, can provide a friction fit between the body and the radiation shield. In accordance with specific embodiments, the after-loader device includes a distal end plug to plug a distal opening of the bore, and a proximal end plug to plug a proximal opening of the bore. The distal end plug and the proximal end plug, when respectively plugged into the distal and proximal openings of the bore, prevent an implant loaded in the bore tYora falling out of the bore. Such end plugs can each include a gripping portion and an insertion portion, and can be made from a radiation blocking material,
In accordance with an embodiment, a tapered nose at the distal end of the body is configured to Ht into a hub of a second type of hollow needle, such as a locking hub needle.
In further embodiments of the present invention, the after-loader device includes an adapter for use in connecting the body of the after-loader device to a second type of hollow needle, such as a locking hub needle. Such an adaptor can include a central portion, a distal hollow shaft and a proximal hollow shaft. The distal hollow shaft is for insertion into a hub of the second type of needle and into a proximal most portion of a lumen of the second type of needle. The proximal hollow shall if for insertion into the distal portion of the bore of the body of the after-loader device. The central portion of the adaptor can includes inner threads, for engaging threads on the hub of the second type of needle. Embodiments of the present invention are also related to brachy therapy kits. Such a kit can include a plurality of after-loader devices, each of which is useful for loading an implant into a hollow needle after the needle is inserted into patient tissue. The kit can also include a plurality of treatment members, each member loaded into a bore of one of the after-loader devices, and maintained in the bore by end-plugs of the after-loader device. Each such member (e.g., a strand) can include a plurality of radioactive sources spaced apart from one another, e.g., in accordance with a treatment plan. Alternatively, or additionally, an implant loaded into a bore can include a plurality of loose seeds separated from one another by spacers. Each the after-loader device of the kit can include a radiation shield that surrounds at least, a main portion of the body of the after-loader device. Also, the kit can include at least one stylet having a length that is at least as Song as a total length of the after-loader device connected with a hollow needle, as well as at least one hollow needle. In specific embodiments, the plurality of treatment members of the kit fulfill an entire predetermined treatment plan for a patient. The kit can also include a tray holding the plurality of after-loader devices loaded with the plurality of treatment members, as well as a pouch housing the tray (which is holding the plurality of after- loader devices loaded with the plurality of treatment members). Additionally, depending on the type of hollow needle included in the kit, the kit can also include at least one adaptor configured to connect the after-loader devices to hub of a locking hub hoi Sow needle.
Embodiments of the present Invention are also directed to methods for implanting implants into patient tissue. In accordance with an embodiment a distal end of a hollow needle is inserted Into patient tissue at a desired location and to a desired depth. Where the hollow needle does not have a sharpened end, a sharp end of a sharp stylet is extended beyond the distal end of the hoHovv needle, to assist with the insertion of the needle. Where the needle has a sharpened distal end, such a sharpened stylet need not be used.
Where the needle hub is a simple cylindrical needle hub of a hollow needle known as an applicator needle, the after-loader device can be connected to the cylindrical needle hub by inserting at least a portion of the cylindrical needle hub into a distal portion of a bore of the after-loader, such that the after-loader is rigidly connected to the cylindrical needle hub of the hollow needle without requiring additional support, A stylet is inserted into an opening at a proximal end of the after-loader device, to urge an implant from the after-loader device into a lumen of the hollow needle.
Certain embodiments employ the use of a stylet having a length that is at least as long as a total length of the after-loader device connected with a hollow needle. Where such a stylet is available, the implant can be urged from the after-loader device, through a lumen of the hollow needle, to a distal end of the hollow needle, while the after-loader device is still connected to the needle. Thereafter, the hollow needle and the after-loader device are retracted, while the stylet is held in place, to thereby deposit the implant at the desired location and to the depth.
In specific embodiments, the implant can be loaded into the bore of the after-loader device, after the after-loader device is connected to the hollow needle, but before the stylet is inserted into the after-loader device. In other embodiments, the implant was already loaded into the bore of the after-loader device before the after-loader device is connected to the hollow needle.
In specific embodiments, where the after-loader device includes end plugs, the end plugs of the after-loader device, which maintain the implant within a bore of the after- loader device, are removed prior to connecting the after-loader device to the hollow needle.
In specific embodiments the implant is a treatment strand or other treatment member, which includes a plurality of radioactive sources spaced apart from one another Alternatively, or additional!}1, the implant can be a plurality of loose seeds and spacers. Other implants are also possible, as described below.
Where the stylet to be employed is not as long as a total length of the after-loader device connected with a hollow needle, the stylet is used to urging an implant from the after-loader device, into a 1 uracil of the hollow needle. The stylet is then retracted from the after-loader, and the after-loader is removed, i.e., disconnected from the hollow needle. Thereafter, a stylet (the same or a different stylet) is inserted into an opening at a distal end of the hollow needle, and the stylet is used to urge the implant to a distal end of the hollow needle. Then, the hollow needle is retracted while the stylet is held in place, to thereby deposit the implant at the desired location and to the depth.
Methods of the present invention also include methods that used the adaptor mentioned above. For example, after a distal end of a hollow needle is inserted into patient tissue, a distal hollow shaft of an adaptor can be inserted through the needle hub and into a proximal portion of a lumen of the hollow needle, and an after-loader device can be connected to a proximal hollow shaft of the adaptor. It is also possible that the adaptor, just described, already be connected to the proximal portion of a hollow needle, when the distal end of the hollow needle is inserted into patient tissue, A stylet can then be inserted into an opening at a proximal end of the after-loader device. Depending upon the length of the stylet, the after-loader body and adaptor may be left in place during the remainder of the implant procedure, or may need to be removed before a stylet is used to urge the implant to the distal end of the hollow needle. The hollow needle (and the after- loader device and adaptor, if still in place) are then retracted, while the stylet is held in place, to thereby deposit tlie implant at the desired location and to the depth.
This summary is not intended to be a complete description of the invention. Other features, aspects, objects and advantages of the invention can be obtained from a review of the specification, the figures, and the claims.
Brief Description of the Drawings FIG. IA is a side view of first type of hollow brachytherapy needle, often referred to as an applicator needle,
FIG. IB is a side view of a second type of hollow brachytherapy needle, sometime referred to as a seed lock needle, or a locking hub needle. FIG. 2A Is a side view of an after-loader in accordance with an embodiment of the present invention, with its shield removed,
FSG. 2B is a side view of the after-loader device of FlG. 2A, with its shield in place. FIG. 2C is a perspective view of the after-loader device of FKJS, 2A & 2B, with its shield removed.
FSG. 2D is a perspective view of the shield of the after-loader device.
FSG. 3 A is a cross- sectional side view of the after-loader of FlG. 2 A mated with. the needle of FIG. I A, and having a stylet disposed within the after-loader device and hollow needle,
FlG. 3B is a cross-sectional side view of the after-loader of FIG. 2A mated with the hollow needle of FIG. IB, and having a stylet disposed within the after-loader device and hollow needle.
FICJ. 4A IS a perspective view of an adaptor, according to an embodiment of the present invention, which can be used to help connect the after-Soader device of FIGS. 2A & 2B to the hollow needle of FIG. 1 B.
FIG. 4B is a cross-sectional view of the adaptor of FIG. 4A.
FIG. 4C is a cross-sectional side view of the after-loader device of FIG. 2A mated with the hoϋow needle of FlG. LB, using the adapter of FiGS. 4A and 4.B. and having a styiei disposed within the bore of the after-foader and adaptor and the hollow needle.
FlG. 5A is a side view of a distal end plug for an after-loader, in accordance with an embodiment of the present invention,
FIG. 5B is a side view of a proximal end plug for an after-loader, in accordance with an embodiment of the present invention, FlG. 5C is a side view of the after-loader of FIGS, 2A-2C (without its shield) with the distal and proximal end plugs of FIGS. 5 A and 5 B in place.
FIG. 6A is a. side view of a distal end plug for an after-loader, In accordance with another embodiment of the present invention,
FIG. 6B is a side view of a proximal end plug for an after-loader, in accordance with another embodiment of the present invention.
FIG. 7 shows a plurality of after-loaded devices within a tray.
FIG. 8 is a high level flow diagram that is used to summarize a method of using an after-loader, in accordance with an embodiment of the present invention. FIG. 9 is a high levei flow diagram that is used to summarise a method of using an after-loader, in accordance with an alternative embodiment of the present invention.
DETAILED DESCRIPTION As explained above, it has generally been difficult and firae consuming for physicians to load a hollow needle (e.g., 102a or 102b) with a strand and/or loose seeds and spacers, especially after the needie has been inserted into patient tissue. As wiii be described below, embodiments of the present invention related to devices and methods for simplifying and expediting such procedures. More specifically, embodiments of the present invention relate to devices, referred to as after-loader devices, that are useful for loading an implant into a hollow needle after the needle is inserted into patient tissue. Embodiments of the present invention also relate to kits that include such after-loader devices, as well as methods for using after-loader devices.
As will be described below, an after-loader of the present invention can simplify and/or expedite the loading of an implant into a hollow needle, especially after the needle has been inserted into patient tissue it is because such a device is useful in loading a hollow needle "after" the needle is inserted into patient tissue, that the device is referred to herein as an "after-loader". Nevertheless, the after-loader device can also be used to pre- ioad a needle (i.e., load an implant into a hollow needle before the needle is inserted into patient tissue), if desired.
Referring to FlG. 2A, an after-loader device 202, according to an embodiment of the present invention, is shown, FlG. 2C shows a perspective view of the after-loader device 202, which is also referred to simply as an after-ioader 202. The after-loader 202 can be used with the applicator needle 102a of FΪG. IA (as shown in FIG. 3A), or alternatively with the locking hub needie 1.02b of FIG. IB (as shown in FIGS. 38 and 4C), providing flexibility in needle choice. The after-loader 202 includes an elongated body 204 having a distal end 206, a proximal end 208, with a bore 210 extending therebetween. The body 204 of the after-loader 202 is shown as having a generally cylindrical shape, however variations on this are possible. The body 204 of the after-loader 202, or the after-loader 202 in general, includes a dista! portion 212, a main portion 214 and a proximal portion 216, In accordance with an embodiment the main portion 214 of the after-loader 202 includes a generally constant outer diameter (e.g., 0.162 inches), and a generally constant inner diameter (e g., 0.055 inches), with the inner diameter being about the same as the inner diameter of the needle with which the after-loader 202 will interface (as mentioned abouve, the inner diameter of the cannula of the hollow needles 102a and 102b can be about 0,042 inches). More generally, the diameter of the bore 210 that extends through the main portion 214 of the after-loader 202 should be slightly larger than the outer diameter of the implant (e.g., strand, seed(s) and/or spacer(s)) that is to be loaded into the after-loader 202. In certain embodiments, the inner diameter of the bore 210 of the main portion 214 of the after- loader 202 can have one or more step., and/or have a taper (rather than having a constant inner diameter), such that the proximal end of the bore 210 within the main portion 214 has a slightly larger diameter than the distal end of the bore 2 K) within the main portion 214.
In the embodiment shown, the distal portion 212 of the after-ioader 202 includes ati enlarged outer diameter (e.g., 0.188 inches), which tapers at each end. More specifically, at the proximal end of the distal portion, the distal portion 212 tapers at a small angle θ (e.g., 5 degrees) until the diameter of the main portion 214 of the body 204 (e.g., 0.162 inches) is reached The purpose of this taper 219 is to provide a friction fit for a shield 250 that slides over the rest of the after-loader 202, the friction fit being attributable to the increase in diameter toward the distal portion 210, The shield 250 is positioned around the after-loader 202 to reduce or minify an amount of radiation that escapes from the after-loader 202 where implants placed in the after-loader 202 are radioactive, FIG. 2B shows the after-loader 202 with its shield 250 in place, FΪG. ID shows a perspective view of the shield 250.
Referring to FIGS. 2A and 2C, the taper at the distal end of the distal portion 212 forms a nose 218 of the after-loader 202, which is tapered at an angle α generally corresponding to an angle of the funnel ed proximal portion 1 12 of the Socking hub needle 102b. Thus, an external angle of the nose 2i S can be approximately 15 degrees in angle, in an embodiment wherein a typical Socking hub needle 102b is to be accommodated. The nose 218 of the after-loader 202 can be positioned within the funnel ed portion 1 12 of the locking hub needle 102b, so that the after-loader 202 is removably mated with the hub 108b of the locking hub needle 102b, as can be appreciated from FlG. 3B, discussed in more detail below. It is also possible that an after-loader 202 not include a tapered nose 218. A funoeled portion 230 of the bore 210 of the after-loader 202 can be tunneled at an angle β to simplify insertion of an implant, and stylet into the bore 210 of the after- loader 202. For example, the funnel can cause an increase in diameter at a 5 to 10 degree angle, and specifically at an 8 degree angle. Such funneled portion 230 of the bore 210 extends through the proximal portion 216 of the body 204.
In accordance with an embodiment, the body 204 of the after-loader 202 can be made of a transparent or translucent material, such as a media! grade plastic, e.g., acrylic, polycarbonate or other plastic, that enables a user (e.g.. physician, clinician, physicist, etc.) to visually verify the contents (i.e., implant) loaded in the after-loader 202. Where the after-loader 202 is made of a plastic, the after-loader 202 may not sufficiently restrict radiation from escaping the after-loader 202. Accordingly, the shield 250 is employed to reduce and preferably prevent leakage. As shown in FIG. 2D, the shield 250 can be a hollow cylinder formed of a material (e.g., stainless steel) that sufficiently restricts the amount of radiation that escapes the shield 250. In such embodiments, the shield 250 can be slid back (i.e., toward the proximal end of the after-loader 202) to reveal the contents of the after-loader 202, for visual verification purposes. In other embodiments, the after- loader 202 itself can be made from a material more opaque to radiation, such as stainless steei, or a plastic impregnated with lead, or some other shielded plastic.
Referring to FIGS. 2A-2C, the enlarged outer diameter of the distal portion 212 of the after-loader 202 serves two purposes. First, it enables the diameter of a distal portion 220 of the bore 210 to be enlarged to accommodate the hub 108a of the applicator needle 102a, as discussed in more detail below. Further, it acts as a stop to hold the shield 250 in place at the proper location after the shield 250 has been slid over the proximal end 208 of the after-loader 202. In accordance with an embodiment, the inner diameter of the distal portion 212 of the after-loader 202 is larger than the inner diameter of the main portion 214 of the after- loader 202, so that the hub 108a of the applicator needle 102a can be accepted therein. In other words, the diameter of the distal portion 220 of the bore 210 (which is the portion of the bore 210 within distal portion 212) is larger than the diameter of the main portion of the bore 210 (i.e., the portion of the bore 210 extending through the main portion 214 of the body 204). More specifically, the distal opening of the portion 220 of the bore 210, extending from the distal end 206 towards the proximal end 208 of the body 204, has a diameter that is slightly larger than the outer diameter of the hub 10Sa of the applicator needle 102a, so that the distal portion 220 of bore 210 is configured to receive, and thereby connect to, the huh 108a of the applicator needle i02a. For example, the diameter of the distal portion 220 of the bore 210 can be 0.099 inches, while the diameter of the main portion of the bore 210, which roughly corresponds to the inner diameter of a hollow needle, can be froπi anywhere from about 0.042 to 0.055 inches, In specific embodiments, the distal portion 220 of the bore 210 has a slight taper from its opening rearward (e.g., an opening diameter of 0.105 inches tapers to 0.985 inches), so that a slight friction fit can be provided between the distal portion 220 of the bore 210 and the hub 108a accepted therein (presuming the outer diameter of the hub 108a is less than 0.105 inches, but greater than 0.985 inches).
Additionally, a depth d of the distal portion 220 of the bore 210 is preferably sufficient to enable the body 204 of the after-loader 202 to rigidly connect to the hub 108a of the needle 102a without requiring any additional support, e.g., from a user or some support structure (e.g., a support rod). Preferably such depth d\% at least 14 inch, and more preferably about Vx inch. However, other depths will work, and are within the scope of the present invention.
FIG. 3 A shows a cross-section of the after-loader 202 accepting the hub 108a of an applicator needle 102a. FKl. 3 A also shows a stylet 302, including a handle 304 at its proximal end, inserted through the bore 210 of the after-loader 202 and the lumen 1 10a of the applicator needle 102a. As mentioned above, the diameter of the distal portion 220 of the bore 210 of the after-loader is slightly larger than the outer diameter of the hub 108a, so the hub 108a fits therein.
FIG. 3 B shows a cross-section of the after-loader 202 with its nose 2 18 within the tunneled portion. 1 12 of a locking hub needle 102b. FlG. 3 A also shows a stylet 302, including a handle 304 at its proximal end, inserted through the bore 210 of the after- loader 202 and the lumen i JOb of the locking hub needle 102b, When used in the manner shown in FSG. 3B> the after-loader 202 may need to be supported by the user, to prevent the after-loader from disengaging from the hub 108b of the needle 102b. To ensure that no such user support is needed, an adaptor 402 of an embodiment of the present invention can be used, as will now be explained with reference to FIGS. 4A-4C.
FIG. 4A is a perspective view of the adaptor 402, in accordance with an embodiment of the present invention. FIG. 4B is a cross-section of the adaptor 402. The adaptor 402 includes a central portion 404, from which extends a distal hollow shaft 406 and a proximal hollow shall 408. The hollow shafts 406 and 408 can be discontinuous (i.e , separate from one another), as shown in HG. 4B. Alternatively, the distai and proximal shafts 406 and 408 can be parts of a continuous shaft that extends through the central portion 404. A bore 4 iO extends axiaily through the entire adaptor 402, whether or not the shafts 406 and 4OS arc continuous. The diameter of the bore 4!0 should be sufficient to allow an implant to pass there-through. Thus, the diameter of the bore 410 can be similar to the diameter of the bores 1 1 Oa and 110b of needles 102a and 102b, which can be similar to the diameter of the major portion of the bore 210 of the after-loader 202 as discussed above. Referring to FlG. 4C, the distai hollow shaft 406 of the adaptor 402 is intended to fit within the proximal end of hub 108b of locking hub needle 102b, and into a most proximal portion of the lumen S I Ob of the cannula 104b. Additional Iy, the central portion 404 can include inner threads 414 to engage the outer threads 1 14 of the hub 108b of the locking hub needle {02b. An outer circumference 412 of the central portion 404 can be textured, to make it easier for a user to turn the adaptor 402 so it screws onto threads 1 14 of the hub 108b The proximal hollow shaft 408 is intended to fit in the enlarged distal portion 220 of the bore 210 of the after-loader 202.
One or more empty after-loader 202 can be provided to a user, so that the user can load each after-loader 202 with an implant and thereafter use the after-loader(s) 202 during an brachytherapy procedure. In another embodiment, one or more already loaded after- loader 202 (i.e., a pre-loaded after-loader) can be provided to a user. More specifically, a facility can load implants into a plurality of after-loaders 202, and provide such pre-loaded after-loaders to a user. The pre-loaded after -loaders 202 can include all the implants that are necessary to fulfill a predetermined patient specific treatment plan, In specific embodiments, each after-loader is pre-loaded with a corresponding strand or other treatment member that has been manufactured to meet a. treatment plan. Such pre-loaded after-loaders 202 can be delivered in a tray having a unique number for each of the preloaded after-loaders 202, so that the user knows which strand or other member is located in which after-loader, and thus knows, where each strand or other member should be implanted. It is also possible that such numbers or similar designations are printed directly on the after -loaders 202. When pre-loaded after-loaders 202 are provided to a user, it is preferred that each pre-loaded after-loader 202 is covered by its shield 250 Also, the packaging that is used to store the plurality of pre-loaded after-loaders can include further shielding, e g , a lead plate can cover a row of pre-loaded after-ioadeis thai aie wilhm a tray
When the after-loader 202 is shipped pre-loaded with a treatment member (e g , strand), or other implant, the openings, at the proximal and distal ends 206 and of the ailet- loader 202 are preferably plugged, U) prevent the treatment member or other implant fiom unintentionally falling out of the after-loader 202 Referring to FlG 5Λ. a distal end plug 502, according to an embodiment of the present invention, is shown FIG 5 B shows a proximal end plug 512, according to an embodiment of the present invention
FIG ^C shows a side view of a pre-loaded after-loadci 202, which is pre-loaded with a strand 502 lhe strand 522 includes a plurality of radioactive seeds. 524 that are spaced apart from one another, e g , in accoi dance with a treatment plan A cut-a\wiy \ icw of the shield 250 is provided, so that it can be seen that the strand 522 is within the bore 210 of the after-loader 202 The opening at the distal end 206 of the after-loader 202 is plugged with the distal end plug 502 Similarly, the opening at the proximal end 208 of the afte* -loader 202 is plugged with the proximal end plug 512 ϊn addition Io preventing a treatment member (e g , strand) or other implant from falling out of the after-loader 202, the end plugs 502 and 512 can also be employed to block radiation from emitting from the ends of the after-loader 202 If that is desired, the end plugs 502 and 512 should be made of a materia! that blocks radiation, e g , stainless stee! Alternatively, the end plugs 502 and 512 need not block jadiation, and can be made of plastic or the IiLe
The distal end plug 502 includes a grip portion 504, that can be gripped to insert the insertion portion 506 of the distal end plug 502 into the opening at the dista! end 206 of the after-loader 202 The diameter of the grip portion 504 is greater than the diameter of the distal portion 220 of the bore 210 The dianietei of the insertion portion 506 of the distal end plug 502 is sized so that it fits within the distal portion 220 of the bore 210, \ et creates a friction fit so the end plug 502 docs not inadveπeπtϊy fall out In accordance with an embodiment, a length or depth of the insertion portion 506 of the distal end plug 502 is aboiϊt the same as the depth of the distal portion 220 of the bore 210 This will keep the distal end of the Ueatment member (c g , strand) or other implant within the confines of the shield 2?0
Similarly, the proximal end plug 512 includes a grip portion 514, that can be gripped to insert the insertion portion 516 of the proximal end plug 512 into the opening at the proximal end 208 of the a tie* -loader 202 T he diameter of the grip portion 514 is greater than the largest diameter of the funnel ed portion 230 of the bore 210. The diameter of the insertion portion 516 of the proximal end plug 512 is sized so that it fits within the funneled portion 230 of the bore 210, yet creates a friction fit so the end plug 512 does not inadvertently fall out. In accordance with an embodiment, a length or depth of the insertion portion 516 of the proximal end plug 512 is about the same as the depth from the proximal end 208 to the most distal point of the funnel 230, This will keep the proximal end of the treatment member (e.g., strand) or other implant within the confines of the shield 250. tt should be noted that the end plugs 502 and 512 need not be shaped as shown in FiGS. 5A and 5B. The end plugs need only he shaped so as to function to maintain the implant within the after-loader 202. For example, where radiation emission from the implant is not a concern, the end plug need not function to block radiation. Alternative designs for the end plugs are shown in FIGS. 6A and 6B, which, respectively, show an alternative distal and plug 602 and alternative proximal end plug 612. Instead of using end plugs, or in addition to using end plugs, an elongate treatment member (that is loaded within the bore 210 of the after-loader 202) can include one or more bumps, rings, wings, polymeric hairs or other protrusions that fπctionally maintains the member within the bore 210, until the member is urged out using a stylet.
FIGS. 4 A, 5B, 6A and 6B illustrate exemplary embodiments of end plugs for use with after-loaders 202. In other embodiments, some other style of end plugs can be employed to retain an implant with an after-loader 202. In still other embodiments, end plugs for use with the after-loader of the present invention can be integral!)' formed with an implant housed within the after -loader,
FlG. 7 shows a plurality of pre-loaded after-loaded devices 202 within a tray 702, according to an embodiment of the present invention. The tray 702 is shown as including a plurality of grooves 704, that are configured to fπctionally hold fifteen after-loaders 202. Of course, the tray 702 can be configured to hold less or more after-loaders 202 Also shown (in dashed line) is a further radiation shield 706, which provides for some additional radiation shielding. Such a tray 702 can be part of a kit of the present invention, and may also have a cover (not shown), both of which can be placed in a pouch 720. Such a pouch 720, e.g., made of Tyvek™, can keep the contents of the tray 702 sterile until they are ready for use, and the pouch is opened to reveal its contents. Methods for using the after-loader 202 shall now be described with reference to FiGS 8 and *■) Steps that ate common to each method are numbered in the same manner, to a\ oici replication of the discussion
Referring to FIG 8, at step 802, the hollow needle is positioned at the desited location, e g , with the assistance of a template At step 804, the hub of the ho! low needle is mated with the distal end 206 of the after-loader 202, either b\ way the enlarged distal portion 220 of the bore 210, the tapered nose 218, or b\ using the adaptor 402 At step 806, with the implant positioned within the after-ioadei 202, and the after-loader connected to the hub of the hollow needle, a stylet 302 is inserted into the opening at the proximal end 20S of the after-loader 202 A stylet 302 for use with the after-loader 202 can be sufficient in length to accommodate both the needle 102 and the aiter-loader 202 Where that is the case, at step 808. the implant is urged toward the distal end of the needle until the implant is positioned at the desired location and depth J hen, the stylet K)2 is held in place while the needle and after-loader are retracted, so that the implant is deposited at a desired location, as indicated at step 810 Alternatively, a stylet of less than sufficient length to accommodate both the needle and the after-loader 202 can be employed When such a stylet h used, the stylet can be used urge the implant from the after-loader 202 to the hollow needle, as indicated at step 806 The stylet can then be removed, and the after-loader 202 disconnected, as indicated at step ^08 in FIG 9 A stylet (the same, or a different stylet) can then be inserted (e g , reinserted) to urge the implant to the desired location and depth, at step 910 At step ^ 12. the needle can then be retracted with the stylet held in position so that the implant is deposited at the desired location and depth
As specified above, each after-lυadcr 202 can be employed for use with one or more radioactive or other treatment seed, one or more treatment member {e g , strand), radioactive iod. radioactive coil, market; or some other implant A strand (also referred to as a treatment strand) can include a plurality of radioactive sources spaced apart from one another, e g in accordance with a treatment plan A strand likely includes a biυabsotbable materia! within which treatment sources (e g , radioactive seeds) arc encapsulated, and spaced apart from one another, e g , in accordance with a treatment plan
As specified above, the after-loaders 202 can be pre-loaded with strands, or other implants so that the pre-loaded after-loaders can be provided to a physician Pre- conllgured strands OJ another implant can be loaded into the after-loader 202 off-site and fitted with end plugs at the distal and proximal ends 206 and 208 of the after-loader, and then shipped to the user for a specific patient. Thus, the proper treatment can be determined as part of a pre-plan. In such embodiments, the after-loader preferably would include its shield 250 securely fitted to the outside surface of the after-loader 202. Such pre-loaded after-loaders can simplify and expedite the implantation process. Further, such pre-loaded after-loaders 202 offer benefits to hospitals or clinics that strhe to minify the amount of handling of the implants performed by staff
It is also possible for a physician to load strands into the after-loaders 202 The physician can do this prior to inserting any needles into patient tissue Alternatively, after needles are inserted into patient tissue, the physician can connect an after-loader 202 to a needle, and then insert the implant into the after-loader 202. Thereafter, the physician would urge the implant from the after-loader 202 into the needle, using a stylet. Other variations are also possible, as would be understood from the description herein.
As will be appreciated, and which can be extrapolated from the embodiments described, the after-loaders 202 can be longer or shorter in length as needed In accordance with specific embodiments, the after-loader 202 can include an outer diameter that at a maximum, does not exceed 5 mm in size to generally match the pitch of a typical template. However, in other embodiments, the after-loader 202 can be larger or smaller in diameter. The previous description of the preferred embodiments is provided to enable any person skilled in the art to make or use the embodiments of the present invention. While the invention has been particularly shown and described with reference to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention.

Claims

What is claimed is'
1. An. after-loader device useful for loading an Implant into a hollow needle after the needle is inserted into patient tissue, the hollow needle having a inner diameter, an outer diameter, a distal end, a proximal end, and a cylindrical needle hub at the proximal end, the cylindrical needle hub having an outer diameter that is greater than the outer diameter of the needle, the after-loader device comprising- an elongated body having a proximal end and a distal end; and a bore that extends axial Iy through said body between said proximal and distal ends of said body; wherein a main portion of said bore has a first diameter that is approximately equal to the inner diameter of the hollow1 needle; wherein a distal portion of said bore has a second diameter that is larger than the outer diameter of the needle hub and configured to receive, and thereby connect to, the needle hub; and wherein a depth of the distal portion of said bore is sufficient to enable the body to rigidly connect to the cylindrical needle hub of the hollow needle without requiring additional support.
2. The after-loader device of claim 1 , further comprising: a radiation shield configured to slide over an outer circumferential surface of a main portion of said body, to thereby cover the main portion of said body.
3. The after-loader device of claim 2, wherein said body is translucent or transparent so that a user can observe an implant loaded into said bore, when said radiation shield is at least partially removed.
4. The after-loader device of claim 2, wherein: a distal portion of said body has an outer diameter that is greater than an outer diameter of said main portion of the body, and greater than an inner diameter of said radiation shield; wherein said distal portion of said body provides a stop for the radiation shield, and also accommodates said distal portion of said bore.
5. The after-loader device of claim 4, further comprising; a tapered outer circumference extending between said distal portion of said body and said main portion of said body; wherein said tapered outer circumference provides for a friction fit between said body and said radiation shield.
6. The after-loader device of claim 1 , further comprising; a distal end plug to plug a distal opening of said bore; and a proximal end plug to plug a proximal opening of said bore; wherein said distal end plug and said proximal end plug, when respectively plugged into said distal and proximal openings of said bore, prevent an implant loaded in said bore from falling out of said bore.
7. The after-loader device of claim 6, wherein each said end piug includes a gripping portion and an insertion portion.
8. The after-loader device of claim 6, wherein said end plugs are made from a radiation blocking material.
9. The after-loader device of claim 1, wherein a proximal portion of said bore is tunneled to assist with inserting an implant and/or a stylet into said bore.
10. The after-loader device of claim 1, further comprising a tapered nose at said distal end of said body, said tapered nose configured to tit into a hub of a second type of hollow needle.
1 1. The a.fter~ioader device of claim 1, further comprising an adapter for use in connecting said body of the after-loader device to a second type of hollow needle
12. The after-loader device of claim 1 i, wherein said adaptor includes; a central portion; a dista! hollow shaft; and a proximal hollow shaft; wherein said dista! hollow shaft is for insertion into a hub of the second type of needle and into a proximal most portion of a lumen of the second type of needle, and wherein said proximal hollow shaft is for insertion into said distal portion of said bore of said body of the after-loader device.
13. The after-loader device of claim 12, wherein said central portion of said adaptor includes inner threads for engaging threads on the hub of the second type of needle
14 An after-loader device useful for loading an implant into a hollow needle after the needle is inserted into patient tissue, the after-loader device comprising; an elongated body including distal portion and a main portion, and a bore that extends axially through said body, wherein a distal portion of said bore, which extends through said dista! portion of said body, is configured to receive, and thereby connect to, a cylindrical needle hub of a hollow needle, and wherein a depth of said distal portion of said bore is sufficient to enable said body to rigidly connect to a cylindrical needle hub of a hollow needle without requiring additional support.
15. The after-loader device of claim 14, further comprising. a radiation shield configured to slide over an outer circumferential surface of said main portion of said body, to thereby cover said main portion of said body,
16. The after-loader device of claim 15, wherein said body is translucent or transparent so that a user cars observe an implant loaded into said bore, when said radiation shield is at least partially removed.
17. The after-loader device of claim 15, wherein: a distal portion of said body has an outer diameter that is greater than an outer diameter of said main portion of the body, and greater than an inner diameter of said radiation shield; wherein said distal portion of said body provides a stop for the radiation shield, and also accommodates said distal portion of said bore.
1 S. The after-loader device of claim 17, further comprising: a tapered outer circumference extending between said distal portion of said body and said main portion of said body; wherein said tapered outer circumference provides for a friction fit between said body and said radiation shield.
19. The after-loader device of claim 14, further comprising; a distal end plug to plug a distal opening of said bore; and a proximal end plug to plug a proximal opening of said bore; wherein said distal end plug and said proximal end plug, when respectively plugged into said distal and proximal openings of said bore, prevent an implant loaded in said bore from falling out of said bore.
20. The after-loader device of claim 14, wherein a proximal portion of said body includes a proximal portion of said bore, which is tunneled to assist with inserting an implant and/or a stylet into said bore.
21. A brachytherapy kit, comprising: a plurality of after-loader devices, each of which is useful for loading an implant into a hollow needle after the needle is inserted into patient tissue; and a plurality of treatment members, each said member including a plurality of radioactive sources spaced apart from one another; wherein each said member is loaded into a bore of one of said after-loader devices, and maintained in said bore by end-plugs or by friction between the member and said bore
22. The kit of claim 21, wherein each said after-loader device includes a radiation shield that surrounds at a main portion of an elongated body of said after-loader device.
23. The kit of claim 21, wherein for each said after-loader device. said elongated body includes proximal portion and a main portion; and said bore extends axial Iy through said body; a distal portion of said bore., which extends through a distal portion of said body, is configured to receive, and thereby connect to, a cylindrical needle hub of a hollow needle; and wherein a depth of said distal portion of said bore is sufficient to enable said body to rigidly connect to a cylindrical needle hub of a hollow needle without requiring additional support.
24. The kit of claim 23, further comprising; at least one stylet having a length that is at least as Song as a total length of a said after-loader device connected with a hollow needle,
25. The kit of claim 24, further comprising; a least one hollow needle.
26. The kit of claim 21, wherein the plurality of treatment members fulfill an entire predetermined treatment plan for a patient,
27. The kit of claim 26, wherein said radiations sources in said treatment members are spaced apart from on another in accordance with the treatment plan,
28, The kit of claim 26, further comprising: a tray holding said plurality of after-loader devices loaded with said plurality of treatment members; and a pouch housing said tray, which is holding said plurality of after-loader devices loaded with said plurality of treatment members, wherein said pouch keeps its contents sterile until said pouch is opened,
29. The kit of claim 2 i , further comprising; at ieast one adaptor configured to connect a said after-loader device to a second type of hollow needle.
30. The kit of claim 29, further comprising; at least one second type of hoi low needle.
31. A method for implanting an implant into patient tissue, the method comprising: inserting a distal end of a hoi Sow needle into patient tissue at a desired location and to a desired depth, the needle having a cylindrical needle hub at its proximal end; connecting an after-loader device to the cylindrical needle hub of the hollow needle by inserting at least a portion of the cylindrical needle hub into a distal portion of a bore of the after-loader, such that the after-loader is rigidly connected to the cylindrical needle hub of the hollow needle without requiring additional support; inserting a stylet into an opening at a proximal end of the after-loader device; urging an implant from the after-loader device, through a lumen of the hollow needle, to a distal end of the ho! Sow needle; and retracting the hollow needle and the after-ioader device, while the stylet is heid in place, to thereby deposit the implant at the desired location and to the depth,
32. The method of claim 31. further comprising: loading the implant into the after-ioader device, after the after-loader device is connected to the hollow needle, but before the stylet is inserted into the after-loader device.
33. The method of claim 31, wherein the implant was loaded into the after-loader device before the after-loader device is connected to the hollow needle.
34. The method of claim 33, further comprising: removing end plugs of the after-loader device, which maintain the implant within a bore of the after-loader device, prior to connecting the after-loader device to the hollow needle.
35. The method of claim 3 L wherein the Implant comprises a treatment member that includes a plurality of radioactive sources spaced apart from one another,
36. The method of claim 31, wherein the implant comprises a plurality of loose seeds and spacers.
37. A method for Implanting an implant into patient tissue, the method comprising: inserting a distal end of a hollow needle into patient tissue at a desired location and to a desired depth, the needle having a cylindrical needle hub at its proximal end; connecting an after-loader device to the cylindrical needle hub of the hollow needle by inserting at least a portion of the cylindrical needle hub into a proximal portion of a bore of the after-loader, such that the after-loader is rigidly connected to the cylindrical needle hub of the needle without requiring additional support; inserting a stylet into an opening at a proximal end of the after-loader device; urging an implant from the after-loader device, into a lumen of the hollow needle; retracting the stylet from the after-loader; removing the after -loader; inserting a stylet into a.n opening at a distal end of the hollow needle; urging the implant to a distal end of the hollow needle; and retracting the hollow needle, while the stylet is held in place, to thereby deposit the implant at the desired location and to the depth.
38. The method of claim 37, further comprising: loading the implant into the after-loader device, after the after-loader device is connected to the hollow needle, but before the stylet is inserted Into the after-loader device.
39. The method of claim 37, wherein the implant was loaded into the after-loader device before the after-loader device is connected to the hollow needle.
40. The method of claim 39, further comprising; removing end plugs of the after-loader device, which maintain the implant within a bore of the after-loader device, prior to connecting the after-loader device to the hollow needle.
41. The method of claim 37, wherein the implant comprises a treatment member that includes a plurality of radioactive sources spaced apart from one another.
42. The method of claim 37, wherein the implant comprises a plurality of seeds and spacers.
43. A method for implanting an implant into patient tissue, the method comprising: inserting a distal end of a hollow needle into patient tissue at a desired location and to a desired depth, the needle having a locking needle hub at its proximal end, inserting a distal hollow shaft of an adaptor through the needle hub and info a proximal portion of a lumen of the hollow needle; connecting an after-loader device to a proximal hollow shaft of the adaptor; inserting a stylet into an opening at a proximal end of the after-loader device; urging an implant from the after-loader device, through the adaptor, and through a lumen of the hoilow needle, to a distal end of the hollow needle; and retracting the hollow needle and the after-loader device, whiie the stylet is held in place, to thereby deposit the implant at the desired location and to the depth.
44. The method of claim 43, further comprising; loading the implant into the after-loader device, after the after-loader device is connected to the hollow needle, but before the stylet is inserted into the after-loader device.
45. The method of claim 43, wherein the implant was loaded into the after-loader device before the after-loader device is connected to the hollow needle.
46. A method for implanting an implant into patient tissue, the method comprising: inserting a distal end of a hollow needle into patient tissue at a desired location and to a desired depth, the needle having a locking needle hub at its proxinia! end; inserting a distal hollow shaft of an adaptor through the needle hub and into a proximal portion of a lumen of the hollow needle; connecting an after-loader device to a proximal hollow shaft of the adaptor; inserting a stylet into an opening at a proximal end of the after-loader device; urging an implant from the after-loader device, through the adaptor, and into a iumett of the hollow needle; retracting the stylet from the after-loader; removing the after-loader and the adaptor; inserting a styiet into an opening at a distal end of the hollow needle; urging the implant to a distal end of the hollow needle; and retracting the hollow needle, while the stylet is held in place, to thereby deposit the implant at the desired location and to the depth,
47. The .method of claim 46, further comprising: loading the implant into the after-loader device, after the after-loader device is connected to the hollow needle, but before the stylet is inserted into the after-leader device.
48. The method of claim 46, wherein the implant was loaded into the after-loader device before the after-loader device is connected to the hollow needle.
PCT/US2007/068595 2006-05-09 2007-05-09 After-loader devices and kits and methods for their use WO2007134126A2 (en)

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US79916106P 2006-05-09 2006-05-09
US60/799,161 2006-05-09
US84783406P 2006-09-28 2006-09-28
US60/847,834 2006-09-28
US11/592,909 2006-11-03
US11/592,909 US7988611B2 (en) 2006-05-09 2006-11-03 After-loader for positioning implants for needle delivery in brachytherapy and other radiation therapy
US11/741,658 2007-04-27
US11/741,652 US7985172B2 (en) 2006-05-09 2007-04-27 After-loader devices and kits
US11/741,652 2007-04-27
US11/741,658 US20080009661A1 (en) 2006-05-09 2007-04-27 Methods for Using After-Loaders

Publications (2)

Publication Number Publication Date
WO2007134126A2 true WO2007134126A2 (en) 2007-11-22
WO2007134126A3 WO2007134126A3 (en) 2008-05-22

Family

ID=38694681

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/068595 WO2007134126A2 (en) 2006-05-09 2007-05-09 After-loader devices and kits and methods for their use

Country Status (2)

Country Link
US (3) US7988611B2 (en)
WO (1) WO2007134126A2 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010112172A1 (en) * 2009-04-01 2010-10-07 Nucletron B.V. Components and assembly for performing brachytherapy treatment of tumour tissue in a human and animal body
CN104147688A (en) * 2014-07-31 2014-11-19 吉林大学 Rapidly-formed self-adaptive afterloading brachytherapy source applicator and manufacturing method thereof

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10004584B2 (en) * 2006-07-10 2018-06-26 First Quality Hygienic, Inc. Resilient intravaginal device
US8641593B2 (en) * 2007-02-28 2014-02-04 C. R. Bard, Inc. Brachytherapy element transfer system
CA2724327A1 (en) 2008-06-04 2009-12-10 Neovista, Inc. Handheld radiation delivery system for advancing a radiation source wire
WO2011079186A1 (en) * 2009-12-23 2011-06-30 Medi-Physics, Inc. Braced brachytherapy needle
US10350431B2 (en) 2011-04-28 2019-07-16 Gt Medical Technologies, Inc. Customizable radioactive carriers and loading system
US9492683B2 (en) 2013-03-15 2016-11-15 Gammatile Llc Dosimetrically customizable brachytherapy carriers and methods thereof in the treatment of tumors
US9821174B1 (en) 2015-02-06 2017-11-21 Gammatile Llc Radioactive implant planning system and placement guide system
US10888710B1 (en) 2016-11-29 2021-01-12 Gt Medical Technologies, Inc. Transparent loading apparatus
US10981018B2 (en) 2019-02-14 2021-04-20 Gt Medical Technologies, Inc. Radioactive seed loading apparatus
CN111298278B (en) * 2020-03-31 2022-03-01 中国医学科学院北京协和医院 Bulb catheter implantation needle source applicator

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010008951A1 (en) * 1999-07-26 2001-07-19 Sierocuk Thomas J. Brachytherapy cartridge including absorbable and autoclaveable spacer
US20020077522A1 (en) * 2000-12-15 2002-06-20 Kawasumi Laboratories, Inc. Protective tool for therapeutic material delivery device, cartridge for therapeutic material delivery device, and a therapeutic material delivery device
US20040034312A1 (en) * 2002-06-03 2004-02-19 Koster Albert Dirk Adrianus Method and apparatus for temporarily inserting and positioning at least one energy emitting source in an animal body
US6726617B1 (en) * 2001-04-09 2004-04-27 Bruno Schmidt Cartridge and applicator

Family Cites Families (173)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1578945A (en) 1923-01-08 1926-03-30 Sanford M Withers Radium needle structure
US2067589A (en) 1935-10-08 1937-01-12 Louis C Antrim Fertilizing stick
US2153889A (en) 1937-07-20 1939-04-11 J A Deknatel & Son Inc Suture
US2575138A (en) 1948-10-29 1951-11-13 Charles E Slaughter Method and apparatus for packaging and package
US2703316A (en) 1951-06-05 1955-03-01 Du Pont Polymers of high melting lactide
US2668162A (en) 1952-03-20 1954-02-02 Du Pont Preparation of high molecular weight polyhydroxyacetic ester
US2758987A (en) 1952-06-05 1956-08-14 Du Pont Optically active homopolymers containing but one antipodal species of an alpha-monohydroxy monocarboxylic acid
US3187752A (en) 1962-04-27 1965-06-08 American Cyanamid Co Non-absorbable silicone coated sutures and method of making
US3297033A (en) 1963-10-31 1967-01-10 American Cyanamid Co Surgical sutures
US3351049A (en) 1965-04-12 1967-11-07 Hazleton Nuclear Science Corp Therapeutic metal seed containing within a radioactive isotope disposed on a carrier and method of manufacture
US3565869A (en) 1968-12-23 1971-02-23 American Cyanamid Co Extrudable and stretchable polyglycolic acid and process for preparing same
CA927032A (en) 1969-06-30 1973-05-22 H. Beacham Harry Flame-retardant resin compositions
BE758156R (en) 1970-05-13 1971-04-28 Ethicon Inc ABSORBABLE SUTURE ELEMENT AND ITS
US3839297A (en) 1971-11-22 1974-10-01 Ethicon Inc Use of stannous octoate catalyst in the manufacture of l(-)lactide-glycolide copolymer sutures
US3752630A (en) 1972-01-05 1973-08-14 Takagi H Apparatus for continuous production of thermoplastic synthetic resin tube with heat-shrinking property
US3811426A (en) 1973-05-21 1974-05-21 Atomic Energy Commission Method and apparatus for the in-vessel radiation treatment of blood
US4052988A (en) 1976-01-12 1977-10-11 Ethicon, Inc. Synthetic absorbable surgical devices of poly-dioxanone
US4141087A (en) 1977-01-19 1979-02-27 Ethicon, Inc. Isomorphic copolyoxalates and sutures thereof
US4086914A (en) 1977-02-11 1978-05-02 Edwin Bailey Moore Implant injector
US4167179A (en) 1977-10-17 1979-09-11 Mark Kirsch Planar radioactive seed implanter
US4416308A (en) 1979-11-30 1983-11-22 Bower James F Flexible one-way valve and method of producing
US4343931A (en) 1979-12-17 1982-08-10 Minnesota Mining And Manufacturing Company Synthetic absorbable surgical devices of poly(esteramides)
US4402308A (en) 1980-11-03 1983-09-06 Scott Walter P Medical implantation device
US4509506A (en) 1981-05-11 1985-04-09 Minnesota Mining & Manufacturing Co. Shielding device for radioactive seed
US4689424A (en) 1981-08-06 1987-08-25 Ethicon, Inc. Radiation sterilizable absorbable polymeric materials and methods for manufacturing the same
US4416659A (en) 1981-11-09 1983-11-22 Eli Lilly And Company Sustained release capsule for ruminants
US4441496A (en) 1982-02-08 1984-04-10 Ethicon, Inc. Copolymers of p-dioxanone and 2,5-morpholinediones and surgical devices formed therefrom having accelerated absorption characteristics
US4452973A (en) 1982-11-12 1984-06-05 American Cyanamid Company Poly(glycolic acid)/poly(oxyethylene) triblock copolymers and method of manufacturing the same
US4510295A (en) 1983-01-20 1985-04-09 Ethicon, Inc. Absorbable polymers of substituted benzoic acid
US4473670A (en) 1983-05-25 1984-09-25 Ethicon, Inc. Salt-filled absorbable polymers
US4612923A (en) 1983-12-01 1986-09-23 Ethicon, Inc. Glass-filled, absorbable surgical devices
US4638809A (en) * 1984-03-22 1987-01-27 Kuperus John H Method of preparing radionuclide doses
US4646741A (en) 1984-11-09 1987-03-03 Ethicon, Inc. Surgical fastener made from polymeric blends
US4754745A (en) 1984-11-21 1988-07-05 Horowitz Bruce S Conformable sheet material for use in brachytherapy
US4697575A (en) 1984-11-21 1987-10-06 Henry Ford Hospital Delivery system for interstitial radiation therapy including substantially non-deflecting elongated member
US4702228A (en) 1985-01-24 1987-10-27 Theragenics Corporation X-ray-emitting interstitial implants
US4741337A (en) 1985-07-17 1988-05-03 Ethicon, Inc. Surgical fastener made from glycolide-rich polymer blends
US4772287A (en) 1987-08-20 1988-09-20 Cedar Surgical, Inc. Prosthetic disc and method of implanting
US4847505A (en) 1987-11-02 1989-07-11 Best Industries, Inc. Storage and transport containers for radioactive medical materials
US4916209A (en) 1987-12-23 1990-04-10 Pfizer Inc. Bioabsorbable polydepsipeptide, preparation and use thereof
US4936823A (en) 1988-05-04 1990-06-26 Triangle Research And Development Corp. Transendoscopic implant capsule
IL86549A (en) 1988-05-30 1991-04-15 Hydro Plan Eng Ltd Process and installation for producing a drip irrigation conduit
US4891165A (en) 1988-07-28 1990-01-02 Best Industries, Inc. Device and method for encapsulating radioactive materials
US4946435A (en) 1988-10-24 1990-08-07 Best Industries, Inc. Flexible sealed radioactive film for radiotherapy, and method of making same
US5205289A (en) 1988-12-23 1993-04-27 Medical Instrumentation And Diagnostics Corporation Three-dimensional computer graphics simulation and computerized numerical optimization for dose delivery and treatment planning
AT397468B (en) 1990-07-11 1994-04-25 Oesterr Forsch Seibersdorf SPOTLIGHT HOLDER AND METHOD AND DEVICE FOR PRODUCING THE SAME
US6099457A (en) 1990-08-13 2000-08-08 Endotech, Inc. Endocurietherapy
US5242373A (en) * 1991-09-17 1993-09-07 Scott Walter P Medical seed implantation instrument
US5324503A (en) 1992-02-06 1994-06-28 Mallinckrodt Medical, Inc. Iodo-phenylated chelates for x-ray contrast
US5264540A (en) 1992-07-20 1993-11-23 Ethicon, Inc. Aromatic polyanhydrides
US5391139A (en) 1992-09-03 1995-02-21 William Beaumont Hospital Real time radiation treatment planning system
US5397816A (en) 1992-11-17 1995-03-14 Ethicon, Inc. Reinforced absorbable polymers
US5405309A (en) 1993-04-28 1995-04-11 Theragenics Corporation X-ray emitting interstitial implants
US5460592A (en) 1994-01-24 1995-10-24 Amersham Holdings, Inc. Apparatus and method for making carrier assembly for radioactive seed carrier
US5833593A (en) 1995-11-09 1998-11-10 United States Surgical Corporation Flexible source wire for localized internal irradiation of tissue
US5713828A (en) 1995-11-27 1998-02-03 International Brachytherapy S.A Hollow-tube brachytherapy device
US5761877A (en) 1996-02-23 1998-06-09 Quandt; W. Gerald System for individual dosage medication distribution
US5860909A (en) 1996-10-18 1999-01-19 Mick Radio Nuclear Instruments, Inc. Seed applicator for use in radiation therapy
US5755704A (en) 1996-10-29 1998-05-26 Medtronic, Inc. Thinwall guide catheter
US6039684A (en) 1997-12-11 2000-03-21 Allegheny University Of The Health Sciences Non-lethal conditioning methods for the treatment of acquired immunodeficiency syndrome
US6312374B1 (en) 1997-03-06 2001-11-06 Progenix, Llc Radioactive wire placement catheter
US6419621B1 (en) 1997-10-24 2002-07-16 Radiomed Corporation Coiled brachytherapy device
US6213932B1 (en) 1997-12-12 2001-04-10 Bruno Schmidt Interstitial brachytherapy device and method
US6561967B2 (en) 1997-12-12 2003-05-13 Bruno Schmidt Interstitial brachytherapy device and method
US5938583A (en) 1997-12-29 1999-08-17 Grimm; Peter D. Precision implant needle and method of using same in seed implant treatment of prostate cancer
US6540693B2 (en) 1998-03-03 2003-04-01 Senorx, Inc. Methods and apparatus for securing medical instruments to desired locations in a patients body
US6327490B1 (en) 1998-02-27 2001-12-04 Varian Medical Systems, Inc. Brachytherapy system for prostate cancer treatment with computer implemented systems and processes to facilitate pre-implantation planning and post-implantation evaluations with storage of multiple plan variations for a single patient
US6360116B1 (en) 1998-02-27 2002-03-19 Varian Medical Systems, Inc. Brachytherapy system for prostate cancer treatment with computer implemented systems and processes to facilitate pre-operative planning and post-operative evaluations
US5928130A (en) 1998-03-16 1999-07-27 Schmidt; Bruno Apparatus and method for implanting radioactive seeds in tissue
DE19815568C2 (en) 1998-03-31 2000-06-08 Bebig Isotopentechnik Und Umwe Process for the production of medical radioactive ruthenium radiation sources by electrolytic deposition of radioactive ruthenium on a carrier, radiation sources produced with this process and electrolysis cell for producing radioactive ruthenium layers
US6010446A (en) 1998-05-20 2000-01-04 Grimm; Peter D. Spacer element for radioactive seed implant treatment of prostate cancer
US6086942A (en) 1998-05-27 2000-07-11 International Brachytherapy S.A. Fluid-jet deposition of radioactive material for brachytherapy devices
US6053858A (en) 1998-06-04 2000-04-25 Advanced Cardiovascular Systems, Inc. Radiation source
US6159143A (en) 1998-06-17 2000-12-12 Scimed Life Systems, Inc. Method and device for delivery of therapeutic agents in conjunction with isotope seed placement
JP2002524108A (en) 1998-07-28 2002-08-06 インナーダイン, インコーポレイテッド Absorbable brachytherapy and chemotherapy delivery devices and methods
US6007475A (en) 1998-08-12 1999-12-28 Cns Technology, Inc. Radioactive therapeutic seeds
US6080099A (en) 1998-08-12 2000-06-27 Syntheon, Llc Radioactive therapeutic seeds
US6387034B1 (en) 1998-08-17 2002-05-14 Georia Tech Research Corporation Brachytherapy treatment planning method and apparatus
US20010047185A1 (en) 1998-08-22 2001-11-29 Stanley Satz Radioactivatable composition and implantable medical devices formed therefrom
IL126341A0 (en) 1998-09-24 1999-05-09 Medirad I R T Ltd Radiation delivery devices and methods of making same
EP0993843B1 (en) 1998-10-14 2006-04-26 Terumo Kabushiki Kaisha Radiation source delivery wire and catheter assembly for radiation therapy
US6200255B1 (en) 1998-10-30 2001-03-13 University Of Rochester Prostate implant planning engine for radiotherapy
ES2259480T3 (en) 1998-11-06 2006-10-01 Ge Healthcare Limited BRAQUITERAPIA PRODUCTS AND METHODS.
US6689043B1 (en) 1998-11-06 2004-02-10 Amersham Plc Products and methods for brachytherapy
US6474535B1 (en) 1998-11-20 2002-11-05 Nycomed Imaging As Welding method and apparatus
US6471631B1 (en) 1998-11-27 2002-10-29 Syntheon, Llc Implantable radiation therapy device having controllable radiation emission
US6132359A (en) 1999-01-07 2000-10-17 Nycomed Amersham Plc Brachytherapy seeds
EP1155418B1 (en) 1999-02-25 2007-04-11 GE Healthcare Limited Medical tools and devices with improved ultrasound visibility
US6200258B1 (en) 1999-08-10 2001-03-13 Syntheon, Llc Radioactive therapeutic seed having selective marker configuration
US6132947A (en) 1999-03-10 2000-10-17 Eastman Kodak Company Cyan coupler, and stabilizer-containing photographic element and process
US6200256B1 (en) 1999-03-17 2001-03-13 The Trustees Of Columbia University In The City Of New York Apparatus and method to treat a disease process in a luminal structure
US6132677A (en) 1999-04-26 2000-10-17 Lockheed Martin Energy Research Corporation Method for making radioactive metal articles having small dimensions
JP4349547B2 (en) 1999-04-28 2009-10-21 メディ−フィジックス・インコーポレイテッド Brachytherapy product and treatment method
US6482178B1 (en) 1999-05-21 2002-11-19 Cook Urological Incorporated Localization device with anchoring barbs
WO2001003761A1 (en) 1999-07-14 2001-01-18 Novoste Corporation Radioactive source train
TW427126U (en) * 1999-07-15 2001-03-21 Wu Bo Kuen Connection structure for fixture and containing article
US6595908B2 (en) 1999-07-23 2003-07-22 Nucletron B.V. Method for analyzing amount of activity
US6267718B1 (en) 1999-07-26 2001-07-31 Ethicon, Endo-Surgery, Inc. Brachytherapy seed cartridge
US6264599B1 (en) 1999-08-10 2001-07-24 Syntheon, Llc Radioactive therapeutic seeds having fixation structure
WO2001028631A1 (en) 1999-10-15 2001-04-26 Deschutes Medical Products, Inc. Brachytherapy instrument and methods
US6398709B1 (en) 1999-10-19 2002-06-04 Scimed Life Systems, Inc. Elongated member for intravascular delivery of radiation
US6264600B1 (en) 1999-10-21 2001-07-24 Peter D. Grimm Hollow suture member with radioactive seeds positioned therein for treatment of prostate cancer
US6436026B1 (en) 1999-10-22 2002-08-20 Radiomed Corporation Flexible, continuous, axially elastic interstitial brachytherapy source
US6450937B1 (en) 1999-12-17 2002-09-17 C. R. Bard, Inc. Needle for implanting brachytherapy seeds
US6575888B2 (en) 2000-01-25 2003-06-10 Biosurface Engineering Technologies, Inc. Bioabsorbable brachytherapy device
US6358195B1 (en) * 2000-03-09 2002-03-19 Neoseed Technology Llc Method and apparatus for loading radioactive seeds into brachytherapy needles
US6846283B2 (en) 2000-03-09 2005-01-25 Neoseed Technology Llc Methods and apparatus for loading radioactive seeds into brachytherapy needles
US6450938B1 (en) 2000-03-21 2002-09-17 Promex, Llc Brachytherapy device
US6428504B1 (en) 2000-04-06 2002-08-06 Varian Medical Systems, Inc. Multipurpose template and needles for the delivery and monitoring of multiple minimally invasive therapies
US6438401B1 (en) 2000-04-28 2002-08-20 Alpha Intervention Technology, Inc. Indentification and quantification of needle displacement departures from treatment plan
US6403916B1 (en) 2000-05-12 2002-06-11 Isostar International, Inc. System and automated method for producing welded end closures in thin-walled metal tubes
GB0011581D0 (en) 2000-05-15 2000-07-05 Nycomed Amersham Plc Grooved brachytherapy
US6616594B2 (en) 2000-05-18 2003-09-09 Integrated Implant Systems, L.L.C. Cartridge-moveable shield
US6572525B1 (en) 2000-05-26 2003-06-03 Lisa Yoshizumi Needle having an aperture for detecting seeds or spacers loaded therein and colored seeds or spacers
US6537192B1 (en) 2000-06-05 2003-03-25 Mentor Corporation Automated radioisotope seed loader system for implant needles
US6616593B1 (en) 2000-06-05 2003-09-09 Mentor Corporation Automated radioisotope seed cartridge
US6356195B1 (en) * 2000-06-15 2002-03-12 Timex Group B.V. Anti-pilferage system
US7988612B2 (en) 2000-07-17 2011-08-02 Medi-Physics, Inc. Carrier-free 103Pd brachytherapy seeds
US6500109B2 (en) 2000-07-21 2002-12-31 Tayman Medical, Inc. Prostate treatment template
NL1016101C2 (en) 2000-09-05 2002-03-07 Nucletron Bv Row of radioactive seeds and non-radioactive spacers and connecting element therefor.
US6805898B1 (en) 2000-09-28 2004-10-19 Advanced Cardiovascular Systems, Inc. Surface features of an implantable medical device
US6530875B1 (en) * 2000-10-20 2003-03-11 Imagyn Medical Technologies, Inc. Brachytherapy seed deployment system
US6554760B2 (en) 2000-10-25 2003-04-29 Gary A. Lamoureux Pre-loaded needle assembly
AU3122702A (en) 2000-11-01 2002-05-15 Medi Physics Inc Radioactive member and method of making
US6450939B1 (en) 2000-11-06 2002-09-17 Peter D. Grimm Hinged spacer element for joining radioactive seeds used in treatment of cancer
CA2425774A1 (en) 2000-11-08 2002-05-16 Theragenics Corporation Radioactive source wire and dual lumen catheter system for brachytherapy
US6612976B2 (en) 2000-11-13 2003-09-02 Isotech, L.L.C. Radioactive medical devices and methods of making radioactive medical devices
US6926657B1 (en) 2000-11-14 2005-08-09 Medi-Physics, Inc. Device for loading radioactive seeds
US6514193B2 (en) 2000-11-16 2003-02-04 Microspherix Llc Method of administering a therapeutically active substance
US7776310B2 (en) 2000-11-16 2010-08-17 Microspherix Llc Flexible and/or elastic brachytherapy seed or strand
US6638205B1 (en) 2000-11-17 2003-10-28 Mds (Canada) Inc. Radioactive medical device for radiation therapy
DE10058163C2 (en) 2000-11-22 2003-07-10 Bebig Isotopen Und Medizintech Method and applicator for positioning and / or ejecting radiation sources via hollow needles into biological tissue
US6719242B2 (en) 2000-12-01 2004-04-13 Sonoco Development, Inc. Composite core
US6472675B2 (en) 2000-12-15 2002-10-29 Theragenics Corporation Container for storing and shipping needle cartridges
EP1232770A1 (en) 2001-02-15 2002-08-21 AEA Technology QSA GmbH Radioactive capsule seed
US6800055B2 (en) 2001-02-21 2004-10-05 Cordis Corporation Low attenuating radioactive seeds
US6572527B2 (en) 2001-02-23 2003-06-03 Mentor Corporation Radioactive seed-holding device
US6497646B1 (en) 2001-03-14 2002-12-24 Cordis Corporation Intravascular radiotherapy source ribbon having variable radiopacity
US6669621B2 (en) 2001-03-14 2003-12-30 Cordis Corporation Method and assembly for containing radioactive materials
US20020169354A1 (en) 2001-05-10 2002-11-14 Munro John J. Brachytherapy systems and methods
US6723052B2 (en) 2001-06-07 2004-04-20 Stanley L. Mills Echogenic medical device
US6549802B2 (en) 2001-06-07 2003-04-15 Varian Medical Systems, Inc. Seed localization system and method in ultrasound by fluoroscopy and ultrasound fusion
JP2003011580A (en) * 2001-06-29 2003-01-15 Mitsubishi Pencil Co Ltd Writing instrument and method for manufacturing ink occlusion substance
US8267995B2 (en) 2001-08-03 2012-09-18 David Castillejos Method and intra sclera implant for treatment of glaucoma and presbyopia
US6656106B2 (en) 2001-08-17 2003-12-02 Bruno Schmidt Device for checking seeds in brachytherapy needle
US6755775B2 (en) 2001-08-30 2004-06-29 North American Scientific, Inc. Apparatus and method for loading a brachytherapy seed cartridge
US7074291B2 (en) 2001-11-02 2006-07-11 Worldwide Medical Technologies, L.L.C. Delivery system and method for interstitial radiation therapy using strands constructed with extruded strand housings
US7060020B2 (en) 2001-11-02 2006-06-13 Ideamatrix, Inc. Delivery system and method for interstitial radiation therapy
US6786858B2 (en) 2001-11-02 2004-09-07 Ideamatrix, Inc. Delivery system and method for interstitial radiotherapy using hollow seeds
US6820318B2 (en) 2001-11-02 2004-11-23 Ideamatrix, Inc. System for manufacturing interstitial radiation therapy seed strands
US6639237B2 (en) 2001-11-02 2003-10-28 Mentor Corporation Brachytherapy medical devices
US7094198B2 (en) 2001-11-02 2006-08-22 Worldwide Medical Technologies, Llc Delivery system and method for interstitial radiation therapy using seed elements with ends having one of projections and indentations
US6761680B2 (en) 2001-11-02 2004-07-13 Richard A. Terwilliger Delivery system and method for interstitial radiation therapy using seed strands constructed with preformed strand housing
CN1622841A (en) 2002-01-25 2005-06-01 米克放射原子能设备公司 Disposable and shielded seed magazine and spacer magazine assembly
CA2474359A1 (en) 2002-01-29 2003-08-07 Sicel Technologies, Inc. Implantable sensor housing and fabrication methods
DE10204818C2 (en) 2002-02-06 2003-11-27 Eurotope Entwicklungsgesellsch Device and method for loading implantation needles with radiation sources from radiation source chains for interstitial brachytherapy of tissue
US20030191355A1 (en) 2002-04-04 2003-10-09 Ferguson Patrick J. Hollow bioabsorbable elements for positioning material in living tissue
US6837844B1 (en) 2002-05-14 2005-01-04 Med-Tec Iowa, Inc. Seed cartridge for radiation therapy
US6656107B1 (en) 2002-05-24 2003-12-02 Mentor Corporation Brachytherapy seed applicators
EP2008690B1 (en) 2002-09-10 2013-11-06 Cianna Medical, Inc. Brachytherapy apparatus
US20060121080A1 (en) 2002-11-13 2006-06-08 Lye Whye K Medical devices having nanoporous layers and methods for making the same
US6969344B2 (en) 2003-02-10 2005-11-29 Bard Brachytherapy, Inc. End portion of first implantation seed spacer that receives and holds any one of implantation seed and second implantation seed spacer
US20040158118A1 (en) 2003-02-10 2004-08-12 Drobnik Christopher D. Terminus-spacer component of a string comprising one or more spacer components and one or more implantation seeds
US7322928B2 (en) 2003-03-17 2008-01-29 Medi-Physics, Inc. Products and methods for brachytherapy
US20040225174A1 (en) 2003-05-06 2004-11-11 Fuller Donald B. Method for computed tomography-ultrasound interactive prostate brachytherapy
US6989543B2 (en) 2003-08-15 2006-01-24 C.R. Bard, Inc. Radiation shielding container for radioactive sources
US20050245785A1 (en) * 2003-10-29 2005-11-03 Tarone Theodore T Biodegradable seed placement device and method
WO2005115543A1 (en) 2004-05-20 2005-12-08 Wisconsin Alumni Research Foundation Directionally emitting radioactive sources for brachytherapy
US7425195B2 (en) 2004-08-13 2008-09-16 Core Oncology, Inc. Radiation shielding device
KR20070104574A (en) 2004-12-30 2007-10-26 신벤션 아게 Combination comprising an agent providing a signal, an implant material and a drug
US7887476B2 (en) * 2005-11-10 2011-02-15 Cianna Medical, Inc. Helical brachytherapy apparatus and methods of using same
US8170647B2 (en) 2006-01-20 2012-05-01 Best Medical International, Inc Fiduciary markers and method of use thereof
US20070224234A1 (en) 2006-03-22 2007-09-27 Mark Steckel Medical devices having biodegradable polymeric regions

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010008951A1 (en) * 1999-07-26 2001-07-19 Sierocuk Thomas J. Brachytherapy cartridge including absorbable and autoclaveable spacer
US20020077522A1 (en) * 2000-12-15 2002-06-20 Kawasumi Laboratories, Inc. Protective tool for therapeutic material delivery device, cartridge for therapeutic material delivery device, and a therapeutic material delivery device
US6726617B1 (en) * 2001-04-09 2004-04-27 Bruno Schmidt Cartridge and applicator
US20040034312A1 (en) * 2002-06-03 2004-02-19 Koster Albert Dirk Adrianus Method and apparatus for temporarily inserting and positioning at least one energy emitting source in an animal body

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010112172A1 (en) * 2009-04-01 2010-10-07 Nucletron B.V. Components and assembly for performing brachytherapy treatment of tumour tissue in a human and animal body
EP2239005A1 (en) * 2009-04-01 2010-10-13 Nucletron B.V. Components and assembly for performing brachytherapy treatment of tumor tissue in an human and animal body
CN102378639A (en) * 2009-04-01 2012-03-14 核通有限公司 Components and assembly for performing brachytherapy treatment of tumour tissue in a human and animal body
US9623261B2 (en) 2009-04-01 2017-04-18 Nucletron B.V. Components and assembly for performing brachytherapy treatment of tumour tissue in a human and animal body
CN104147688A (en) * 2014-07-31 2014-11-19 吉林大学 Rapidly-formed self-adaptive afterloading brachytherapy source applicator and manufacturing method thereof

Also Published As

Publication number Publication date
US20080009661A1 (en) 2008-01-10
US20080009660A1 (en) 2008-01-10
US20070265488A1 (en) 2007-11-15
US7988611B2 (en) 2011-08-02
US7985172B2 (en) 2011-07-26
WO2007134126A3 (en) 2008-05-22

Similar Documents

Publication Publication Date Title
US7985172B2 (en) After-loader devices and kits
JP5129751B2 (en) Brachytherapy devices and methods of use thereof
US6530875B1 (en) Brachytherapy seed deployment system
US7887476B2 (en) Helical brachytherapy apparatus and methods of using same
US8641593B2 (en) Brachytherapy element transfer system
WO2007078453A2 (en) Brachytherapy apparatus for asymmetrical body cavities
AU2021236575B2 (en) Radiotherapy seeds and applicators
JP2007535334A (en) Seed and spacer placement for brachytherapy
CA2624952C (en) Packaging system for brachytherapy devices
US20070265487A1 (en) Applicators for use in positioning implants for use in brachytherapy and other radiation therapy
US7025717B2 (en) Semi-automatic needle loader
CN104822416B (en) Percutaneous interstitial type plesioradiotherapy equipment
US8944984B2 (en) Radiation/drug delivery method and apparatus
US20080269540A1 (en) Seed cartridge adaptor and methods for use therewith
EP1529553A1 (en) Test device for testing positioning of a radioactive radiation source and method using the same
US20230001232A1 (en) Radiotherapy Applicator with Perpendicular or Angled Radial Dispensing
RU2808510C2 (en) Implant for brachytherapy and method of introducing radioactive seeds into body tissue
RU2791920C2 (en) Radioactive grains and applicators
RU2813795C2 (en) Stopper for controlling movement of stylet relative to needle for brachytherapy and method of introducing radioactive seeds into body tissue
RU2808508C2 (en) Radioactive grain applicator
Deginder et al. Novel and inexpensive system for interstitial 125I seed implants

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 07762069

Country of ref document: EP

Kind code of ref document: A2

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 07762069

Country of ref document: EP

Kind code of ref document: A2