JP2007524471A - Preparation method and system of preload needle for brachytherapy - Google Patents

Abstract

Systems and methods used for fast and efficient preload needle services in brachytherapy use third-party vendors using sterile seeds, spacers, needles, and autosterilized part filling devices in an aseptic environment Provided without the need to go through. The system and method can be used to treat, for example, prostate cancer.
[Selection] Figure 1

Description

  The present invention relates generally to radiation therapy. Specifically, the present invention relates to a system and method for quickly and aseptically preparing a preload needle for brachytherapy.

  Brachytherapy is a general term for medical treatment in which a radiation source is arranged in the vicinity of a diseased tissue, and there are cases where a radiation source is temporarily inserted (or inserted) into a patient's body and may be permanently inserted. Therefore, the radiation source is located near the affected area to be treated. Therefore, there is an advantage that a high dose of radiation can be administered to the affected area while keeping the radiation exposure of the surrounding or intervening healthy tissue relatively low.

  It has been proposed to use brachytherapy for the treatment of arthritis and various diseases including breast cancer, brain tumors, liver cancer, ovarian cancer and other cancers, especially male prostate cancer (eg JC Blasko). et al., The Urological Clinicals of North America, 23, 633-650 (1996) and H. Ragde et al., Cancer, 80, 442-453 (1997)). Prostate cancer is the most prevalent disease among male malignant tumors in the United States, and its death toll exceeds 44,000 in 1995 alone. In some treatments, the radiation source is temporarily inserted and removed after the scheduled period. Alternatively, the radiation source may be permanently inserted into the patient's body and disintegrated for a predetermined period to become inactive. Whether to use a temporary or permanent insertion depends on the isotope selected and the duration and intensity of the treatment.

  Permanent implantation for prostate treatment has a relatively short half-life compared to temporary sources and contains low-energy radioisotopes. Examples of radiation sources that can be permanently inserted include those containing iodine-125 or palladium-103 as radioisotopes. Radioisotopes are generally enclosed in a case such as titanium to form a “seed” that is inserted. Some temporary insertions for the treatment of prostate cancer include iridium-192 as a radioisotope.

  A conventional radiation source used for brachytherapy is a so-called seed, which is a sealed container made of, for example, titanium, in which a radioactive isotope is housed in a sealed chamber through which the radiation can penetrate the container / chamber wall. (U.S. Pat. Nos. 4,323,055 and 3,510,049). Such seeds are only suitable for use with radioisotopes that emit radiation that can penetrate chamber / container walls. Thus, seeds are used with radioisotopes that emit gamma rays or low energy x-rays, rather than radioisotopes that emit beta rays.

  There are several examples of commonly used seeds. OncoSeed (registered trademark) (manufactured by Amersham Health) seeds consist of welded titanium capsules containing iodine-125 adsorbed on a silver wire. OncoSeed seeds with an apparent activity of 0.191 to 1.01 millicuries are indicated for permanent tissue penetration of selected localized tumors that are low to moderate radiosensitivity. They can be used as primary treatment (such as prostate cancer or unresectable tumor) or for treatment of residual lesions after resection of the primary tumor. This apparent range of seeds can be used to treat superficial, intraperitoneal, and intrathoracic tumors. In general, tumors of the head, neck, lungs, pancreas, and prostate (early) are treated.

  An apparent total radioactivity OncoSeed seed of greater than 1.01 millicuries is indicated for intra-tissue treatment of tumors with the characteristics of unresectable, localized, and moderate radiosensitivity. These seeds can be used for selective irradiation applications as temporary implants.

  OncoSeed seeds are also indicated for the treatment of residual tumors in conjunction with or after completion of other treatment regimens such as external radiation therapy and chemotherapy. In addition, OncoSeed seeds can be transplanted into recurrent tumors.

  Another type of seed commonly used is EchoSeed® (Amersham Health). The EchoSeed seed consists of a welded titanium capsule containing iodine-125 adsorbed on a silver wire. A clearly designed groove on the outer surface of the capsule makes it possible to enhance the visualization under ultrasound.

  EchoSeed seeds with an apparent total radioactivity of 0.297-0.673 millicuries are indicated for permanent tissue penetration of selected localized tumors with low to moderate radiosensitivity. They can be used as primary treatment for prostate cancer or unresectable tumors.

  The EchoSeed seed can also be used for the treatment of residual lesions after resection of the primary tumor. EchoSeed seeds are further indicated for the treatment of residual tumors in conjunction with or after completion of other treatment modalities such as external radiation therapy and chemotherapy. In addition, recurrent tumors can be treated with EchoSeed seeds.

  A third example of a seed is RAPID Strand® (manufactured by Amersham Health). RAPID Strand is a welded titanium containing a number of (usually 10) OncoSeed seeds (Iodine-125 adsorbed on a silver wire) that are spaced apart from each other within a polyglactin absorbent braided absorbent material. Capsule). The braided material containing OncoSeed is reinforced and then sterilized with ethylene oxide. The seed is housed in a plastic spacing jig in a stainless steel shielding tube that attenuates over 99% of the iodine-125 photons.

  RAPID Strand is indicated for permanent tissue penetration of selected localized tumors that are low to moderate radiosensitivity. They can be used as primary treatment (such as prostate cancer or unresectable tumor) or for the treatment of residual lesions after resection of the primary tumor.

  RAPID Strand can be applied in conjunction with or after completion of other treatment regimens, such as external radiation therapy and chemotherapy.

  Generally, radioactive seeds are filled into the needle and then the needle is inserted into a treatment site, such as the prostate, using ultrasound images to guide the insertion process. Radioactive seeds are individually placed inside the needle and connected individually in a string configuration by being placed in the treatment site after removal from the needle or by filling inside a hollow absorbent suture member.

  U.S. Pat. No. 5,460,592 discloses a method and apparatus for carrying radioactive devices. The device includes a flexible elongated mesh or braided bioabsorbable carrier material having spaced apart radioactive seeds disposed therein. Upon heating, the carrier material that holds the seed becomes semi-rigid. The length of the semi-rigid carrier material with the radioactive seed disposed therein is then used to insert the radioactive seed into or near the treatment site, such as a tumor, for example. The dosing needle or applicator cartridge can be filled.

  In general, seeds such as Onco Seed seeds and Echo Seed seeds are not sterilized at the time of shipment and need to be sterilized before use. After filling the needle, sterilization methods such as steam sterilization, gamma radiation, pulse light sterilization can be used.

  RAPID Strand is sterilized at the time of shipment. The RAPID Strand is held in a plastic spacing jig inside the stainless steel shielding tube. The assembled RAPID Strand, plastic spacing jig, and steel shielding tube in the plastic tray are sealed inside a white sterile pouch sealed in a bag. When RAPID Strand is prepared aseptically (opening, cutting, and filling into a sterile needle), it does not need to be re-sterilized thereafter.

  Filling the needle by the end user involves a lot of complexity. In the general method disclosed in U.S. Pat. No. 5,242,373, a seed plug is assembled manually from loose seeds and biodegradable spacers (eg, made from Cutgut) that are alternately picked up from a dish. The spacers can be of any desired length and can be placed between the seeds to provide the necessary spacing between the seeds. The assembled plug is then inserted into the patient's body through the needle. The problem with this method is that the person making the plug is exposed to irradiation from a loose seed in the dish and is also exposed to irradiation when filling the seed into the insertion needle. A further disadvantage is that a significant number of seeds and spacers must be handled individually and each must be configured in the correct orientation to achieve the desired "plug" where the ends meet. is there. Seeds / spacers are typically very small, for example 4-6 mm in length, and will be handled manually and time consuming, and the associated radiation dose is dangerous. The filled needle must then be sterilized before clinical use. However, this method allows several seeds to be inserted into the patient's body at once with a pre-made plug, reducing the time spent in the operating room and reducing the spatial spacing of the seeds prior to insertion. It is used because it has the advantage of being identifiable.

  Due to the complexity and time-consuming nature of the needle filling process, services to provide preloaded needles are becoming increasingly desirable. This is because it can provide a sterilely inserted prescription-filled needle for immediate use in medical applications.

  Currently, services that provide preloaded needles include end users placing orders with seed manufacturers according to a prescribed treatment plan (eg, number and type of seeds, etc.). Seed manufacturers ship the required number of seeds and spacers to a third party vendor, such as a pharmacy, according to order from inventory. In one method, a third party vendor fills the needle with seeds and / or spacers using the method described above. Once seeded, these preload needles are sterilized using steam sterilization, gamma radiation, or pulse light sterilization. The sterile preload needle is then shipped to another sterilization facility for sterilization (biological indicator) testing. After sterility testing, the sterile preload needle is returned to a third party vendor for labeling and packaging. Alternatively, the seed can be filled at the pharmacy and then shipped to the sterilization site as a filled unit. The filling needle is returned to the pharmacy, but sterility is not confirmed until the BI is read. Finally, the labeled and packaged preload needle is shipped to the end user. The entire process takes about 7-10 business days.

Currently, there are several third party companies that offer such preloaded needle services at a significant cost, both in monetary price and time from order receipt to delivery. It is therefore highly desirable to provide a preload needle service in a fast and efficient manner so that the time from order receipt to shipment can be significantly reduced and the radioactivity lost in the seed can be minimized.
U.S. Pat. No. 4,323,055 U.S. Pat. No. 3,350,049 US Pat. No. 5,460,592 US Pat. No. 5,242,373 J. et al. C. Blasko et al, The Urological Clinicals of North America, 23, 633-650 (1996). H. Ragde et al. , Cancer, 80, 442-453. (1997)

  Thus, seeds and spacers can be aseptically filled without suffering all the disadvantages of known sources, preferably automating the process and whether or not using an automated manufacturing process. There is a need for improved methods for preload needle service.

  The present invention does not require a third party vendor and provides a system for quick and efficient preload needle service including, for example, sterilization parts and auto sterilization part filling devices. Preferably, the ordering and shipping process is performed automatically.

  The present invention also provides a method for performing preload needle service quickly and cost effectively using sterilized parts and auto sterilized parts filling devices without the need for third party vendors. All steps are performed aseptically, so there is no need for additional sterilization steps.

In one aspect of the invention, a method is provided for providing a preload needle service by a seed manufacturer without the need for a third party vendor,
a) receiving an order for a device from an end user with a needle filling pattern specifying the type and number of seeds;
b) supplying a sterile seed, a spacer and a needle with a sterile plug;
c) filling the plugged needle with sterile seed in a sterile environment according to a prescribed needle filling pattern;
d) enclosing the preload needle in a shielded steel box;
e) shipping the box to the end user.

  In another aspect of the invention, a method is provided for providing a preload needle service by a seed manufacturer without the need for a third party vendor, and step c) of the method is performed using an automatic seed filling device. The

In another aspect of the invention, a method is provided for providing a preload needle service by a seed manufacturer without the need for a third party vendor,
f) removing the preload needle from the sterile packaging and using the needle for insertion;
g) returning the shielding box to the seed manufacturer for reuse.

In yet another aspect of the present invention, a system is provided for providing a preload needle service by a seed manufacturer without the need for a third party vendor,
a) a computer system for receiving a needle filling pattern including device orders and seed numbers and types from end users and tracking order processing information;
b) a plurality of sterilized seeds, spacers and needles with sterilized plugs as ordered on the computer;
c) an automatic seed filling device for filling sterile needles and / or spacers into needles with sterile plugs according to orders received on a computer;
d) including a shielding box for shipping the preload needle to the end user.

  The systems and methods of the present invention provide a quick, convenient and cost-effective preload needle service for use in brachytherapy. This is particularly beneficial for urgent orders. In addition, the time required to process and ship the preload needle order is greatly reduced (from 7-10 business days to 1-2 business days), thereby maintaining the seed radioactivity longer. Unlike current preload seed services, the method of the present invention uses sterilized parts to perform filling in a sterile environment. Thus, there is no need to sterilize the preload needle assembly and the preload needle need not be sent to another facility for sterility testing. Therefore, a lot of time and costs are saved.

  Referring to the figures, FIG. 1 is a flow chart illustrating the method of the present invention. The first step 10 includes sending an order for the device and the needle filling pattern of the device from the end user. The order is preferably received from a computer source in an automated or web-based system, although it is also contemplated that other known methods for receiving and transferring orders may be encompassed by the present invention. Yes.

  In the next step 20, the order is then sent to the seed manufacturer's order processing department for processing. Subsequently, selection of sterile seed 30, selection of spacer 40, selection of calibration seed 50, selection of bulk seed 60, selection of twisted seed 70, and / or selection of a needle with plug (preferably reclosable) There is a combination of steps selected from 80 (with pouch).

  Then, at step 90, the manufacturer selects either inventory or special order and receives the necessary seeds, spacers, and plugged needles as needed. Then, in step 100, using the filling plan formulated according to the order and the physician's instructions, the manufacturer can use the automatic seed filling device in step 110, the manual seed filling device in step 120, the semi-automatic seed filling device in step 130, the step Select from 140 shipping containers and perform aseptic filling of the needles in step 150 according to the filling schedule.

  At step 160, the filled needle is labeled according to the plan and put into aseptic packaging aseptically to prepare and ship the shipment. When the doctor receives the order at step 170 and the insertion is performed, the shipping box is returned to the manufacturer at step 180.

  Now, the present invention will be specifically described. As described above, the end user sends device orders and needle filling patterns to the seed manufacturer, including the number and type of seeds required.

  Any conventional radioactive seed can be used as the radiation source. Examples include the radioactive seeds disclosed in U.S. Pat. Nos. 5,404,309, 4,784,116, 4,702,228, 4,230,555, and 3,325,049, the disclosures of which are incorporated herein by reference. Part of “Seed” means any sealed container, such as a metal container, containing or encapsulating a radioisotope. Suitable biocompatible container materials include metals or metal alloys such as titanium, gold, platinum, and stainless steel; polyesters and vinyl polymers, and plastics such as polyurethane, polyethylene, and poly (vinyl acetate) polymers; graphite and the like Composite materials; including glass, such as a matrix containing silicon oxide, and any other biocompatible material. Titanium and stainless steel are preferred materials for the container.

  The radioactive seed also includes a suitable radioisotope encapsulated within a polymer or ceramic matrix.

  A typical radioactive seed is generally cylindrical. Typical seed dimensions can be about 4.5 mm long and about 0.8 mm in diameter.

  Any radioisotope suitable for use in brachytherapy can be used in a radioactive seed. Non-limiting examples include palladium-103, iodine-125, strontium-89, sulfur-35, cesium-131, gold-198, thulium-170, chromium-56, arsenic-73, yttrium-90, phosphorus -32 and mixtures thereof. Particularly preferred are palladium-103 and iodine-125. One or more radioactive isotopes can be used for the radioactive seed used in the present invention. Common types of seeds include OncoSeed, EchoSeed, and RΑPID Strand.

  The order can be received by the person in charge over the phone, or more preferably on a computer system, which can process it and maintain order tracking information.

  The order is then sent to the seed manufacturer's order processing department for processing. Sterile seeds, spacers and plug needles are provided from seed manufacturer's inventory according to order. For example, sterile EchoSeed and sterile OncoSeed are available from Amersham Health. Sterile RAPID strand is sold by Amersham Health. Cartridge sterilization spacers are also manufactured by Amersham Health. In addition, calibration seeds and loose seeds can be sterilized if necessary. The needle with a plug is sold by CP Medical.

  The spacer can be made from any non-toxic, biocompatible, bioabsorbable material, or a mixture of such materials. As used herein, a bioabsorbable material is any material that is largely metabolized in the patient's body and ultimately excluded from the body. Suitable bioabsorbable materials include poly (glycolic acid) (PGA) and poly (lactic acid) (PLA), glycolic acid and lactate polymers and copolymers such as polyester amides of lactic acid, polydioxanone, etc. . Such materials are specifically described in US Pat. No. 5,460,592, the disclosure of which is hereby incorporated by reference. Suitable commercially available polymers include polyglycapron 25 (MONCRYL) (registered trademark), polyglactin 910 (VICRVL) (registered trademark) and polydioxanone (PDS II), all sold by Ethicon (New Jersey, USA). Has been.

Other suitable bioabsorbable polymers and polymer components that can be used in the present invention are described in the following patents. U.S. Pat. No. 4,052,588, which discloses a component comprising extruded and oriented filaments of polymers of p-dioxanone and 1,4-dioxapan-2-one; poly [L (-) lactide-co-glycolide suitable as an absorbable suture U.S. Pat. No. 3,839,297 disclosing a component comprising U.S. Pat. No. 3,939,033 which discloses the use of a component comprising a polyglycolide homopolymer as an absorbable suture; discloses a component comprising a high molecular weight polymer of glycolide and lactide. U.S. Pat. No. 2,668,162; U.S. Pat. No. 2,703,316 discloses a polymer comprising lactide and a copolymer of lactide and glycolide; discloses an optically active homopolymer of L (-) lactide, i.e. a component comprising poly-L-lactide. US Pat. No. 2,758,987; absorbable suture and US Pat. No. 3,636,956 discloses a component comprising a copolymer of L (−) lactide and glycolide having all functions; including synthetic absorbable crystals homomorphic to copolyoxalate polymers produced from mixtures of cyclic and linear diols U.S. Pat. No. 4,141,087 discloses components; U.S. Pat. No. 4,441,496 discloses components comprising a copolymer of p-dioxanone and 2,5-morpholinedione; poly (glycolic acid) / poly (oxyalkylene) ABA triblock copolymer U.S. Pat. No. 4,425,973; U.S. Pat. No. 4,510,295 which discloses substituted benzoic acid, dihydric alcohol, and polyesters of glycolide and / or lactide; Surgical made from a synthetic absorbent polymer containing an absorbent glass filler US Patent Disclosing Device for Use No. 4612923; US Pat. No. 4,646,741 discloses a surgical fastener comprising a blend of a copolymer of lactide, glycolide and poly (p-dioxanone); US discloses a surgical fastener made from a polymer of glycolide-enriched blend US Pat. No. 4,714,337; US Pat. No. 4,916,209 which discloses a bioabsorbable semi-crystalline depsipeptide polymer; US Pat. No. 5,264,540 which discloses a bioabsorbable aromatic polyanhydride polymer; and radioactivity sterilization of dihydric alcohols. U.S. Pat. No. 4,689,424 which discloses an absorbent polymer. These disclosures are incorporated herein by reference. Bioabsorbable polymers and polymer components are disclosed in U.S. Pat. No. 4,473,670, which discloses components of fillers comprising bioabsorbable polymers and poly (succinimide). The disclosure of which is incorporated herein by reference), and US Pat. No. 5,512,280, which discloses bioabsorbable polymers and finely divided sodium chloride or potassium chloride fillers, the disclosure of which is incorporated herein by reference. Is particularly useful when it comprises a bioabsorbable filler as described in US Pat. Such fillers can improve the stiffness of the bioabsorbable polymer and polymer component.

  Once the necessary parts, i.e. sterile seeds, sterile spacers, sterile needles with sterile plugs, and / or sterile twisted seeds such as RAPID Strand, are taken out of stock, the needles follow the prescribed needle filling plan, e.g. The seed manufacturer's facility is ready to be filled in a sterile environment.

  In order to perform needle filling aseptically, sterile parts, ie seeds, spacers, needles and needle packaging, are placed in a laminar flow hood. The needle is removed from the outer package, filled as per the insertion plan, and finally repackaged in the inner package. Needle packaging is unique in that the sterile needles are double-wrapped and can be repackaged aseptically without additional packaging after filling. Preferably, the needle is filled using an automatic needle filling device. Details of the automatic needle filling device and needle packaging will be described later.

  2 and 3 are a front view and a side view, respectively, of an embodiment of an automatic needle filling device. These drawings are not to scale, internal features are shown in non-proportional sizes to aid in clarity of illustration. The filling device is intended to facilitate the preparation of the seed insertion needle and is not used to administer the seed directly to the patient. The filling device 1 has an elongated body 3 having a front wide surface 5 'and a rear wide surface 5 ", a first short surface 7' and a second short surface 7", and an upper end surface 9 'and a lower end surface 9 ". The body 3 is provided with a longitudinal through-hole 11 extending from the opening 6 on the upper end surface 9 'to the administration opening 8 on the lower end surface 9 "and having step diameters D1, D2, D3. The diameter D1 of the through hole 11 is greatest at the upper part 13 which extends from the upper end surface 9 'to the intermediate part 15 starting through the through hole 11 at a distance of about one third. The intermediate portion 15 has an intermediate diameter D2, and extends from the lower surface of the upper portion 13 through the through hole 11 downward to a distance of about one half. The diameter D3 of the through-hole 11 is the narrowest at the lower part 17 extending from the lower surface of the intermediate part 15 to the lower end surface 9 ″. The lower part 17 serves as a seed transport path for guiding the seed to the administration opening 8. Any description of the direction in this description is a reference framework when the filling device 1 is in the desired operating orientation of the filling device, with the top surface 9 'being the top and the filling device being held substantially vertical. Please understand that it is based on.

  The body 3 is made from a radiation shielding material of a thickness suitable to shield the operator from the radiation emitted by the radioactive seeds contained therein. The main body 3 comprises a side opening 19 in the first short surface 7 '. This opening 19 leads to a recess 23 adapted to receive a standard seed magazine (not shown). The recess 23 includes a first cylindrical portion 25 having a diameter D4 adapted to receive the seed magazine body, and a rectangular portion 27 adapted to receive and maintain the rectangular positioning arm of the seed magazine. The rectangular portion 27 intersects the through hole 11 at a distance of about one third from the lower end surface 9 ″. The length and orientation of the cylindrical portion 25 and the rectangular portion 27 are such that the seed magazine is completely inserted into the recessed portion 23. Then, the seed administration hole (described later) of the seed magazine is adapted to align with the through hole 11.

  The front wide surface 5 ′ is provided with a spacer transport path in the form of a spacer inlet opening 29 that leads to a spacer receiving recess 31 connected to the outlet 8 of the through-hole 11 by an internal chute 33. The opening 29 is large enough to allow a spacer (not shown) to easily fill the recess 31. The lower part 35 of the spacer receiving recess 31 is preferably funnel-shaped in order to make it easier for the spacer to enter the chute 33. The diameter of the chute 33 is larger than the diameter of the spacer so that the spacer can be conveyed to the outlet 8 through the chute 33.

  The through-hole 11 can receive seed dispensing means such as a stepped cylindrical plunger 37 shown in the upper position in FIGS. The plunger 37 includes an upper portion 39 having a diameter D5 smaller than D1 and larger than D2, and a length equal to or longer than the length of the through-hole upper portion 13. The upper portion 39 is connected to a concentric intermediate portion 41 having a diameter D6 smaller than D2 and larger than D3, and a length substantially equal to or longer than the length of the through-hole intermediate portion 15. The intermediate part 41 is connected to a concentric lower part 43 having a diameter D7 which is smaller than D3 and smaller than the seed administration hole of the seed magazine. The lower portion 43 has a length that is substantially the same as or longer than the length from the bottom surface of the through-hole intermediate portion 15 to the bottom surface of the rectangular portion 27. Plunger portions 39, 41, 43 and through-hole portions 13, 15, 17 can be varied as desired, the only requirement is that the plunger 37 is a recessed portion 43 as shown in FIGS. It is possible to pull back to the seed filling upper position above the seed dosing hole of the seed magazine arranged at 23, and the plunger lower part 43 is arranged in the recessed part 23 as shown in FIG. It is also possible to push down to a lower dose position extending through the seed dosing hole of the seed magazine. This makes it possible to push any seed placed in the seed dosing hole downward in the through hole 11 and drop it to the outlet 8 and pass it. The plunger 37 is preferably provided with sealing means 45 such as an O-ring to prevent unwanted material from entering the lower portion of the through hole 11. The upper end surface of the plunger 37 has a larger surface area than the plunger upper portion 39 and can include an actuating surface 47 that can be used to lift and depress the plunger 37. If desired, the plunger 37 can be provided with elastic means such as a spring 49 that biases the plunger 37 to the upper filling position.

  The lower end surface of the through hole is provided with adapter means such as a threaded boss 51 or luer needle fixture to which an insertion needle or capsule or other container can be attached. It is conceivable to provide a universal adapter.

  6 and 7 are a side view and an end view, respectively, of a seed magazine 53 or a spacer magazine 53A that can be fitted into the filling device. The magazine 53 / 53A has an elongated hollow main body 55 having a hexagonal cross section. Other shaped cross-sections are also possible, such as round, square, oval. When used to contain radioactive seeds, the body 55 is preferably manufactured from a material having radioactive shielding properties, such as leaded plastic, stainless steel, lead glass, lead, tungsten. The filling end of the body is closed by a detachable end plate 57 and has a seed or spacer dosing outlet 59 arranged between two placement arms 61 with the other end projecting longitudinally. The outlet 59 includes a vertical seed dosing hole 63 drilled through the placement arm 61. The seeds 65 or the spacers 65A are arranged in a line inside the magazine 53 / 53A and are pressed toward the hole 63 by elastic means such as a spring 67 inside the magazine 53 / 53A. The force applied by the spring 67 is sufficient to prevent the seed 65 or spacer 65A from falling out of the hole 63 under the influence of gravity due to friction between the wall of the hole 63 and the end seed 65 or spacer 65A in the hole 63. It is a size.

  Preferably, the magazine 53A used for the spacer is filled with the spacer 65A and is preferably made from a synthetic bioabsorbable material. Prior art spacers were made from cut goot, but were animal-derived materials that were undesirable from the standpoint of regulatory and customer availability. An example of such a synthetic bioabsorbable material is Vicryl® consisting of about 90% polyglycolic acid and 10% polylactic acid. The spacer material is also preferably resistant to the temperatures used for heat sterilization by autoclaving or dry heat sterilization. The spacer 65A can be sterilized and fed into the sterilization magazine 53A with a sterilized integrated packaging material such as Tyvek®. Sterilization can be performed in an appropriate manner depending on the spacer components used, such as heating or exposure to ethylene oxide gas (when sterilization is required after magazine packaging and a gas-permeable packaging material is required). The use of pre-wrapped sterilization spacers is advantageous because operators do not need to fill their magazines 53A into the spacers 65A and do not have to spend time sterilizing the spacers before use. This ensures that the sterile spacer is used.

  Similarly, seed 65 can also be supplied sterilized and preloaded into the seed 53 magazine. This magazine 53 can be sterilized with a sterile integrated packaging material such as Tyvek®. The seed and magazine can be sterilized in a suitable manner with respect to spacer 65A of the spacer magazine, for example, as described above. Preferably, various package sizes can be used, such as a package 65 containing a magazine 53 filled with 5 seeds, or 10 seeds, or 15 seeds.

  Here, the use of the filling device for filling the insertion needle is illustrated. An operator holds the filling device 1 in an upright position or places it on a stand in an upright position. The seed magazine 53 including the seed 65 is inserted through the opening 21 until the magazine seed administration hole 63 is aligned with the through hole 11. Although not shown, the filling device 1 preferably has locking means such as a detent to keep the magazine 53 in place. Next, the insertion needle is attached to the adapter means 51. In order to prevent the seed and spacer from falling off the bottom surface of the needle, the bottom surface of the needle can be provided with a detachable closing means such as a plug or an end cap. The operator then depresses the plunger 37 to the lower seed dispensing position. As the plunger 37 is pushed down, the plunger lower portion 43 passes through the seed administration hole 63 of the magazine 53 and pushes the seed 65 out of the magazine 53 into the through-hole lower portion 17. Since the diameter of the through hole lower portion 17 is larger than the diameter of the seed, the seed freely passes through the through hole 11, exits from the lower end surface thereof, passes through the adapter 51, and enters the needle. The plunger 37 is then lifted to the upper filling position. As the plunger lower portion 43 passes through the seed administration hole 63 of the magazine 53 again, a new seed 65 is filled into the seed administration hole by the elastic means 67 of the magazine 53. Next, the operator places a spacer 65A having a desired size in the spacer accommodating recess 31, and releases the spacer 65A. The spacer 65A drops the internal chute 33 having a diameter larger than that of the spacer, and enters the needle via the adapter 51. This procedure is repeated until the desired number of seeds and spacers are filled into the needle. The needle can be removed from the adapter 51 and used or stored for later use. The procedure can be repeated for all needles required for treatment.

  Here, the use of the filling device of the present invention to form a seed plug is illustrated. An operator holds the filling device 1 in an upright position or places it on a stand in an upright position. The seed magazine 53 containing the seed is inserted through the opening 21 until the seed administration hole of the magazine is aligned with the through hole 11. The seed plug container is then attached to the adapter means 51. This container is preferably transparent to allow the operator to confirm that the filling is proceeding without problems and to see the number of seeds and their spacing. In order to shield the operator from radiation, the transparent container and any other transparent parts of the device of the present invention are preferably made of a radiation-attenuating transparent material such as leaded acrylic, as described below. To facilitate identification of the number of seeds and their spacing, the container is preferably provided with a scale symbol. In order to prevent the seed from falling off the bottom of the container, the bottom of the container is provided with a removable plug or is otherwise sealed. Then, similar to the above example, the operator pushes the plunger 37 down to the seed application position and feeds the seed into the container. Next, the operator places a spacer 65A having a desired length in the spacer accommodating recess 31, and releases the spacer 65A. The space falls on the internal chute 33 having a diameter larger than that of the spacer 65 </ b> A and enters the needle via the adapter 51. This procedure can be repeated until the desired number of seeds 65 and spacers 65A are filled into the container, and then the container can be removed from the adapter 51 and used or stored for later use.

  If, for example, the operator wishes to remove the seed 65 from the seed magazine 53 in order to measure radioactivity, the seed magazine 65 is placed under any suitable container under the filling device 1 and the seed 37 is depressed by depressing the plunger 37. 65 can be released into the container and installed as usual.

  FIG. 8 shows a second embodiment of the filling apparatus 101 of the present invention. For the sake of brevity, many features have functions similar to those of the first embodiment of the present invention and will not be described in this embodiment. In this embodiment, the filling device includes a first seed administration unit such as the plunger 137, a second spacer administration unit such as the plunger 197, and the first magazine accommodation recess 123 and the second magazine accommodation recess 183. The first magazine receiving recess 123 is adapted to receive and maintain the seed magazine 53, and the second magazine receiving recess 183 is adapted to receive and maintain the spacer magazine 53A. As described above, the spacer magazine 53 </ b> A includes the spacer 65 </ b> A that has been cut in advance, and operates similarly to the seed magazine 53. Preferably the magazine is sterilized and the magazine contents are sterilized before being inserted into the magazine. Furthermore, it is desirable to sterilize the filled empty magazine and filling device, for example by heating with autoclaving. To avoid confusion, the seed magazine and spacer magazine can be different shapes and sizes. This is a favorable situation, especially since the spacer 65A and the seed 65 often have different lengths. For example, the length of the spacer 65A can be 5.5 mm, and the length of the seed 65 can be 4.5 mm. Alternatively, for economic reasons, it is possible to use the same magazine for the seed and spacer, in which case it is preferable to use different colors or other landmarks to avoid confusion. In either case, it is useful to use different colors for different types of magazines, for example, spacers are fed into a white magazine and seeds are fed into a blue magazine. When using magazines of different shapes or sizes, the first magazine recess diameter D4 and the second magazine recess diameter D14 and / or to prevent the wrong type of magazine from being maintained in the recess. Or the shape of these recesses should be adapted to correspond.

  The first plunger 137 is movably fitted in the first stepped through-hole 111 leading to the outlet 108 to which the adapter 151 can be attached, and the second plunger 197 likewise leads to the outlet 108. The second stepped through hole 171 is movably fitted. The filling device 101 can be operated in the same way as the filling device 1, but instead of manually filling the individual spacers through the spacer outlet openings, the filling device 101 can fill the spacers by depressing the plunger 167. it can.

  9 and 10 show a third embodiment of the filling device 201 of the present invention. For the sake of brevity, many features have similar functions as the first and second embodiments of the present invention and will not be described in this embodiment. For clarity of illustration, the hidden portion of the plunger is shown by a solid line in FIG. 9, and the plunger is completely omitted in FIG. In this embodiment, the filling device includes first seed administration means such as a plunger 237, second spacer administration means such as a plunger 297, and the first magazine accommodation recess 223 and the second magazine accommodation recess 283. . The first magazine receiving recess 223 is adapted to receive and maintain the seed magazine 53, and the second magazine receiving recess 283 is adapted to receive and maintain the spacer magazine 53A. As described above, to avoid confusion, the seed magazine 53 and the spacer magazine 53A can be different shapes or sizes or colors. The first plunger 237 is in the first stepped through hole 211 leading to the top of the first arm 275 of the Y-shaped groove 277, and the second plunger 297 is the second arm of the Y-shaped groove 277. It is in the second stepped through-hole 271 that leads to the top of 279. The two arms 275, 279 of the Y-shaped groove meet at the top of the vertical leg 281 of the Y-shaped groove 277. The arms 275 and 279 are preferably wider at the top and taper toward the intersection with the leg 281. The arm 275 functions as a seed transport path, and the arm 279 functions as a spacer transport path. Leg 281 extends downward to opening 208 in bottom surface 285 of the filling device. In order to prevent the seed 65 and spacer 65A from becoming clogged with the leg 281, the dimensions of the leg 281 are preferably narrow enough to prevent the seed and spacer from passing each other (or beginning to pass each other). Selected. A detachable shielding device, such as a pin 287, can be inserted into the hole 289 extending from the rear surface of the filling device toward the front surface of the filling device and intersecting the leg 281. When inserted into hole 289, this pin 287 prevents seed and spacer from passing through leg 281. It is further contemplated that the pin 287 can also be a valve-type member that is a spring biased to shield the leg 281. When the spring bias is released, the pin 287 provides an opening in fluid communication with the leg 281 to allow the seed and spacer plugs to pass through. The front surface of the filling device 201 is preferably made from a radiation shielding material such as leaded acrylic so that the operator can view the contents of the legs 281 while shielding the radiation emitted by the seeds in the legs 281. A transparent portion 291. This transparent portion 291 can be detachable quickly and easily to clean the passages, remove foreign objects, or facilitate removal of clogged seeds or spacers. If the seed needs to be removed, this rapid removal means that the operator is exposed to the radiation from the seed for a very short time and therefore receives a negligible dose of radiation. Once the seed and spacer plugs are formed, the pins 287 are placed in the shield position, the seeds and spacers fall onto the pins 287, and the legs 281 gradually fill. The transparent portion 291 includes tick marks to help identify the number of seeds and spacers in the device. The transparent portion 291 allows the operator to check the progress of the plug configuration, and if the operator is interrupted during plug formation, the operator can check the status of the plug being configured upon resumption. Non-standard arrangements of seeds and spacers can also be visually confirmed through the transparent portion 291 prior to filling into the needle, for example, the seeds are separated by various numbers of spacers.

  The filling device 201 can be operated in the same manner as the filling device 101.

  In another embodiment of the present invention, shown schematically in FIG. 11, a single plunger 337 is shown used to alternately fill spacers 65A and seeds 65. The plunger 337 is connected to a piston 351 having two extensions 353, 355 aligned with the arms 375, 379 of the Y-shaped groove 377 forming a seed and spacer transport path. The extension 353 is shorter than the extension 355. This is because when the plunger 337 is pushed down, the extension 355 passes through the first magazine receiving recess port before the extension 353 passes through the magazine (not shown) in the second magazine receiving recess port 357. It means passing through a magazine (not shown) in 359. Plunger 337 includes three recesses 361 'to 361 "' that can cooperate with spring-filled index pins 363 supported within bore 311. The first recess 361 'is either extension. Is also aligned with the index pin 363 when not in line with the magazine receiving recess ports 357, 359. The second recess 361 "is when the extension 355 passes the level of the magazine receiving recess ports 357, 359. , Align with the index pin 363. The third recess 361 ″ ″ aligns with the index pin 363 when the extension 353 passes the level of the magazine receiving recess port 357, 359. The operator can set the first recess 361 ′ to the index pin 363. After lifting the plunger 337 until it is aligned with the magazine, the magazine can be loaded onto the filling device, assuming that the first magazine contains seeds and the second magazine contains spacers. The seed 65 can be released from the first magazine by lowering the plunger 337 until the second recess 361 ″ is aligned with the index pin 363. The spacer 65 'can then be released by depressing the plunger 337 until the third recess 361 "" is aligned with the index pin 363. It is desired to release more spacers before releasing more seeds. If so, the plunger is raised until the second recess 361 ″ is aligned with the index pin 363 and then pushed down again. If it is desired to fill the seed, the plunger is raised until the first recess 361 ′ is aligned with the index pin 363 and then pushed down again until the second recess 361 ″ is aligned with the index pin 363.

Alternatively, an automated seed and spacer filling device can be used to form a twisted product according to the customer order at step 10 of FIG. FIG. 15 shows an automatic seed and spacer filling device 500 based on the filling apparatus described in US Pat. No. 6,730,003 assigned to the assignee of the present application. The filling device 500 produces a twisted braid that incorporates a series of seeds and spacers in a desired order. The twisted braid can then be inserted into the needle assembly and provided to the end user. The disclosure of this US patent is incorporated herein by reference. The filling device 500 supports individual seeds from the seed magazine holder 534 and the center of the hollow braid 532 by the escapement mechanism 532. And a seed push rod 510 for pushing into a hub needle 530 extending therethrough. A servo motor controls the operation of the push rod 510. A tensioning piston 512 mechanically teaches the braid material to the hub needle and continues to fill the braid 532 material with seeds and spacers. The vibrating ball feeder 514 sends the bulk spacer to the vibrating feed track 516, and the vibrating feed track 516 sends the seed to the escapement mechanism 532 in a line. The escapement mechanism 532 includes a pneumatic escapement piston 536 for operating a mechanism that alternately feeds seeds and spacers into the hub needle for insertion into the central portion of the braid 532.

  The filling device 500 further includes a spacer release / reset button 518 for releasing a spacer that has been incorrectly fed into the escapement mechanism. Such spacers are ejected through a spacer ejection plate 522 that covers the spacer ejection holes and is activated by a spacer ejection / reset button 518. A hub needle release button 520 is provided to actuate the release of the hub needle 530 upon completion of filling.

  Once properly filled, device 500 will automatically operate. The operator fills the device with a magazine of seeds, a bulk spacer in a vibrating ball and a hub needle of braided material. After filling the device 500 with the three main parts, pressing the start button causes the device to automatically fill the braid material with seeds and spacers. The machine also supplies precise tension and spacing during the filling operation with the braided material tensioning piston. When the twisting is complete, the operator resets the device 500 to the starting position by depressing the reset switch. The machine is typically set by a programmable logic controller 540 to fill 10 seeds and 11 spacers per twist. Programmable logic controller 540 is programmable to provide for the loading of any combination of seeds and spacers.

  FIG. 12 shows a needle with a plug. The sealed outer bag 410 includes a plurality of inner bags 412 such as three. Each inner bag 412 includes a plurality of needles 416. The outer bag 410 is the primary sterilization barrier for the parts and its contents are sterilized when received as material for use in the present invention. The outer bag 410 will be delivered in a box 480 with appropriate packaging to protect the contents from damaging the sterility barrier.

  Needle 416 is preferably a standard 18 gauge brachytherapy needle. One end of the needle is closed with a bioabsorbable material. This plug allows the parts to be maintained after filling. The needle plug material is a mechanical barrier that is placed at the free tip of the needle. During the insertion process, the plug material and filling parts are inserted into the patient's body.

  Each needle 416 has a cylindrical plastic shield 420 to ensure safety during shipping and use. The plastic shield 420 is mechanically fitted to the needle 416, and the uppermost part 420a of the shield is fitted on the slope of the needle luer fixture 422 without any gap. The bottom surface 424 of the cylindrical plastic needle shield 420 includes a plug 425 to ensure that the filling part does not fall off the needle. It also protects the filling needle from external debris. The plug is a soft rubber-like material that twists into the needle shield.

  Each needle 416 has a stylet 426. As shown in FIG. 12, the stylet 426 is packaged in the inner package 412 together with the needle 416. After filling the seed and spacer parts into the needle, the stylet is inserted through the luer fixture into the needle and advanced until the tip of the stylet reaches the part in the needle. An elastomer or deformable guard 430 is placed on the stylet 426 and fits within a luer fixture on the needle to ensure that the stylet is not advanced during the shipping process.

  The inner bag 412 is plastic and the top of the bag is Tyvek material with an adhesive backside sealing layer. Needle 426 is filled into inner bag 412 and the bag is not initially sealed. Once the needle filling has taken place, the filling needle 416 is again placed in the inner bag and an adhesive back layer 415 is used to seal the inner bag. The sealed inner bag is then removed from the aseptic assembly area for packaging and shipment to the end user.

  The outer bag 410 is a sterile package. This is made from plastic and Tyvek and includes a number of unsealed inner bags. After being brought into the sterile assembly area, the outer bag is discarded.

  When using needle packs with sterile plugs, aseptic methods must be used. The bag 410 is sprayed with isopropyl alcohol and transported to the aseptic assembly area. The unsealed bag 412 is then removed from the bag 410.

  The needle and stylet are then removed from the bag 412. A cylindrical plastic needle shield 420 is on each needle 416. The shield plug placed on the free end 424 of the needle shield 420 and the rubber guard 430 placed on the needle stylet are then removed. Each needle 416 can then be placed on the seed filling device.

  Each needle 416 can be filled with sterile seed and spacers according to the recipe and then removed from the used filling device. The stylet 426 is then placed in the needle 416 and advanced until the components inside advance into the lower portion of the needle and seal the needle plug media. The stylet 426 is then withdrawn about a half inch from the needle. The rubber guard 430 is then placed on the stylet slightly above the luer fixture on the needle.

  The stylet 426 is again inserted about one-half inch into the needle. This inserts the rubber guard corner tip 426 into the slope of the luer fixture on the needle. The filling needle is then labeled and reinserted into the bag 412.

  After filling all the needles, they are returned into the bag 412 to expose the adhesive back side of the bag and an adhesive layer 415 is placed over the front of the bag 412 to ensure a new sterility barrier. Finally, the sealed bag 412 is removed from the aseptic assembly area and placed in the shipping container 418.

  The shipping container is made from a shielding material, preferably a shielded returnable stainless steel box. This shielded box with preload needles is shipped from the packaging seed manufacturer's packaging facility to the end user in sterile packaging for immediate use in medical applications.

  The physician can return the shipping box 418 to the manufacturer for relabeling and reuse.

  The invention described and claimed in this specification is not intended to be limited to the scope of these embodiments, since the specific embodiments disclosed are considered illustrative of some aspects of the invention. Any equivalent embodiments are considered to be within the scope of this invention. Indeed, various modifications of the invention will become apparent to those skilled in the art from the foregoing description, in addition to those shown and described herein. Such modifications are also considered to fall within the scope of the appended claims.

FIG. 2 is a schematic diagram of the method of the present invention. 1 is a front view of one embodiment of an automatic seed filling device in a first stage. FIG. FIG. 3 is a side view of the device of FIG. 2. FIG. 2 is a front view of the filling device of FIG. 1 in a second stage. FIG. 5 is a side view of the device of FIG. 4. 1 is a side view of one embodiment of a magazine suitable for use with a filling device. FIG. FIG. 7 is an end view of the magazine of FIG. 6. It is a front view of 2nd Embodiment of a filling device. It is a front view of 3rd Embodiment of a filling device. FIG. 10 is a side view of the device of FIG. 9. FIG. 10 is a front view of a fourth embodiment of the filling device. FIG. 3 is a view of a sterile needle package of the present invention for inserting an empty needle into a filling device. It is a figure which shows the individual inclusion of the sterilization needle packaging of FIG. It is a figure which shows each inclusion of a filling needle. FIG. 3 shows an automatic seed filling device for forming a continuous array of seeds and spacers.

Claims (4)

A method of providing a preload needle service by a seed manufacturer without the need for a third party vendor,
a) receiving an order for a device from an end user with a needle filling pattern specifying the type and number of seeds;
b) supplying a sterile seed, a spacer and a needle with a sterile plug;
c) filling the plugged needle with sterile seed in a sterile environment according to a prescribed needle filling pattern;
d) enclosing the preload needle in a shielded steel box;
e) shipping the box to the end user. A method of providing a preload needle service by a seed manufacturer without the need for a third party vendor,
a) receiving an order for a device from an end user with a needle filling pattern specifying the type and number of seeds;
b) supplying a sterile seed, a spacer and a needle with a sterile plug;
c) filling the plugged needle with sterile seed in an aseptic environment according to a prescribed needle filling pattern using an automatic seed filling device;
d) enclosing the preload needle in a shielded steel box;
e) shipping the box to the end user. f) removing the preload needle from the sterile packaging and using the needle for insertion;
and g) returning the shielding box to the seed manufacturer for reuse. A system for providing a preload needle service by a seed manufacturer without the need for a third party vendor,
a) a computer system for receiving a needle filling pattern including device orders and seed numbers and types from end users and tracking order processing information;
b) a plurality of sterilized seeds, spacers and needles with sterilized plugs as ordered on the computer;
c) an automatic seed filling device for filling sterile needles and / or spacers into needles with sterile plugs according to orders received on a computer;
d) A system including a shielding box for shipping the preload needle to the end user.

Images