WO2000004953A2 - Brachytherapy device including an anti-static handle - Google Patents
Brachytherapy device including an anti-static handle Download PDFInfo
- Publication number
- WO2000004953A2 WO2000004953A2 PCT/US1999/015981 US9915981W WO0004953A2 WO 2000004953 A2 WO2000004953 A2 WO 2000004953A2 US 9915981 W US9915981 W US 9915981W WO 0004953 A2 WO0004953 A2 WO 0004953A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- elongate member
- handle
- stylet
- throughbore
- needle
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/01—Devices for producing movement of radiation source during therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1027—Interstitial radiation therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1007—Arrangements or means for the introduction of sources into the body
- A61N2005/1011—Apparatus for permanent insertion of sources
Definitions
- This invention relates generally to medical devices and, in particular, to a brachytherapy device for exposing to radioactivity a human or veterinary patient.
- Brachytherapy is a known medical treatment for tumors and the like. More specifically, brachytherapy is a radiation treatment which entails the use of a solid or enclosed radioisotopic source positioned either on the surface of the body of the patient or at a short distance from the area to be treated.
- brachytherapy is sometimes referred to as "interstitial" brachytherapy, in which radioactive implants are inserted into a tumor to be treated. Radioactivity from the implant shrinks the tumor or preferentially kills the cancerous cells making up the tumor, resulting in successful treatment of the patient.
- the present disclosure will use the word "brachytherapy" to refer to this latter form of treatment.
- Brachytherapy typically involves the steps of positioning the end of a needle, cannula, catheter, or other elongate member or the like in or near the tumor; inserting a radioactive material into the needle, cannula, catheter or the like; allowing the radioactive material to remain near the tumor for a specific length of time; and removing the radioactive material and the needle, cannula, catheter, or other elongate member or the like after the treatment time has expired.
- the order of the positioning and inserting steps is chosen as desired, depending upon the particular tumor being treated, the nature of the radioactive material and the characteristics of the needle, cannula, catheter, or elongate member or the like being used.
- access to the tumor can be established prior to the positioning and inserting steps via an introducer sheath or another needle, cannula, catheter or the like.
- the radioactive material introduced during brachytherapy is often contained in a plurality of pellets or "seeds" which are inserted into an open end of the needle, cannula, catheter, or other elongate member and the like. Such seeds are sealed to prevent the leakage of the radioactive material from them.
- a stylet or other push rod is often used to advance the seeds to an appropriate position in the elongate member.
- One commonly used seed comprises an iridium or iridium/platinum alloy core encased in a sheath of platinum.
- the iridium is irradiated to render it radioactive, in particular, to yield gamma-emitting 192 Ir.
- a variety of other radioactive materials are known for this purpose, and are equally useful in brachytherapy.
- the radioactive seeds are 3 mm in length; during use, the individual seeds are separated by inert spacers of 7 mm length, so that there exists a known standard distance of one centimeter ( 1 cm) between the centers of the seeds. Knowledge of this distance is useful to the treating physician or surgeon for a variety of known reasons.
- the diameter of the radioactive seeds is selected as desired for the tumor to be treated, typically at or below about 0.040 in. (1 .0 mm) diameter.
- the plastic materials often employed as handles for the elongate members are susceptible to generating an appreciable amount of static electricity.
- static electricity can cause the synthetic materials conventionally employed as spacers to cling to the handle ("static cling"), making it impossible to load the spacers into the elongate member through the handle.
- static electricity when discharged, can also generate interference with some of the various sensing and other equipment present in the operating room.
- a static spark can be an ignition source in the presence of the oxygen and/or ether commonly employed within the operating room.
- brachytherapy devices in particular, in those devices in which the elongate member is rigid
- the stylet or other push rod used to advance and position the radioactive seeds and the spacers.
- the stylet move with a minimal amount of force, since the radioactive seeds are often retained in the elongate member merely by a small ( 1 mm) wax plug in the distal end of the elongate member.
- a small ( 1 mm) wax plug in the distal end of the elongate member.
- a brachytherapy device which included a handle that was antistatic or static electricity-free, or that was at least static electricity reduced by an amount to substantially eliminate (that is, eliminate to an extent desired for practical purposes) static interference, static cling and the risk of generating an ignition spark.
- a controlled amount of friction between the elongate member and the stylet of a brachytherapy device such that the stylet would not fall from the elongate member under weight of the stylet, yet also such that only a minimal amount of force was needed to overcome that friction, and such that such friction could be provided virtually the entire time any portion of the stylet was received in the elongate member.
- the device of the present invention is directed to several improvements in brachytherapy devices.
- the present invention first involves employing a handle on the needle, cannula, catheter, or other elongate member and the like which is particularly configured for brachytherapy.
- the handle is anti-static, obviating the problems previously encountered with conventional needle handle materials.
- the handle includes a specifically angled ramp surface which particularly facilitates the introduction of the radioactive seeds and the spacers into the elongate member, making brachytherapy procedures quicker and easier to perform.
- the device includes a portion near an end of either the elongate member or the stylet which provides a predetermined, local increase in friction between them, which prevents the stylet from falling out of the elongate member during use, yet which does not cause the stylet to bind in the elongate member and interfere with its easy smooth movement within the elongate member. All three of these improvements are included within the preferred embodiment of the invention. The practical importance of solving these problems must not be overlooked. It is highly desirable during brachytherapy that both the patient and the healthcare staff be exposed to as little radiation as possible. Changes which shorten the time of exposure by even a few seconds can be important.
- the present invention speeds the introduction of the radioactive seeds into the elongate member, prevents the loss of time associated with replacing a stylet which has fallen outside the operating field, and avoids the risk of ignition associated with the use of ether as an anaesthetic. Taken together or separately, the improvements of the present invention represent a significant advance in brachytherapy procedures.
- the present invention is directed to a brachytherapy device for exposing to radioactivity a human or veterinary patient, comprising: an elongate member capable of containing radioactive material, the elongate member being adapted for introduction into the patient; and a handle at the proximal end of the elongate member, the handle being anti-static and being manipulable by a healthcare practitioner.
- the anti-static or reduced-static electricity material of the handle is at least incapable of generating a static spark under normal operating room conditions. More preferably, the material of the handle is incapable of generating a static spark even under unusual conditions, so that the material can properly be described as static-free, at least, for all practical purposes.
- the device of the present invention will likely be most commonly used for containing radioactive seeds (small pellets of an encapsulated radioactive material).
- Such seeds are spaced apart in the conventional manner by a plurality of inert spacers located one each between the individual seeds. It is preferred that the conductivity of the anti-static or reduced-static electricity material of the handle is sufficient to substantially preclude static cling of the spacers to the handle.
- Suitable materials for the handle are expected to include polycarbonate resins, acrylic resins, acetal resins and hydroscopic nylon blends. It is preferred that the polycarbonate resins, the acrylic resins and the acetal resins be carbon-filled.
- the brachytherapy device of this aspect of the present invention is preferably intended to be used with a plurality of radioactive seeds. More particularly, the device is preferably adapted to allow the introduction of the radioactive seeds into the elongate member through the handle and the subsequent containment of the seeds in the elongate member. The spacers are similarly introduced and contained in the elongate member, located between individual ones of the plurality of seeds.
- the brachytherapy device of this first aspect of the present invention preferably includes an elongate member which is hollow, configured, for example, as a needle or cannula.
- the device of this aspect of the present invention preferably further comprises a stylet slidably received in the elongate member.
- the elongate member preferably includes a longitudinal throughbore therein, and the handle connected to the elongate member includes an interior ramp surface therein in communication with the longitudinal throughbore of the elongate member.
- the interior ramp surface of the handle is preferably f rustoconical in shape and possesses an included apical angle of at least about 1 6°, and more preferably about 24°. Additional surfaces leading into the ramp surface are of course contemplated within the present invention, but are probably not preferred, while an additional bore surface in the handle leading away from the ramp surface and to the elongate member is convenient and is described in more detail below.
- the present invention is directed to a brachytherapy device for exposing to radioactivity a human or veterinary patient, comprising: an elongate member capable of containing a radioactive material, the elongate member being adapted for introduction into the patient, and the elongate member including a longitudinal throughbore therein and a proximal end; a stylet slidably receivable in the longitudinal throughbore of the elongate member, the stylet including a distal end; and a portion near at least one of the proximal ends of the elongate member and the distal end of the stylet, the portion providing a local, defined amount of friction between the elongate member and the stylet; wherein the stylet is otherwise generally closely dimensioned to the longitudinal throughbore in the elongate member such that the stylet would be generally freely movable in the throughbore in the absence of the portion.
- the brachytherapy device of the present invention preferably includes the handle disclosed above.
- the elongate member is configured as a needle or a cannula.
- the entire insertable length of the stylet is equal to or just slightly less than the overall length of the elongate member and connected handle, so that the stylet can be used to eject the contained radioactive material and the inert seeds from the elongate member during and/or after treatment of the patient.
- the portion providing the localized friction can be formed in a variety of ways.
- the portion can comprise a crimp in the elongate member.
- the portion can comprise an elliptical or oval deformation of the elongate member.
- the portion providing localized friction can instead comprise a cap near the proximal end of the elongate member.
- the cap preferably includes a V- shaped notch and a recess in the notch, the recess being dimensioned to receive the distal end of the stylet therethrough, and the notch being dimensioned to allow access through it to the throughbore in the elongate member.
- the portion can be formed as a projection (such as an annular ring or an evenly spaced plurality of projections) inside the handle itself, preferably located distal of the ramp surface (for example, on the additional bore surface).
- a projection such as an annular ring or an evenly spaced plurality of projections
- the portion providing localized friction will still be near the proximal end of the elongate member.
- the portion can comprise a crimp or flange on the stylet. This is probably the easiest way to form the portion.
- the size of the portion need not be very large to achieve the goals of this aspect of the present invention. Indeed, in devices employing needles and stylets of the sizes indicated below, the portion providing localized friction can be barely visible to the unaided eye. Accordingly, the accompanying drawing should be considered as showing the portion in exaggerated scale, in comparison to the balance of the embodiments disclosed in the drawing.
- the device of the present invention is preferably employed with the radioactive seeds and the spacers mentioned above. It is highly desirable that there be no way for the seeds and spacers to become trapped unintentionally within the elongate member after use.
- the seeds and spacers are retained within the throughbore of the elongate member in any convenient way, for example, by a small plug of wax closing the distal end of the throughbore.
- the seeds and retainers are ejected from the elongate member and implanted in the patient at the treatment site. Therefore, the portion preferably possesses a minimum transverse extent in any direction which is greater than the smallest transverse dimension of the radioactive seeds and the spacers.
- a simple bend, curve or kink in either the elongate member or the stylet is likely to be unacceptable in providing a predetermined and localized amount of friction between them. Even a relatively small kink would likely provide far too much friction, and would be expected to require an unacceptable amount of force to achieve relative movement of the stylet and elongate member.
- a bend or curve would cause the stylet to rub against the elongate member at two or more moving locations; the resulting frictional resistance to movement would therefore be expected to disadvantageous ⁇ vary in dependence upon the length of the particular segment of the stylet which happened to lie within the elongate member at one time or another during use.
- the present invention is directed to a brachytherapy device for exposing to radioactivity a human or veterinary patient, comprising: an elongate member capable of containing a radioactive material, the elongate member being adapted for introduction into the patient, and the elongate member including a longitudinal throughbore therein and a proximal end; a stylet slidably receivable in the longitudinal throughbore of the elongate member, the stylet including a distal end; a portion near at least one of the proximal end of the elongate member and the distal end of the stylet, the portion providing a local, defined amount of friction between the elongate member and the stylet; and a handle connected to the elongate member, wherein the handle includes an interior ramp surface therein in communication with the longitudinal throughbore of the elongate member; wherein the interior ramp surface of the handle is frustoconical in shape and possesses an included apical angle of at least about 1
- the medical device of the present invention possesses significant advantages over prior brachytherapy devices.
- the preferred ramp surface in the handle facilitates the insertion of the radioactive seeds and the spacers into the elongate member.
- the preferred anti-static handle eliminates, for practical purposes, the previously encountered risks of static interference, static cling and ignition spark generation.
- the localized friction portion provides a controlled and predetermined amount of friction between the elongate member and the stylet of a brachytherapy device, preventing the stylet from falling from the elongate member, while also preventing or reducing the risk of unintended ejection of the radioactive seeds and inert spacers from the elongate member. Such friction is provided virtually the entire time any portion of the stylet is received in the elongate member.
- FIG. 1 is a side view of a first preferred embodiment of the present invention
- FIG. 2 is a cross-sectional view taken along line of 2 - 2 FIG. 1 ;
- FIG. 3 is a cross-sectional view taken along line 3 - 3 of FIG. 2;
- FIG. 4 is an enlarged view of a portion of the view shown in FIG. 2;
- FIG. 5 is a cross-sectional view taken along line 5 - 5 of FIG. 4;
- FIG. 6 is a cross-sectional view of another preferred embodiment of the present invention, similar to FIG. 5;
- FIG. 7 is a top view of a portion of another preferred embodiment of the present invention.
- FIG. 8 is a side view of the portion of the invention shown in FIG. 7;
- FIG. 9 is a cross-sectional view taken along line 9 - 9 of FIG. 8;
- FIG. 1 0 is a cross-sectional view of a portion of another preferred embodiment of the present invention, comparable to FIG. 2;
- FIG. 1 1 is a partial cross-sectional view of a portion of another preferred embodiment of the present invention.
- FIG. 1 2 is a right hand (top) view of the portion of the invention shown in FIG. 1 1 .
- a first embodiment of a brachytherapy device 1 0 is thereshown, useful for exposing to radioactivity a human or veterinary patient.
- the brachytherapy device 10 first comprises an elongate member 1 2 capable of containing a radioactive material, the elongate member 1 2 being adapted for introduction into the patient.
- the elongate member 1 2 can be either flexible (such as a catheter) or rigid
- the elongate member (such as a needle or cannula), depending upon the particular tumor being treated and the particular radioactive material being employed.
- the elongate member (such as a needle or cannula), depending upon the particular tumor being treated and the particular radioactive material being employed.
- 1 2 is rigid and composed of a suitable medical grade material, such as stainless steel.
- the elongate member 1 2 is configured as a rigid tubular member such as a needle or cannula, most preferably as a needle. Accordingly, while the elongate member 1 2 can sometimes be referred to herein as the needle 1 2, it should be understood that the elongate member 1 2 need not necessarily be a needle.
- the needle or other elongate member 1 2 preferably includes a longitudinal throughbore 1 6 therein, extending from the proximal end 1 8 of the needle 1 2 to the distal end 20 of the needle 1 2.
- the inner and outer diameters of the needle or other elongate member 1 2 are selected in dependence upon the particular tumor being treated, the route of access to the tumor and the configuration of the radioactive material to be inserted in it.
- the embodiments of the brachytherapy device 10 disclosed herein are generally useful with either small radioactive seeds or larger radioactive seeds, as large as about 0.040 in. (about 1 .0 mm) in diameter and several millimeters (for example, 3 mm as is conventional) in length.
- a convenient inner diameter for the needle 1 2 is about 0.041 to 0.042 in. (1 .04 to 1 .07 mm), while a convenient outer diameter for the needle 1 2 is about 0.053 ⁇ 0.001 in. ( 1 .35 ⁇ 0.03 mm).
- the needle 1 2 conveniently includes a sharp, beveled tip 68 at its distal end 20.
- the needle 1 2 might bear on it a plurality of etched markings spaced 1 cm apart; these would allow the position of the device 10 with respect to the tumor to be judged with fair precision.
- the needle 1 2 bears on its distal end 20 some dimpling 70 which serves to permit the position of the distal end 20 to be determined even more precisely by ultrasound or echo location.
- the dimpling 70 is ECHOGENICTM-brand dimpling (ECHOGENICTM is a trademark of Cook Incorporated, Bloomington, Indiana USA).
- this first preferred embodiment of the brachytherapy device 1 0 of the present invention also comprises a stylet 14 or other push rod slidably receivable in the longitudinal throughbore 1 6 of the needle or other elongate member 1 2.
- the stylet 1 4 includes a proximal end 22 carrying on it a stylet knob 72, and a distal end 24 opposite the proximal end 22.
- a plurality of etched markings 32 are positioned on the stylet 14 near its proximal end 22, for allowing the relative position of the distal end 24 of the stylet 1 4 with respect to the distal end 20 of the needle 1 2 to be judged with good precision.
- the markings 32 are spaced 1 cm apart.
- the brachytherapy device 10 of the present invention next comprises a handle or hub 34 connected to the needle or other elongate member 1 2, for example, at the proximal end 1 8 of the needle 1 2.
- the handle 34 includes a recess 38 receiving part of the distal end 1 8 of the needle 1 2 therein.
- the handle 34 is retained on the needle 1 2 by an adhesive 38 positioned in the recess 36.
- the handle 34 also preferably includes a tapered ramp surface 40 opposite the recess 38, extending into and partway through the handle 34 in communication with the longitudinal throughbore of the needle 1 2.
- the handle 34 preferably further includes an additional bore surface 78 extending between the ramp surface 40 and the recess 36 (and thereby the proximal end 1 8 of the needle 1 2) for achieving such communication.
- the transverse diameter of the bore surface 78 is preferably the same as the interior diameter of the needle 1 2.
- the handle 34 of the of the needle 1 2 is adapted for manipulation by a healthcare practitioner, for example, the operating physician or surgeon.
- the handle 34 preferably includes an outwardly extending flange 74 and a tactile post 76 on the flange 74.
- the brachytherapy device 1 0 of the present invention is preferably used in conjunction with a plurality of radioactive seeds and inert spacers of conventional type. Only a single conventional platinum-encased 192 lr-platinum alloy radioactive seed 26 is shown in FIG. 1 , along with a single inert spacer 28 composed, for example, of suture material. Other radioactive seeds 26 or other radioactive material configurations can of course be used as well.
- the particular radioactive material used in the seeds 26 and/or the number of seeds 26 is selected in dependence upon the size of the tumor to be treated and the dose of radioactivity to which the patient is to be subjected.
- the individual seeds 26 are each separated by one of the spacers 28. Also preferably, in the conventional manner the individual seeds are
- the needle or other elongate member 1 2 and its attached handle 34 are oriented vertically during insertion of the radioactive seeds 26 and inert spacers 28 into the throughbore 1 6 of the needle 1 2.
- a 1 mm wax plug 30 in the distal end 20 of the needle (shown in phantom in FIG. 1 ), closely adjacent the sharp tip 68 of the needle 1 2, prevents the seeds 26 and spacers 28 from falling out the distal end 20 of the needle 1 2.
- the ramp surface 40 in the handle 34 is particularly adapted to assist insertion of the seeds 26 and spacers 28.
- the ramp surface 40 is preferably frustoconical (a truncated cone) in shape, and preferably possesses an included apical (apex) angle of at least about 1 6°.
- the “included” angle refers to the complete angle swept by the ramp surface 40, not the angle the ramp surface 40 makes with respect to its axis.
- the included apical angle of the frustoconical ramp surface 40 is most preferably about 24°.
- An included apical angle of at least 1 6° not only facilitates engagement of the seeds 26 and spacers 28 with the additional bore surface 78 in the handle 34, it also facilitates engagement of the distal end 24 of the stylet 14 with the seeds 26 and spacers 28 to allow their proper and complete positioning in, and proper advancement through, the bore defined by the bore surface 78 and the interior of the needle 1 2. It should be evident that this is the second aspect of the present invention mentioned above. It should also be evident that a change in the taper of the ramp surface 40, or the inclusion of an additional surface portion, proximal of the ramp surface 40 but having a shape different from that of the ramp surface 40, is not precluded. An additional surface portion of different shape (that is, other than frustoconical) is not preferred, however. If such a different shaped surface is present, it should have a larger diameter than the proximal diameter of the ramp surface 40.
- the handle 34 is preferably composed of an anti-static, a static electricity-free, or a reduced-static electricity material.
- the three phrases should be considered to have the same meaning: the material of the handle 34 is sufficiently conductive to be incapable of, and is otherwise incapable of, generating a static spark under normal operating room conditions. Because of variations in operating room temperature, humidity, and presence or absence of other sources of static charge, a more quantitative definition of these phrases may not really be possible.
- the conductivity of the handle 34 be sufficient to preclude or substantially preclude static cling of the inert spacers 28 to the handle 34. This, too, is a matter of practical consequence, rather than a matter of precise numerical limits.
- the reduced-static electricity material of the handle 34 comprises a polycarbonate resin, an acrylic resin, an acetal resin or a hydroscopic nylon blend.
- the polycarbonate resin, the acrylic resin or the acetal resin is preferably carbon-filled.
- Other polymeric materials such as polyacetylene polymers, poly- -phenylene polymers, poly( -phenylene sulphide) polymers, polypyrrole polymers and poly-1 ,6-heptadiyne polymers, are believed to possess the requisite conductivity for use in the present invention.
- these other polymeric materials can require modification to meet the mechanical requirements of the invention (resistance to sterilization techniques, mechanical strength, adhesion to the elongate member, and other practical requirements).
- the brachytherapy device 1 0 of the present invention further preferably comprises a portion 64 located near either the proximal end 1 8 of the needle or other elongate member 1 2, or the distal end 24 of the stylet 14, which provides a local, defined amount of friction between the elongate member 1 2 and the stylet 14.
- the former of these locations is shown in FIGs. 4 through 6 and FIGs. 10 through 1 2, while the latter of these locations is shown in FIGs. 7 through 9.
- the stylet 14 is otherwise generally closely dimensioned to the throughbore 1 6 of the needle 1 2, such that the stylet 14 would be generally freely movable in the throughbore 1 6 in the absence of the portion 64.
- the stylet 14 can have a diameter of about 0.038 in. (0.97 mm).
- the portion 64 can comprise a crimp 44 (FIGs. 4 and 5) in the needle 1 2, an elliptical or oval deformation 46 of the needle 1 2 (FIG. 6), or even an annular projection 66 on the bore surface 78 in the handle 34 (FIG. 1 0).
- the portion can comprise a cap 50 carried on the handle 34 which partially covers the ramp surface 40.
- the cap 50 preferably includes a wall 58 from which a flange 60 extends inwardly and engages a groove 62 on the handle 34.
- the cap 50 also preferably includes a V-shaped notch 54 and a small, semicircular recess 56 in the apex of the notch 54.
- the recess 56 is dimensioned to receive the distal end 24 of the stylet 14 therethrough and provide localized friction against the stylet 14, while the notch 54 is dimensioned to allow access therethrough to the throughbore 1 6 in the needle 1 2 (via the ramp surface 40), each when the flange 60 is engaged with the groove 62.
- the cap 50 can further include a retaining ring 52 which engages the groove 62 when the flange 60 does not, keeping the cap 50 associated with the handle 34 and needle 1 2 even when not in use.
- the portion 64 is instead positioned near the distal end 24 of the stylet 14.
- the portion 64 can comprise a crimp or flange 48 on the stylet 1 4 (FIGs. 7 through 9), or some other alteration in the uniformity of the diameter or circumference of the distal end 24 of the stylet 1 4.
- a crimp or flange 48 is probably the simplest way to form the portion 64.
- the crimp or flange 48 is located about 1 cm proximal of the distal extremity of the distal end 24 of the stylet 14.
- the transverse deformation of the portion 64 is shown exaggerated to some degree in the Figures; the actual amount of deformation is preferably adequate to provide a local, predetermined and defined amount of friction just adequate to prevent sliding of the stylet 14 in the throughbore 1 6 of the needle or other elongate member 1 2 under weight of the stylet 14. Moreover, it is important that the portion 64 not interfere with the insertion or removal of the radioactive seeds 26 and inert spacers 28 from the needle 1 2. Accordingly, the portion 64 should possess a minimum transverse extent which is greater than the largest transverse dimension of the seeds 26 and the spacers 28.
- the crimp or flange 48 on the stylet 14 can be about 0.035 in. by about 0.040 in. (0.89 mm by 1 .02 mm) when the stylet is about 0.037 to 0.039 in. (0.94 to 0.99 mm) in diameter.
- the minimum transverse width of the crimp or flange 48 in the view shown in FIG. 7 (and FIG. 9) is about 0.035 to 0.036 in. (0.89 to 0.91 mm)
- the maximum transverse width of the crimp or flange 48 in the view shown in FIG. 8 (and FIG. 9) is about 0.039 to 0.040 in. (0.99 mm to 1 .02mm).
- the portion 64 should be sized similarly when positioned near the proximal end 1 8 of the needle 1 2, rather than near the distal end 24 of the stylet 14.
- the overall lengths of the needle or other elongate member 1 2, of the handle 34 and of the stylet 14 are selected in dependence upon the site of the particular tumor to be treated.
- a typical embodiment of the brachytherapy device 1 0 of the present invention can have a handle 34 which is about 1 .21 in. (3.07 cm) in overall length, a needle 1 2 which is about 20.0 cm ⁇ 0.1 cm in overall length, and a stylet 14 which is about 23.0 cm - 0.1 cm, + 0.0 cm, in overall length.
- the needle can range in length from 5 to 50 cm depending on the particular treatment and anatomical site. What is more important than these precise lengths, however, the relative length of the stylet 1 4, the needle 1 2 and the handle 34 when fully engaged. More particularly, it is highly desirable that the length of the stylet 14 be such that, when the stylet 14 is fully received in the needle 1 2 and the knob 72 abuts the handle 34, the proximal end 24 of the stylet 14 is just exposed through the sharp tip 68 of the needle 1 2, or extends perhaps a millimeter or so through it. This ensures that when the stylet 14 is advanced to this position all of the radioactive seeds 26 and inert spacers 28 are ejected from the needle 1 2.
- the present invention thus provides a brachytherapy device 1 0 which possesses significant advantages over prior devices for that purpose.
- the preferred ramp surface 40 in the handle 34 facilitates the insertion of the radioactive seeds 26 and the spacers 28 into the needle or other elongate member 1 2.
- the preferred anti-static, reduced-static, or static-free handle 34 eliminates, for practical purposes, the previously encountered risks of static interference, static cling and ignition spark generation.
- the localized friction portion 64 near the proximal end 1 8 of the needle 1 2 or the distal end 24 of the stylet 14 provides a controlled and predetermined amount of friction between the needle 1 2 and the stylet 1 4 of the brachytherapy device 1 0, preventing the stylet 14 from falling from the needle, while also preventing or reducing the risk of unintended ejection of the radioactive seeds 28 and inert spacers 26 from the needle 1 2.
- Such friction is advantageously provided virtually the entire time any portion of the stylet 14 is received in the needle 1 2.
- the present invention is useful for the introduction of a contained radioactive material during brachytherapy, and therefore finds applicability in human and veterinary medicine. It is to be understood, however, that the above-described device is merely an illustrative embodiment of the principles of this invention, and that other devices and methods for using them may be devised by those skilled in the art, without departing from the spirit and scope of the invention. It is also to be understood that the invention is directed to embodiments both comprising and consisting of the disclosed parts.
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Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU51029/99A AU762130B2 (en) | 1998-07-20 | 1999-07-15 | Brachytherapy device including an anti-static handle |
CA002337333A CA2337333A1 (en) | 1998-07-20 | 1999-07-15 | Brachytherapy device including an anti-static handle |
EP99935578A EP1098679A2 (en) | 1998-07-20 | 1999-07-15 | Brachytherapy device including an anti-static handle |
JP2000560944A JP2003516768A (en) | 1998-07-20 | 1999-07-15 | Brachytherapy device with antistatic handle |
KR1020007014391A KR20010071512A (en) | 1998-07-20 | 1999-07-15 | Brachytherapy Device Including An Anti-Static Handle |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US9346998P | 1998-07-20 | 1998-07-20 | |
US60/093,469 | 1998-07-20 |
Publications (2)
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WO2000004953A2 true WO2000004953A2 (en) | 2000-02-03 |
WO2000004953A3 WO2000004953A3 (en) | 2000-04-27 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US1999/015981 WO2000004953A2 (en) | 1998-07-20 | 1999-07-15 | Brachytherapy device including an anti-static handle |
Country Status (7)
Country | Link |
---|---|
US (1) | US6210315B1 (en) |
EP (1) | EP1098679A2 (en) |
JP (1) | JP2003516768A (en) |
KR (1) | KR20010071512A (en) |
AU (1) | AU762130B2 (en) |
CA (1) | CA2337333A1 (en) |
WO (1) | WO2000004953A2 (en) |
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- 1999-07-15 EP EP99935578A patent/EP1098679A2/en not_active Withdrawn
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- 1999-07-15 US US09/354,073 patent/US6210315B1/en not_active Expired - Lifetime
- 1999-07-15 WO PCT/US1999/015981 patent/WO2000004953A2/en not_active Application Discontinuation
- 1999-07-15 KR KR1020007014391A patent/KR20010071512A/en active IP Right Grant
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- 1999-07-15 AU AU51029/99A patent/AU762130B2/en not_active Ceased
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Cited By (7)
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EP1377342A4 (en) * | 2000-10-25 | 2006-11-29 | Gary A Lamoureux | Pre-loaded needle assembly |
US7056274B2 (en) | 2001-07-13 | 2006-06-06 | Apple Marc G | Catheter with concentric balloons for radiogas delivery and booster radiosources for use therewith |
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EP3762103A4 (en) * | 2018-03-08 | 2021-12-01 | Alpha TAU Medical Ltd. | Radiotherapy seeds and applicators |
AU2021236575B2 (en) * | 2018-03-08 | 2023-02-02 | Alpha Tau Medical Ltd. | Radiotherapy seeds and applicators |
Also Published As
Publication number | Publication date |
---|---|
AU762130B2 (en) | 2003-06-19 |
EP1098679A2 (en) | 2001-05-16 |
WO2000004953A3 (en) | 2000-04-27 |
JP2003516768A (en) | 2003-05-20 |
AU5102999A (en) | 2000-02-14 |
US6210315B1 (en) | 2001-04-03 |
CA2337333A1 (en) | 2000-02-03 |
KR20010071512A (en) | 2001-07-28 |
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