Process and device to detect and remove a d.i.u.
4 claims: 1 independent, 3 dependent
- 1REIVINDIC - lã Processo para, a detecção e extracção de um dispositi vo intrauterino que possui uma porção magnética que compreende as fases de:a. Introduzir no útero de uma doente uma sonda que compreer. de um meio de preensao e pelo menos um gerador por efeito de Hal3 em ligação eléctrica com um dispositivo indicador que responde à • tensão de saída do gerador por efeito de Hall^ b. detectar a localização da porção com a sonda;c. ajustar a posição da sonda em resposta ao dispositivo indicador ate que a sonda, esteja, na proximidade imediata do dispositivo intraut erino % d. actuar no meio de preensão para agarrar uma porção do dispositivo intrauterino;e e. extrair a sonda juntamente com o dispositivo intrauteri. no do útero. 2ê Processo de acordo com a reivindicação 1, caracterizado por a referida sonda ser feita de materiais que são capazes de manter um dipolo magnético. - Processo de acordo com a reivindicação 1, caracterizado por o referido dispositivo intrauterino ser um dispositivo uterino em forma de T. — 4— — Processo de acordo com a reivindicação 3, caracterizado por a referida porção magnética, estar situada, na baste do dispositivo intrauterino em forma de T. Processo de acordo com a reivindicação 1, caracterizado por a relação entre a distância dos polos do dipolo da porção magnética e a secção transversal da porção magnética ser igu al pelo menos a 2?1. — 6- — Processo de acordo com a reivindicação 1, caracterizado por a referida relação ser igual pelo menos a 5:1. - 7â » Processo de acordo com a reivindicação 1, caracterizado por o meio de preensão ser aotuado por um êmbolo. Processo de acordo com a reivindicação 1, caracterizado por o meio de preensão compreender pelo menos dois elementos em forma de dedos opostos que se separam quando são actuados. «. ga „ Processo para a deteoção interna de um dispositivo intrauterino que possui uma porção magnética que compreende a in troô-ução na vagina, na uretra ou no recto de uma doente de uma sonda que compreende pelo menos um gerador por efeito de Hall em ligação elêctrica com um meio indicador que compreende a tensão de saída do gerador por efeito de Hall. - 10§ Processo de acordo com a reivindicação 9, caracterizado por a referida sonda ser feita de materiais que são incapazes de manter um dipolo magnético. llã Processo de acordo com a reivindicação 9, caracterizado por a referida sonda ser introduzida na vagina da doente. Dispositivo para a deteoção e translocação de um íman que compreende um gerador por efeito de Hall, um meio indica dor que responde á tensão de saída do gerador por efeito de Hall em ligação elêctrica com o referido gerador, e meios de preensão para a ligação temporária ao íman do dispositivo. ~ 13S Dispositivo de acordo com a reivindicação 12, caracterizado por o referido dispositivo compreender dois geradores por efeito de Hall para a deteoção ao longo de eixos dispostos perpendicularmente um ao outro. - 14â - 23 ι\ π Dispositivo de acordo com a reivindicação 12, caracterizado por o referido dispositivo compreender três geradores por efeito de Hall dispostos perpendicularmente entre si. - 15a Dispositivo de acordo com a reivindicação 12, caracterizado por compreender uma, porção da sonda adaptada para ser introduzida no útero da doente. - I6ã Dispositivo de acordo com a reivindicação 12, caracterizaô.o por a referida porção da sonda ser construída de materi ais incapazes de reter um dipolo magnético. - 17â Dispositivo de acordo com a reivindicação 12, caracterizado por 0 referido meio de preensão compreender pelo menos dois elementos em forma de dedos opostos que se separam quando actuados. - I8ã Localizador para a detecção de um íman caracterizado por compreender dois geradores por efeito de Hall dispostos perpendicularmente entre si e um dispositivo indicador que responde ã tensão de saída dos geradores por efeito de Hall em ligação eléctrica com os referiõ.os geradores. - 19ã localizador de acordo com a reivindicação 18, caracterizado por compreender três geradores por efeito de Hall dispostos perpendicularmente entre si. - 20S Localizador de acordo com a reivindicação 18, caracterizado por compreender uma porção de sonda adaptada para ser ir troduzida na vagina de uma, doente. - 21- Localizador de acordo com a reivindicação 20, carac- 24 terizado por a referida porção de sonda ser feita de materiais in capazes de reter um dipolo magnético. - 22ã Processo para a-produção da secção polimérica de um dispositivo intrauterino, caracterizado por a referida secção com preender uma porção magnética para a detecção e/ou para, a remoção de uma secção polimérica incapaz de reter um dipolo magnético, que compreende as fases des 1) dispersar de maneira homogénea material magnético em par tíeulas ou material no qual pode ser induzido um dipolo magnético, num material polimêrico em partículas ou fundido;
- 22) moldar a mistura magnética resultante para lhe dar a for ma de pelo menos uma porção do dispositivo intrauterino e, se a porção magnética não constituir toda, a porção polimérica do dispo s i t ivo intr aut er ino;
- 33) fixar na porção magnética moldada material polimêrico pa ra completai 1 a secção polimérica, do dispositivo intrauterino. „ 23a „ Processo de acordo com a reivindicação 22, caracterizado por compreender ainda a fase des
- 44) induzir um dipolo magnético no dispositivo intrauterino. - 24^ Dispositivo intrauterino produzido pelo processo de a cordo com a reivindicação 22. A requerente declara que 0 primeiro ped,ido desta, patente foi depositado nos Estados Unid,os da América em 23 de Janei ro de 1984, sob 0 número da série 573?073.
Independent claims4
142 paragraphs in 3 sections, as filed
PROCESS AND DEVICE FOR DETECTION AND REMOVAL OF A YUTRAUTERINE DEVICE.
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Descriptive Story
Background of the invention
The present invention comprises an intrauterine contraceptive device (IUD) as well as methods for detecting and removing an IUD from a patient.
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Intrauterine devices of varying shapes are often provided with an appendix made of a monofilament plastic material that extends across the cervix and allows the IUD to be removed when desired by pulling on the appendix. However, the presence of an appendix is associated with pelvic inflammatory diseases, as reported by HJ Tatum in Fertility and Sterility, Volume 39, NS. 2, page 141-143 (1983)? N<sub>O</sub>Ç'<sub>0</sub> Lee et al. In Obstetrics & Gynecology, NS. 1, Vol. 62, July 1983, and RH Eaufman et al, in Obstetrics & Gynecology, Supplement, p. S88, September 1983.
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In more detail, the appendix of an IUD extending downward from the endometrial cavity through the cervical canal into the vagina has been suspected since 1920 of forming a ladder through which bacteria
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they rise from the vagina to the pelvic organs and reproduce internally (uterus, fallopian tubes, ovaries, and adjacent structures). Clinical studies have suggested that the uterine cavity is sterilized by itself within 30 days of IUD insertion, see DR Mishell et al, in Obstetrics & Gynecology, page 119? September 1, 1966. If the IUD has a mono- or bifilament transcervieal appendix that extends into the vagina? bacteria may persist in the uterine cavity in small numbers for more than 30 days. A parallel study using an IUD whose appendix was previously removed showed that the uterus remained sterile for an indefinite period of time following introduction. Although IUDs with multiple filament appendages (Dalkon Protection, lajzlin springs and Birnberg arches) are particularly likely to give rise to an upward pelvic infection, IUDs with single or bifilament appendages (lip-loop, Sof-T-Coil, Tatum T , GYNE-T, Gopper T and Oopper 7) may not be entirely without risk. Delayed use of an appended IUD can contribute to an infection that rises from the vagina and reaches the pelvic reproductive organs. Such an infection may result in reduced fertility.
Pelvic infectious disease (PID) may result from the direct diffusion of microorganisms rising from the vagina through the uterine cavity (endometritis) and the fallopian tube cavities (salpingitis) and may then extend to the ovaries (oophoritis). When both the fallopian tubes and ovaries are struck, a very severe form of PID can occur - the rich fallopian abscess. This fallopian ovarian abscess is a potentially life-threatening complication. Can DTP also diffuse upward from the uterus (cervix and fundus) through the pericervical and perimetrial lymphatic vessels into the periovarial and salpine mesosi areas? and which include the bladder? the intestines, the kidneys are. ment. Much less often, periurethral and perivesical lymphatic vessels can carry microorganisms to the bladder and upper urinary tract. It is therefore not logical to assume that the transcervial appendage of an IUD may contri. fit for these types of pelvic inflammatory diseases. An IUD without an appendix would minimize or nullify the role of the IUD as a factor.
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which contributes to the development of pelvic infectious diseases.
Transuterine perforation of an appended IUD into the peritoneal cavity can create a passageway for bacteria to move from the vagina through the uterine cavity into the peritoneal cavity. When the appendix that has been in contact with the bacterial flora of the vagina enters the peritoneal cavity following perforation of the uterus, peritonitis may develop.
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In addition, an IUD appendix may cause irritation of the cervical epithelium, leading to acute and / or chronic cervititis. This may in turn be accompanied by a vaginal discharge. An intrauterine pregnancy, which occurs when there is an IUD in the uterine cavity, has been found to increase the risk of miscarriage or premature birth. At 10 to 12 weeks of pregnancy and when the IUD has an appendix, it is often collected into the uterine cavity. Bacteria that are near, on or within the portion of the appendix that was originally in the vagina may cause septic embryonic abortion when entering the pregnant uterine cavity. Such a septic embryonic abortion is a potentially life-threatening complication for both the mother and the fetus. It is logical that a pregnancy occurring while in an uterus without an appendix in the womb cannot be threatened by an upward infection, as there would have been no transcervical appendage in the vagina to serve as a conduction pathway for the blood vessels. they rise into the womb.
Detecting an IUD in the uterus and removing it are important aspects of IUD design. IUDs are placed in the womb for long periods of time during which inadvertent removal or expulsion may occur, for example when a tampon is removed or during the menstrual period. Although the presence of the appendix provides a means of detection and removal, the presence of the appendix can be annoying to the wearer.
The use of magnetic materials in IUDs is known, as can be seen from RGA Technical Notes N2. 675 (Ju-3 ft
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1966) and U.S. Patents 3,042,030, 3,467,087,
805 777, 3,908,646, 3,913,573, and 3,996,933. Magnetic IUDs are provided to permit external detection, for example by passing a magnetic needle through the abdomen, or for removal of the IUD. However, the removal systems described in the reference depend on the force of attraction between the IUD magnet and the uterine magnetic probe that should be sufficient to allow removal of the magnetic probe, that is, by magnetic forces. Such designs are unrealistic or impractical due to the fact that the magnetic force necessary for carrying out said manipulation through the cervix is far greater than can be obtained with magnets small enough for use in an IUD. This limitation may have been recognized in U.S. Patent 3,805,777, in which the magnet is in the form of a mark which is in fact an appendix carried within the IUD. A magnetic probe is inserted into the uterus which pushes said mark through the cervix which is picked up and then removed from the entire IUD by pulling on said mark. The maximum magnetic force that can be used in such a system is believed to be insufficient to permit manipulation of the mark across the lap for many, if not most, or all attempts at such an operation. In addition, the magnetic mark of such a system may become an appendix due to its inadvertent fall across the lap.
It is an object of the present invention to provide an intrauterine device (IUD) which is easily and precisely detected in the uterus by non-invasive external means or by an intravaginal or intrarectal probe inserted without invasion of the uterus.
Another object of the present invention is an appendix-free IUD which is nonetheless easily removed from the uterus with minimal intrauterine manipulation.
Another object of the present invention is a t-system. emotion of an IUD that contains a magnetic portion with minimal body manipulation. By the location and speed of the IUD, one. Such a system reduces the risk of infection, uterine
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other trauma, and minimize the patient's discomfort.
Another object of the present invention is an extraction system which can be applied in a wide variety of IUD shapes and dimensions to avoid the need for separate and unique extractors for the various IUD forms.
Summary of the Invention
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The present invention relates to an intrauterine device (IUD), in particular a Tatun T, which has a magnetic portion to allow rapid and accurate detection and / or removal of the IUD without utilizing the magnetic force of attraction for translocation of the IUD itself. For removal of the uterus, a Hall effect probe is inserted into the uterus and guided to the IHD through the field created by the magnetic portion. A contact with the IUD is established, a gripping device is actuated to temporarily attach to the IUD, and the entire joint with the IUD can then be removed. Also included in the present invention are IUD detection and removal processes, methods for detecting only the IUD by external or internal means, for example by introducing a Hall effect probe into the vagina and probes for detection and translocation. as well as for detecting only the IUD. The present invention also relates to the processes for producing a magnetic IUD and to the IUDs produced by such processes.
Brief Description of Drawings
Fig. 1 illustrates an extraction probe (10) and a locator probe (20) according to the present invention, in perspective view, with a control console, for example for use in a medical office.
Fig. 2 is a schematic cross-section of the extraction probe taken along line 2-2 of FIG. 1.
Fig. 3 is an enlarged cross-sectional view of portions of the extraction probe shown in FIG. 2.
Fig. 4 is a top view along line 4-4 of FIG. 3
- 5 <sub>L</sub>ea- $ og
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Fig. 5 θ is an enlarged sectional view of the tip and mechanical fingers of the extraction probe. In this view, the mechanical fingers are fully extended after the location of the intrauterine device.
Fig. 6 shown in fig. 5 Around the end is a view of the tip of the extraction probe and after retraction of the spherical mechanical fingers of the intrauterine device.
Fig. 7 is a schematic view of the Hall e-generators located at the tip of the extraction probe, for example shown in phantom in fig. 5 and 6, particularly indicating each of the three dimensional directions in which one of the Hall effect generators detects the presence of magnetic materials.
Fig. 8 is a plan view of an intrauterine device according to an embodiment of the present invention. In this embodiment, the magnetic material is introduced into a cavity that is coaxial with the shaft axis of the intrauterine device.
Fig. 9 is a cross-sectional view taken along line 9-9 of FIG. 8
Fig. 10 is a plan view of a second embodiment of an intrauterine device according to the present invention. In this embodiment, the magnetic material is homogeneously mixed with the plastic of the UIU on its stem.
Fig. 11 is a cross-sectional view taken along line 11-11 of FIG. 10
Hall Effect - The magnetic IUD according to the present invention is detected and / or located by one or more Hall effect generators. A Hall effect generator is a dis. positive four-state solid state which is capable of producing an output voltage V proportional to the input current product I1, the magnetic flux density B of the magnetic material to be detected and the sine of the angle formed by B with the
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Hall effect generator plan. More details are given in Technical Bulletin N<sup>2</sup>. H-100 and H-101 of FW Bell, Ihc. 6120 Hanging ffioss Boad, Orlando, Florida 32 807 and in Electronic Products Magazine, pages 59-62, September 18, 1972, United Technical Publications, New York, NY Thus, “*<sup>AND</sup>I-I00 <sup>Z</sup>0 <sup>B sen</sup> · Θ or, if sen θ ~ 1 (ie O = 90<sup>2</sup>) <sup>V</sup>H ”^ 00 <sup>I</sup>Ç <sup>B</sup> or being:
II
V_ = Hall output voltage, mV n
Ή00 TlB (sensitivity constant - product and open circuit), mV / mA KG.
Magnetic sensitivity (with or without load) for a specified control current, mV / KG.
Control current, mA (continuous or alternating)
Magnetic flux density, IG (continuous or alternating)
From the above equations, it can be seen that when magnetizing a particular specified mass of magnetic material to produce a particular magnetic field, the output voltage of a Hall effect generator with one. Constant input current will be proportional. the arrangement of the generator relative to the magnet as the magnetic flux density increases as we approach the magnet. In addition, if the magnetic material is arranged in a cylindrical shape along the axis of the IUD rod, the density of the magnetic flux at a given distance from the end of the magnet dipole depends on whether the Hall-effect generator plane is the same. perpendicular to the axis of the magnet or rotated to the side of the rod. This result can be appreciated from a consideration of the magnetic force lines coming from a dipole, since the maximum density of these lines extends axially from the dipole end and bends backwards in the direction of the dipole. opposite dipole. When the power lines
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extend backward from the end of the dipole, its density decreases. Thus, the approximation of a Hall effect generator on the side of a magnetic dipole will result in a lower output voltage than the approximation at the same distance along the dipole axis.
Hall effect generators for use in probes or detectors according to the present invention include those provided by PW Bell Incorporated, series BH-200 and BH-700. In particular, Hall effect generators that can be placed with the plane of the generator perpendicular to the axis of the magnetic pole, see generator 63 in FIG. 7? include generators BH-202, BH-203, BH-204 β BH-20S, which may be arranged with their plane containing the axis of the extraction or locating probes, see generators 64 and 65 in FIG. 7, include BH-206 and BH-209 ·
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Extraction Probe - The extraction probe is used in the process according to the present invention for detecting and extracting or removing an intrauterine device having a magnetic portion:
The. Inserting a probe comprising a gripping device and at least one Hall-effect generator into an uterus of a patient in electrical connection with an indicating device that responds to the output voltage of the generator-effect
Hall?
B. Looking for the location of the magnetic portion with the probe?
ç. Adjusting the position of the probe in response to the indicator device until the probe is in close proximity to the intrauterine device?
d. Activating the gripping device to grasp a portion of the intrauterine device? and
and. Extracting the probe with the intrauterine device from the uterus.
• The mechanical portion of the extraction probe may be des *. as a flexible recovery tool or as a
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positive of mechanical fingers known in the art. The mechanical part comprises a tubular housing containing one or more, preferably from two to four, gripping fingers extending outwardly from the housing after being actuated, for example, at the distal end of the housing by a plunger which is pressed manually. 0 The gripping device may include a single mechanical finger if opposed to a fixed flange extending axially from the outer drum assembly 41 shown in FIG. 2, When the fingers are contained within the case, they touch each other incompletely so as to create an opening that overall resembles the cross section of at least one portion of the IUD. Preferably such a cross section is that of the IUD stem portion and the opening between the fingers when contained within the housing prior to actuation is smaller than the cross section of the proximal end of the IUD stem for example the diameter the ball at the distal end of the IUD stem is greater than the opening between the probe fingers when the fingers are contained within the probe housing. The mechanical portion of the probe is analogous to a mechanical finger device, .. for example the NS.s GA 354 and 353 mechanical finger tool from Eenosha, Wisconsin Snap-on Tools and the NS Flexible Retrieval Tool. 2391 of the Ε-Ώ Tool Oompany of Lancaster, Pennsylvania.
It is essential that any of the detection devices described herein for the magnetic IUD be made of materials that do not interfere with the detection of a magnetic field and are unable to maintain a magnetic dipole. Thus, the extraction probe may be constructed of austenitic 300 series stainless steel, brass, beryllium copper alloy, aluminum alloy or other analogous plastic materials suitable for tool making. Thus, in the extractor probe of the present invention, there is substantially no attractive magnetic force between the IUD and the extractor probe or locating probe as described below.
In addition to the mechanical fingers, other grip devices may be used to retrieve and extract the IUD. For example, a loop that can be closed, for example made with a mono-
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filament, a set of vise jaws, a bushing that opens and closes by rotating a knob or any other similar gripping device which may be disposed at the end of a probe of a size adapted to be inserted into a womb human. Thus, the extraction probe according to the present invention comprises a Hall-effect generator and indicating means responsive to the output voltage of the Hall-effect generator in electrical connection with the generator, and a gripping device for clamping. of the magnet in the probe. Preferably, such a probe contains two or three Hall-effect generators disposed perpendicularly to one another, one of the generators being placed perpendicular to the axis of the probe itself, facing directly forward. The plane of the second generator extends radially from the probe axis and the third will extend radially, compliant with the probe axis, but at an angle of 90 ° to the second.
locator - The locator is constructed as the extractor probe without the gripping means. In addition, while the extraction probe is dimensionally suitable for insertion into the uterus, the locator may have such dimensions or dimensions to be inserted into the vagina without introduction through the cervical opening and into the uterus. The distal end of the locator comprises one, two or three Hall-effect generators, electrically connected to an indicating device responsive to the output voltage of the generators or generator. The method according to the present invention for using the locator comprises introducing a probe into a patient's vagina comprising at least one Hall effect generator electrically connected with an output voltage responsive indicating device of the generator.
Internal detection by means of a locator according to the present invention may also be accomplished with an intrarectal or transurethral locator having a Hall effect probe as described, suitably modified for such introduction. In addition, a Hall effect probe locator may be used externally, for example in the form of a shovel placed on a patient's abdomen and may be used in
- 10 combination oom an internal probe.
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Indicator - Hall voltage or voltages or generators must be set to provide a signal to the extraction or locating probe operator to indicate the proximity of the magnetic IUD. The indicator means may be audible, such as sound that becomes louder as the probe approaches the IUD, or visual, for example one or more measuring instruments that record the distance from the probe to the IUD. To a simple place! without a gripping means, a two-position indicator will suffice, for example a light that comes on after being exceeded by a Hall effect generator output threshold value or a two-light system, one of which is lit below the threshold while the other lit above the threshold. A more complex indicator system may be used when using two or more Hall effect generators, as the information generated may be used to indicate the position of the probe relative to the IUD in two or three dimensions. Thus, the indicator can accurately display the distance from the IUD to the probe in terms of left, or right, up, down, and forward.
output of the amplified generator and
In short, the electronic circuits that drive Hall-effect generators are made up of three main sections. The first is the source of electric current, each of which having Hall effect generators has one of these sources. These sources can be of the constant current type or with any other waveform, the most commonly used sources being direct current, alternating current, sinusoidal or square wave current. Second, the Hall effect generator voltages are amplified by voltage preamplifiers. These amplifiers can be single or multi-stage, differential input or single terminal devices. The purpose of this section is to amplify the low Hall effect voltages to a useful level so that they can be utilized by the final floor, the control floor. This third floor translates the voltages from the preamplifiers and drives them.
• appropriate indicators. Indicators can be flags a- 11 © Q $ 00:
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sound and visual range, and can range from its simple range of light to beeps or true visual position indicators. Translation circuits may include devices such as threshold detectors, linear register amplifiers, and other complex digital or analog devices.
Intrauterine Device (IUD) - The forms of the IUDs to be used in the system according to the present invention may be chosen from a wide variety used in the art. In this regard reference may be made to the text Atlas of Intrauterine Conveyption, by RJ, Thompson of Hemisphere Publishing Corporation, Washington (1982). Such shapes include loops, bobbins, Y-shapes and T-shapes, the materials being a physiologically inert plastic material having a section of about 1 mm and a total length of about 3 to 6 cm. Preferably, the shape chosen for the IUD used in the present invention has a protruding cylindrical portion with a terminal end in which the magnetic portion is located to allow the probe to approach the maximum magnetic flux portion of one of the two poles of the magnet. Using a circular shape for the IUD will require the magnetic probe to approach the IUD along transverse magnetic force lines that are not as strong as the front lines for one of the magnet poles in the IUD. Preferably, the IUD used in the present invention is generally in the form of a T, also known as Tatum T, as shown in U.S. Patent 3,533,406. Modifications introduced in the basic Tatum T include the inclusion of various time-release pharmaceuticals, locating wires, a limiter to prevent the Tatum T arms from bending upward, a researcher to prow or break the cervical opening, copper coils. to prevent conception and an additional set of arms on the tee to prevent expulsion of the uterus. See U.S. Patents 3,888,975, 3,898,986,
902 483, 3 935 860, 3 971 367, 3 993 057, 3 993 058, 4 198 966,
326 511 and 4,381,001. The IUD according to the present invention may have any or more of the modifications indicated.
IUD according to the present invention and made of a quality plastic material suitable for pharmaceutical purposes which
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0 SOOO
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It is flexible and has the property of having elastic memory so that when it deforms it will substantially resume its molded shape. Suitable plastics include polyethylene and polypropylene, with polyethylene being preferred. A particular polyethylene for use in the IUD according to the present invention is Alathon brand obtained from DuPont of Nemours of Wilmington, Delaware, for example Alathon 20 having a density of 0.920 and a melt index of 1.9 . It may be included within the plastics material, or homogeneously or from a reservoir, one or more pharmaceutical agents, as mentioned, to affect the patient's reproductive cycle or to decrease the sperm's viability to enter the uterus. . In addition, a δ-ray opaque agent may be included to provide an additional means of detecting IUDs in the womb. For this barium sulfate is used as is known in the art.
The preferred form of the Tatun S IUD according to the present invention comprises a vertical shank of about 36 mm and a cross section of about 1.6 mm, preferably circular, although rectangular, square or elliptical sections may be used. A stem has a forward end or proximal end and a distant end or distal end. Attached to the stem at the distal end is a transverse member about 32 mm long and consisting of a left arm and a right arm extending outward in both directions from the stem. The shank and transverse element may be joined by being molded together into one piece or may be attached by means of a null groove in the shank that is inserted into a transverse element hole as shown in US Pat. No. 4,198,966. The cross-sectional element may have any of the sections described above for the rod and that section may be independent of the section chosen for a particular rod. Preferably, the plastic material is a material which has considerable memory, such that after the arms are bent and inserted into a 9 mm diameter hole to a depth of 19 mm for five minutes, the arms resume. its perpendicular position. to the stem with a tolerance of 5.5 mm within one minute.
í ®Q | MB
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I »
Can one or more radially-extending holes be provided in the rod and / or arm? about 0 - 5 mm in diameter. These holes are provided for fixing solid copper wire or copper pipe with an outer diameter of about 0? 3 mm? wound around the shaft and / or one or both arms? as shown in U.S. Patent Nos. 4,198,966 and 4,326,511.
The exposed ends of the Tatum S IUD are rounded to prevent any damage to the uterine cavity endometrial wall. When placed inside the uterus? Do IUD Arms Extend to the Pallopian Tubes? extending the stem down towards the cervical opening. Preferably? the proximal end of the rod is shaped as a ball about 3 mm in diameter to allow grasping by the extra probe. Preferably? the magnetic portion of the IUD comprises at least a portion of the stem and preferably one of the induced dipole poles of the magnetic portion is situated at the proximal end of the stem.
IUDs according to the present invention may be molded by any of the known plastic molding techniques - for example as described in Modera Plastics Encyclopedia Ι9θ1 ~ -1982? edited by J. Agranoff, McGraw Hill? New York (1998), in particular by the injection molding technique described on page 315; Using the two-load casting technique allows the transverse element or the transverse element and a rod portion to be formed of a plastic material without magnetic material? followed or preceded by formation of the proximal end of the rod of plastic material containing magnetic material.
Magnetic material can be introduced into the IUD by one of several possible processes. First? The magnetic material may be homogeneously dispersed in the plastic material prior to molding to obtain the final shape of the IUD. Second? a homogeneous dispersion of plastic and magnetic material may be used for only a portion of the IUD. Like this? Can a two-load molding technique with two plastic loads be used? this is? one with magnetic material and one without it. Sm third - 14 -
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- a magnetic sleeve or cylinder can be attached to the IUD. For example, a hole may be drilled in the desired portion of the IUD, and a granular or solid hole-shaped magnet may be inserted into it and frictionally held in place by glue-cast plastic, or by providing a cap in the hole placed after the introduction of the magnet.
Thus, the magnetic IUD according to the present invention may be prepared by the process comprising the deg
1) Homogeneously disperse magnetic material into particles or matter! in which a ma dipole can be produced
Gnetic, in a particulate or fused polymeric material;
(2) Shaping the resulting magnetic mixture to form at least a portion of the intrauterine device and, if the magnetic portion does not include the entire polymeric portion of the intrauterine device.
3) Attach to the molded magnetic portion polymeric material to complete the polymeric removal of the intrauterine device.
In addition, after said molding, a magnetic dipole is induced in the IUD.
(0 The insertion of the IUD into the womb can be accomplished with the help of introducers known in the art, including those described, in European Patent 49,660 published 14 April 1982 and US Patents 3,880,156, 3,918 444,
927 666, 4 143 656, 4 026 281 and 4 249 525.
Magnetic materials - The magnetic field you need. required for the system according to the present invention may be provided by a material which is magnetized prior to its incorporation into the IUD, in which case no particulate material may be used and the magnet must be in the physical form in which it will appear on the magnet. , or a material may be incorporated into the IUD with induction of a dipo. magnetic material after manufacture, in which case particulate material may be used. The materials to be used in the present invention for
<img file="PT79857B_D0024.tif" />
<img file="PT79857B_D0025.tif" />
The magnetic portion of the IUD includes any materials in which it is possible to induce and maintain a magnetic dipole over a long period of time, substantially a permanent magnet. Such materials are described in the texts Rermanent Magnets and lagnetism, edited by D. Hadfield, p. 212-219 and 142-155, John Wiley & Sons, Inc. New York (1962), Rare Sarth Perma Magnets, by Ξ.Α. Nesbitt and JH Wernick, p. 77-93, 147-159, θ 177-1θ9, Aoademic Press, NY (1973), Cobalt Alloy Permanent Magnets by RJ Elliot, Plenum Press, New York (1972) and include alnico alloys and permanent rare-cobalt system alloy magnets. Preferably, the magnetic material is a cobalt rare earth alloy and includes all known alloys, such as ROo ^ and RgOo ^y, intermetallic compounds such as those described in U.S. Patents 3,560,200, 3,695,945, 4,082 58¾ 4 172 717 and reprint 31 317. Other magnetic materials for use in the present invention include those described by J. Driler et al in Transactions on Magnetics, Vol. Mag-9 N<sup>s</sup>. 3, p. 444-447 (1973) and by H. Tsutsui, et al., In the Journal of Dental Research, Vol. 58, R2, 6, p. 1597-1606 (1979). Magnet salts are included in a rare earth metal such as samarium, cobalt and, optionally, a controlled impurity introducer material, such as copper, to stabilize the alloy or affect the grain boundaries. Rare earth and cobalt magnets provide the strongest permanent magnets known today and remain stable for many years in the environment of the human body.
The shape of the magnetic portion of the IUD is such that a relationship is obtained between the distance separating the induced dipole poles on the magnet and the magnet cross section greater than one. Thus, the shape of the magnetic portion of the IUD is preferably non-spherical. Preferably, the relationship between the separation distance, the dipole poles and the cross section of the magnetic material is at least 2-1, more preferably at least 5.1. The reason for this preference is that the magnet intensity is proportional to the number of lines of force passing through a unit of area at one given distance from the magnet. On a spherical magnet, the density of the magnetic field power lines at any point around the sphere is substantially less than the density of the magnetic field.
<img file="PT79857B_D0026.tif" />
- for the same amount of magnetic material as a cylinder. As is the density of the magnetic field lines that is detected by the Hall-effect probe according to the present invention, it is preferred to predict the magnetic portion of the IUD contained within a projection thereof, for example at the terminal portion of the projection. Considered the other way, the magnetic field of a spherical magnet generally decreases with the inverse of the distance to magnet cube, while the magnetic field of an isolated pole decreases with the inverse of the square of the distance to the magnet.
The magnetic field of the magnetic portion of the IUD is at least about 1 gauss at a distance of 1 mm, preferably 10 mm from one of the dipole poles. The magnetic field can be induced into the material capable of holding it by placing the pre-molded magnetic insert or granulated magnetic material IUD in a. .Intense magnetic field. The magnetic field of charge must be able to exceed the coercive field of the permanent magnet material along the axis of its cylindrical shape. Such magnetic fields or charge magnets are widely used and exist in the market.
The foregoing description of various aspects of the present invention may be better understood by reference to the accompanying drawings.
Fig. 1 illustrates a signaling console, a locating probe and an extraction probe according to the present invention. The extraction probe (10) is supported on an operator's palm, with the fingers attached to the handles (11) and the palm applied to the plunger (12). The cable (13) directs the electrical current from the console (30) to the Hall effect generators and transmits in the opposite direction the voltage generated to the console (30). The mechanical fingers 14 are located at the distal end of the extraction probe and are actuated by depressing the plunger 12 as shown in FIGS. 5 θ 6, The set screw (15) secures the outer cylinder of the extraction probe to the inner cylinder and allows passage of the middle cylinder when pushing the plunger (12). The coupling 16 is a standard electrical coupling which allows the ac to be disconnected. bo (13) of the extraction probe (10). The locating probe (20) is represented with an interior Hall effect generator at (21),
I 6G $ 0Q_ |
<img file="PT79857B_D0027.tif" />
<img file="PT79857B_D0028.tif" />
At the distal end, the cable (22) carrying the input current and the output voltage of the generator by Iiall is carried by the cable (22) and has the electrical connection (23) which allows the disconnecting the cable (22) from the locating probe (20). In both probes 10 and 20, the electrical connections 16 and 23, respectively, are intended to permit cleaning and sterilization of the probes. It should be noted that a portion or all of the rod portions of the probes 10 and 20 which are introduced into the patient may be curved to allow easier introduction or the rods may be made of flexible material. allow the physician to bend the rods according to the needs prior to introduction. Console (30) is shown to include an on / off switch (31) for the entire unit and a pilot lamp (32) that illuminates when the switch is in the on position. Corresponding switches are illustrated. (33) θ (35) θ pilot lamps (34) and (36), respectively for the extraction probe and stop, the locating probe. A two-dimensional display device (37) is shown to indicate the radial distance from the probe tip, (10) or (20) to the magnetic target of the IUD. The two-dimensional display device indicates the distance in terms of -x, ψχ, -y, «:«, y and x representing two directions as shown in FIG. 7. The display device 38 is one dimensional and indicates the axial distance from the probe tip 10 or 20 to the IUD magnet along the 4-z direction shown in FIG. Thus, when probe (10) or (20) moves along the axis of the IUD magnet, successive lamps in the viewer (3θ) light up from bottom to top. When the top lamp comes on, the effective contact between the probe tip and the IUD has been established. Cable 39 provides an output electrical power, for example the mains voltage of 120 V, although power may be supplied by an internal battery.
Fig. 2 is a cross-sectional view of the extractor probe (10) comprising three assemblies: the outer cylinder assembly (40), the middle cylinder assembly (50) and the inner cylinder assembly (60). The outer cylinder assembly (40) contains a distal portion (41) with a relatively narrow diameter to allow passage through the cervical opening.
<img file="PT79857B_D0029.tif" />
<img file="PT79857B_D0030.tif" />
Calc, a conical portion (42) and a proximal portion (43) of relatively large diameter to allow easy manipulation by the physician. The middle cylinder (50) contains the mechanical finger bases (51) and the mechanical finger tips (52) extending radially outwardly from the probe axis. The finger bases (51) are made of elastic metal and clamp against the inner diameter of the outer cylinder (40) such that when they extend, as a result of the piston operation, the distance between the tips (52) increases. ) of the opposite fingers, as shown in FIG. 5. At least two open areas (53) are provided between the bases of the mechanical fingers (51) to allow the setscrew (15) to pass through. There are fig. 2 Also shown is the base (54) of the plunger (12) which is pressed against the palm of the hand during actuation of the extractor. The spring (55) is provided to hold the mechanical fingers in the closed position when not operated. Inner cylinder (60) comprises one end dis. such that (61) carries the Hall-effect generator and a proximal end (62) which carries the Hall-effect generator wires electrically connected to the joint (16).
Fig. 3 θ is an enlarged cross-sectional view of FIG. 2 and shows the axial Hall effect generator (63) which detects magnetism in the axial direction of the probe, a transverse Hall effect generator (64) which detects magnetism in the -x, + x direction and a second effect generator Hall (65) which detects magnetism in the direction -y, + y. The three generators by effect. Halls are placed inside a plug (66) of epoxy or other thermostable or thermoplastic materials. Cable 67 leads the wires between the electrical connection joint 16 and Hall effect generators 63, 64 and 65. It should be noted that each generator must be provided with 4 wires, ie. This is two for the applied current and two for the generated voltage.
Fig. 4 is a top view of the extraction probe showing the tapered portion (42) of the outer cylinder assembly (40) the distal end (61) of the inner cylinder, the screws (15), the openings (53) between the mechanical fingers and the finger caps (52).
ί \
<img file="PT79857B_D0031.tif" />
Fig. 5 illustrates an intrauterine device 80 having a magnetic portion 81 in the process of being grasped by an extraction probe according to the present invention. Fig.
shows the bases (51) of the mechanical fingers after actuation of the plunger. As described above, the mechanical fingers are made of an elastic metal having a shape such that they compress against the diameter of the outer cylinder (40). After being pushed outwardly of the outer cylinder 40, the fingertips 52 separate from each other and open sufficiently to allow the spherical end 82 of the IUD to pass through. through them.
Fig. 6 illustrates the extraction probe and IUD 80 shown in FIG. 5 after releasing the plunger and movement of the mechanical fingers again to their resting position. At this position, the extraction probe was connected to the IUD.
I »
Fig. 7 is a representation of the alignment of the three Hall effect generators (63)? (84) and (65) within the extraction probe. Arrows starting from the generators represent the directions of the maximum detection capabilities of the Hall effect generators (63), (64) © (65), respectively. Since the arrows are represented at 902 angles to the generators, the sine value is 1 and we will have the maximum output voltage for a given generator at a particular distance from a magnet.
Fig. 8 illustrates an IUD (80) in the form of a Tatum S carrying a magnetic material (81) within the Rod (83). The spherical end (82) of the IUD is designed to allow attachment of the extraction probe. The transverse member (84) consisting of a right arm (85) and a left arm (86) is attached to the rod (83). The terminal portions (87) of the arms are rounded to prevent damage to the uterine tissue.
Fig. 9 is a cross-sectional view of a portion of the IUD of FIG. 8 and represents a plug (89) made of a pack. plastic material that is introduced into the exposed portion of the cavity * (88) after filling the cavity (88) with material (81),
<img file="PT79857B_D0032.tif" />
Fig. 10 illustrates a second embodiment of the IUD that can be used in the system according to the present invention. The IUD (90) is provided with a magnetic portion (91) formed by a homogeneous mixture of the magnetic material and the plastic material used in the remaining portion of the IUD (90). Also provided is a spherical end (92) for extraction with a extraction probe according to the present invention, the rod (93) and the transverse member (94), consisting of a right arm (95) and a left arm (96). ). In the second embodiment there is also provided a hole (97) in the rod (93) supporting a helical copper wire (98) around the rod (93). It is known in the art to increase the contraceptive effect of a copper-produced IUD. Copper sleeves (99) on the right and left arms (95) θ (96) are also provided. Copper sleeves are small diameter copper tube sections that pass over arms 95 and 96 and are slightly dented to ensure their maintenance in the IUD during use.
Fig. 11 is a cross-sectional view of the end of the PICT of FIG. 10 and shows the homogeneous mixture (100) of magnetic material and plastic used to mold OIU.
Contents3
4 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4
16 members in 11 offices
Priority claims1
| Document | Office | Kind | Date |
|---|---|---|---|
| 57307384 | United States of America | A |
Members16
| Document | Office | Kind | |
|---|---|---|---|
| PT79857A | Portugal | A | |
| IL74122A0 | Israel | A0 | |
| NO850261L | Norway | L | |
| AU3796885A | Australia | A | |
| AU3796885A | Australia | A | |
| KR850005266A | Republic of Korea | A | |
| EP0153021A1 | European Patent Office (EPO) | A1 | |
| BR8500283A | Brazil | A | |
| JPS60236639A | Japan | A | |
| US4572162A | United States of America | A | |
| ES539742A0 | Spain | A0 | |
| ES8604772A1 | Spain | A1 | |
| ZA85505B | South Africa | B | |
| PT79857BThis record | Portugal | B | |
| US4727866A | United States of America | A | |
| AU571938B2 | Australia | B2 |
Numbers
- Application
- 79857
Titles
- English
- PROCESS AND DEVICE TO DETECT AND REMOVE A D.I.U.
Classification
- CPC, 5
- A61B5/06
- A61F6/14
- A61B17/52
- A61F6/18
- A61B5/062
- IPC, 4
- A61B5 06
- A61B17 52
- A61B17 42
- A61F6 18
