Apparatus for knotting drawstrings of medical devices or medical devices containing drugs
10435269 ยท 2019-10-08
Assignee
Inventors
Cpc classification
International classification
Abstract
The present invention provides an apparatus for making knots in flexible element attached to a medical device and methods using said apparatus.
Claims
1. An apparatus (20) that receives a contraceptive intrauterine device (1) which apparatus (20) makes a knot in a flexible element (2) attached to the contraceptive intrauterine device (1, the apparatus (20) comprising: (i) a guiding means (ABC) that guides the flexible element (2), wherein the guiding means (ABC) comprises at least 3 separate guiding means parts and which guiding means (ABC) forms a geometrical volume which is dimensioned to contain the contraceptive intrauterine device (1) disposed in a flat horizontal orientation entirely; (ii) a first fixating means that fixes the contraceptive intrauterine device (1) at a first position (10) outside the geometrical volume formed by the guiding means (ABC); (iii) a second fixating means that fixes the contraceptive intrauterine device (1) at a second position (10) entirely within the geometrical volume formed by the guiding means (ABC), wherein the contraceptive intrauterine device (1) is disposed in the flat horizontal orientation; and (iv) a tensioning means (40) located outside the guiding means (ABC), wherein the tensioning means tightens the knot and comprises one or more of a coil, spring, weight or suction device; wherein the guiding means (ABC), first fixating means and second fixating means are disposed in a mutually fixed positional relation, and are configured to spin as a group constrained around a single axis of rotation positioned within the guiding means (ABC), relative to the tensioning means (40), and the tensioning means is disposed in fixed positional relation to the single axis of rotation, and wherein the contraceptive intrauterine device (1) has a flat form and is insertable into an external body orifice.
2. The apparatus (20) according to claim 1, wherein one of the at least three separate guiding means parts (A) is located closest to the second position (10) corresponding to an end of the contraceptive intrauterine device (1) onto which the flexible element (2) is fixed.
3. The apparatus (20) according to claim 2, wherein a diameter or a location of said one of the at least three separate guiding means parts (A) with respect to the second position (10) defines the length of the flexible element (2) between the knot and the contraceptive intrauterine device (1).
4. The apparatus (20) according to claim 1, additionally comprising a translational displacer that translates the contraceptive intrauterine device (1) from the first position (10) to the second position (10), by lifting the contraceptive intrauterine device (1) over or under and inside one or more closed loops formed in the flexible element (2) by the apparatus (20).
5. The apparatus (20) according to claim 4, wherein said translational displacer is a robotic arm.
6. The apparatus (20) according to claim 1, wherein the guiding means (ABC) is configured for retraction into or lifting away from the apparatus (20) in order to release the flexible element (2).
7. The apparatus (20) according to claim 1, wherein the flexible element comprises strands, the strands being directed towards or away from the guiding means (ABC) by the tensioning means (40).
8. The apparatus (20) according to claim 1, wherein the flexible element (2) is provided to the apparatus (20) in the form of a spindle or bobbin or already cut.
9. The apparatus (20) according to claim 8, wherein the flexible element (2) is capable of maintaining tension.
10. The apparatus (20) according to claim 1, wherein all movements or rotations of the apparatus (20) are automated.
11. A combination comprising an apparatus (20) and a contraceptive intrauterine device (1), wherein the apparatus (20) receives the contraceptive intrauterine device (1) and makes a knot in a flexible element (2) attached to the contraceptive intrauterine device (1), the apparatus (20) comprising: (i) a guiding means (ABC) that guides the flexible element (2), wherein the guiding means (ABC) comprises at least 3 separate guiding means parts, which guiding means (ABC) forms a geometrical volume which is dimensioned to contain the contraceptive intrauterine device (I) disposed in a flat horizontal orientation entirely; (ii) a first fixating means at a first position (10) that fixes the contraceptive intrauterine device (1) outside the geometrical volume formed by the guiding means (ABC); (iii) a second fixating means at a second position (10) that fixes the contraceptive intrauterine device (1) disposed in the flat horizontal orientation entirely within the geometrical volume formed by the guiding means (ABC); and (iv) a tensioning means (40) located outside the guiding means (ABC), wherein the tensioning means (40) tightens the knot and comprises one or more of a coil, spring, weight or suction device; wherein the guiding means (ABC), first fixating means and second fixating means are disposed in a mutually fixed positional relation, and are configured to spin as a group constrained around a single axis of rotation positioned within the guiding means (ABC), relative to the tensioning means (40), and the tensioning means (40) is disposed in fixed positional relation to the single axis of rotation, and wherein the contraceptive intrauterine device (1) has a flat form and is insertable into an external body orifice.
12. The combination according to claim 11, wherein the contraceptive intrauterine device (1) contains a drug.
13. The combination according to claim 11, wherein one of the at least three separate guiding means parts (A) is located closest to the second position (10) corresponding to an end of the contraceptive intrauterine device (1) onto which the flexible element (2) is fixed.
14. The combination according to claim 13, wherein a diameter or a location of said one of the separate guiding means parts (A) with respect to the second position (10) defines the length of the flexible element (2) between the knot and the contraceptive intrauterine device (1).
15. The combination according to claim 11, additionally comprising a translational displacer that translates the contraceptive intrauterine device (1) from the first position (10) to the second position (10), by lifting the contraceptive intrauterine device (1) over or under and inside one or more closed loops formed in the flexible element (2) by the apparatus (20).
16. The combination according to claim 15, wherein said translational displacer is a robotic arm.
17. The combination according to claim 11, wherein the guiding means (ABC) is configured for retraction into or lifting away from the apparatus (20) in order to release the flexible element (2).
18. The combination according to claim 11, wherein the flexible element comprises strands, the strands being directed towards or away from the guiding means (ABC) by the tensioning means (40).
19. The combination according to claim 11, wherein the flexible element (2) is provided to the apparatus (20) in the form of a spindle or bobbin.
20. The combination according to claim 11, wherein all movements or rotations of the apparatus (20) are automated.
21. The combination according to claim 11, wherein the flexible element (2) is capable of maintaining tension.
22. The combination according to claim 11, wherein the contraceptive intrauterine device (1) comprises a T-shape.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1)
(2)
DETAILED DESCRIPTION OF THE INVENTION
(3) Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art. All publications referenced herein are incorporated by reference thereto.
(4) The articles a and an are used herein to refer to one or to more than one, i.e. to at least one of the grammatical object of the article.
(5) Throughout this application, the term about is used to indicate that a value includes the standard deviation of error for the device or method being employed to determine the value.
(6) The recitation of numerical ranges by endpoints includes all integer numbers and, where appropriate, fractions subsumed within that range (e.g. 1 to 5 can include 1, 2, 3, 4 when referring to, for example, a number of elements). The recitation of end points also includes the end point values themselves (e.g. from 1.0 to 5.0 includes both 1.0 and 5.0)
(7) Throughout this application, the terms device or devices are used to denote any object that is inserted into an external body orifice. Among these devices we consider, but do not limit ourselves to: intra-uterine devices (IUD) or intra-uterine systems (IUS), tampons, hearing aids. As far as IUD and IUS are concerned, the practical use (e.g. contraceptive, medicinal), optional additional components (e.g. antibiotics, antiseptics, hormones) and material (e.g. copper, silver, polyethylene) are not deemed critical for this invention.
(8) Throughout this application, the terms element or elements are used to denote any flexible object that can be knotted. Among these elements we consider, but do not limit ourselves to: wires, cables, strings, ribbons, hairs, cords, chains, bands. Furthermore, the type of material in which these elements are fabricated is not deemed critical for this invention. This element can consist of one or multiple strands. The element may be present on e.g. a spindle or bobbin or be already cut beforehand. Said spindle or bobbin should be capable of retaining a certain amount of tension on the element.
(9) Throughout this application, the term translating means is used to denote any part of the apparatus that can be displaced in a translational fashion. Among these types of movement we consider, but do not limit ourselves to: sliding, rolling, dropping. Furthermore, the type of material in which these translating means are fabricated is not deemed critical for this invention. The translational movement is considered a relative movement between different parts of the apparatus, and not referred to a fixed point of reference.
(10) Throughout this application, the term rotation is used to denote any relative rotational movement between different parts of the apparatus, and not referred to a fixed point of reference. Among these types of movement we consider, but do not limit ourselves to: turning, twisting, spinning.
(11) Throughout this application, the term guiding means is used to denote any part of the apparatus that guides the flexible element along a certain element. The guiding means can form one geometric shape allowing the making of a loop, or can comprise several individual guiding means that together form a geometric shape allowing the making of a loop. Among these types of guiding means we consider, but do not limit ourselves to: bolts, hooks, clamps, arches, staples, holes, trenches, clasps and elements built therefrom. Furthermore, the type of material in which these guiding means are fabricated is not deemed critical for this invention.
(12) Throughout this application, the term tensioning means is used to denote any part of the apparatus that keeps the flexible element under constant tension. Among these types of tensioning means we consider, but do not limit ourselves to: coils, springs, weights, suction devices. Furthermore, the type of material in which these tensioning means are fabricated is not deemed critical for this invention.
(13) Throughout this application, the term restraining means is used to denote any part of the apparatus that keeps the translating means restrained to a certain position on the apparatus. Among these types of restraining means we consider, but do not limit ourselves to: studs, pins, hooks, bolts, clamps, clasps. Furthermore, the type of material in which these restraining means are fabricated is not deemed critical for this invention.
(14) Throughout this application, the term releasing action is used to denote any action that releases the flexible element from the guiding means. Among these types of releasing steps we consider, but do not limit ourselves to: lifting, retracting, sliding off.
(15) Throughout this application, the term fixating means is used to denote any part of the apparatus that keeps the device fixed to a certain position. Among these types of fixating means we consider, but do not limit ourselves to: studs, pins, hooks, bolts, clamps, clasps, adhesive tape, magnets. Furthermore, the type of material in which these fixating means are fabricated is not deemed critical for this invention.
(16) In the following detailed description of the invention, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration only of specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
(17) In one embodiment, the apparatus (20) consists of two settings defined by a fixating means (10 and 10), to which a device (1) is secured, while part of the apparatus (20) provides a rotational movement. The device is connected to an element (2), which is to be knotted. The end of the element (2) (all ends in case of multiple strands) is attached to a tensioning means (40), which maintains tension on the string. The apparatus (20) contains a guiding means (ABC) surrounding the fixating means (10). Said guiding means (ABC) is placed in such a way that the surface area defined by the guiding means (ABC) is large enough to allow mechanical threading of the device (1) through said guiding means (ABC).
(18) In a preferred embodiment of the invention, guiding means (ABC) comprises 3 individual guiding means A, B and C.
(19) In an alternative embodiment, guiding means (ABC) forms one continuous guiding means, which can be any geometrical shape allowing for the making of a loose loop around device (1).
(20) In an alternative embodiment, guiding means (ABC) comprises 2 individual guiding means A and BC, which together can form any geometrical shape allowing for the making of a loose loop around device (1).
(21) If applicable, the diameter of part A of the guiding means and its position with respect to device (1) can define the position of the knot vis vis the device (1) and can hence be optimized according to the preferred position of said knot for a certain application (i.e. will be dependent on the type of device).
(22) The fixating means (10) ensure optimal placement of the device (1) and can serve to fine-tune the position of the knot vis vis the device. Again, said position can help in optimizing said position of the knot for a certain application (i.e. will be dependent on the type of device).
(23) During the first step (labeled as step 1 in
(24) In a second step (labeled as step 2 in
(25) In a third step (labeled as step 3 in
(26) In a fourth step (labeled as step 4 in
(27) In a fifth step (labeled as step 5 in
(28) In an alternative embodiment of the invention, the guiding means B and C form one guiding means (BC) which undergoes a releasing action in the fourth step.
(29) In an alternative embodiment of the invention, the guiding means A, B and C form one guiding means (ABC), which undergoes a releasing action in the fourth step and does not require the fifth step.
(30) The type and thickness of the knot (3) can be varied by the number of rotations effectuated by the apparatus (20).
(31) The length of the string between the device and the knot can be accurately defined by the final position of the fixating means (10) with respect to guiding means A. This can be achieved by either modifying the position of the fixating means (10), or by modifying the position of guiding means A.
(32) The number and positioning of the guiding means can be varied to better emulate the shape of the device (1) and ease the threading action. The order during which the guiding means undergo a releasing action with respect to the element (2) is not deemed critical for the invention. Nevertheless, a final releasing step from guiding means A is the preferred embodiment of the invention.
(33) In one embodiment, the apparatus (20) consists of a translating means (10), which can provide a translational movement. This translating means (10) contains a setting (11) to which the device (1) can be secured. The device is connected to an element (2), which is to be knotted. The end of the element (2) (all ends in case of multiple strands) is attached to a tensioning means (40), which maintains tension on the string. The apparatus (20) contains a guiding means (ABC) adjacent to the translating means (10). Said guiding means (ABC) is placed in such a way that the surface area defined by the guiding means is large enough to allow mechanical threading of the device (1) through said guiding means (ABC).
(34) The diameter and position of guiding means A will define the position of the knot vis vis the device and can hence be optimized according to the preferred position of said knot for a certain application (i.e. will be dependent on the type of device).
(35) Additional restraining means (50) ensure optimal placement of the translating means (10) on the apparatus (20) and can help in fine-tuning the position of the knot vis vis the device. Again, said position can help in optimizing said position of the knot for a certain application (i.e. will be dependent on the type of device).
(36) Below, a preferred embodiment of the method according to the invention is described:
(37) During the first step, the device (1), to which the element is attached (2), is mounted on the setting (11) in the translating means (10). The starting position of the translating means (10) holding the device (1) is outside the area defined by the guiding means (ABC), labeled as position 1 in
(38) In a second step, the apparatus (20) effectuates one or more rotations, creating one or more loops of the element (2). The constant tension of the element (2) provided by the tensioning means (40) ensures that the loops remain tightened around the guiding means (ABC).
(39) In a third step, the device (1) is released from the translating means (10).
(40) In a fourth step, the translating means (10), without the device, is moved under the loops, so that it is located in the area defined by the guiding means (ABC), and restrained as such by the restraining means (50).
(41) In a fifth step, the device (1) is re-attached to the translating means (10) from above the loops. This threading action effectively creates the knot (3).
(42) In an optional sixth step, the translating means (10), holding the device (1), is moved with respect to guiding means A to define the final length of the element between the knot (3) and the device (1), and restrained as such by the restraining means.
(43) In a seventh step, the element (2) is released from the guiding means B and C by a releasing action. This action effectively tightens the knot (3) around guiding means A by the tension provided by the tensioning means (40).
(44) In an eighth step, the element (2) is released from guiding means A by a releasing action, tightening the final knot (3).
(45) In a final step, the element (2) is out to desired length and the device (1) is released from the translating means (10).
(46) In an alternative embodiment of the invention, the guiding means B and C form one guiding means (BC).
(47) In an alternative embodiment of the invention, the guiding means A, B and C form one guiding means (ABC), which undergoes a single releasing action in the seventh step and does not require the eighth step.
(48) In essence, the invention provides a method for making a knot in a flexible element connected to a device using the apparatus (20) according to the invention comprising the steps of:
(49) a) placing the device (1), to which the element (2) is attached, in the first position (10) on the apparatus (20), outside the area defined by guiding means (ABC);
(50) b) rotating the guiding means (ABC) one or more times with respect to the tensioning means (40), thereby forming one or more closed loops in element (2);
(51) c) translating the device (1) from its first position (10) to its second position (10) inside the area defined by guiding means (ABC), by lifting it over or under the closed loop(s) formed in step b);
(52) d) releasing element (2) from guiding means (ABC), under constant tension by the tensioning means (40), thereby forming the final knot (3).
(53) The type and thickness of the knot (3) can be varied by the number of rotations effectuated by the apparatus (20).
(54) The type and thickness of the knot (3) can also be varied by the number of translations effectuated by the translating means (10).
(55) The type and thickness of the knot (3) can furthermore be varied by the number of threading actions effectuated by release and re-attachment of the device (1) to the translating means (10).
(56) The type and thickness of the knot (3) can be varied by any combination of rotations, translations and/or threading actions mentioned above in any order and/or repetition.
(57) The length of the string can be accurately defined by the final position of the setting (11) on the translating means (10) with respect to guiding means A. This can be achieved by either optional step six, or by modifying the position of guiding means A.
(58) The number and positioning of the guiding means can be varied to better emulate the shape of the device (1) and ease the threading action. The order during which the guiding means undergo a releasing action with respect to the element (2) is not deemed critical for the invention. Nevertheless, a final releasing step from guiding means A is the preferred embodiment of the invention.
(59) The apparatus (20) of the invention can make knots while one or more ends of the flexible elements are already attached to the device. The apparatus (20) of the invention renders it possible to make knots in flexible elements each of which consists of two or more strands.
(60) Examples of certain alternative embodiments according to the invention are given below.
(61) In an embodiment, the invention relates to an apparatus (20) for making a knot in a flexible element (2) attached to a medical device (1), which optionally contains a drug, comprising:
(62) (i) a guiding means (ABC) for guiding the element (2) fixed to the device (1), wherein guiding means (ABC) forms a geometrical figure which is large enough to contain the device (1);
(63) (ii) a first position (10) outside the geometrical figure formed by guiding means (ABC), to which the device (1) can be affixed;
(64) (iii) a second position (10) to which the device (1) can be affixed after being lifted over or under the closed loop(s) to form a relatively loose knot in the element (2), wherein said second position (10) is inside the geometrical figure formed by guiding means (ABC);
(65) (iv) means for tightening the knot through a tensioning means (40); wherein means (i), (ii) and (iii) can be rotated with respect to means (iv).
(66) In an embodiment, the invention relates to an apparatus (20) as described above, wherein the guiding means (ABC) comprises at least three separate guiding means parts, A, B and C, or comprises two separate guiding means A and BC, forming a geometrical figure which is large enough to contain the device (1).
(67) In an embodiment, the invention relates to an apparatus (20) as described above, additionally comprising a translating means, capable of translating the device from position 10 to position 10, by lifting the device over or under and inside the one or more closed loops formed in the element (2) by the apparatus (20).
(68) In an embodiment, the invention relates to an apparatus (20) as described above, wherein guiding means (ABC) can be retracted into or lifted away from the apparatus (20) in order to release element (2).
(69) In an embodiment, the invention relates to an apparatus (20) as described above, wherein the diameter and/or location of part A of the guiding means with respect to position (10) defines the length of the element between knot and device.
(70) In an embodiment, the invention relates to an apparatus (20) as described above, wherein one or more strands of the element are directed towards or away from the guiding means (ABC) by tensioning means (40).
(71) In an embodiment, the invention relates to an apparatus (20) as described above, wherein part A of the guiding means is located closest to the end of the device (1) whereon the element (2) is fixed.
(72) In an embodiment, the invention relates to an apparatus (20) as described above, wherein the element (2) is provided to the apparatus in the form of a spindle or bobbin or already cut, preferably capable of maintaining a certain tension on the element.
(73) In an embodiment, the invention relates to an apparatus (20) as described above, wherein all movements or rotations of the apparatus are automated.
(74) In an embodiment, the invention relates to an apparatus (20) as described above, wherein said translation means is a robotic arm.
(75) In an embodiment, the invention relates to a method for making a knot in a flexible element connected to a device using the apparatus (20) according to any one of claims 1 to 10, comprising the steps of:
(76) a) placing the device (1), to which the element (2) is attached, in the first position (10) on the apparatus (20), outside the area defined by guiding means (ABC);
(77) b) rotating the guiding means (ABC) one or more times with respect to the tensioning means (40), thereby forming one or more closed loops in element (2);
(78) c) translating the device (1) from its first position (10) to its second position (10) inside the area defined by guiding means (ABC), by lifting it over or under the closed loop(s) formed in step b);
(79) d) releasing element (2) from guiding means (ABC), under constant tension by the tensioning means (40), thereby forming the final knot (3).
(80) In an embodiment, the invention relates to a method as described above, wherein the number of rotations, translations and threading actions can be adjusted to tailor the thickness of the knot.
(81) In an embodiment, the invention relates to a method as described above, which is automated.
(82) In an embodiment, the invention relates to a method as described above, wherein the translation movement of device (1) is performed by a robotic arm.
(83) In an embodiment, the invention relates to a method as described above, wherein the device is an intra uterine device (IUD), for contraceptive purposes or for intra uterine treatment, a tampon, a hearing aid, or the like.