Joining devices, kits and methods
11166711 · 2021-11-09
Assignee
Inventors
Cpc classification
A61B2017/0414
HUMAN NECESSITIES
A61B2017/0472
HUMAN NECESSITIES
A61B2017/0462
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
International classification
Abstract
A device comprising: a flexible tube comprising a first collapsible end portion; a first actuating element segment secured to the first collapsible end portion and extending along the first collapsible end portion, wherein, when the first collapsible end portion is threaded through a first aperture and the first actuating element segment is pulled proximally, the first collapsible end portion collapses proximally and forms a bulge larger than the first aperture, thereby anchoring the flexible tube against a rim of the first aperture.
Claims
1. A device comprising: a flexible tube comprising a first collapsible end portion, a first end portion and a second end portion; a first actuating element segment secured to the first collapsible end portion and extending along the first collapsible end portion, wherein, when the first collapsible end portion is threaded through a first aperture and the first actuating element segment is pulled proximally, the first collapsible end portion collapses proximally and forms a bulge larger than the first aperture, thereby anchoring the flexible tube against a rim of the first aperture, wherein said first actuating element comprises a thread or a rigid roll, said first end portion comprises a first elongated hardened element, and said second end portion comprises a second elongated hardened element, wherein said second elongated hardened element is threaded on the said second end portion by a loop.
2. The device of claim 1, wherein said first elongated hardened element is located at a tip of the said first end portion.
3. The device of claim 1, wherein the first and second end portions are a tubular mesh.
4. A method for closing a gap between a first object and a second object, the method comprising: connecting the firt object and the second object with the device of claim 1, thereby closing a gap between the first object and the second object.
5. The method of claim 4, wherein said gap is a tear in meniscus tissue, said first object is a proximal wall of said meniscus tissue and said second object is a peripheral distal wall of said meniscus tissue.
6. The method of claim 5, further comprising puncturing the meniscus tissue, wherein puncturing the meniscus tissue is performed by two tubular needles of an applicator.
Description
BRIEF DESCRIPTION OF THE FIGURES
(1) Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.
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DETAILED DESCRIPTION
(42) The disclosed devices, kits and methods may be used for anchoring in various industrial and medical fields. Generally, the disclosed device may include an elongated tube, whether hollow or solid, and an actuating element secured to an end of the elongated tube; an end portion of the tube may be inserted into an aperture, and the actuating element may then be pulled. During this pulling, a portion of the elongated tube may collapse (such as form multiple folds one over the other) and form a bulge which serves as an anchor at an opposite side of the aperture.
(43) This anchor may be used for firmly securing the tube to an element in which the aperture is situated. Optionally, in order to release the anchor, the actuating element may be pushed, thereby expanding the collapsed portion of the tube and eliminating the bulge.
(44) In a more complex variety of the device, two or more such bulges may be formed at different areas of the tube, such as at its two opposing ends or even along its length. This may allow the convenient anchoring of two or more elements to one another.
(45) In the medical field, the present device may be used in surgical procedures where fixation of two or more tissues to one another is required. Examples include fixation of bones, soft tissues, or any combination thereof. Additionally, one or more surgical implants may be affixed to a bodily tissue using the device.
(46) For simplicity of discussion, the present devices, kits and methods are discussed herein with reference to meniscus repair, in which a tear in the meniscus tissue is repaired by affixing together the two opposing sides of the tear. However, those of skill in the art will recognize that the devices, kits and methods may be similarly used for many other medical and/or industrial applications.
(47) The use of the disclosed devices, kits and methods in meniscus repair procedures may be relatively easy and fast and may provide a firm and reliable closure of the tear and minimization of the damage.
(48) The term “two elements”, as referred to herein with respect to joining of these elements, may relate to two separate elements or to two portions of the same element (i.e., each portion is referred to as an element). For example, two separate elements may be joined together, or two portions of an element may be joined together, for example, to close a tear in the element which divides the element into two portions.
(49) The term “collapse” and its derivations, as referred to herein with respect to some component of the disclosed devices and kits, including a portion of the flexible tube of the disclosed devices and kits, may relate to the folding of the component on or into itself
(50) The term “pulling proximally” and its derivations as referred to herein with respect to an actuating element, an actuating element segment or a flexible tube of the disclosed devices and kits, may include each direction which causes a portion of a flexible tube of the disclosed devices and kits to collapse.
(51) Disclosed herein is a device, which may include a flexible tube and an actuating element segment. The flexible tube may include a collapsible end portion. The actuating element segment may extend along the collapsible end portion. The actuating element segment may be secured to the collapsible end portion.
(52) The collapsible end portion may be threaded through an aperture. When the first actuating element segment is pulled proximally, the collapsible end portion may collapse proximally and form a bulge larger than the first aperture. Thus, the flexible tube may be anchored against a rim of the aperture.
(53) The flexible tube may be made of flexible materials such as rubber and/or a woven material (i.e., a mesh), e.g., woven threads. The collapsible end portion may be made of materials which collapse when applying force on them, e.g., in a specific direction. Thus, the collapsible end portion may be, for example, a mesh collapsible end portion, i.e., made of a woven material or a knitted material. The actuating element segment may be, for example, a thread or a rigid roll.
(54) In some embodiments, the flexible tube may include two collapsible end portions and two actuating element segments, correspondingly. Reference is now made to
(55) Exemplary device 100 may include a flexible mesh tube 110 and two actuating element segments 140A and 140B. Flexible mesh tube 110 may include two collapsible end portions 120A and 120B and a middle portion 130. Each of collapsible end portions 120A and 120B may optionally include a hardened tip 150A and 150B, respectively. Actuating element segments 140A and 140B may be secured to hardened tips 150A and 150B of collapsible end portions 120A and 120B, respectively. However, in this and every other embodiment of the specification, the term “hardened tip” may also relate to a configuration in which an actuating element segment is secured to a collapsible end portion by other means, such as glue, knotting and/or the like.
(56) Each of actuating element segments 140A and 140B may extend along collapsible end portions 120A and 120B, respectively. Actuating element segments 140A and 140B may extend along an inner void of collapsible end portions 120A and 120B, respectively, as shown in
(57) Collapsible end portions 120A and 120B may be threaded through a first and a second aperture, respectively, while leaving middle portion 130 out of the first and second apertures. Thus, device 100 may be formed in a U-shape, as exemplified in
(58) Hardened tips 150A and 150B may be formed, for example, by melting the material of flexible mesh tube 110 and/or by over-molding a certain material or glue on the flexible mesh tube. In some medical applications, due to biocompatibility concerns, it may be desired to use the melting technique.
(59) Hardened tips 150A and 150B may be of different shapes and other than rectangular, as shown in
(60)
(61) In some embodiments an actuating element segment may be threaded laterally and repeatedly through a collapsible end portion. In such embodiments, when the actuating element segment is pulled, the collapsible end portion may fold laterally and repeatedly on itself. Reference is now made to
(62)
(63) Reference is now made to
(64) Collapsible end portion 310 may include hardened portion 340 located along collapsible end portion 310 at a predefined distance from a tip of collapsible end portion 310. Collapsible end portion 310 may further include hardened tip 330 located at the tip of collapsible end portion 310. Hardened portion 340 may be tubular in order to allow free passage of actuating element segment 320 through collapsible end portion 310.
(65) When actuating element segment 320 is pulled proximally, collapsible end portion 310 may collapse into a section of an inner void of collapsible end portion 310 formed between hardened tip 330 and hardened portion 340, as shown in
(66) Reference is now made to
(67) Collapsible end portion 355 may include a hardened tip 365. Hardened tip 365 may include barbs 370 located at two opposite sides of hardened tip 365. When actuating element segment 360 is pulled proximally and collapsible end portion 355 collapses, barbs 370 may secure hardened tip 365 to collapsible end portion 355 by grasping collapsible end portion 355 at two respective opposite locations. Collapsible end portion 380 may include a hardened tip 390. Hardened tip 390 may include barbs 395 located at a side of hardened tip 390. When actuating element segment 385 is pulled proximally and collapsible end portion 380 collapses, barbs 395 may secure hardened tip 390 to collapsible end portion 380 by grasping collapsible end portion 380 at a respective location. In some embodiments, hardened tips 365 and 390 may include barbs such as barbs 370 and 395 in various numbers and located thereon according to various configurations.
(68) In some embodiments, the disclosed devices may be used for repairing a tear in a meniscus tissue. In some embodiments, such devices may include two collapsible end portions and two actuating element segments, correspondingly. The two collapsible end portions may be threaded through two apertures made in the meniscus tissue through the tear in order to bring two edges of the tear closer together. When the two actuating element segments are pulled proximally, the flexible tube may be anchored against a peripheral distal wall of the meniscus tissue thereby maintaining the tear closed, either fully (i.e. opposing surfaces of the tear are in contact) or almost fully (i.e. opposing surfaces of the tear are at a very short distance from each other, such as 1-2 tenths of a millimeter apart; the surfaces may contact each other at some points).
(69) A kit for repairing a tear in a meniscus tissue is herein disclosed. The kit may include an implant and an applicator. The implant may be similar to the devices disclosed herein. The applicator may be configured to deploy the implant in the meniscus tissue. The applicator may be used to puncture the meniscus tissue in order to form at least one aperture passing through the tear. At least one collapsible end portion of a flexible tube of the implant may be then threaded through the aperture in order to bring the edges of the tear closer together. Pulling the actuating element segment which is secured to the collapsible end portion may anchor the implant to the meniscus tissue thus maintaining the tear closed.
(70) Reference is now made to
(71) Applicator 400 may include two tubular needles 410A and 410B. Applicator 400 may further include a housing 430 configured to hold needles 410A and 410B and cover them when applicator 400 is in a non-operative mode as show in
(72) With reference to
(73) Referring now to
(74) Referring back to
(75) In some embodiments, a collapsible end portion of the disclosed implant may be deployed in the meniscus tissue through another opening, such as top opening 480 of tubular needle 450 of
(76) In some embodiments, an applicator which includes only one tubular needle may be used to deploy the disclosed implant, while including a flexible tube with two collapsible end portions. Reference is now made to
(77) Implant 575 may be positioned in applicator 560, as shown in Fig.11 (i.e., in a U-shape) in order to insert hardened tips 585A and 585B into openings 570A and 570B, respectively. The two rods may be then pushed distally within openings 570A and 570B, respectively, in order to maintain hardened tips 585A and 585B in place.
(78) Reference is now made to
(79) In a step 605, a first collapsible end portion of a flexible tube may be threaded through the first aperture, entering through the most proximal element and exiting through the most distal element. The flexible tube may be the flexible tube of the disclosed devices.
(80) In a step 610, a first actuating element segment secured to the first collapsible end portion may be pulled proximally. The first actuating element segment may extend along the first collapsible end portion. The first collapsible end portion may then collapse proximally and form a bulge larger than the first aperture, thereby anchoring the flexible tube against a rim of the first aperture.
(81) Optionally, the first actuating element segment may extend along an inner void of the first collapsible end portion and may exit the flexible tube through a middle portion of the flexible tube, as shown in
(82) Optionally, the first actuating element segment may be threaded laterally and repeatedly through a the first collapsible end portion, as shown in
(83) Optionally, the first collapsible end portion may include a hardened portion located along the first collapsible end portion at a predefined distance from a tip of the first collapsible end portion, as shown in
(84) Optionally, the first collapsible end portion may include a hardened tip. The first actuating element segment may be secured to the hardened tip, advantageously to a center of a bottom surface of the hardened tip, as shown in
(85) In an optional step 615, a second aperture passing through the at least two elements may be formed. This step may be similar to step 600.
(86) In case the at least two elements are separable, they may be arranged to assure firm and effective joining of the two or more elements. The location of the entrance of the first and/or second aperture in the most proximal element and/or the path of the first and/or second aperture through the two or more elements may be selected to assure firm and effective joining of the two or more elements.
(87) In an optional step 620, the second collapsible end portion of the flexible tube may be threaded through the second aperture. This step may be similar to step 605.
(88) In a further optional step, the second collapsible end portion may be stretched distally, thereby bringing the bulge formed over the distal rim of the first aperture closer to the distal rim and a middle portion of the flexible tube closer to the proximal element (i.e., a proximal surface of the most proximal element).
(89) In an optional step 625, a second actuating element segment secured to the second collapsible end portion may be pulled proximally. This step may be similar to step 620. The first actuating element segment and the second actuating element segment may be pulled in a separate manner.
(90) In an optional step, when the device includes two flexible separate actuating elements, such as threads, the two separate actuating elements may be tied. Reference is now made to
(91) In some embodiments, the disclosed methods may be used for repairing a tear in a meniscus tissue. The method may then use the disclosed devices and kits for repairing a tear in a meniscus tissue. In such a case, the at least two elements to be joined are a peripheral distal wall of the meniscus tissue (also known as the peripheral portion of the meniscus) and a proximal wall of the meniscus tissue (also known as the free end portion of the meniscus). The two collapsible end portions may be threaded through two apertures made in the meniscus tissue through the tear in order to bring two edges of the tear closer together. When the two actuating element segments are pulled proximally, the flexible tube may be anchored against the peripheral distal wall of the meniscus tissue thereby maintaining the tear closed.
(92) Optionally, the first and/or second apertures may be formed by two tubular needles of an applicator. The applicator may be similar to an applicator of the disclosed kits.
(93) The method may then further include an optional step, according to which a tip of the first and/or second collapsible end portions is placed in the respective tubular needle of the applicator. In another optional step, the rod located within the respective tubular needle may be pushed distally in order to hold the first and/or second collapsible end portion against a distal rim of the opening of the respective tubular needle. Thus, the tip of the first and/or second collapsible end portion may be maintained in place while the first and/or second collapsible end portion is threaded through the first and/or second aperture. In a further optional step, when the applicator is in place (i.e., beyond the distal rim of the respective first or second aperture) the rod may be retracted proximally, thus letting the tip of the respective collapsible end portion out of the respective tubular needle through the opening of the respective tubular needle to lie beyond the distal rim of the respective first or second aperture (i.e., on a distal surface of the distal element).
(94) The distal stretching of the second collapsible end portion may be performed by pushing the second tubular needle, which holds the tip of the second collapsible end portion (i.e., by its rod), distally until the bulge formed over the distal rim of the first aperture and the middle portion are brought closer to the distal rim of the first aperture and the proximal element, respectively.
(95) Reference is now made to
(96) According to
(97) According to
(98) According to
(99) According to
(100) The disclosed devices and kits may be operated according to the above disclosed methods.
(101) A further device is herein disclosed. The device may include a flexible tube and an actuating element. The flexible tube and the actuating element may be in the form and/or made similar to the flexible tube and the actuating element segments of the device disclosed herein above and referred by
(102) When the end portion and the collapsible end portion are threaded through two apertures, respectively, and the actuating element is pulled proximally, the collapsible end portion may collapse proximally and form a bulge in vicinity to the second elongated hardened element. A length dimension of the first elongated hardened element may be larger than the respective aperture. The bulge and a length dimension of the second elongated hardened element may be larger than the respective aperture. As a result of the above, the flexible tube may be anchored against a rim of each of the two apertures.
(103) In some embodiments, the collapsible end portion may include a hardened tip and the actuating element may be secured to the hardened tip.
(104) Reference is now made to
(105) Device 720 is arranged in the
(106) In some embodiments, the first and second elongated hardened elements may have an involute shape, such as elongated hardened elements 728A and 728B. Reference is now made to
(107) In some embodiments, the first and second elongated hardened elements may be made of polymer. Reference is now made to
(108) Exemplary device 750 may be similar to device 720 of
(109) In some embodiments, the disclosed devices may be used for repairing a tear in a meniscus tissue. The end portion and the collapsible end portion may be threaded through two apertures, respectively, made in the meniscus tissue through the tear in order to bring two edges of the tear closer together. When the actuating element segment is pulled proximally, the flexible tube may be anchored against a peripheral distal wall of the meniscus tissue thereby maintaining the tear closed.
(110) Kits for repairing a tear in a meniscus tissue are disclosed herein. Reference is now made to Fig.18A, which shows a top transparent view of an exemplary kit 770 including an applicator 772 and an implant 774. Applicator 772 may be similar to applicator 400 of
(111) Actuating element 782 may be secured to collapsible end portion 778B, and optionally to hardened tip 784. First elongated hardened element 778A may be located at a tip of end portion 776A. Second elongated hardened element 778B may be threaded on collapsible end portion 776B. Optionally, first and second elongated hardened elements 778A and 778B may be involute. Optionally, first and second elongated hardened elements 778A and 778B may be made of polymer and/or may be similar to elongated hardened elements 758A and 758B of
(112) Applicator 772 may include a first tubular needle 782A and a second tubular needle 782B. First tubular needle 782A may include a first rod 783A and a first opening 781A. Second tubular needle 782B may include a second rod 783B and a second opening 781B. First rod 783A and second rod 783B may be positioned within first tubular needle 782A and second tubular needle 782B, respectively. First rod 783A may include a graded tip. Second rod 783B may include a recess at its tip. Alternatively or additionally, applicator 772 may include an opening which may be located laterally with respect and in each of tubular needles 782A and 782B (i.e., a first and a second lateral opening, not shown in this view).
(113) End portion 776A and collapsible end portion 776B may be threaded through two apertures by applicator 772, respectively. First tubular needle 782A may be configured to puncture the meniscus tissue to form a respective aperture. First opening 781A or the lateral opening may be configured to allow insertion of first elongated hardened element 778A into first tubular needle 782A. First rod 783A may be configured to maintain a first elongated hardened element 778A in place within first tubular needle 782A. Second tubular needle 782B may be configured to puncture the meniscus tissue to form a respective aperture. Second opening 781B or the second lateral opening may be configured to allow insertion of second elongated hardened element 778B and collapsible end portion 776B into second tubular needle 782B. Second rod 783B may be configured to maintain second elongated hardened element 778B and collapsible end portion 776B in place within second tubular needle 782B. The recess of second rod 783B may be configured to accommodate hardened tip 784.
(114) Actuating element 782 may be then pulled proximally. As a result of that, collapsible end portion 776B may collapse proximally and form a bulge in vicinity to second elongated hardened element 778B. A length dimension of first elongated hardened element 778A may be larger than the respective aperture. The bulge and a length dimension of second elongated hardened element 778B may be larger than the respective aperture, thereby anchoring flexible mesh tube 775 against a peripheral distal wall of the meniscus tissue.
(115) Alternatively, any applicator known in the art may be used in order to deploy implant 774 in the meniscus tissue by puncturing the meniscus tissue to form two apertures passing through the tear and threading end portion 778A and collapsible end portion 778B through the two apertures, respectively.
(116) In some embodiments, kit 770 may include an applicator which includes only one tubular needle configured to deploy implant 772 in the meniscus tissue. The applicator may be similar to applicator 560 of
(117) Reference is now made to Fig.18B, which shows a top transparent view of another exemplary kit 790 including an applicator 794 and an implant 792. Applicator 784 may include a tubular needle 802. Tubular needle 802 may include an opening, which may be front opening 803 and/or a lateral opening (not shown) and a rod (both not shown in this view). Implant 792 may be similar to implant 775 of
(118) Front opening 803 may be configured to allow insertion of flexible mesh tube 804 into tubular needle 802. The rod may be positioned within tubular needle 802 and may be configured to maintain flexible mesh tube 804 in place within the tubular needle Tubular needle 802 may be configured to puncture the meniscus tissue to form the two apertures and deploy implant 792 in the meniscus tissue.
(119) In an alternative applicator (not shown), two elongated hardened elements may be positioned within a pair of suitable side grooves inside an elongated needle. These grooves may be disposed sequentially along the length of the elongated needle.
(120) Reference is now made to
(121) In a step 812, an end portion of a flexible tube and a first elongated hardened element located at a tip of the end portion may be threaded through a respective aperture of the apertures, entering through the most proximal element and exiting through the most distal element. The first elongated hardened element may be then placed beyond a distal rim of the respective aperture (i.e., on a distal surface of the most distal element). The flexible tube may be similar to the flexible tube of the disclosed devices.
(122) In a step 814, a collapsible end portion of the flexible tube and a second elongated hardened element threaded thereon may be threaded through a respective aperture of the apertures, entering through the most proximal element and exiting through the most distal element. The second elongated hardened element and at least a section of the collapsible end portion extending distally there from may be placed beyond a distal rim of the respective aperture (i.e., on a distal surface of the most distal element).
(123) Optionally, each of the first and second elongated hardened elements may have an involute shape. Optionally, each of the first and second elongated hardened elements may be made of polymer. Optionally, the collapsible end portion may include a hardened tip. The actuating element may be secured to the hardened tip, advantageously to a center of a bottom surface of the hardened tip, as shown in
(124) In a step 816, an actuating element secured to the collapsible end portion and extending along the collapsible end portion may be pulled proximally. The section of the collapsible end portion may then collapse proximally and form a bulge in vicinity to the second elongated hardened element. A length dimension of the first elongated hardened element may be larger than the respective aperture. The bulge and a length dimension of the second elongated hardened element may be larger than the respective aperture. Thus, the flexible tube may be anchored against the distal rim of each one of the two apertures (i.e., against the distal surface of the most distal element).
(125) In case the at least two elements are separable, they may be arranged to assure firm and effective joining of the two or more elements. The location of the entrance of the first and/or second aperture in the most proximal element and/or the path of the first and/or second apertures through the other elements may be selected to assure firm and effective joining of the two or more elements.
(126) In a further optional step, the collapsible end portion may be stretched distally, thereby bringing the bulge formed over the distal rim of the respective aperture closer to the distal rim and a middle portion of the flexible tube closer to the most proximal element (i.e., a proximal surface of the most proximal element). Thus, tightening the joining of the two or more elements.
(127) In some embodiments, the disclosed methods may be used for repairing a tear in a meniscus tissue. The method may then use the disclosed devices and kits for repairing a tear in a meniscus tissue. In such a case, the two or more elements to be joined may include a peripheral distal wall of the meniscus tissue and a proximal wall of the meniscus tissue. The end portion and the first elongated hardened element may be threaded through a first aperture made in the meniscus tissue through the tear. The collapsible end portion and the second elongated hardened element may be threaded through a second aperture made in the meniscus tissue through the tear. Thereby bringing two edges of the tear closer together. When the actuating element is pulled proximally, the flexible tube may be anchored against the peripheral distal wall of the meniscus tissue thus maintaining the tear closed.
(128) Optionally, the first and second apertures may be formed by a first and a second tubular needle of an applicator. The applicator may be similar to an applicator of the disclosed kits.
(129) The method may then further include an optional step, according to which the first elongated hardened element may be placed in the first tubular needle of the applicator parallelly with respect to the first tubular needle.
(130) In another optional step, the collapsible end portion and the second elongated hardened element may be placed in the second tubular needle of the applicator. The second elongated hardened element may be placed parallelly with respect to the second tubular needle.
(131) In a further optional step, a first rod located within the first tubular needle may be pushed distally in order to hold the end portion against a distal rim of a first lateral opening of the first tubular needle.
(132) In another optional step, a second rod located within the second tubular needle may be pushed distally in order to hold the flexible tube against a distal rim of a second lateral opening of the second tubular needle. Thus, the first elongated hardened element and the collapsible end portion and the second elongated hardened element may be maintained in place, respectively, while the end portion and the collapsible end portion are threaded through the first and second apertures, respectively.
(133) In a further optional step, when the first needle is in place (i.e., beyond the distal rim of the first aperture), the first rod may be retracted proximally, thus letting the first elongated hardened element out of the first tubular needle through the first lateral opening to lie beyond the distal rim of the first aperture (i.e., on a distal surface of the peripheral distal wall). Alternatively, the first rod may be pushed distally, thus letting the first elongated hardened element out of the first tubular needle through a first top opening to lie beyond the distal rim of the first aperture (i.e., on a distal surface of the peripheral distal wall).
(134) In another optional step when the second needle is in place (i.e., beyond the distal rim of the second aperture) the second rod may be retracted proximally. Thus, letting the second elongated hardened element and at least an end section of the collapsible end portion extending from the second elongated hardened element out of the second tubular needle through the second lateral opening. Alternatively, the second rod may be pushed distally. Thus, letting the second elongated hardened element and at least an end section of the collapsible end portion extending from the second elongated hardened element out of the second tubular needle through the second top opening. The second elongated hardened element and at least the end section may then lie beyond the distal rim of the second aperture (i.e., on a distal surface of the peripheral distal wall).
(135) The distal stretching of the second collapsible end portion may be performed by pushing the second tubular needle, which holds the second elongated hardened element and at least an end section of the collapsible end portion (i.e., by the second rod), distally. This may be performed in order to bring the first elongated hardened element located over the distal rim of the first aperture closer to the distal rim of the first aperture and to bring the middle portion of the flexible tube closer to the proximal wall, respectively, thereby further closing the tear.
(136) Optionally, each of the first and second elongated hardened elements may have an involute shape. Optionally, each of the first and second elongated hardened elements may be made of polymer. Optionally, the collapsible end portion may include a hardened tip and the actuating element may be secured to the hardened tip.
(137) Reference is now made to
(138) According to
(139) According to
(140) According to
(141) According to
(142) According to
(143) According to
(144) According to
(145) A further device is herein disclosed. The device may include a flexible tube and an actuating element. The flexible tube and the actuating element may be in the form and/or made similar to the flexible tube and the actuating element segments of the devices disclosed herein above, with the modification described herein below. The flexible tube may include a first and a second end portion. The first end portion may include a first elongated hardened element located at a tip of the end portion. The second end portion may include a second elongated hardened element threaded thereon, a pulling anchor located along the second end portion and a collapsible segment extending from the pulling anchor towards a middle portion of the flexible tube. The actuating element may be secured to the pulling anchor and extend therefrom along the second end portion towards the middle portion of the flexible tube.
(146) When the first end portion is threaded through a first aperture, and the second end portion is threaded back and forth, at least once, through a second aperture, and such that the second elongated hardened element and the pulling anchor are located at different sides with respect to the second aperture, the actuating element may be pulled proximally. As a result, the collapsible segment of the second end portion may collapse towards the second elongated hardened element and form a bulge larger than the second aperture. In addition, the first aperture may be smaller than a length dimension of the first elongated hardened element and the second aperture smaller than a length dimension of the second elongated hardened element. Thus, the flexible tube may be anchored against a rim of the first aperture and two rims at two sides of the second aperture.
(147) The first and second elongated hardened elements may be similar to the elongated hardened elements of the above disclosed devices, as described, for example, with respect to
(148) Reference is now made to
(149) Pulling anchor 870 may be formed by melting flexible mesh tube 862 and/or by over-molding, as discussed above. Alternatively, pulling anchor 870 and any other pulling anchor of the specification may be formed by any other technique for localized circumferential narrowing of flexible mesh tube 862, such as by deploying a ring, a belt, a thread and/or the like around the flexible mesh tube.
(150) In some embodiments, the disclosed devices may be used for repairing a tear in a meniscus tissue. The first and second end portions may be threaded through two apertures, respectively, made in the meniscus tissue through the tear in order to bring two edges of the tear closer together. When the actuating element segment is pulled proximally, the flexible tube may be anchored against a peripheral distal wall and a proximal wall of the meniscus tissue thereby maintaining the tear closed.
(151) A kit for repairing a tear in a meniscus tissue is herein disclosed. The kit may include and implant, similar to implant 860 of
(152) The first end portion may be threaded through a first aperture and the second end portion may be threaded back and forth, at least once, through a second aperture, by the applicator. The threading may be performed such that the second elongated hardened element and the pulling anchor are located at different sides with respect to the second aperture. The actuating element may be then pulled proximally. As a result, the collapsible segment of the second end portion may collapse towards the second elongated hardened element and form a bulge larger than the second aperture. In addition, the first aperture may be smaller than a length dimension of the first elongated hardened element and the second aperture smaller than a length dimension of the second elongated hardened element. Thus, the flexible tube may be anchored against a rim of the first aperture and two rims at two sides of the second aperture.
(153) Reference is now made to
(154) In a step 902, a first end portion of a flexible tube and a first elongated hardened element located at a tip of the first end portion may be threaded through the first aperture. The first elongated hardened element may be then placed beyond a distal rim of the first aperture.
(155) In a step 914, a second end portion of the flexible tube may be threaded back and forth through the second aperture. A second elongated hardened element threaded on the second end portion and a pulling anchor located along the second end portion may be then placed at different sides with respect to the second aperture.
(156) In a step 916, an actuating element secured to the pulling anchor and extending along the second end portion may be pulled proximally. As a result of that, a collapsible segment of the second end portion, extending from the pulling anchor towards a middle portion of the flexible tube, may collapse towards the second elongated hardened element and form a bulge larger than the second aperture. A length dimension of the first elongated hardened element may be larger than the first aperture, and a length dimension of the second elongated hardened element may be larger than the second aperture, thereby anchoring the flexible tube to the two elements.
(157) In some embodiments, the disclosed method may be used for repairing a tear in a meniscus tissue. The method may then use the disclosed devices and kits for repairing a tear in a meniscus tissue. In such a case, the two or more elements to be joined may include a peripheral distal wall of the meniscus tissue and a proximal wall of the meniscus tissue. The first end portion and the first elongated hardened element may be threaded through a first aperture made in the meniscus tissue through the tear. The second end portion and the second elongated hardened element may be threaded through a second aperture made in the meniscus tissue through the tear. Thereby bringing two edges of the tear closer together. When the actuating element is pulled proximally, the flexible tube may be anchored against the peripheral distal wall and the proximal wall of the meniscus tissue thus maintaining the tear closed.
(158) Reference is now made to
(159) According to
(160) A first end portion 884A of a flexible tube 882 of implant 880 and a first elongated hardened element 890A located at a tip of first end portion 884A may be threaded through the first aperture by the applicator. Advantageously, while puncturing meniscus tissue 896. First elongated hardened element 890A may be placed beyond peripheral distal wall 898. A second end portion 884B of flexible tube 882 of implant 880 may be threaded back and forth through the second aperture by the applicator. A second elongated hardened element 890B, threaded on second end portion 884B, and a pulling anchor 870 located along second end portion 884B, may be placed at different sides with respect to the second aperture (i.e., one beyond peripheral distal wall 898 and the other before proximal wall 900).
(161) According to
(162) According to
(163) According to
(164) A flexible tube according to the disclosed devices, kits and methods, which may be used in medical procedures, may be made of materials such as polyester (for example, DYNEEMA®, by Koninklijke DSM N.V. of TE Heerlen, Netherlands), nylon or a medical suture. The flexible mesh tube may be formed by braiding, knitting or weaving. A length of a flexible tube according to the disclosed devices, kits and methods for repairing a meniscus tissue may range between 8 to 55 millimeters, 20 to 40 millimeters, 25 to 35 millimeters, 8 to 20 millimeters or 40 to 55 millimeters. A diameter of a bulge formed by a portion of a flexible tube according to the disclosed devices, kits and methods used in medical procedures may be between 1 to 8 millimeters, 3 to 7 millimeters, 5 to 6 millimeters, 1 to 3 millimeters or 6 to 8 millimeters.
(165) An actuating element or an actuating element segment according to the disclosed devices, kits and methods, which may be used in medical procedures, may be made of materials such as polyester (for example, DYNEEMA®), nylon or a suture. A length of an actuating element or an actuating element segment according to the disclosed devices, kits and methods for repairing a meniscus tissue may range between 8 to 55 millimeters, 20 to 40 millimeters, 25 to 35 millimeters, 8 to 20 millimeters or 40 to 55 millimeters. A thickness of an actuating element or an actuating element segment according to the disclosed devices, kits and methods used in medical procedures for joining soft tissues may range between 0.05 to 1.2 millimeter, 0.3 to 1.0 millimeters, 0.5 to 0.8 millimeters, 0.1 to 0.3 millimeters or 0.8 to 1.2 millimeters. A thickness of an actuating element or an actuating element segment according to the disclosed devices, kits and methods used in medical procedures for joining sclerous tissues may range between 1 to 17 millimeter, 5 to 14 millimeters, 8 to 11 millimeters, 1 to 4 millimeters or 13 to 17 millimeters.
(166) A volute elongated hardened element according to the disclosed devices, kits and methods, which may be used in medical procedures, may be made of materials such as polyester (for example, DYNEEMA®), nylon or a suture. A thickness of a thread used to form a volute elongated hardened element according to the disclosed devices, kits and methods, which are used in medical procedures for joining soft tissues may range between 0.05 to 1.2 millimeter, 0.3 to 1.0 millimeters, 0.5 to 0.8 millimeters, 0.1 to 0.3 millimeters or 0.8 to 1.2 millimeters. A thickness of a thread used to form a volute elongated hardened element according to the disclosed devices, kits and methods used in medical procedures for joining sclerous tissues may range between 0.5 to 5 millimeter, 1 to 4 millimeters, 2 to 3 millimeters, 0.5 to 2 millimeters or 3 to 5 millimeters. A length of an elongated hardened element according to the disclosed devices, kits and methods, which are used for meniscus repair, may range between 2 to 11 millimeter, 4 to 9 millimeters, 6 to 7 millimeters, 2 to 5 millimeters or 9 to 11 millimeters. A width of an elongated hardened element according to the disclosed devices, kits and methods, which are used for meniscus repair, may range between 0.5 to 3 millimeter, 1 to 2.5 millimeters, 1.5 to 2 millimeters, 0.5 to 1.5 millimeters or 2 to 3 millimeters.
(167) Reference or description of one end portion of a flexible tube of the disclosed devices and kits, may also apply to the other end portion of the flexible tube.
(168) The devices, kits and methods disclosed with respect to repairing of a meniscus tissue, may also apply to the devices, kits and methods for joining two elements, with the required modifications.
(169) The disclosed devices and kits may be operated according to the disclosed methods.
(170) The descriptions of the various embodiments of the present invention have been presented for purposes of illustration but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.