Suturing device, in particular for suturing lacerations of the meniscus

Abstract

A suturing device, in particular for suturing lacerations of the meniscus, including a needle provided with a longitudinal cavity developing along a main direction, at least a first and a second member slidably inserted in said cavity and arranged in succession along said main direction and a surgical thread slidably inserted in the cavity and connected to the first and the second member. The first and the second member each comprises at least a pair of bodies connected together by means of a junction element.

Claims

1. A suturing device, comprising: a tubular body provided with a longitudinal cavity extending along a main direction between a first end portion and a second end portion; at least a sliding member slidably inserted in said longitudinal cavity; and a surgical thread slidably inserted in said longitudinal cavity and connected to said sliding member; wherein said sliding member comprises at least one pair of bodies connected together by means of a junction element, wherein said surgical thread comprises a first end portion and a second end portion, wherein the first end portion of the surgical thread is slidably secured to a middle portion of said junction element, and the second end portion of the surgical thread projects externally to the second end portion of the tubular body, and wherein said pair of bodies are defined by a first sphere and a second sphere, said second sphere having a peripheral groove housing the surgical thread when the sliding member is disposed within the tubular body, so as to minimize a size of the tubular body.

2. The suturing device according to claim 1, wherein said junction element is a flexible/elastic body.

3. The suturing device according to claim 2, wherein the junction element develops substantially into a “V” shape with two angled portions extending between two free ends and a common vertex, wherein said two free ends are each connected to a respective body.

4. The suturing device according to claim 3, wherein the vertex of the junction element is connected to the surgical thread.

5. The suturing device according to claim 1, wherein the junction element develops substantially into a “V” shape with two angled portions extending between two free ends and a common vertex, wherein said two free ends are each connected to a respective body.

6. The suturing device according to claim 5, wherein the vertex of the junction element is connected to the surgical thread.

7. The suturing device according to claim 1 wherein each body has a through hole within which an end of the junction element is inserted.

8. The suturing device according to claim 7, wherein the junction element has enlarged portions at its ends, so as to interfere with edges of the corresponding through hole, thus preventing the body from sliding.

9. The suturing device according to claim 1, comprising movement means for said member configured to translate said sliding member from a rest position, in which it is housed inside the cavity of the tubular body, to an operating position, in which it is proximal to or externally projecting from an end of the tubular body.

10. The suturing device according to claim 9, wherein said movement means comprise at least one actuating member distal from said end of said tubular or body and operable by a user.

11. A suturing device, comprising: a tubular body provided with a longitudinal cavity extending along a main direction between a first operational end portion and a second end portion; at least a first sliding member and a second sliding member slidably inserted in said longitudinal cavity; and a surgical thread slidably inserted in said longitudinal cavity and extending between the first operational end portion of the tubular body and the second end portion of the tubular body, the surgical thread comprising a first end portion; wherein each of said first and second sliding members comprise at least one pair of bodies connected together by a junction element, wherein said surgical thread is slidably secured to a middle portion of said junction element of the second sliding member, wherein the first end portion of the surgical thread is constrained to the junction element of the first sliding member, and wherein said pair of bodies of the second sliding member are defined by a first sphere and a second sphere, said spheres each having a peripheral groove housing the surgical thread when the second sliding member is disposed within the tubular body, so as to minimize a size of the tubular body.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) These characteristics and the corresponding technical advantages will become more apparent from the following exemplary, and therefore non-limiting description of a preferred, and therefore not exclusive, embodiment of a suturing device, in particular for the suturing of lacerations of the meniscus, as described in the attached drawings, where:

(2) FIG. 1 shows a schematic view of a suturing device, in particular for the suturing of lacerations of the meniscus according to the present invention;

(3) FIG. 2 shows a schematic cross-sectional view of part of the device of FIG. 1;

(4) FIG. 3 shows a perspective view of a suturing device, in particular for the suturing of lacerations of the meniscus that is being used;

(5) FIGS. 4a-4d show a schematic sequence of surgical steps performed by using the suturing device of FIG. 3;

(6) FIG. 5 shows a special suturing device, in particular for the suturing of lacerations of the meniscus according to the present invention;

(7) FIG. 6 schematically shows a suturing device according to the present invention in an alternative application.

DETAILED DESCRIPTION

(8) With reference to the appended figures, number 1 indicates a suturing device, in particular for suturing lacerations of the meniscus, according to the present invention.

(9) Device 1 is therefore mainly used in the orthopaedic sector, preferably when arthroscopic surgery or semi-open technique are used for repairing the meniscus.

(10) Such a device therefore comprises at least one needle 2 extending along its own main direction “A” and provided with a longitudinal cavity 3.

(11) The needle 2 has a first operational and pointed end portion 2a, and a second end portion 2b, preferably connected to the handle of the device 1.

(12) Note that the first end portion 2a may have a rectilinear orientation, aligned with the remaining part of the needle, or a curved orientation, with a variable angle according to the needs of the surgeon and lacerated area that needs suturing.

(13) Preferably, the needle 2 is a substantially tubular body and the longitudinal cavity 3 is of the through type, which also extends along the main direction “A” between a first opening located at the first end portion 2a and a second opening located at the second end portion 2b.

(14) Therefore, the cavity 3 is a duct laterally occluded by the needle wall and accessible from the openings.

(15) A first 4 and a second 5 member, as well as a surgical thread 6 are housed (or can be housed) Inside the needle 2, in particular inside the cavity.

(16) The members 4, 5 are shaped bodies to define an abutment to abut the outer wall of the meniscus during the pulling of the thread.

(17) Preferably, these first 4 and second 5 members are slidably inserted into the longitudinal cavity 3 of the needle 2.

(18) More preferably, the first 4 and second 5 members are completely contained in the cavity 3 of the needle 2.

(19) Moreover, such members 4, 5 are arranged in succession along the main direction “A”.

(20) Such members 4, 5 are also mutually connected through the surgical thread 6, which is also slidably inserted into the cavity 3 (as it will be better explained hereinafter).

(21) According to one aspect of the present invention, the first 4 and the second 5 members each comprise at least a pair of bodies 7, 8, 10, 11 connected together by means of a junction element 9,12.

(22) Preferably, the bodies are each defined by a sphere 7, 8, 10, 11 or a substantially spherical body.

(23) Note that, in the spirit of the present invention, by using the term “sphere” what is not intended is restricting the conformation of the elements constituting the members to perfectly spherical bodies, but those “substantially spherical” elements, having an oval or ovoid shape, are also encompassed, since they may as well meet the specifications of the present invention.

(24) In other words, in its most generic sense, the term sphere is used here to simply define a “rounded, preferably spherical body”.

(25) Therefore, the first member 4 comprises a first 7 and a second 8 sphere (or first and second body) that are connected one to the other by means of a special junction element 9.

(26) In the same way, the second member 5 comprises a first 10 and a second 11 sphere (or first and second body) that are connected one to the other by means of a special junction element 12.

(27) Preferably, such spheres 7, 8, 10, 11 have a diameter (or more generically a transverse size) substantially corresponding to an inside diameter of the cavity 3.

(28) In other words, the spheres 7, 8, 10, 11 are substantially shaped for the cavity 3.

(29) Therefore, these spheres 7, 8, 10, 11 are substantially inserted to fit in the cavity 3.

(30) In the preferred embodiment of the invention, the spheres (or bodies) 7, 8, 10, 11 are made of polymeric material, more preferably of Poly-Ether-Ether-Ketone (PEEK) or Poly-L-lactide-co-D, L-lactide (PLDLLA).

(31) The junction element 9, 12 is a bridge that connects the two spheres 7, 8, 10, 11 (or the two bodies) of each member 4, 5.

(32) In certain embodiments, such a junction element 9, 12 is flexible to allow a relative movement between said spheres (or bodies) 7, 8, 10, 11 of each member 4, 5. For example, such a junction element 9, 12 can be made of a portion of surgical thread, preferably a multi-filament suturing thread.

(33) Alternatively, in an embodiment that is not illustrated, the junction element comprises a rigid pin extending between two ends each secured to a respective sphere.

(34) In this embodiment, the junction element acts as a spacer between the two spheres of the individual member.

(35) Preferably, the surgical thread 6 is slidably associated to said second member 5, more preferably (but not necessarily) to the junction element 12 of the member.

(36) In the preferred embodiment, in fact, the surgical thread 6 is associated to said second member 5 in correspondence of the respective junction element 12 by means of a knot or wrapping in which the thread 6 is maintained sliding.

(37) Therefore, the thread 6 is slidably constrained to the junction element 12 so as to slide along the thread by varying the length of the thread portion 6a interposed between the first 4 and the second 5 member, thus allowing the laceration to be sutured.

(38) In other words, the thread defines the knot or wrapping that remains substantially in position on the second member 5 (or on the junction element 12), but it is slidable in such a way that the thread portion 6 defining the knot or the wrapping, changes upon pulling by the surgeon.

(39) Therefore, the knot or wrapping does not move, whereas the thread 6 that defines it, is slidable.

(40) In the preferred embodiment, this sliding knot or wrapping is a double thread point or the likes.

(41) Advantageously, in such a way the knot does not move along the tissues, but the thread 6 only moves linearly, which greatly reduces friction and the wear action of the thread.

(42) Therefore, the surgical thread 6 extends between a first end portion 6a constrained to the first member 4, and a second end portion 6b, in use externally projecting to an end opposite the needle tip 2, or externally projecting to the second end portion 2b.

(43) More in detail, the thread 6 comprises a first suturing portion 13, interposed between the first 4 and the second 5 member having a variable length, and a second pulling portion 14, which develops between the second member 5 and the second end portion 6b.

(44) Preferably, the second end portion 6b can be held by the surgeon to pull the thread 6b, thus allowing the sliding thereof with respect to the second member 5 and reducing the length of the first portion 13 for suturing the laceration.

(45) Note that the first portion, the junction between the two members 4, 5, has a substantially linear development, i.e. without the presence of knots or wrapping between the two members 4, 5.

(46) In fact, the only functional knot or wrapping in the thread 6 is located at the second member 5, in particular at the junction element 12.

(47) With the expression “functional knot or wrapping”, what is meant is the knot or wrapping that is able to perform an additional function other than the function of keeping together the two elements, e.g. allowing the sliding of an element (thread 6) in relation to the other element (junction element 12).

(48) In the illustrated embodiment, in fact, the thread also has a fixing knot at its first end portion 6a to immovably constrain the same thread 6 to the junction portion 9 of the first member 4.

(49) Note that the at least second sphere 8 of the first member 4 and spheres 10, 11, of the second member 5 have a peripheral groove 15 for housing the surgical thread 6 so as to minimize the size of the needle 2.

(50) In particular, the grooves 15 extend along the main direction “A” of the needle 2 and are accessible peripherally so as to house the thread 6 when the members are inside the needle 2, thus allowing its release after sliding out. Preferably, all the spheres are equipped with such a groove 15.

(51) Advantageously, in such a way it is possible to simultaneously minimize the size of the needle 2 (or the cavity 3) and maximize the size of the surgical thread 6 (which can substantially reach the value for the sphere radius).

(52) Preferably, in fact, the surgical thread 6 presents a gauge between 2-0 and 0 on the USP scale, or preferably equal to 0 on the USP scale (about 0.350-0.399 mm).

(53) Associated to the second end portion 2b of the needle 2, what is envisaged are movement means 16 of the first 4 and second 5 member configured to translate each member 4, 5 from a rest position, in which it is housed inside the cavity 3 of the needle 2 to an operating position, in which it is proximal to or externally projecting from the tip of the needle 2.

(54) Therefore, the movement means 16 comprise at least one distal actuating member 16a from the tip (or from the first end portion 2a) of said needle 2 and operable by a user.

(55) Therefore, the movement means 16 are projecting from the second end portion 2b of the needle 2 and comprise both a handle 16b and said actuating member 16a.

(56) Preferably, the actuating member comprises at least a pusher element (not shown) slidably inserted into the needle 2 (or in the cavity) to get hold of the members 4, 5 and drive them from the rest position to the operating position.

(57) Moreover, such actuating member is also provided with a control portion, proximal to the handle, that can be used by a user (i.e. the surgeon) for manoeuvring the pusher element.

(58) Note that the pusher element is movable in at least three configurations, namely a first configuration in which both members are in the rest position, a second configuration in which the first member is in the operating position and the second member is in the rest position (or in an intermediate position between the two) and a third configuration in which both members are in the operating position.

(59) With reference to FIG. 6 an alternative application of the device 1′ is shown according to the present invention.

(60) In this application, the member 4′ is used as a bone anchor, for example for attaching tissues such as tendons.

(61) Operationally, the procedure or graft procedure is comparable to what has been described up to now, the only difference is related to the need to preliminarily drill the bone cortical tissue “CB” giving access to the organic component “SB” of the bone, i.e. the soft bone tissue.

(62) More precisely, in this embodiment the method envisages to drill a hole in the bone by means of a tool able to realize an undercut “UC” between the cortical tissue “CB” and the bone organic component “SB”.

(63) Therefore, downstream of the drilling, the cortical tissue “CB” has a through hole “H1” of diameter d1, whereas the bone organic component “SB” has a cavity “H2” substantially concentric to the hole “H1” and having a diameter d2 greater than diameter d1.

(64) Alternatively, a similar procedure may provide for the drilling of a through-hole in the bone such as to have just one through-hole “H1” of diameter d1; in such an alternative the member 4′ is not placed inside the bone cavity, but outside it, so as to define, for example, an anchor for the new fixing of the bone in the event of fracture.

(65) Therefore, in the present embodiment, the device is inserted in the hole “H1” so as to pass completely through the bone (anchor for the new fixing of the bone) or for access to the cavity “H2” (anchor for tissue fixation), without substantial modifications in the operating principle and in the structure of the device.

(66) For this reason, explicit reference will be hereinafter made to just one embodiment illustrated in FIG. 6 (tissue fixation), in which after the drilling of the bone the device 1′, the needle in particular, is inserted into the cavity “H2”.

(67) Note that in this application, given the absence of a direct drilling by the device 1′, the needle can be equivalently replaced by a tubular (or semi-tubular) body devoid of a tapered portion, whose only purpose is allowing the sliding of members on the inside.

(68) Structurally, moreover, this embodiment of the device 1′ may comprise a single member 4′ (formed by two bodies 7′, 8′) insertable into the cavity “H2”.

(69) Preferably, the single member 4′ is formed by at least two bodies 7′ and 8′ connected to one another by a junction element 9′.

(70) The suturing thread 6′ is fixed to said junction element 9′, preferably in a middle portion of said element.

(71) In this manner, after inserting the two bodies 7′, 8′ one after the other in the cavity “H2” through the tubular body, upon pulling the suturing thread 6′ toward the outside of the same cavity “H2” the corresponding rotation of the two bodies 7′, 8′ in the cavity “H2” occurs, so that they are placed one next to the other and they cannot pass through the hole “H1”.

(72) In this regard, in fact, the two bodies 7′, 8′ each have a transverse size shorter than the hole diameter “H1” so that they can enter the cavity “H2”, but which, after being added to the size of the other body, is longer than the diameter of the hole “H1”, so as to be able to define the fixing anchor that is used by the surgeon, for example, to connect a tendon to the bone.

(73) Preferably, and in accordance with what has been described, the two bodies 7′, 8′ are spheres.

(74) The junction element 9′ is preferably a flexible/elastic body that allows a simple rotation and does not hinder insertion.

(75) Preferably, each body 7′, 8′ has a through hole within which an end of the junction element 9′ is inserted.

(76) More preferably, the junction element 9′ has enlarged portions at its ends, so as to interfere with the edges of the corresponding through hole, thus preventing the body 7′, 8′ from sliding.

(77) In the preferred embodiment, the junction element develops substantially into the “V” shape, i.e. it has two angled portions extending between two free ends and a common vertex.

(78) In particular, the two free “V” ends are each connected to a respective body 7′, 8′.

(79) Preferably, the vertex is connected to the suturing thread 6′.

(80) In the preferred embodiment, the suturing thread 6′ and the junction element 9′ are made in one piece. This allows to guarantee the correct positioning of the thread 6′ with respect to the junction element 9′ and therefore to facilitate rotation inside the cavity “H2”.

(81) Alternatively, however, the thread 6′ may be knotted or secured (also slidably) to the junction element 9′ in some other way.

(82) Structurally, therefore, the device 1′ according to the present invention used as a bone anchor could be simplified (no needle and member reduction), without thereby deviating from what is the spirit of the present invention, of which, therefore, such application is fully part.

(83) In this respect, therefore, everything that has been previously described in relation to the suturing device for suturing lacerations of the meniscus and compatible with the application of the herein discussed bone anchor is also applicable, both structurally and procedurally.

(84) The invention achieves the intended objects and provides important advantages.

(85) In fact, the use of members comprising (at least in part) pairs of spheres connected together by means of junction elements allows on the one hand to minimize the efforts on the tissues after suturing the laceration and on the other hand to minimize the size of the needle.

(86) Moreover, by being able to fully insert both the members and the thread inside the needle (a tubular and not grooved needle) there is no need to provide the device with a containment tube, thus making it a more compact and simple device.

(87) Furthermore, by providing the spheres with an adequate groove what is possible is increasing the size of the surgical thread up to substantially the size of the radius of each sphere, thus allowing to reach even the gauge=or the upper gauge.

(88) Again, the absence of knots between the two members and the substantial absence of annular wrappings between the knot and the second member makes less critical and less invasive the pulling phase and suturing of the laceration, as the friction of the thread on the tissues is greatly reduced.