EP4076221A1 - Dispositif chirurgical pour le greffage chirurgical d'un greffon os-tendon-os dans une articulation délocalisée et/ou subluxée - Google Patents

Dispositif chirurgical pour le greffage chirurgical d'un greffon os-tendon-os dans une articulation délocalisée et/ou subluxée

Info

Publication number
EP4076221A1
EP4076221A1 EP20839146.6A EP20839146A EP4076221A1 EP 4076221 A1 EP4076221 A1 EP 4076221A1 EP 20839146 A EP20839146 A EP 20839146A EP 4076221 A1 EP4076221 A1 EP 4076221A1
Authority
EP
European Patent Office
Prior art keywords
relative
tubular element
abutment
graft
seat
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20839146.6A
Other languages
German (de)
English (en)
Inventor
Matteo Mantovani
Beatrice PAPA
Stefano SBARDELLATI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Apis Srl
Original Assignee
Apis Srl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Apis Srl filed Critical Apis Srl
Publication of EP4076221A1 publication Critical patent/EP4076221A1/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0805Implements for inserting tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0847Mode of fixation of anchor to tendon or ligament
    • A61F2002/087Anchor integrated into tendons, e.g. bone blocks, integrated rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to the technical sector of methods and surgical means for surgical grafting of a graft constituted by a graft constituted by bone-tendon-bone in a in a dislocated and/or subluxated joint, in particular when the joint is a scapholunate joint of a patient.
  • graft constituted by bone-tendon-bone are taken to mean a graft, in a single body, which comprises: a portion of a first joint bone; a portion of the capsular-ligament zone of the joint: and a portion of a second joint bone.
  • a second solution can include collecting a graft from another healthy joint and positioning the graft in a grafting site in the dislocated and/or subluxated joint by drawing the graft using a guide wire into an appropriate channel in the patient up to a grafting site.
  • the aim of the present invention consists in reducing and/or obviating the above-cited drawbacks relative to the surgical means and methods for surgical grafting of the graft in a dislocated and/or subluxated joint.
  • the present invention has the aim of guaranteeing the correct positioning of the graft in the grafting site.
  • a further aim of the present invention is to position, with high precision, the graft in a dislocated and/or subluxated joint, in particular if scapholunate, with simple surgical methods, by making available a surgical device for surgical grafting of a graft constituted by bone-tendon-bone in a dislocated and/or subluxated joint which is constructionally simple and economical as well as reliable in use.
  • the aims and objectives are obviated with a surgical device for surgical grafting of a graft constituted by a graft constituted by bone-tendon-bone in a in a dislocated and/or subluxated joint according to claim 1 and with a surgical method according to claim 11.
  • the present invention enables positioning the graft in the grafting site with high precision, by carrying out a surgical method that is simple and reliable.
  • the applicant has experimentally found that when the graft is pushed, for example by means of a cylinder-piston system, into the grafting site, the same graft positioning accuracy that is obtained according to the invention is not obtained. This is probably due to the fact that by pushing the graft the ligament part thereof tends to be crushed. Consequently the portion of bone of the graft that is proximal to the access point tends to be incorrectly located.
  • the device of the invention is simple, easy to realise and therefore relatively economical. It follows that the costs correlated to the stabilisation of a dislocated joint will be significantly reduced with respect to the prior art.
  • the surgical device of the invention enables actuating the claimed surgical method. Obviously this method can comprise each step of use of the surgical device.
  • FIG. 1 is a schematic view from above of an embodiment of a surgical device according to the invention in a relative first configuration
  • figure 2 is a schematic lateral view of the surgical device of figure 1
  • figure 3 is a schematic section view, taken along plane Ill-Ill of figure 2 of the surgical device of figure 1;
  • figure 4 is a schematic and perspective lateral view of a component of the surgical device of figure 1;
  • figure 5 is a schematic section view, taken along a longitudinal plane Ill-Ill of the component of figure 4;
  • figure 5A is a larger-scale schematic view of detail K of figure 4
  • figure 6 is a schematic view from above of the component of figure 4.
  • FIG. 7 is a schematic view from above of the graft/surgical device unit of figure 1;
  • figure 8 is a schematic lateral view of the group of figure 7;
  • figure 9 is a schematic section view, taken along plane Ill-Ill of figure 8 of the unit of figure 7;
  • - figure 10 is a schematic section view from above and in larger scale of the unit of figure 7 with the relative surgical device in a relative second configuration
  • - figure 11 is a schematic section view from above and in larger scale of the unit of figure 7 with the relative surgical device in a relative third configuration
  • FIG. 12 is a schematic section view, from above of the unit of figure 7 with the relative surgical device in a relative fourth configuration
  • figure 13 is a schematic section view, taken along a longitudinal plane, of the unit of figure 12;
  • FIG. 14 is a schematic section view of a surgical device in the relative fourth configuration and of the insert.
  • FIG. 15 is a schematic view of the structure i.e. a hand.
  • reference numeral (1) denotes a device for surgical grafting of a graft constituted by bone-tendon-bone according to the invention.
  • first tubular element (2) which internally forms a relative tunnel and which has a relative operating end (23) and a relative connecting end (24), opposite one another (see figures 4-6);
  • a support element (4) forming a relative seat for supporting a graft (61) to be grafted into a patient, wherein the seat is superiorly open, at a relative first side (43) and at a relative second side (42) (see figures 4, 5 and 6), wherein the support element (4) is solidly fixed to the first tubular element (2) the first side (43) of the seat being at the operating end (23) of the first tubular element (2) so that the first side (42) of the seat permanently projects from the tunnel only longitudinally, with respect to the tunnel, by a predetermined distance (D) (see figures 4-6);
  • an abutment element (8) which is slidably insertable in the tunnel and which has a relative abutment extremity (81) and a relative coupling extremity (82) which are opposite one another and a relative intermediate portion arranged between the abutment extremity (81) and coupling extremity (82);
  • the first tubular element (2) is coupled externally on the abutment element (8) with a possibility of sliding, with respect to the abutment element (8), between a first position (see figures 1-3, 7-11) in which the relative operating end (23) is at the abutment extremity (81) of the abutment element (8) and a second position (see figures 12-14) to a second position in which the relative operating end (23) is at the intermediate portion of the abutment element (8) and wherein the second side (42) of the seat is at the abutment extremity (81) of the abutment element (8); wherein the medical device further comprises:
  • a locking element (7) predisposed and configured to reversibly lock the first tubular element (2) in the relative first position in order, when the first tubular element (2) is locked in the relative first position and a graft (61) which is a graft (61) constituted by bone-tendon-bone is accommodated in the seat of the support element (4), to enable the positioning of the support element (4) and the graft (61), in a grafting site (68), accessible from a relative access point (100) obtained in a patient, and in order to enable, once the seat and the graft (61) are positioned in the grafting site (68), to move the first tubular element (2) from the relative first position to the relative second position keeping the abutment element (8) immovable by means of the second gripping element (6) in order to cause the support element (4) to exit from the grafting site (68) maintaining the graft (61) in the grafting site (68) by means of the relative abutment with the abutment extremity (81) of the graf
  • the support element and the first tubular element are preferably in a single body and form a unit obtainable by removal of a terminal longitudinal sector of a suitable tube as this simplifies the construction of the surgical device (1) of the invention.
  • the surgical method of the invention of stabilisation of a dislocated and/or subluxated joint in a patient by the grafting into that joint of a graft (61) constituted by bone-tendon-bone to comprise the following steps:
  • a medical device comprising: a first tubular element (2) which internally forms a relative tunnel and which has an operating end (23); a support element (4) forming a seat which is superiorly open, at a relative first side (43) and at a relative second side (42), wherein the support element (4) is solidly fixed to the first tubular element (2) with the first side (43) of the seat being at the operating end (23) and so that the second side of the seat permanently projects from the tunnel only longitudinally, with respect to the tunnel, by a predetermined distance (D); a first gripping element (5) solidly fixed to the connecting end (24) of the first tubular element (2); an abutment element (8) having a relative abutment extremity (81) and a relative coupling extremity (82) which are opposite one another and a relative intermediate portion arranged between the extremities(81, 82); a second gripping element (6) which is not slidably insertable in the tunnel and which is solidly fixed to the coupling extremity (82); wherein the
  • the first tubular element (2) comprises a relative slot (28) (see figures 4-6) which is a through-slot arranged longitudinally with respect to the first tubular element (2) at an intermediate portion of the first tubular element (2) situated between the respective operating end (23) and connecting end (24), wherein the slot (28) has a longitudinal extension equal to or greater than a said predetermined distance (D); and the medical device further comprises:
  • first fixing means which pass through the slot (28) and which solidly fix the second tubular element (9) to the abutment element (8) in order to enable moving the first tubular element (2) from the relative first position to the relative second position maintaining both the abutment element (8) and the second tubular element (9) immobile;
  • a positioning element (93) mounted externally on the second tubular element (9) at the relative positioning end (91) so as to project longitudinally from the positioning end (91) and relatively movably with respect to the second tubular element (9) longitudinally thereto and, consequently, to the abutment element (8) solidly constrained thereto;
  • - second fixing means for reversibly fixing the positioning element (93) to the second tubular element (9) in order, once the seat and the graft (61) are positioned in the grafting site (68), to enable moving the positioning element (93) towards the patient up to a relative abutment position (see figures 10-14) wherein the positioning element (93) abuts the patient at the access point and to reversibly fix the positioning element (93) in the abutment position in order to be able to maintain the abutment element (8) immobile pushing the second gripping element (6) against the body of the patient while the first tubular element (2) is moved from the relative first position to the relative second position.
  • the surface of the patient abutting the positioning element (93) is indicated in a broken line and with numeral reference number (95).
  • the positioning element (93) can comprise or be a ring and the second fixing means can comprise a threaded hole made transversally in the ring and an element that can be screwed to the threaded hole.
  • the positioning element (93) and the relative fixing thereof enables, once the positioning element (93) is blocked, to maintain the abutment element (8) immovable pushing the second gripping element (6) against the body of the patient while the first tubular element (2) is moved from the relative first position to the relative second position.
  • the medical device further comprises: a second tubular element (9) solidly constrained to the abutment element (8) and coupled externally on the first tubular element (2) and with a possibility of longitudinal sliding, with respect to the first tubular element (2); - a positioning element (93) mounted externally on the second tubular element (9) at the relative positioning end (91) thereof with the positioning element (93) projecting longitudinally from the positioning end (91); wherein the surgical method comprises following steps, subsequent to step H):
  • step I) it comprises the following substep:
  • the preferred embodiments of the device of the invention are those in which the abutment element (8) comprises a first hole (33) (see figures 3, 9, 13, and 14), preferably threaded, arranged transversally with respect to the abutment element (8); wherein the second tubular element (9) has a second hole, preferably threaded, arranged transversally to the second tubular element (9), in which the second tubular element (9) is coupled externally on the first tubular element (2) the second hole being at the slot (28) and the first hole (33); and in which the first fixing means comprise one from an externally threaded element (29) (for example a screw or a grub screw) (see figures 3, 7, 10-11) which is screwed into the second hole, passes through the slot (28) and is also screwed in the first hole (33) or a pin insertable by interference in both the holes.
  • an externally threaded element (29) for example a screw or a grub screw
  • the holes are threaded and the first fixing means comprise or more preferably are constituted by an externally threaded element (29), for example a screw or a grub screw.
  • the positioning end (91) of the second tubular element (9) is advantageously externally threaded, and the positioning element (93) and the fixing means together constitute an internally-threaded ring-nut which is screw-coupled to the threaded positioning end (91) of the second tubular element (9).
  • steps H1 and H2 of the surgical method are contemporaneous and include screwing the ring-nut to the second tubular element (9).
  • the support element (4) comprises a reference element (45) (see figures 1, 3-4 and 5-6) which is radiographically detectable and which is arranged between the first side (43) and the second side (42) of the relative seat (preferably centrally with respect to the seat) to enable arranging, in the seat, a bone- tendon-bone grafting (61) with the relative tendon (62) at the reference element with the purpose of enabling, under radiographic control, the positioning of the tendon (62) in the grafting site (68) at the position of the lesion of the ligament of the dislocated and/or subluxated joint.
  • the surgical method according to the invention that can be carried out with the embodiment has the step of F) comprising the following substep:
  • step H) positioning the graft (61) in the seat with the relative ligament arranged at a reference element that is radiographically detectable and included in the seat; and the step H) comprises the following substep:
  • the reference element (45) is a third hole (as shown in figures 3, 4-5 and 6), and preferable that the third hole is a through-hole as it would be more detectable with a greater radiographic contrast.
  • the locking element (7) is advantageously rotatably constrained (preferably advantageously at a relative end and more preferably transversally to a plane passing through the slot (28)) to one only from among the first gripping element (5) and the second gripping element (6) and comprises first coupling means for engaging with second coupling means provided in one from among the first gripping element (5) and the second gripping element (6) which is not rotatably constrained to the locking element (7).
  • the locking element (7) is preferably rotatably constrained to the first gripping element (5) and the second gripping element (6) comprises the second coupling means.
  • the first coupling means can be disengaged from the second coupling means using the thumb of the hand holding the second gripping element (5).
  • the second coupling means can comprise or be constituted by a pin arranged transversally to a plane passing through the slot (28).
  • the first coupling means preferably comprise or are constituted by a hook (66) having a concavity engageable with the pin (65) identifiable in figure 12.
  • the first tubular element (2) comprises a relative first portion (22) and a relative second portion (21) which are longitudinal and contiguous to one another; the first portion (22) comprises the operating end (23) and the slot (28) and has a relative transversal section having relative external dimensions; the second portion (21) comprises the connecting end (24) and has a relative transversal section having relative external dimensions that are greater than the dimensions of the section of the first portion.
  • the slot (28) and the second tubular element (9) are preferably configured in such a way that, when the first tubular element (2) is in the relative first position, the second tubular element (9) can abut the second portion (23) (see figures 1-3 and 7-11). In this way it is possible to more easily note when the first tubular element (2) is in the relative first position.
  • the slot (28) is preferably arranged in the first portion (22) of the first tubular element (2).
  • the first tubular element (2), the support element (4), the second tubular element (9) are cylindrical and that the support element (4) is formed as a longitudinal section of a further tubular element.
  • the further tubular element preferably has the same external diameter and more preferably the same internal diameter, as the first portion (22) of the first tubular element (2), and/or the second portion (21) has the same external diameter as the second portion of the first tubular element (2). More preferably the first and second portion (21) have the same internal diameter and the abutment element (8) and the first tubular element (2) together constitute a cylinder-piston system.
  • the support element and the first tubular element are in a single body, to have and form a unit obtainable by removal of a terminal longitudinal sector of a suitable tube, preferably having a circular section, as this simplifies the construction of the surgical device (1) of the invention.
  • the surgical device (1) according to the invention is sterilisable, i.e. is realised in one or more sterilisable materials.
  • the surgical device (1) according to the invention for stabilisation of a dislocated and/or sub dislocated scapholunate joint.
  • the joint is a scapholunate joint
  • the graft (61) has been harvested from a carpo-metacarpal joint arranged at the second metacarpal and the trapezoid.
  • step A) comprises the following substeps:
  • step B is the following:
  • step C) inserting a Kirschner wire (69) (also known as a K-wire) between the scaphoid (104) and the capitate (105), preferably under radiographic control; inserting a Kirschner wire (67) between the semilunar (106) and the radial (107), (preferably sotto radiographic control); and carrying out, with the Kirchner wires inserted, a reductive manoeuvre of the joystick type of the DISI of the semilunar (106) and of the rotatory subluxation of the scaphoid 104 of the subluxation of the scapholunate joint; that step C) is the following:
  • step D) carrying out the first surgical incision (100) between the middle-third and the first-lower of the scaphoid (104), obtaining the access point; step D) comprises the following substeps:
  • the graft (61) is autologous to limit the possibility of rejection of the graft (61).
  • a surgical handle can be used, of known type and couplable to the Kirschner wire, to the surgical drill and to the surgical bur.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un dispositif chirurgical pour le greffage chirurgical d'un greffon constitué d'un os-tendon-os dans une articulation délocalisée et/ou subluxée. Le dispositif permet de positionner le greffon dans un site de greffage dans l'articulation avec une grande précision. En particulier, l'utilisation d'un élément de butée (8) et d'un élément de verrouillage (7) permet au greffon d'être positionné au niveau du site de greffe avec une précision et une stabilité élevées.
EP20839146.6A 2019-12-19 2020-12-17 Dispositif chirurgical pour le greffage chirurgical d'un greffon os-tendon-os dans une articulation délocalisée et/ou subluxée Pending EP4076221A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102019000024676A IT201900024676A1 (it) 2019-12-19 2019-12-19 Dispositivo chirurgico per l'innesto chirurgico di un innesto costituito da osso-tendine-osso in un'articolazione lussata e/o sub-lussata
PCT/IB2020/062127 WO2021124212A1 (fr) 2019-12-19 2020-12-17 Dispositif chirurgical pour le greffage chirurgical d'un greffon os-tendon-os dans une articulation délocalisée et/ou subluxée

Publications (1)

Publication Number Publication Date
EP4076221A1 true EP4076221A1 (fr) 2022-10-26

Family

ID=70155156

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20839146.6A Pending EP4076221A1 (fr) 2019-12-19 2020-12-17 Dispositif chirurgical pour le greffage chirurgical d'un greffon os-tendon-os dans une articulation délocalisée et/ou subluxée

Country Status (3)

Country Link
EP (1) EP4076221A1 (fr)
IT (1) IT201900024676A1 (fr)
WO (1) WO2021124212A1 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2131141A1 (fr) * 1993-09-24 1995-03-25 James A. Boucher Dispositif protegeant le greffon ligamentaire et methode
US6623524B2 (en) * 2000-06-09 2003-09-23 Arthrex, Inc. Method for anterior cruciate ligament reconstruction using cross-pin implant with eyelet
US6833005B1 (en) * 2001-02-02 2004-12-21 John P. Mantas Ligament graft system and method

Also Published As

Publication number Publication date
IT201900024676A1 (it) 2021-06-19
WO2021124212A1 (fr) 2021-06-24

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