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WO2021124212A1 - Surgical device for the surgical grafting of a bone-tendon-bone graft in a dislocated and /or sub-luxated joint - Google Patents

Surgical device for the surgical grafting of a bone-tendon-bone graft in a dislocated and /or sub-luxated joint Download PDF

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Publication number
WO2021124212A1
WO2021124212A1 PCT/IB2020/062127 IB2020062127W WO2021124212A1 WO 2021124212 A1 WO2021124212 A1 WO 2021124212A1 IB 2020062127 W IB2020062127 W IB 2020062127W WO 2021124212 A1 WO2021124212 A1 WO 2021124212A1
Authority
WO
WIPO (PCT)
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.)
Ceased
Application number
PCT/IB2020/062127
Other languages
French (fr)
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
Priority to EP20839146.6A priority Critical patent/EP4076221A1/en
Publication of WO2021124212A1 publication Critical patent/WO2021124212A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0805—Implements for inserting tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/087—Anchor integrated into tendons, e.g. bone blocks, integrated rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers 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.

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  • 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

The present invention relates to a surgical device for surgical grafting of a graft constituted by bone-tendon-bone in a dislocated and/or subluxated joint. The device enables positioning the graft in a grafting site in the joint with great precision. In particular, the use of an abutment element (8) and of a locking element (7) enables the graft to be positioned at the graft site with high precision and stability.

Description

SURGICAL DEVICE FOR THE SURGICAL GRAFTING OF A BONE-TENDON-BONE GRAFT IN A DISLOCATED AND /OR SUB-LUXATED JOINT FIELD OF THE INVENTION
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. The terms “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.
DESCRIPTION OF THE PRIOR ART
It is known that body joints are subject to dislocations and/or subluxations, to obviate which various solutions have been offered, the first of which includes the fixing of the two bones of the dislocated and/or subluxated joint to one another by means of a surgical screw. This, evidently, reduces the possibility of movement of the joint. 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. Obviously, for there to be a perfect integration of the graft in the dislocated and/or subluxated joint, it is fundamentally important for the graft ligament to be correctly positioned in the grafting site and not to be compressed. This is because, in this case, the portions of the graft bone might integrate in a zone of the joint in which there was originally only the ligament with the obviously consequences that this would involve.
It is particularly laborious and imprecise to perform a surgical grafting in a scapholunate joint that is dislocated and/or subluxated. From the foregoing, relating to the surgical methods and surgical means for the surgical grafting of the graft in a dislocated and/or subluxated joint, the need to be able to correctly position the graft in a grafting site in the joint emerges with particular importance, in particular if it is a scapholunate joint. SUMMARY OF THE INVENTION
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.
In particular, 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. In fact, according to the invention it is possible to correctly position the graft inserted in the seat in the grafting site, by virtue of the presence and immovability of the abutment element, while the support element exits from the grafting site, the graft remains in position as any possible dragging out of the grafting site is opposed by the abutment with the abutment of the graft with the abutment extremity of the abutment element.
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.
Also worthy of note is the fact that 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.
BRIEF DESCRIPTION OF THE DRAWINGS
The characteristics of the invention will be described in the following in which some preferred but not exclusive embodiments of the surgical device will be described with reference to the accompanying tables of drawings, in which:
- figure 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;
- figure 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;
- figure 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;
- figure 14 is a schematic section view of a surgical device in the relative fourth configuration and of the insert; and
- figure 15 is a schematic view of the structure i.e. a hand.
In the section views the broken lines are omitted to make the illustration clearer.
DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference to the appended figures, reference numeral (1) denotes a device for surgical grafting of a graft constituted by bone-tendon-bone according to the invention.
It comprises:
- a 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);
- a first gripping element (5) which is solidly fixed to the connecting end (24) of the first tubular element (2);
- 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);
- 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 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 abutment element (8) due to the movement of the first tubular element (2).
It is clear that the first tubular element (2) and the abutment element (8) together constitute a cylinder-piston system.
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.
It is preferable for 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) predisposing a graft (61) constituted by bone-tendon-bone;
B) carrying out a reductive manoeuvre of the dislocation or subluxation of the joint;
C) carrying out a first surgical incision (100) (see figure 15) in one of the bones of the joint, laterally to the relative ligament, obtaining an access point;
D) after having carried out a reductive manoeuvre, obtaining a channel which extends from the access point to a grafting site (68) in the joint;
E) predisposing 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 first tubular element (2) is coupled externally on the abutment element (8) with a possibility of sliding, with respect to the abutment element (8), from a first position in which the relative operating end (23) is at the abutment extremity (81) of the abutment element (8) 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); a locking element (7) predisposed and configured to reversibly lock the first tubular element (2) in the relative first position;
F) locking the first tubular element (2) in the relative first position (see figures 1-3 -7-11), and arranging the graft (61) in the seat;
G) inserting the surgical device (1) on the second side (42) of the seat in the channel, keeping the first tubular element (2) blocked;
H) moving the seat up to the grafting site (68) so as to position the graft (61) inserted in the seat in the grafting site (68);
I) keeping the abutment element (8) immovable by means of the second gripping element (5), unlocking and moving the first tubular element (2) from the relative first position to the relative second position, causing the support element (4) to exit from the grafting site (68) leaving the graft (61) in the grafting site (68) by means of the relative abutment with the abutment extremity (81) of the abutment element (8) due to the movement of the first tubular element (2).
In a particularly preferred embodiment of the surgical device according to the invention, 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:
- a second tubular element (9) coupled externally on the first tubular element (2) with a possibility of longitudinal sliding, with respect to the first tubular element (2) and with a relative positioning end (91) (see figures 13-14) which is arranged distally to the connecting end (24) of the first tubular element (2); and
- 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 (not illustrated) 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. In figures 10-14 the surface of the patient abutting the positioning element (93) is indicated in a broken line and with numeral reference number (95).
In a preferred embodiment of the surgical device (1) of the invention 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.
It is clear that 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. This enables actuating the following embodiment of the method in accordance with the invention: wherein 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):
H1) keeping the seat in the grafting site (68) immovable, moving the positioning element (93), with respect to the second tubular element (9), towards the patient up to a relative abutment position in which the positioning element (93) abuts the patient at the access point;
H2) reversibly fixing the positioning element (93) in the abutment position; and wherein step I) it comprises the following substep:
11) keeping the abutment element (8) immovable by pushing it against the patient while the first tubular element (2) is moved from the relative first position to the relative second position.
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. In this way it is possible to solidly fix the second tubular element (9) to the abutment element (8) simply and reliably using economical components. 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). In this way, while keeping the abutment element (8) immovable by manually acting on the second gripping element (5), the positioning of the positioning element (93) in the relative abutment position using the free hand is particularly facilitated. This enables the surgeon to work easily without the aid of third persons. When the ring-nut is included, steps H1 and H2 of the surgical method are contemporaneous and include screwing the ring-nut to the second tubular element (9).
In a particularly preferred embodiment of the surgical device, in which 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. Consequently the surgical method according to the invention that can be carried out with the embodiment has the step of F) comprising the following substep:
F1) 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:
H3) under radiographic control, moving the seat up to the grafting site (68) up to positioning the tendon (62) of the graft (61) inserted in the seat at the position of the lesion of the ligament of the dislocated and/or subluxated joint. To simplify the realisation and reduce the costs of the device of the invention, it is advantageous for the reference element (45) to be 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.
With the aim of enabling the surgeon to use one hand only to release the first tubular element (2) while, with the other hand, holding the second gripping element (6) and keeping the abutment element (8) immovable, 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).
As shown in figures from 1-3 and 7-15, 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. In this case 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). In this case, 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.
In a preferred embodiment of the surgical device (1) according to the invention, 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. In this embodiment, 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).
To facilitate the insertion into the tunnel of the surgical device (1) and the relative movement of the various components of the device, it is preferable that 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. As previously reported, it is preferable for the support element and the first tubular element to be 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.
Obviously the surgical device (1) according to the invention is sterilisable, i.e. is realised in one or more sterilisable materials.
Particularly advantageous is the use of the surgical device (1) according to the invention for stabilisation of a dislocated and/or sub dislocated scapholunate joint.
In this case, in the surgical method of the invention the joint is a scapholunate joint, and the graft (61) has been harvested from a carpo-metacarpal joint arranged at the second metacarpal and the trapezoid.
In this case and with reference to figure 15, according to a relative preferred actuation of the surgical method of the invention, includes: that step A) comprises the following substeps:
A1) carrying out a second surgical incision (101) at the second metacarpal
(108); and
A2) collecting, through the second surgical incision (101), the graft from the carpo-metacarpal joint from the second metacarpal (108) and the trapezoid
(109) base, (according to the Cuenod bone-grafting surgical procedure) see reference number(103) of figure 15; that step B) is the following:
B) 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:
C) 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:
D1) coupling a Kirschner guide wire to a surgical drill, inserting a Kirschner guide wire through the access point using a surgical drill to move it in direction AL and L, converging towards the centre of the semilunar 106 (preferably under radiographic control); and
D2) decoupling the Kirschner wire from the surgical drill and coupling it to a surgical bur, and activating the bur to obtain the channel.
In the surgical method of the invention it is preferable that the graft (61) is autologous to limit the possibility of rejection of the graft (61).
To actuate step D1 and D2 a surgical handle can be used, of known type and couplable to the Kirschner wire, to the surgical drill and to the surgical bur.
It is understood that the above has been described by way of non-limiting example and that technical-functional variants are considered to fall within the protective scope of the invention as claimed in the following.

Claims

1. A surgical device for surgical grafting of a graft (61) constituted by bone- tendon-bone comprising:
- a 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;
- 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), 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);
- a first gripping element (5) which is solidly fixed to the connecting end (24) of the first tubular element (2);
- 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 extremities;
- 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 first tubular element (2) is coupled externally on the abutment element (8) with a possibility of sliding, with respect to the abutment element (8), from a first position in which the relative operating end (23) is at the abutment extremity (81) of the abutment element (8) 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); the medical device further comprising:
- 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 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 abutment element (8) due to the movement of the first tubular element (2).
2. The surgical device according to the preceding claim, wherein the first tubular element (2) comprises a relative slot (28) 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 the predetermined distance (D); wherein the medical device further comprises:
- a second tubular element (9) coupled externally on the first tubular element (2) with a possibility of longitudinal sliding, with respect to the first tubular element (2), and with a relative positioning end (91) which is arranged distally to the connecting end (24) of the first tubular element (2); and
- 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 to second tubular element (9);
- 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 in which 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.
3. The surgical device according to the preceding claim, wherein the abutment element (8) comprises a first hole (33) which is threaded and arranged transversally to the abutment element (8); wherein the second tubular element (9) has a second hole which is threaded and arranged transversally to the second tubular element (9), wherein 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 wherein
- the first fixing means comprise an externally threaded element (29) which is screwed into the second hole, passes through the slot (28) and is also screwed in the first hole (33).
4. The surgical device of claim 2 or 3, wherein the positioning end (91) of the second tubular element (9) is externally threaded, and wherein 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).
5. The surgical device of any one preceding claim, wherein the support element (4) comprises a reference element (45) which is radiographically detectable and which is arranged between the first side and the second side of the relative seat to enable arranging, in the seat, a bone-tendon-bone insert with the relative tendon at the reference element with the purpose of enabling, under radiographic control, the positioning of the tendon in the grafting site (68) at the position of the lesion of the ligament of the dislocated and/or subluxated joint.
6. The surgical device according to any one preceding claim, wherein said reference element is a third hole.
7. The surgical device of any one preceding claim, wherein the locking element (7) is rotatably constrained 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).
8. The surgical device according to the preceding claim, wherein the locking element (7) is rotatably constrained to the first gripping element (5) and the second gripping element (6) comprises the second coupling means.
9. The surgical device of any one preceding claim, wherein 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, wherein the first portion (22) comprises the operating end (23) and the slot (28) and has a relative transversal section having relative external dimensions, and wherein 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, and wherein the slot (28) and the second tubular element (9) are 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.
10. The surgical device of any one preceding claim, wherein the first tubular element (2), the support element (4), the second tubular element (9) are cylindrical and wherein the support element (4) is conformed as a longitudinal section of a further tubular element.
11. A surgical method for stabilisation of a dislocated and/or subluxated joint in a patient by a grafting into that joint of a graft constituted by bone-tendon- bone, the surgical method comprising following steps:
A) predisposing a graft constituted by bone-tendon-bone;
B) carrying out a reductive manoeuvre of the dislocation or subluxation of the joint;
C) carrying out a first surgical incision in one of the bones of the joint, laterally to the relative ligament, obtaining an access point;
D) after having carried out a reductive manoeuvre, obtaining a channel which extends from the access point to a grafting site in the joint;
E) predisposing a medical device comprising: a first tubular element which internally forms a relative tunnel and which has an operating end; a support element forming a seat which is superiorly open, at a relative first side and at a relative second side, which support element is solidly fixed to the first tubular element with the first side of the seat at the operating end 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; a gripping element which is solidly fixed to the connecting end of the first tubular element; an abutment element having a relative abutment extremity and a relative coupling extremity which are opposite one another and a relative intermediate portion arranged between the extremities; a second gripping element which is not slidably insertable in the tunnel and which is solidly fixed to the coupling extremity; wherein the first tubular element is coupled externally on the abutment element with a possibility of sliding, with respect to the abutment element, from a first position in which the relative operating end is at the abutment extremity of the abutment element and a second position in which the relative operating end is at the intermediate portion of the abutment element and in which the second side of the seat is at the abutment extremity of the abutment element; a locking element predisposed and configured to reversibly lock the first tubular element in the relative first position;
F) locking the first tubular element in the relative first position, and arranging the graft in the seat;
G) inserting the device on the second side of the seat in the channel, keeping the first tubular element blocked;
H) moving the seat up to the grafting site so as to position the graft inserted in the seat in the grafting site;
I) keeping the abutment element immovable by means of the second gripping element, unlocking and moving the first tubular element from the relative first position to the relative second position, to cause the support element to exit from the grafting site, and leaving the graft in the grafting site by means of the relative abutment with the abutment extremity of the abutment element due to the movement of the first tubular element.
12. The surgical method of the preceding claim, wherein the medical device further comprises: a second tubular element (9) solidly constrained to the abutment element and coupled externally on the first tubular element and with a possibility of longitudinal sliding, with respect to the first tubular element; and a positioning element mounted externally on the second tubular element at the relative positioning end thereof with the positioning element projecting longitudinally from the positioning end; wherein the surgical method comprises following steps, subsequent to step H):
H1) keeping the seat in the grafting site immovable, moving the positioning element, with respect to the second tubular element, towards the patient up to a relative abutment position in which the positioning element abuts the patient at the access point;
H2) reversibly fixing the positioning element in the abutment position; and wherein step I) it comprises the following substep:
11) keeping the abutment element immovable by pushing it against the patient while the first tubular element is moved from the relative first position to the relative second position.
13. The surgical method of any one preceding claim, wherein step F) comprises the following substep:
F1) positioning the graft in the seat with the relative ligament arranged at a reference element that is radiographically detectable and included in the seat; and wherein step H) comprises the following substep: H3) under radiographic control, moving the seat up to the grafting site up to positioning the ligament of the graft inserted in the seat at the position of the lesion of the ligament of the dislocated and/or subluxated joint.
14. The surgical method of any one preceding claim, wherein the joint is a scapholunate joint, the graft has been harvested from a carpo-metacarpal joint arranged at the second metacarpal and the trapezoid.
15. The surgical method of the preceding claim, wherein step A) comprises the following substeps:
A1) carrying out a second surgical incision at the second metacarpal; and A2) collecting the graft from the carpo-metacarpal joint through the second incision from the second metacarpal and the trapezoid base; and wherein step B) is the following:
B) inserting a Kirschner wire between the scaphoid and the capitate; inserting a Kirschner wire between the semilunar and the radial; and carrying out, with the Kirchner wires inserted, a reductive manoeuvre of the joystick type of the DISI of the semilunar and of the rotatory subluxation of the scaphoid of the subluxation of the scapholunate joint; and wherein step C) is the following:
C) carrying out the first surgical incision between the middle-third and the first- lower of the scaphoid, obtaining the access point; and wherein step D) comprises the following substeps:
D1) coupling a Kirschner guide wire to a surgical drill, inserting a Kirschner guide wire through the access point and moving it using a surgical drill in direction AL and L, converging towards the centre of the semilunar; and D2) decoupling the Kirschner wire from the surgical drill and coupling it to a surgical bur, and activating the bur to obtain the channel.
16. The surgical method of any one preceding claim, wherein the graft is autologous.
PCT/IB2020/062127 2019-12-19 2020-12-17 Surgical device for the surgical grafting of a bone-tendon-bone graft in a dislocated and /or sub-luxated joint Ceased WO2021124212A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20839146.6A EP4076221A1 (en) 2019-12-19 2020-12-17 Surgical device for the surgical grafting of a bone-tendon-bone graft in a dislocated and /or sub-luxated joint

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102019000024676 2019-12-19
IT102019000024676A IT201900024676A1 (en) 2019-12-19 2019-12-19 SURGICAL DEVICE FOR SURGICAL GRAFTING OF A BONE-TENDON-BONE GRAFT IN A LUXURATED AND / OR SUB-LUXURATED JOINT

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WO2021124212A1 true WO2021124212A1 (en) 2021-06-24

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PCT/IB2020/062127 Ceased WO2021124212A1 (en) 2019-12-19 2020-12-17 Surgical device for the surgical grafting of a bone-tendon-bone graft in a dislocated and /or sub-luxated joint

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EP (1) EP4076221A1 (en)
IT (1) IT201900024676A1 (en)
WO (1) WO2021124212A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658289A (en) * 1993-09-24 1997-08-19 Linvatec Corporation Ligament graft protection apparatus and method
US20010053934A1 (en) * 2000-06-09 2001-12-20 Arthrex, Inc. Method of ACL reconstruction using allograft bone cross pin implant
US6833005B1 (en) * 2001-02-02 2004-12-21 John P. Mantas Ligament graft system and method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5658289A (en) * 1993-09-24 1997-08-19 Linvatec Corporation Ligament graft protection apparatus and method
US20010053934A1 (en) * 2000-06-09 2001-12-20 Arthrex, Inc. Method of ACL reconstruction using allograft bone cross pin implant
US6833005B1 (en) * 2001-02-02 2004-12-21 John P. Mantas Ligament graft system and method

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EP4076221A1 (en) 2022-10-26

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