WO2020058634A1

WO2020058634A1 - Surgical kit for humeral shoulder prosthesis implant

Info

Publication number: WO2020058634A1
Application number: PCT/FR2019/052182
Authority: WO
Inventors: Yves Lefebvre; Stéphane AUDEBERT; Johannes Barth; Christophe CHAROUSSET; Jérôme GARRET; David GALLINET; Arnaud Godeneche; Jacques GUERY; Thierry JOUDET
Original assignee: Shoulder Friends Institute
Priority date: 2018-09-20
Filing date: 2019-09-18
Publication date: 2020-03-26
Also published as: FR3086163B1; FR3086163A1

Abstract

A surgical kit for a humeral shoulder prosthesis implant, comprising: - a humeral stem (1) having a diaphyseal portion (4) extending along a diaphyseal axis (40), and a metaphyseal portion (5) in the form of a flared corolla in which a metaphyseal window (58) is provided, intended to receive a graft of cancellous material harvested from the humerus; - a tool for harvesting cancellous material from the humerus, comprising a punch whose shape matches the metaphyseal window in order to allow a graft of cancellous material to be removed that is shaped so as to be accommodated, without clearance, inside the metaphyseal window; and - a graft pusher capable of cooperating with the harvesting tool in order to push the graft out of the punch. The present invention finds an application in the field of humeral fracture stems.

Description

Surgical kit for shoulder prosthesis humeral implant

The present invention relates to a surgical kit for a shoulder prosthesis humeral implant.

It relates more particularly to a kit comprising a humeral rod having a diaphyseal part shaped to be implanted in a medullary cavity of a humerus, and a metaphyseal part shaped to bear on a resected metaphyseal portion of the humerus, where the part metaphyseal is in the form of a flared corolla which extends the diaphyseal part, and where this metaphyseal part presents a metaphyseal window formed through and intended to receive a spongy material taken from the humerus.

Such a humeral rod with such a metaphyseal window is generally called a “humeral fracture rod” because it is conventionally used in the case of a fracture of the upper end of the humerus in order to ensure lasting anatomical reconstruction of the shoulder joint.

To fill the metaphyseal window in spongy material and thus promote osteointegration, it is known to take by means of a scraper of spongy material in the previously cut humeral head, and to fill the metaphyseal window with this spongy material. However, this technique has the drawback of being inconvenient and time-consuming for the surgeon, without taking into account the risk of filling the metaphyseal window with spongy material which will be incomplete and therefore less effective.

The present invention aims in particular to solve this drawback by proposing a surgical kit for a humeral implant for a shoulder prosthesis, which facilitates the operation of filling the metaphyseal window with spongy material, and which guarantees complete filling and therefore effective for osseointegration.

To this end, it offers a surgical kit for a shoulder prosthesis humeral implant, said surgical kit comprising a humeral rod having:

- a diaphyseal part of elongated shape, extending along a diaphyseal axis and shaped to be implanted in a medullary cavity of a humerus; and - a metaphyseal part shaped to rest on a resected metaphyseal portion of the humerus, where the metaphyseal part is in the form of a flared corolla which extends the diaphyseal part to a flat proximal face, and in which is formed a metaphyseal window opening into an opposite medial face and side face, said metaphyseal window being intended to receive a spongy graft taken from the humerus;

where this surgical kit also includes:

a tool for collecting spongy material in the humerus, said collecting tool comprising a cookie cutter of a shape complementary to the metaphyseal window to allow to take a graft of spongy material shaped to be accommodated without play inside the metaphyseal window; and

- a graft pusher suitable for cooperating with the removal tool to push the graft out of the punch.

Thus, thanks to such a surgical kit, the sampling tool makes it possible to remove spongy material, in particular from the previously cut humeral head, in the form of a shaped graft which is dimensioned to adapt to the metaphyseal window, then push this graft by means of a graft pusher, and finally place the graft in an adjusted manner inside the metaphyseal window of the humeral stem, thus completely filling the metaphyseal window in spongy material.

In a particular embodiment, the metaphyseal window is delimited by:

- a concave lower face and an opposite concave upper face;

- a flat lower medial face followed by a flat upper medial face to connect the lower face to the upper face of the medial side, where the lower medial face and the upper medial face are inclined relative to each other and are join to form a concave medial wedge; and

- a flat lateral face to connect the lower face to the upper face of the lateral side.

Such a shape of the metaphyseal window proves to be particularly advantageous for optimizing the size and the effect of the graft, it being noted that the punch necessarily has the same geometric conformation as the metaphyseal window. According to one characteristic, the flat lateral face of the metaphyseal window extends parallel to the diaphyseal axis, at more or less 5 degrees.

According to another characteristic, the lower medial face and the upper medial face of the metaphyseal window are inclined relative to the diaphyseal axis.

According to another characteristic, the upper medial face of the metaphyseal window is parallel to the proximal face, at more or less 5 degrees.

According to another characteristic, the medial corner has a radius of curvature greater than the radii of curvature of the lower face and of the upper face of the metaphyseal window.

In a particular embodiment, the cookie cutter has a shape complementary to that of the metaphyseal window with a predefined peripheral over-rib which makes it possible to take an over-grafted graft relative to the metaphyseal window.

Thus, because of this peripheral over-rib, the graft will have to be mounted in force inside the metaphyseal window, which is possible with spongy material, and which will improve the filling of the metaphyseal window by the graft.

Advantageously, the peripheral over-coast is between 0.5 and 2 millimeters.

According to one possibility of the invention, the medial face and the lateral face of the metaphyseal part each have a flat part, so that the metaphyseal part has a reduced width at the level of these two flat parts, and the metaphyseal window opens at least partially into these two flats.

Advantageously, the cookie cutter has a length which is greater than the width of the metaphyseal part of the humeral rod at the level of the two flats.

In a particular embodiment, the removal tool includes an extended grip handle:

- on one side by an upper end provided with a striking surface, and

- on the other side by an extension which ends in the cookie cutter.

In a first embodiment, the sampling tool also has an internal channel which traverses its entire sampling tool. length by opening into the striking surface and into the punch, and the graft pusher comprises a rod intended to be engaged inside the internal channel of the removal tool, its introduction being made on the side of the striking surface until reaching the inside of the cookie cutter to be able to push the graft out of the cookie cutter.

In a second embodiment, the removal tool has an extraction window in the extension, where this extraction window crosses radially the extension, and where the punch is opening internally in this extraction window, and the graft pusher comprises a stud of shape complementary to the cookie cutter, where this stud is intended to be engaged inside the cookie cutter so as to be able to push the graft out of the punch part in the direction of the extraction window.

In this second embodiment, the removal tool removes the graft which is then trapped in its cookie cutter, and then this removal tool is placed on the pad to push the graft to the extraction window, with the advantage of not risking fracturing the cortical part of the graft.

According to another possibility of the invention, the metaphyseal part has a concave medial curvature in the extension of the metaphyseal part and in which is formed a medial notch located at the level of the metaphyseal window in a plane orthogonal to the diaphyseal axis .

Such a medial notch is advantageous for the passage and the maintenance of sutures which will maintain a cohesion of the pieces of humerus in the case of a fracture.

According to another characteristic, the medial notch is delimited at least by a first face extending parallel to the diaphyseal axis, at more or less 5 degrees, and by a second face extending parallel to the proximal face, at plus or minus 5 degrees, where the first side and the second side meet to form a concave bottom.

Other characteristics and advantages of the present invention will appear on reading the detailed description below, of nonlimiting examples of implementation, made with reference to the appended figures in which:

- Figure 1 is a schematic side view of a humeral rod for a surgical kit according to the invention; - Figure 2 is a zoomed in side view of the metaphyseal part of the humeral rod of Figure 1;

- Figures 3 and 4 are schematic perspective and partial views of the humeral rod of Figure 1;

- Figure 5 is a schematic side and partial view of the humeral rod of Figure 1;

- Figure 6 is a schematic perspective view of a first sampling tool for a surgical kit according to the invention, adapted to the humeral rod of Figures 1 to 5;

- Figure 7 is a front view of the first sampling tool of Figure 6, to view the shape of the cookie cutter;

- Figure 8 is a schematic perspective view of a first graft pusher suitable for cooperating with the first removal tool of Figure 6 for a surgical kit according to the invention;

- Figure 9 is a schematic perspective view of a second sampling tool for a surgical kit according to the invention, adapted to the humeral rod of Figures 1 to 5;

- Figure 10 is a zoomed perspective view of the second sampling tool of Figure 9, to view the extraction window;

- Figure 11 is a schematic perspective view of a second graft pusher suitable for cooperating with the second removal tool of Figure 9 for a surgical kit according to the invention;

- Figure 12 is a schematic view of the first removal tool of Figure 6 during a removal operation of a spongy material graft in a previously cut humeral head; and

- Figure 13 is a schematic view of the humeral rod of Figure 1, the metaphyseal window is filled with the graft removed during the removal operation of Figure 12.

In the following description, a surgical kit according to the invention comprises a humeral rod 1 as illustrated in FIGS. 1 to 5, a sampling tool 2, 200 as illustrated in FIGS. 6 and 7 or in the figures 9 and 10, and a graft pusher 3, 300 as illustrated in FIG. 8 or in FIG. 11.

Referring to Figures 1 to 5, the humeral rod 1 comprises a diaphyseal part 4 of elongated shape, extending along a diaphyseal axis 40, and having a distal termination 41 of generally rounded shape which ends in a vertex 42; this vertex 42 can be placed on the axis diaphyseal 40 as is the case in an embodiment illustrated and given as a nonlimiting example, or which can be eccentric or offset with respect to the diaphyseal axis 40.

The humeral rod 1 further comprises a metaphyseal part 5 which is in one piece with the diaphyseal part 4. The diaphyseal part 4 is shaped to be implanted in a medullary cavity of a humerus, while the metaphyseal part 5 is shaped to rest on a resected metaphyseal portion of the humerus.

The metaphyseal part 5 is in the form of a flared corolla which extends the diaphyseal part 4 to a plane proximal face 51 centered on a central axis 50. This central axis 50 is orthogonal to the proximal face 51 and is also inclined relative to the diaphyseal axis 40.

The metaphyseal part 5 is provided with a cavity 52 open on the proximal face 51 and intended to receive a humeral insert (not illustrated) which has:

- or a hemispherical cap shaped for articulation with a glenosphere of a glenoid implant, in the case of a shoulder prosthesis called "inverted";

- or a spherical joint head shaped for articulation on a joint body of a glenoid implant, in the case of a shoulder prosthesis called "anatomical".

This cavity 52 can be cylindrical or frustoconical and has, in both cases, a cylindrical perimeter 53 at the level of the proximal face 51 centered on the central axis 50; such a perimeter 53 can possibly be chamfered.

The metaphyseal part 5 has a convex lateral curvature 54 and a concave medial curvature 55 in the extension of the diaphyseal part 4.

A medial notch 56 is formed in the concave medial curvature 55. This medial notch 56 is delimited by a first face 561 extending parallel to the diaphyseal axis 40 (more or less 5 degrees) and by a second face 562 s' extending parallel to the proximal face 51 (more or less 5 degrees), where the first face 561 and the second face 562 meet to form a concave bottom 563 having a radius of curvature between 1, 5 and 3 centimeters. The metaphyseal part 5 also has a medial face 57 and a lateral face 57 opposite in the extension of the diaphyseal part 4, and in addition this medial face 57 and this lateral face 57 each have a flat 570, so that the metaphyseal part 5 has a reduced width LA at the level of these two flats 570.

The metaphyseal part 5 also has a metaphyseal window 58 formed transversely across the width and which therefore opens into the opposite medial face 57 and lateral face 57. This metaphyseal window 58 is intended to receive a GR graft made of spongy material taken from a TH cutter head previously cut, as illustrated in FIGS. 9 and 10.

This metaphyseal window 58 opens at least partially into the two flats 570 provided on the medial face 57 and the lateral face 57. This metaphyseal window 58 is also located at the level of the medial notch 56 in a plane orthogonal to the diaphyseal axis. 40.

This metaphyseal window 58 is delimited by:

- a concave lower face 580 and an opposite concave upper face 581;

- a lower medial face 582 flat followed by an upper medial face 583 plane to connect the lower face 580 to the upper face 581 on the medial side, where the lower medial face 582 and the upper medial face 583 are inclined relative to one another to each other and join to form a concave medial corner 584; and

- A flat side face 585 for connecting the lower face 580 to the upper face 581 on the lateral side.

More precisely, this metaphyseal window 58 has the following geometric characteristics:

- the flat side face 585 extends parallel to the diaphyseal axis 40, at more or less 5 degrees;

- The upper medial face 583 is parallel to the proximal face 51, at more or less 5 degrees;

- The lower medial face 582 is inclined relative to the diaphyseal axis 40 by an angle A1 of between 20 and 30 degrees;

- The upper medial face 583 is inclined relative to the diaphyseal axis 40 by an angle A2 between 130 and 150 degrees; - The medial corner 584 has a radius of curvature between 3.5 and 5.5 centimeters;

- The lower face 580 has a radius of curvature less than that of the medial corner 584 and between 1, 5 and 3 centimeters; and

- The upper face 581 has a radius of curvature less than that of the medial corner 584 and between 1, 5 and 3 centimeters.

The remainder of the description relates to the other elements of the surgical kit, namely the sampling tool and the graft pusher, by describing a first embodiment comprising a first sampling tool 2 and a first graft pusher 3, and a second embodiment comprising a second removal tool 200 and a second graft pusher 300.

Each sampling tool 2, 200 is provided for taking, from a TH cut humerus head previously, of a GR graft made of spongy material, as illustrated in FIG. 12.

Each sampling tool 2, 200 includes an extended gripping handle 20:

- on one side by an upper end provided with a striking surface 21, and

- on the other side by an extension 22 which ends in a cookie cutter 23 of complementary shape to the metaphyseal window 58 to allow the removal of a graft GR of spongy material shaped to be accommodated without play inside the window metaphyseal 58, as seen in Figure 13.

For each sampling tool 2, 200, the cookie cutter 23 is therefore formed of a closed peripheral wall delimited internally by:

- a concave lower face 230 and an opposite concave upper face 231;

- a lower medial face 232 plane followed by an upper medial face 233 plane to connect the lower face 230 to the upper face 231 on the medial side, where the lower medial face 232 and the upper medial face 233 are inclined relative to one another to each other and meet to form a concave medial wedge 234; and

- A flat side face 235 for connecting the lower face 230 to the upper face 231 on the lateral side.

For each sampling tool 2, 200, the cookie cutter 23 therefore has a shape complementary to that of the metaphyseal window 58 but with a predefined peripheral over-rib, which is between 0.5 and 2 millimeters and which is in particular on the order of 1 millimeter, to allow take a GR graft slightly overcut with respect to the metaphyseal window 58. Thus, the GR graft must be force fitted inside the metaphyseal window 58, which is possible with spongy material therefore compressible.

For each sampling tool 2, 200, the cookie cutter 23 also has a length LO up to a stop 24, where this stop 24 projects externally and radially with respect to the cookie cutter 23, in order to form a stop during sampling because this retainer 24 abuts against the TH humerus head.

In addition, this length LO is greater than the width LA of the metaphyseal part 5 of the humeral rod 1 at the level of the two flats 570 and therefore at the level of the metaphyseal window 58, which will make it possible to obtain a GR graft which will overflow medial and lateral of the metaphyseal window 58.

Furthermore, the first sampling tool 2 also has an internal channel 24 which passes through the sampling tool 2 throughout its length, opening into the striking surface 21 and into the punch 23.

The first graft pusher 3 is itself able to cooperate with the first removal tool 2 to push the graft GR out of the punch 23 and, for this purpose, this first graft pusher 3 comprises a gripping handle 30 extended:

- on one side by an upper end provided with a striking surface 31, and

- on the other side by a rod 32 intended to be engaged inside the internal channel 24 of the sampling tool 2, its introduction being made on the side of the striking surface 21, until reaching the interior of cookie cutter 23 to be able to push the graft GR out of cookie cutter 23.

The second removal tool 200 has an extraction window 25 in the extension 22, where this extraction window 25 crosses radially the extension 22, and where the punch 23 opens out internally in this window This extraction window 25 has a length LE equivalent to or greater than the length LO of the cookie cutter 23.

The second graft pusher 300 is itself able to cooperate with the second removal tool 200 to push the graft GR out of the punch 23 and more specifically to push the graft GR inside the window of extraction 25. For this purpose, this second graft pusher 300 includes a stud 33 of complementary shape to the cookie cutter 23 and whose length LA is equivalent to the length LO of the cookie cutter 23.

This stud 33 is intended to be engaged inside the cookie cutter 23 in an adjusted manner, its introduction being made on the side of the cookie cutter 23, in order to be able to push the graft GR out of the cookie cutter 23 in the direction of the extraction window 25, until the graft GR is fully received in the extraction window 25. It then suffices to extract the graft GR radially out of the extraction window 25.

This second graft pusher 300 may also include a support base 34 provided with a cavity 35 for receiving the head of the TH humerus, with possibly spikes or points 36 projecting into the cavity 35 to block the head. of humerus TH.

The stud 33 protrudes from the support base 34. It may be possible to have two studs 33 of two different sizes, to cooperate with sampling tools 300 having two punch sizes 23, in order to respond to a range of several humeral stems 1 having two sizes of metaphyseal window 58.

Claims

1. Surgical kit for a shoulder prosthesis humeral implant, said surgical kit comprising a humeral rod (1) having:

- a diaphyseal part (4) of elongated shape, extending along a diaphyseal axis (40) and shaped to be implanted in a medullary cavity of a humerus; and

- a metaphyseal part (5) shaped to rest on a resected metaphyseal portion of the humerus, where the metaphyseal part (5) is in the form of a flared corolla which extends the diaphyseal part (4) to a proximal face (51) plane, and in which is formed a metaphyseal window (58) opening into a medial face (57) and a lateral face (57) opposite, said metaphyseal window (58) being intended to receive a graft (GR) spongy material taken from the humerus;

said surgical kit further comprising:

- a sampling tool (2; 200) of spongy material in the humerus, said sampling tool (2) comprising a cookie cutter (23) of a shape complementary to the metaphyseal window (58) to enable a graft to be removed ( GR) of spongy material shaped to be housed without play inside the metaphyseal window (58); and

- a graft pusher (3; 300) adapted to cooperate with the removal tool (2; 200) to push the graft (GR) out of the punch (23). 2. Surgical kit according to claim 1, in which the metaphyseal window (58) is delimited by:

- a lower concave face (580) and an opposite concave upper face (581);

- a flat lower medial face (582) followed by a flat upper medial face (583) for connecting the lower face (580) to the upper face (581) on the medial side, where the lower medial face (582) and the face upper medial (583) are inclined relative to each other and meet to form a concave medial corner (584); and

- a flat side face (585) for connecting the bottom face (580) to the top face (581) on the side side.

3. The surgical kit as claimed in claim 2, in which the flat side face (585) of the metaphyseal window (58) extends parallel to the diaphyseal axis (40), at more or less 5 degrees.

4. Surgical kit according to any one of claims 2 and 3, in which the lower medial face (582) and the upper medial face (583) of the metaphyseal window (58) are inclined relative to the diaphyseal axis (40 ).

5. Surgical kit according to the preceding claim, wherein the upper medial face (583) of the metaphyseal window (58) is parallel to the proximal face (51), at more or less 5 degrees.

6. Surgical kit according to any one of claims 2 to 5, in which the medial corner (584) has a radius of curvature greater than the radii of curvature of the lower face (580) and of the upper face (581) of the metaphyseal window (58).

7. Surgical kit according to any one of the preceding claims, in which the punch (23) has a shape complementary to that of the metaphyseal window (58) with a predefined peripheral over-rib which makes it possible to remove a graft ( GR) over-rated with respect to the metaphyseal window (58).

8. Surgical kit according to the preceding claim, in which the peripheral surface is between 0.5 and 2 millimeters.

9. Surgical kit according to any one of the preceding claims, in which the medial face (57) and the lateral face (57) of the metaphyseal part (5) each have a flat part (57), so that the metaphyseal part ( 5) has a reduced width (LA) at the level of these two flats (57), and the metaphyseal window (58) opens at least partially into these two flats (57).

10. Surgical kit according to the preceding claim, wherein the punch (23) has a length (LO) which is greater than the width (LA) of the metaphyseal part (5) of the humeral rod (1) at the level of the two flats (57).

11. Surgical kit according to any one of the preceding claims, in which the sampling tool (2; 200) comprises an extended grip handle (20):

- on one side by an upper end provided with a striking surface

(21), and

- on the other side by an extension (22) which ends in the cookie cutter

(23).

12. The surgical kit according to claim 11, in which the sampling tool (2) also has an internal channel (24) which crosses the sampling tool (2) throughout its length, opening into the striking surface ( 21) and in the punch (23), and the graft pusher (3) comprises a rod (23) intended to be engaged inside the internal channel

(24) of the sampling tool (2), its introduction being on the side of the striking surface (21) until reaching the inside of the punch (23) to be able to push the graft (GR ) out of the cookie cutter (23).

13. The surgical kit as claimed in claim 11, in which the sampling tool (200) has an extraction window (25) in the extension.

(22), where this extraction window (25) crosses radially the extension (22), and where the punch (23) is opening internally in this extraction window (25), and the graft pusher (300) comprises a stud (33) of shape complementary to the cookie cutter (23), where this stud (33) is intended to be engaged inside the cookie cutter (23) so as to be being able to push the graft (GR) out of the cookie cutter (23) towards the extraction window (25).

14. Surgical kit according to any one of the preceding claims, in which the metaphyseal part (5) has a concave medial curvature (55) in the extension of the metaphyseal part (5) and in which a medial notch (56) is formed. ) located at the level of the metaphyseal window (58) in a plane orthogonal to the diaphyseal axis (40).

15. Surgical kit according to the preceding claim, in which the medial notch (56) is delimited at least by a first face (561) extending parallel to the diaphyseal axis (40), at more or less 5 degrees, and by a second face (562) extending parallel to the proximal face (51), at more or less 5 degrees, where the first face (561) and the second face (562) meet to form a concave bottom (563) .