Instrument for the removal of a bone insert and corresponding method

Abstract

A method for the removal of a bone insert for a shoulder prosthesis, which provides for: forming a hole inside a proximal bone portion; inserting in the hole an operating end of an instrument provided with a moveable cutting element deep-cutting a distal base of the bone insert, by rotating the instrument through 360 degrees around its longitudinal axis; removing the instrument from the hole; inserting and fixing a pin element inside the hole; milling the bone insert; removing the bone insert and the pin element attached thereto.

Claims

1. Method for the removal of a bone insert, for example of a bone insert for a shoulder prosthesis, the method comprising: forming a hole of predefined diameter inside a proximal bone portion from which said bone insert is to be removed; inserting inside said hole an operating end of an instrument provided with a cutting element, wherein said cutting element is moveable to project through a side opening in said operating end, transversely with respect to a longitudinal axis of the instrument; deep-cutting by the cutting element a distal base of said bone insert, wherein said instrument is pushed and is rotated through 360 degrees around the longitudinal axis of the instrument; removing the instrument from said hole; inserting and fixing a pin element inside said hole; perimetrally milling the bone insert at a predefined second diameter, by centering a milling cutter on said pin element; removing the bone insert and the pin element attached thereto.

2. Method according to claim 1, wherein said deep-cutting has an essentially circular shape in a spongy part of the bone to be cut.

3. Method according to claim 1, wherein said bone is a long bone, in particular a femur or a humerus.

4. Method according to claim 1, wherein a flange is integral with said pin and removal of the bone insert and of the pin is performed by engaging with said flange.

5. Method according to claim 4, wherein perimetrally milling the bone insert is performed by a circular milling cutter circumscribing said flange.

6. Method according to claim 1, wherein said hole has a frustoconical form matching said operating end.

7. Method according to claim 6, wherein said operating end is a frustoconical portion of a larger-diameter operating head housing an adjustment mechanism of the projecting cutting element.

8. Method according to claim 1, wherein said proximal bone portion in which said hole is formed is flattened or made concave beforehand or afterwards, so as to receive a flat or convex flange from which said pin element projects.

9. Method according to claim 8, wherein said pin element is inserted with interference fit inside the hole until the flange achieves a bearing contact.

10. Method according to claim 1, wherein said pin element is perimetrally threaded or partially threaded.

11. Method according to claim 1, wherein said pin element is hollow.

12. Method according to claim 11, wherein perimetrally milling the bone insert is performed by centering the milling cutter on a guide rod inserted inside a cavity of said hollow pin element.

13. Method according to claim 1, wherein said cutting element is made to project only when said operating end is completely inserted inside said hole.

14. Method according to claim 13, wherein said cutting element is movably guided from a rest position, where it is concealingly housed inside said operating end, to an operative position, where it projects through a side opening in said operating end, transversely with respect to the longitudinal axis of the instrument.

15. Method according to claim 1, wherein said pin element is configured for attachment to a shoulder prosthesis portion.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows a diagrammatic cross-sectional view of a reverse total shoulder prosthesis according to the prior art;

(2) FIG. 2 shows a diagrammatic perspective view of a bone portion to which the method of the present invention is applied, for example the head of a humerus;

(3) FIG. 2A is a diagrammatic longitudinally sectioned view of the bone portion according to FIG. 2;

(4) FIG. 3 shows a diagrammatic side view of an instrument provided in accordance with the present invention during approach towards a bone portion to be treated;

(5) FIG. 4 shows a perspective picture view showing the instrument of the present invention before an operating step;

(6) FIG. 5 shows a diagrammatic cross-sectioned side view of the instrument according to the present invention at the start of an operating step;

(7) FIG. 6 shows a diagrammatic cross-sectioned side view, similar to that of FIG. 5, in which the instrument according to the present invention is at the start of an operating step;

(8) FIG. 7 shows a perspective picture view showing a portion of the instrument according to the invention during its operating step;

(9) FIG. 8 shows a diagrammatic cross-sectioned side view of the instrument according to FIG. 7 during operation;

(10) FIG. 9 shows a perspective view of a detail of the instrument according to the invention;

(11) FIG. 10 shows a longitudinally sectioned view of a detail of the bone according to FIG. 2, in which a deep cut has been made using the instrument according to the invention;

(12) FIG. 11 shows a diagrammatic perspective view of a detail of the bone according to FIG. 2 in which a prosthesis component is about to be inserted;

(13) FIG. 12 shows a longitudinally sectioned view in which the prosthesis portion according to FIG. 11 has been inserted in the bone portion according to FIG. 2;

(14) FIG. 13 shows a partially sectioned diagrammatic view of the bone portion according to FIG. 2 undergoing successive operating steps of the method according to the invention;

(15) FIGS. 14 and 15 show respective partially sectioned diagrammatic views of operating steps of the method according to the invention;

(16) FIG. 16 is a perspective picture view of the example shown in FIG. 15 from a different view point;

(17) FIG. 17 shows laterally sectioned view of a detail of the bone portion according to FIG. 2 practically at the end of the operating steps of the method according to the invention;

(18) FIG. 18 is a perspective picture view of extraction and removal of an insert performed using the instrument and the method according to the present invention.

DETAILED DESCRIPTION

(19) As already mentioned above, the removal method according to the present invention, which will be described in detail below, is applicable to the removal of any bone insert, which could also be situated in the femoral iliac zone, without this involving any limitation of the Applicant's rights.

(20) However, the attached drawings show in diagrammatic form the head portion of a bone along the human skeleton, for example the head of a humerus, as an example application of the method according to the invention.

(21) The removal method is described below with reference to a surgical technique applied to the implantation of a reverse total shoulder prosthesis shown in FIG. 1, but only by way of a non-limiting example and for the purpose of simplification of description of the invention.

(22) FIG. 1 shows in diagrammatic form a reverse total shoulder prosthesis 1 with an already known structure.

(23) In the sector of total shoulder prostheses, reverse prostheses comprise, on one side, a glenoid component associated with the glenoid cavity G of a scapula S of a patient and terminating in a convex articular surface 11A and, on the other side, a component integrated in the humerus H defining a concave articular surface 22A; these two articular surfaces 11A, 22A, cooperating with each other, recreate the shoulder joint.

(24) FIG. 1 shows a shoulder prosthesis 1 comprising a glenoid component or glenoid cavity and a humeral component, indicated by the numbers 10 and 20, respectively, and situated in the scapula S and in the humerus H of a patient. The glenoid component 10 comprises a head 11 which has, on the opposite side to the glenoid cavity G of the scapula S, an articular convex face 11A with a generally semispherical form and, on the side directed towards the glenoid cavity G of the scapula S, a flat face 11B. In the illustrative example shown in the figures, the face 11B is generally flat, but it may also have a more elaborate geometry and be for example substantially concave or convex.

(25) The glenoid component 10 further comprises an anchoring stem 12 which extends transversely with respect to the projecting face 11B, in the opposite direction to the face 11A, and the free end of which is firmly anchored in the glenoid cavity G, thus ensuring joining of the glenoid component to the side of the scapula S. The shank 12 may be externally threaded or, in general, have a surface which favors anchoring. A bone insert 2 is arranged between the face 11B of the glenoid portion 10 of the prosthesis and the glenoid cavity G of the scapula S, said insert having a substantially cylindrical external shape, with a circular base, the external diameter of which is substantially the same as the diameter of the head 11.

(26) The bone implant 2 to be associated with the glenoid component of the prosthesis is removed from the upper epiphysis of the humerus of the shoulder of the same patient. In this way the risk of rejection, poor biocompatibility or the potential transmission of diseases or infections is reduced.

(27) Moreover, in this way advantageously also resection and forming of the head of the humerus which is suitable for engagement of the other humeral component of the reverse total prosthesis is obtained.

(28) The humeral component 20 of the reverse prosthesis comprises a medullary stem 21 intended to be inserted inside the medullary cavity M of the humerus H. At the top end the stem 21 widens into a head 22 which has on its side opposite to the shank 21 a concave articular surface 22A with a semispherical form having a radius substantially the same as that of the convex surface 11A. When the prosthesis 1 is implanted, as shown in FIG. 1, the surfaces 11A and 22A are directed in contact against each other, allowing the various movements required by the shoulder.

(29) Owing to the presence of the implant 2, the face 11A is situated at a predefined distance from the glenoid surface G and this arrangement is referred to, in the technical jargon of the sector, as induced lateralization. Advantageously, the lateralization of the glenoid component of the prosthesis also induces an increase in the muscular tension of the rotator cuff. The glenoid and humeral prosthetic components are thus stabilized and therefore benefit from improved relative rotation and a better mobility without any longer the risk of a shoulder dislocation. Furthermore, the geometric center of articulation of the prosthesis is situated correctly in the glenoid cavity.

(30) Advantageously, according to the present invention, the surgical method and the instrument described here allow easier removal of the bone insert 2, for example both for a reverse prosthesis 1 of the shoulder, such as that described above, and for other types of operations which in any case require the removal of bone inserts from a patient.

(31) The steps of the surgical method developed by the Applicant may be easily understood from the sequence shown in FIG. 2 onwards.

(32) The description which follows does not intend to describe all the steps involved in the surgical treatment for removal of the bone insert 2, but only those steps which are most important and relevant to the description of the invention; therefore, detailed explanations as to how the patient is positioned or how the head of the humerus or the glenoid cavity are surgically exposed will be omitted.

(33) For the purposes of the present invention, the humeral epiphysis 3 undergoes firstly a milling operation to define a concave recess 4 which has substantially the shape of a spherical cup.

(34) A central hole 5 of predefined diameter, in particular a hole with a frustoconical shape, is formed in the bottom of this recess 4.

(35) Obviously, the person skilled in the art will understand that the shape of the hole 5 may be cylindrical if necessary.

(36) The milling resection means for performing a resection in the humeral epiphysis and defining the concave recess 4 as well as the drilling means for centrally boring the hole 5 are of the conventional type and may be used in cooperation with a centering or guide stem (not shown in that conventional) which helps define the direction of application of these means for forming the hole 5 centered in the recess 4.

(37) Similarly, the person skilled in the art will understand that the steps for forming the recess 4 and the hole 5 could also be reversed with the formation of the hole 5 which may precede the removal of the bone material from the humeral epiphysis until the concave recess 4 is obtained.

(38) In any case, at the end of these first operating steps, the head of the humerus has a receiving seat 6 formed by the assembly of the hole 5 and concave recess 4 which is subsequently intended to house a pin element 25 visible in FIGS. 11 and 12. This pin element 25 comprises a flange 23, with shape matching that of the concave recess 4, and a pin 24 projecting centrally and intended to be inserted inside the hole 5.

(39) Preferably the pin 24 has circular and longitudinal grooves for better anchoring of the pin element 25 inside the hole 5 and stabilization of the flange 23 inside the recess 4 of the receiving seat 6.

(40) In accordance with the present invention, an instrument 9 is brought up close with its operating end 15 so that it may be inserted inside the seat 6, as shown in FIG. 3.

(41) The internal structure of the instrument 9 can be seen from the cross-sectional view shown in FIGS. 4, 5, 6 and 8.

(42) The instrument 9 comprises a stem-like body 40 extending along a longitudinal axis (x-x) and provided with a proximal grip and a distal operating head 15. The distal operating head is slidably mounted on one end of the stem 40 between a rest position and an operative position.

(43) The operating head 15 is provided internally with a cutting element 30, in particular a blade having a predefined constant lateral thickness.

(44) An end tip 16 projects coaxially from said operating head 15 and forms a kind of laterally open frustoconical bit.

(45) The operating head 15 has internally a pushing mechanism 8 for acting on the cutting element 30 so as to displace it angularly from a rest position, where it is concealingly housed inside the end tip 16, and an operative position where it projects through a side opening 27 in the end tip.

(46) The cutting element 30 has a blade 31 extending substantially in a direction transverse to said longitudinal axis x-x when it is in the operative position.

(47) As is clearly shown in FIGS. 6, 7 and 8, when the blade 31 of the cutting element 30 starts to emerge through the side opening 27 of the end tip 16 it also starts to perform its incision function in the spongy part of the bone to be cut. As the end 31 performs its action, a cut 7 is formed and, following rotation of the instrument 9 through 360, this cut assumes an essentially circular form.

(48) The cutting element 30 is curved, essentially in the form of a semi-circle or circle arc, and comprises a widened portion 28, which extends over most of the circle arc and is slidable inside a guide 18 provided in the solid-material portion of the operating head 15, and a tapered blade 31, which is angularly movable between said rest position, where it is concealingly housed inside the end tip 16 of the operating head 15, and said operative position, where it extends transversely with respect to the longitudinal axis (x-x) in the manner of a sickle.

(49) The widened proximal portion 28 is slidable inside the circular-rim guide 18 of matching shape formed in the operating head 15, thus moving angularly about a point of instantaneous rotationdiagrammatically indicated by Owhich is also the center of the curved cutting element 30 and the circular-rim guide 18. A pin 35 is also provided, integral with the cutting element 30, and extends perpendicularly with respect to the plane in which said cutting element 30 lies, as can be clearly seen in FIG. 9.

(50) A guide slot 33, which is eyelet-shaped, is formed transversely with respect to the axis x-x on the distal end of the stem and is engaged by the pin 35 and acts on the said pin during displacement from the rest position to the operative position.

(51) The operating head 15 has an essentially cylindrical shape and surrounds the pushing mechanism 8 and the distal end portion 8, which is preferably fork-shaped, of the stem 40.

(52) The solid-material distal portion 39 of the operating head 15 is associated with the end tip 16 which is substantially the end part of a cylindrical shaped lid or cover with a frustoconical end tip 16, which covers both the distal end 38 of the stem 40 and the distal solid-material portion 39 of the operating head 15 so as to be formed integrally therewith.

(53) A pin 26 is provided projecting laterally from the operating head 15 so as to be snap-engaged by a deformable element formed in the cylindrical cover and visible in FIG. 4.

(54) When the end tip 16 fixed to the operating head of the instrument 9 is inserted inside the hole 5, the distal surface of the operating head 15 comes into mating contact with the recess 4 of the seat 6 on the epiphysis of the humerus.

(55) The pushing mechanism 8 also comprises a resilient element 34 arranged between the stem 40 and the operating head 15 and constantly biasing the stem 40 and the operating head 15 away from each other and therefore the cutting element 30 towards said rest position.

(56) The side opening 27 in the end tip 16 is an opening extending along the entire longitudinal extension of the end tip, as shown in FIG. 7, so as to allow the blade 31 of the cutting element 30 to emerge fully.

(57) The pushing mechanism 8, and in any case the distal end portion 38 of the stem 40, is slidable inside the operating head 15 with a predefined longitudinal travel. The fork-shaped distal end 38 of the stem 40 engages with the pin 35 via the guide slot 33 and therefore forces the cutting element 30 to slide inside its matching seat 18 against the action of the resilient means 34.

(58) The distal end 38 of the stem 40 has a circular cross-section and diameter smaller than the internal diameter of the operating head 15 and has the function of receiving a section of the resilient element 34 and guiding it during the compression and release phase.

(59) By means of the pushing or pressing force applied by the surgeon acting on the grip 19 of the stem 40 the blade 31 may be gradually made to protrude against the action of the resilient recall means 34, so that the resection action occurs gradually with rotation of the instrument through 360.

(60) Once the blade 31 has completed, acting in the manner of a sickle, the operations for resection of the deep base of the bone insert 2, thus performing the circular cut 7, the instrument 9 may be removed, releasing the resilient means which perform their elastic recall action 34 recalling the cutting element 30 inside the end tip 16 of the operating head 15.

(61) In this way, the instrument is free again and may be removed.

(62) The end portion 3 of the bone M which is operated on for removal of the inert 2 has a cross-section as shown in FIG. 10 where a deep base 47 of the insert 2 has been defined by means of a circular cut 7.

(63) At this point it is possible to insert the pin element 25also called metal backwhich has an engaging portion 24 with perimetral grooves and is inserted by means of an interference fit inside the hole 5 until the flange makes bearing contact inside the matching recess 4 of the seat 6, as clearly shown in FIGS. 11 and 12.

(64) The flange 23 has holes for stabilizing bone screws.

(65) Thereafter the method according to the invention envisages successive terminal operative steps, some of which may be defined as being optional.

(66) For example, FIG. 13 shows a guide rod 45 which has a threaded end 44 inserted inside the pin element 25.

(67) The pin 24 is internally hollow and has a thread inside which the aforementioned end 44 of the guide rod 45 may be engaged.

(68) This guide rod acts as a guide for a milling cutter 50 provided with an end tool 48 with an essentially circular shape designed to perform core-boring of the insert 2 around the flange 23.

(69) FIG. 15 shows diagrammatically the action performed by the tool 48 of the milling cutter 50 on the head of the humerus M.

(70) The perimetral milling or core-boring operation produce a cylindrical cut 43 which penetrates deep as far as the circular cut 7. In this way the insert 2 is easily resected from the surrounding bone material and may be easily removed by means of a suitable removal instrument.

(71) The milling cutter 50 is then removed and an extractor 55 with a gripping head 54 is used to remove the insert 2 thus cut. As clearly shown in FIG. 18, the extractor 55 is in turn guided along the guide rod 45 which is still fastened to the pin element 25. The gripping head 54 is snap-engaged with the flange 23 of the pin element 25 and the insert attached to the pin element 25 may be removed.

(72) More particularly, the extractor 55 of the metal back 25 snap-engages onto the guide rod 45. The head 54 enters inside the screw holes of the flange 23 of the metal back 25 in order to stabilize the rotational movement about the axis of the extractor and therefore allow directional adjustment of the implant.

(73) The operating steps which allow removal of the bone insert 2 from the portion 3 of bone H may be summarized extremely succinctly as follows: forming a hole 5 of predefined diameter inside a bone portion from which the insert 2 is to be removed; inserting inside the hole 5 the operating end 16 of the instrument 9 provided with a cutting element 30; the cutting element 30 being movably guided from a rest position, where it is concealingly housed inside the end tip 16 of the operating head 15, to an operative position, where it projects through a side opening 27 in the said end tip 16, transversely with respect to a longitudinal axis x-x of the instrument 9; deep-cutting a base of the insert 2 by rotating the instrument 9 through 360, as is clearly shown in FIG. 7; removing the instrument 9 from the hole 5; inserting and fixing a pin element 25 inside said hole 5; perimetrally milling the insert 2 of predefined diameter by centering a milling cutter 50 on said pin element 25; removing the insert 2 and the pin element 25 attached thereto.

(74) The fact that the seat 6 also comprises the surface recess 4 is entirely optional. Obviously, this surface recess 4 may advantageously receive the flange 23 attached to the pin 25

(75) This flange 23 is integral with the pin 25 and removal of the insert 2 is performed by engaging the flange 23 using the extractor 55 which can be seen in FIGS. 17 and 18.

(76) Once a circular base 47 of the bone insert 2 has been deep-cut, it is merely required to mill perimetrally the insert using a circular milling cutter circumscribing the flange 23 of the pin element 25 which is fixed to the insert 2 even before the milling operation is performed.

(77) It is entirely clear that, as a result of the method according to the present invention, it is possible to reduce and speed up the operating steps designed to remove the bone insert useful for combining with implanted prostheses.

(78) The removal methods are furthermore less invasive than those proposed by the prior art and allow most of the bone material to be conserved and used for the insert to be removed.

(79) An instrument for removal of a bone insert, for example for a shoulder prosthesis, comprises: a stem-like body extending along a longitudinal axis (x-x) and provided with a proximal grip and a distal operating head slidably associated with the stem-like body for movement towards and away from each other; a cutting element inside said operating head; and an end tip projecting coaxially from said operating head, characterized in that it comprises further: a pushing mechanism, inserted inside said operating head and acting on said cutting element so as to displace it angularly from a rest position, where it is concealingly housed inside said end tip, to an operative position where it projects through a side opening in the end tip; said cutting element having an end extending substantially in a direction transverse to said longitudinal axis when in the operative position.

(80) Advantageously, the cutting element is curved or has the form of a circle arc and comprises a widened proximal portion slidable inside a guide of matching shape formed in the operating head and a tapered end portion which is angularly movable between the rest position, where it is concealingly housed inside the end tip of the operating head, and the operative position, where it extends transversely projecting relative to the longitudinal axis.

(81) The pin is integral with the widened proximal portion, perpendicular thereto and is movable inside a guide slot formed in the stem.

(82) The operating head has an essentially cylindrical shape and comprises a circular-rim guide inside which the cutting element is movably guided.

(83) The distal portion of the operating head is slightly concave, while the end tip has a frustoconical form with a base diameter smaller than the diameter of the operating head and projecting coaxially with the longitudinal axis from the distal portion.

(84) It should be noted that the pushing mechanism also comprises a resilient element which constantly biases said cutting element towards said rest position.

(85) Moreover, the pushing mechanism comprises a distal end of the stem acting on the cutting element.

(86) In greater detail, the pushing mechanism is such that the stem is slidable inside said operating head with a predefined longitudinal stroke so that its distal end acts on said cutting element against the action of spring-loaded means; sliding of the stem is obtained by means of an advancing and retracting movement engaged on a perimetral portion.

(87) The distal end of the stem has a circular cross-section and diameter smaller than the internal diameter of the operating head, while the spring-loaded means consist of a spring wound around the distal end of the stem.

(88) The spring extends resiliently inside a variable-extension, cylindrical, annular gap which is defined between an inner edge of the operating head and an edge formed by the smaller diameter of the distal end of the stem.

(89) A resilient element constantly biases the operating head and the stem away from each other and said cutting element towards said rest position is arranged between the operating head and the stem.

(90) The cutting element is formed integrally with the pin and projects from the matching seat formed in the operating head under the pushing force of the distal end of the stem.

(91) The side opening in the end tip is an opening extending along the entire longitudinal extension of said end tip.

(92) A guide pin projects laterally and perpendicularly from the cutting element and is slidable inside a guide slot formed at the distal end of the stem.

(93) The pushing mechanism comprises the distal end of the stem and a pin associated with the cutting element; the distal end acts on the pin when the stem is moved towards the operating head.

(94) The approach movement of the stem is performed against the action of resilient means.

(95) The distal end of the stem has a circular cross-section and diameter smaller than the internal diameter of the operating head and the spring-loaded means consist of a spring wound around the distal end of the stem.

(96) The spring extends resiliently inside a variable-extension, cylindrical, annular gap which is defined between an inner edge of the operating head and an edge formed by the smaller diameter of the distal end of the stem.

(97) A method for removing a bone insert intended, for example, for a shoulder prosthesis, comprises the steps of: forming a hole of predefined diameter inside a bone portion from which said insert is to be removed; inserting inside said hole an operating end of an instrument provided with a cutting element; said cutting element being movably guided from a rest position, where it is concealingly housed inside said end, to an operative position, where it projects through a side opening in the said end, transversely relative to a longitudinal axis of the instrument; deep-cutting a base of said insert by rotating said instrument through 360 degrees; removing the instrument from said hole; inserting and fixing a pin element inside said hole; perimetrally milling an insert of predefined diameter by centering a milling cutter on said pin element; removing the insert and the pin element attached thereto.