# US 11,304,809 B2 · Temporary spacer device for joints of the human body

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- Number: US 11,304,809 B2
- Document ID: US11304809B2
- Status: Granted
- Kind: B2
- Application number: 15/733,548
- Filed: 2018-03-07
- Published: 2020-12-24
- Granted: 2022-04-19
- Earliest claimed: 2018-03-07
- Applicants: Cossington Limited
- Inventors: Augusto Magagnoli; Robert Michael Meneghini; Bryan Donald Springer; Scott Matthew Sporer; Stephen Joseph Incavo
- Web page: https://patentgrep.com/patent/US11304809B2

## CPC

- A61F 2/30724: {Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity}
- A61F 2/38: for elbows or knees
- A61F 2/3859: {Femoral components}
- A61F 2/389: {Tibial components (A61F2/3868 takes precedence)}
- A61F 2/4684: {Trial or dummy prostheses}
- A61F 2/30771: {applied in original prostheses, e.g. holes or grooves}
- A61F 2002/30329: {Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements}
- A61F 2002/30332: {Conically- or frustoconically-shaped protrusion and recess}
- A61F 2002/30359: {Pyramidally- or frustopyramidally-shaped protrusion and recess}
- A61F 2002/30362: {with possibility of relative movement between the protrusion and the recess}
- A61F 2002/3037: {Translation along the common longitudinal axis, e.g. piston}
- A61F 2002/3039: {with possibility of relative movement of the rib within the groove}
- A61F 2002/30518: {with possibility of relative movement between the prosthetic parts}
- A61F 2002/30672: {temporary}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/30878: {with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts}
- 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 (dental prosthetics A61C)

## Abstract

A temporary spacer device for a joint of the human body such as a knee joint includes a first component or femoral component, adapted to be constrained to a bone or to the femoral bone of a patient, at the joint of the human body; a second component or tibial component, adapted to be constrained to a bone or tibial bone of a patient, at the joint of the human body, and at least one stem having a proximal end, wherein the first component or femoral component and/or the second component or tibial component include at least one housing seat for the proximal end of the at least one stem, adapted to allow the inclination and/or rotation of the at least a stem with respect to an insertion axis of the proximal end into the at least one housing seat.

## Claims

### Claim 1

A temporary spacer device, for an articulation of a human body, comprising
a first component or femoral component, adapted to be constrained to a first bone or to a femoral bone of a patient, at a joint of the human body;
a second component or tibial component, adapted to be constrained to a second bone or tibial bone of the patient, at the joint of the human body; and
at least one stem having a proximal end, a distal end, and an elongated body therebetween, said elongated body defining a longitudinal axis,
wherein one or both of said first component or femoral component and said second component or tibial component comprise at least one housing seat for said proximal end of said at least one stem, so as to allow a change in inclination with respect to said housing seat and/or a rotation of said at least one stem with respect to an insertion axis of said proximal end in said at least one housing seat,
wherein said elongated body comprises at least one recess containing a filling material, and
wherein said filling material comprises an acrylic bone cement, or a solid, fluid and/or viscous material adapted to convey and release at least one pharmaceutical or medical substance, and at least one pharmaceutical or medical substance.

### Claim 2 (depends on 1)

The temporary spacer device according to claim 1, wherein said at least one stem comprises one or both of a first stem, placed at said first component or femoral component and/or a second stem, placed at said second component or tibial component, or vice versa.

### Claim 3 (depends on 1)

The temporary spacer device according to claim 1, wherein said first component or femoral component has one or more of a “C”-shaped configuration in plan view from above, a “U”-shaped lateral configuration, or a first surface, configured to face or to be constrained to the first bone or to the femoral bone, and a second surface, configured to face said second component or tibial component, and wherein said first surface has a concave shape, configured as a “U”, and said second surface has a convex shape, configured as a “U”.

### Claim 4 (depends on 3)

The temporary spacer device according to claim 3, wherein said second component or tibial component has one or more of a “C”-shaped configuration in plan view from above, or comprises a first surface, configured to face and/or be constrained to the second bone or the tibial bone, and a second surface, configured to face said first component or femoral component, or comprises an insert, provided with an opening for housing a second housing seat of said at least one housing seat and/or said stem, wherein said insert is configured to be interposed between said first surface and the second bone or the tibial bone of the patient.

### Claim 5 (depends on 4)

The temporary spacer device according to claim 4, wherein said at least one housing seat comprises a first housing seat, placed at said first surface of said first component or femoral component or a second housing seat, located at said first surface of said second component or tibial component, wherein said at least one housing seat comprises at least one cavity, for housing said proximal end of said at least one stem.

### Claim 6 (depends on 5)

The temporary spacer device according to claim 5, wherein said at least one housing seat comprises a first housing wall, wherein said first housing wall delimits said at least one cavity and departs from said first surface of said first component or femoral component moving away from the first component or femoral component and/or extending towards the first bone or femoral bone of the patient, and/or wherein said housing seat comprises a second housing wall, wherein said second housing wall delimits said at least one cavity and departs from said first surface of said second component or tibial component moving away from the second component or tibial component and/or extending towards the second bone or tibial bone of the patient.

### Claim 7 (depends on 6)

The temporary spacer device according to claim 6, wherein said proximal end has a conical, pyramidal, or frusto-pyramidal conformation.

### Claim 8 (depends on 6)

The temporary spacer device according to claim 6, wherein said at least one cavity has a cylindrical, conical, pyramidal, frusto-conical, or frusto-pyramidal conformation, or a configuration to house in the slack or loose manner said proximal end and wherein said at least one cavity has a gap or opening for inserting said proximal end.

### Claim 9 (depends on 8)

The temporary spacer device according to claim 8, wherein said at least one cavity has a depth corresponding and/or greater than a length of said proximal end of said at least one stem, or wherein said gap or opening has a size greater than the diameter of the cross-section of said proximal end but smaller than a size of a base of the elongated body of the at least one stem, wherein said base is connected to said proximal end.

### Claim 10 (depends on 9)

The temporary spacer device according to claim 9, wherein said first or said second housing wall has a peripheral upper edge supporting said base of said at least one stem.

### Claim 11 (depends on 10)

The temporary spacer device according to claim 10, wherein said elongated body presents a tapered thinning arrangement towards the distal end and/or a section crossing the longitudinal axis having a circular or polygonal shaped, and wherein said elongated body comprises a circular outer wall or a first longitudinal face and a second longitudinal face parallel to each other.

### Claim 12 (depends on 11)

The temporary spacer device according to claim 11, wherein said elongated body and/or the circular outer wall of the elongated body and/or at least one of the first and second faces of the elongated body comprises the at least one recess, configured to contain the filling material, or wherein said elongated body and/or the circular outer wall and/or at least one of the first and second faces of the elongated body comprises the at least one recess and the filling material housed in said at least one recess.

### Claim 13 (depends on 12)

The temporary spacer device according to claim 12, wherein said at least one recess has a longitudinal and/or parallel path to the longitudinal axis of the at least one stem and a depth of smaller size than an extension in plan of said at least one recess and/or a length of said at least one recess.

### Claim 14 (depends on 12)

The temporary spacer device according to claim 12, wherein said at least one recess has a rectangular or trapezoidal shape with rounded corners, wherein a short side of the rectangular or trapezoidal shape is located at said proximal or distal end and a long side of the rectangular or trapezoidal shape is parallel to the longitudinal axis of said at least one stem or has an annular band conformation.

### Claim 15 (depends on 12)

The temporary spacer device according to claim 12, wherein said at least one recess is alternated with respect to a subsequent at least one recess from at least one intermediate rib, and wherein said at least one rib is parallel to the base.

### Claim 16 (depends on 6)

The temporary spacer device according to claim 6, wherein said first or said second housing wall is parallel to the insertion axis, or perpendicular to the first surface of said first component or femoral component and/or the first surface of said second component or tibial component, or is inclined with respect to the insertion axis or the first surface of said first component or femoral component or the first surface of said second component or tibial component.

### Claim 17 (depends on 1)

The temporary spacer device according to claim 1, wherein said at least one stem comprises an inner core shaped as a rod.

### Claim 18 (depends on 1)

The temporary spacer device according to claim 1, wherein said temporary spacer device or said at least one stem are preformed and made of a biologically compatible material, and wherein said biologically compatible material is porous or provided with interconnected pores and canalicoli.

### Claim 19 (depends on 1)

A kit for realization of a spacer device, comprising:
the temporary spacer device according to claim 1, wherein said first component or femoral component, said second component or tibial component, and said at least one stem are each provided in different sizes; and
a filling material adapted to be received in one or more recesses defined on said at least one stem.

### Claim 20

A temporary spacer device, for an articulation of a human body, comprising:
a first component or femoral component, adapted to be constrained to a first bone or to a femoral bone of a patient, at a joint of the human body;
a second component or tibial component, adapted to be constrained to a second bone or tibial bone of the patient, at the joint of the human body; and
at least one stem having a proximal end, a distal end, and an elongated body therebetween, said elongated body defining a longitudinal axis,
wherein one or both of said first component or femoral component and said second component or tibial component comprise at least one housing seat for said proximal end of said at least one stem, dimensioned to house the proximal end of the at least one stem in a slack or loose manner by having a diameter larger than a diameter of a cross-section of said proximal end so as to allow a change in inclination with respect to said housing seat and a rotation of said at least one stem with respect to an insertion axis of said proximal end in said at least one housing seat, and
wherein said elongated body comprises at least one recess configured to contain a filling material.
