The present invention relates to prosthetic systems for replacement of parts of bones, and more particularly to prosthetic systems for replacement of mid-shaft parts of long bones.
Severe trauma and disease can lead to significant amounts of bone loss. In some instances, it is necessary to excise intercalary bone from a long bone, that is, part of the diaphysis or bone shaft between the ends of the long bone, but it is not necessary to excise the ends of the long bone. Thus, for example, a portion of the shaft of the humerus may need to be excised to remove a malignancy, while the ends of the humerus defining parts of the shoulder and elbow joint may be healthy. Similarly, it may be necessary to excise part of the shaft of the tibia or femur while the ends of these bones are healthy. Rather than remove the healthy ends of the bone, it may be desirable to leave the healthy portions of the bone in place and remove the damaged or diseased bone. In these circumstances, the empty span between the ends of the bone must be replaced with some type of mid-shaft prosthesis that spans the distance between the native bone ends. The mid-shaft prosthesis can include stems that fit into the intramedullary canals of the native bone ends and a body that extends between these stems. However, it may be difficult to implant such a mid-shaft prosthesis. Implantation can require that the native bone ends be distracted proximally and distally in order to fit the mid-shaft prosthesis into position. Since the native bone ends are surrounded by and connected to soft tissue, distraction of the native bone ends can damage the soft tissue and the connections between the soft tissue and the native bone ends.
Moreover, different bones undergo different types of stress in use. For example, the femur and tibia will tend to be subjected to compressive forces, while the humerus, radius and ulna will tend to be subjected to tension.
The present invention addresses the need for intercalary prosthetics that can be used to replace portions of the diaphyseal parts of the long bone that have been removed or excised. The present invention addresses this need while also addressing the need for such prosthetics that can be implanted and affixed to the remaining parts of the native bone while minimizing damage to soft tissue at the ends of the native bone.
In one aspect, the present invention provides an intercalary implant for use in replacing a missing portion of the shaft of a long bone, wherein the long bone includes native proximal and distal portions having intramedullary canals. The implant comprises a first stem member, a second stem member and a collar. The first stem member includes a stem portion to be received in the intramedullary canal of one of the native portions of the long bone and a threaded male portion to be positioned outside of the intramedullary canal. The second stem member includes a stem portion to be received in the intramedullary canal of the other of the native portions of the long bone. The second stem member further includes a spacer portion to be positioned outside of the intramedullary canal and a shoulder to be positioned outside of the intramedullary canal. The spacer portion is between the stem portion and the shoulder. The collar includes an annular base portion with an opening and a cylindrical portion open at one end. The cylindrical portion has a threaded interior surface to receive and mate with the threaded male portion of the first stem member. The collar receives part of the second stem member through the opening in the base portion of the collar, and the collar is movable in a proximal-distal direction along at least part of the length of the spacer portion of the second stem member between an extended position and a retracted position. In the extended position the annular base portion of the collar is spaced from the stem portion of the second stem member and abuts the shoulder of the second stem member and the cylindrical portion of the collar extends over and beyond the shoulder of the second stem member. In the retracted position the collar is positioned so that at least part of the shoulder is exposed. The shoulder and the opening of the annular base portion of the collar are sized and shaped so that when the collar is threaded onto the threaded male portion of the first stem member the position of the first stem member is fixed with respect to the position of the second stem member.
In another aspect, the present invention provides a surgical kit for use in treating a long bone of a patient wherein a portion of the shaft of the long bone is missing or resected and native proximal and distal portions of the long bone remain. The kit comprises a first stem member, a second stem member and a collar. The first stem member includes a stem portion and a threaded male portion. The second stem member has an overall axial dimension and includes a stem portion, a spacer portion having an axial dimension and a radial dimension, and a shoulder having an axial dimension and a radial dimension. The spacer portion is between the stem portion and the shoulder. The radial dimension of the shoulder is greater than the radial dimension of the spacer portion. The collar member includes an annular base portion with an opening and a cylindrical portion open at one end. The collar member has a threaded interior surface to receive and mate with the threaded male portion of the first stem member. The cylindrical portion has an interior radial dimension and an axial dimension. The annular base portion has a radial dimension and the opening of the annular base portion has a radial dimension. The radial dimension of the shoulder of the second stem member is greater than the radial dimension of the opening in the annular base portion of the collar. The interior radial dimension of the cylindrical portion of the collar is greater than the radial dimension of the spacer of the second stem member and the radial dimension of the shoulder of the second stem member. The axial dimension of the cylindrical portion of the collar is greater than the axial dimension of the shoulder of the second stem member.
In another aspect, the present invention provides a method of surgically replacing a missing part of the shaft of a long bone. The method comprises preparing the long bone so that proximal and distal portions of the long bone remain. The proximal and distal portions of the long bone each having an intramedullary canal. An intercalary implant is provided. The intercalary implant has a first stem member, a second stem member and a collar. The first stem member includes a stem portion and a male threaded portion. The second stem member includes a stem portion, a spacer and a shoulder. The collar includes a female threaded portion. The stem portion of one of the stem members is implanted in the intramedullary canal of the proximal portion of the long bone. The stem portion of the other of the stem members is implanted in the intramedullary canal of the distal portion of the long bone. The male portion of the first stem member is positioned against the shoulder of the second stem member without distracting the proximal and distal parts of the bone in the proximal-distal direction. The collar is threaded onto the threaded male portion of the second stem member without distracting the proximal and distal parts of the bone in the proximal-distal direction to assemble the intercalary implant.
In another aspect, the present invention provides, in combination, a proximal portion of a long bone, a distal portion of the long bone and an intercalary implant. The proximal portion has an intramedullary canal and a resected end surface. The distal portion has an intramedullary canal and a resected end surface. The two resected end surfaces are spaced from each other. The intercalary implant comprises a first stem member, a second stem member and a collar. The first stem member has a stem portion received in the intramedullary canal of one of the portions of the long bone. The second stem member has a stem portion received in the intramedullary canal of the other portion of the long bone. One of the stem members also has a male threaded member. The collar has a female threaded portion engaging the male threaded member. The other stem member has a spacer and a shoulder connected to its stem portion. At least a portion of the collar bears against a portion of the shoulder. The distance between the resected end surfaces of the bone portions is fixed by the intercalary implant.
Additional features of the present invention will become apparent to those skilled in the art upon consideration of the following detailed description of preferred embodiments exemplifying the best mode of carrying out the invention as presently perceived.
The mid-shaft prosthesis 18 illustrated in
As shown in
To avert the potential for soft tissue damage, the present invention obviates the need for proximal-distal distraction of the native bone ends 12, 14. In the present invention, first and second stem members 40, 42, shown in
The first and second stem members 40, 42 of the present invention can be connected by means of a collar 44, shown in
As shown in
A surgical kit utilizing the principles of the present invention could include several sizes and types of first stem members 40 with threaded male portions 50; for example, such stem members could be provided with stem portions of different lengths, some of which could have porous surfaces. Generally, at least a set of the first stem members 40 of the surgical kit would include threaded male portions 50 having similar characteristics such as size and thread characteristics, so that all of the first stem members 40 of the set would be interchangeable. Additional sets of first stem members with different sizes of male threaded portions could be included to accommodate different diameters of bone.
The first stem member 40 also includes a stop member 53 defining an enlarged diameter shoulder 54 at the junction of the stem portion 48 and the threaded male portion 50. The enlarged diameter shoulder 54 has a radial dimension shown at “r1” in
As shown in
As shown in
The axial dimension of the spacer portion, shown at “a2” in
A surgical kit utilizing the principles of the present invention could include several sizes and types of stem members with spacer portions 58 and shoulders 60; for example, such stem members could be provided with stem portions 56 of different lengths, some of which could have porous surfaces. As illustrated in
The radial dimension r2 of the shoulder 60 is greater than the radial dimension r3 of the spacer 58 of the second stem member 42. Although in the illustrated embodiment the shoulder 60 is annular in shape, other shapes may be used so long as the shoulder 60 serves as a stop to limit movement of the movable collar 44.
It should be understood that “radial dimension” as used throughout this specification and claims should not be interpreted as requiring any particular shape of any portion of the first and second stem members or collar; “radial dimension” should be interpreted as including a width of the relevant portion of the stem members.
An example of a suitable collar member 44 is illustrated in
The annular base portion 70 of the collar 44 has an overall radial dimension shown at “r4” in
The hollow cylindrical portion 72 of the collar 44 is threaded to mate with the threaded male portion 50 of the first stem member 40. The cylindrical portion 72 of the collar 44 is open opposite the base 70 to receive the threaded male portion 50 of the first stem member 40. The cylindrical portion 72 of the collar 44 has an interior radial dimension r7 (shown in
In the illustrated embodiment, the mating threaded parts, that is, the male threaded portion 50 of the first stem member 40 and the collar 44, have a locking threaded relationship. One way of producing such a locking threaded relationship is to form a wedge ramp in the threads of the female collar 44 using equipment available from Spiralock Corporation, a Detroit Tool Industries Company, of Madison Heights, Mich. A locking threaded relationship is valuable in limiting possible loosening of the threaded connection through vibration or use. It should be understood that use of a wedge ramp and use of Spiralock Corporation equipment are identified as examples only; the present invention is not limited to the use of locking threads or any particular types of locking threads unless expressly called for in the claims.
The collar 44 has an extended position and a retracted position on the second stem member 42. In the extended position shown in
The present invention also provides a method of replacing a missing part of the shaft of a long bone, such as part 64 of bone 10. The long bone 10 is prepared so that proximal and distal portions 12, 14 of the long bone remain. The distal end of the proximal portion 12 and proximal end of the distal portion 14 can be resected in a standard manner and cut or planed to define flat planar surfaces. The intramedullary canals 52 of the proximal and distal portions 12, 14 of the long bone 10 can be reamed in a standard manner to prepare the bone portions 12, 14 to receive the implant 46.
Suitable trials duplicating the span that will be provided by the intercalary implant 46 can be used prior to implantation to ensure that the length of the intercalary implant 46 will be appropriate.
One of the stem portions of one of the stem members is implanted in the intramedullary canal of the proximal portion of the bone and the stem portion of the other stem member is implanted in the intramedullary canal of the distal portion of the bone. In the embodiment illustrated in
It should be understood that the present invention could involve use of stem members 40, 42 with stem portions 56 designed to be cemented in place in the intramedullary canal or stem members with stem portions designed to be interference fit in the intramedullary canal. The surgical method used will include appropriate steps to accommodate the design selected for the particular patient.
When implanted, the shoulder 54, stop member 53 and male threaded portion 50 of the first stem member 40 are exposed beyond the end surface of the bone end; the remainder of the first stem member 40 is received in the bone end. When implanted, the spacer 58 and disc or stop member 62 of the second stem member 42 are exposed beyond the end surface of the bone end. The entire collar 44 is also exposed outside of the bone.
After the two stem portions 40, 42 have been implanted, assembly of the intercalary implant 46 may then be completed. As shown in
An assembly of the components 40, 42, 44 of the intercalary implant is illustrated in
It should be understood that the overall length of the part of the intercalary implant spanning the gap left in the bone shaft could also include a part of the male threaded portion 50 of the first stem member 40 if for some reason the collar 44 is not tightened until it abuts the shoulder 54 of the first stem member 40.
It should be understood that the above-described surgical technique is provided by way of example only, and that the present invention is not limited to that technique unless expressly called for in the claims.
An alternative intercalary prosthesis, kit and method is disclosed in an application for U.S. Patent filed concurrently herewith by Stephen A. Hazebrouck and entitled “Intercalary Prosthesis, Kit and Method,” which is incorporated by reference herein in its entirety.
While only specific embodiments of the invention have been described and shown, it is apparent that various alternatives and modifications can be made thereto. Those skilled in the art will also recognize that certain additions can be made to the illustrative embodiments. For example, a spacer element could also or alternatively be provided on the first stem member 40 between the threaded male portion 50 and the stem portion 48. It is, therefore, the intention in the appended claims to cover all such alternatives, modifications and additions as may fall within the true scope of the invention.
Number | Name | Date | Kind |
---|---|---|---|
4011602 | Rybicki | Mar 1977 | A |
4016874 | Maffei et al. | Apr 1977 | A |
4384373 | Sivash | May 1983 | A |
4467794 | Maffei et al. | Aug 1984 | A |
4502160 | Moore et al. | Mar 1985 | A |
4634444 | Noiles | Jan 1987 | A |
4655462 | Balsells | Apr 1987 | A |
4676797 | Anapliotis et al. | Jun 1987 | A |
4787907 | Carignan | Nov 1988 | A |
4826144 | Balsells | May 1989 | A |
4830344 | Balsells | May 1989 | A |
4876781 | Balsells | Oct 1989 | A |
4888021 | Forte | Dec 1989 | A |
4915366 | Balsells | Apr 1990 | A |
4934666 | Balsells | Jun 1990 | A |
4938768 | Wu | Jul 1990 | A |
5011496 | Forte | Apr 1991 | A |
5072070 | Balsells | Dec 1991 | A |
5079388 | Balsells | Jan 1992 | A |
5082390 | Balsells | Jan 1992 | A |
5100407 | Conrad | Mar 1992 | A |
5108078 | Balsells | Apr 1992 | A |
5117066 | Balsells | May 1992 | A |
5139276 | Balsells | Aug 1992 | A |
5314479 | Rockwood | May 1994 | A |
5334184 | Bimman | Aug 1994 | A |
5352227 | O'Hara | Oct 1994 | A |
5358524 | Richelsoph | Oct 1994 | A |
5411348 | Balsells | May 1995 | A |
6197065 | Martin et al. | Mar 2001 | B1 |
6290725 | Weiss | Sep 2001 | B1 |
6364909 | McGee | Apr 2002 | B1 |
6447549 | Taft | Sep 2002 | B1 |
6454810 | Lob | Sep 2002 | B1 |
6613092 | Kana et al. | Sep 2003 | B1 |
6712855 | Martin et al. | Mar 2004 | B1 |
6712858 | Grundei et al. | Mar 2004 | B1 |
20010041941 | Boyer, II et al. | Nov 2001 | A1 |
20030149486 | Huebner | Aug 2003 | A1 |
20030204262 | Ferguson | Oct 2003 | A1 |
Number | Date | Country |
---|---|---|
3535158 | Apr 1987 | DE |
3903438 | Aug 1990 | DE |
19633865 | Feb 1998 | DE |
19722389 | Dec 1998 | DE |
0 212 192 | Mar 1987 | EP |
1234557 | Aug 2002 | EP |
1358860 | Nov 2003 | EP |
2633509 | Jan 1990 | FR |
WO 0205732 | Jan 2002 | WO |
Number | Date | Country | |
---|---|---|---|
20040193267 A1 | Sep 2004 | US |