# Patent

## Title
Methods for connecting a longitudinal member to a bone portion

## Abstract

An apparatus (10) includes a fastener (16) engageable with a bone portion to connect a longitudinal member (12) to the bone portion. A housing (40) has a first passage (42) configured to receive the longitudinal member (12) and a second passage (44) extending transverse to the first passage. The fastener (16) extends through an opening (50) in the housing (40) into the second passage (44). A longitudinal axis (18) of the fastener (16) is positionable in any one of a plurality of angular positions relative to a longitudinal axis (46) of the second passage (44). A spacer (60) received in the second passage (44) of the housing (40) is engageable with the fastener (16) and the longitudinal member (12). A member (70) applies a force to prevent relative movement between the fastener (16) and the housing (40) and permit manual movement of the fastener (16) relative to the housing (40) against the force when the longitudinal member (12) is disengaged from the spacer (60). A clamping mechanism (90) clamps the longitudinal member (12), the spacer (60), and the housing (40) to the fastener (16) to prevent movement of the fastener relative to the housing.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation of U.S. application Ser. No. 10/075,668, filed Feb. 13, 2002 now U.S. Pat. No. 7,066,937, which is incorporated by reference in its entirety.


TECHNICAL FIELD
The present invention relates to an apparatus which is used to retain bone portions, such as vertebrae of a spinal column, in a desired spatial relationship.
BACKGROUND OF THE INVENTION
A known apparatus for retaining vertebrae of a spinal column in a desired spatial relationship is disclosed in U.S. Pat. No. 6,280,442. U.S. Pat. No. 6,280,442 discloses an apparatus including a longitudinal member extendable along the spinal column. A fastener engageable with a vertebra of the spinal column connects the longitudinal member to the vertebra. A housing has a first passage through which the longitudinal member extends and a second passage with a longitudinal axis extending transverse to the first passage. The fastener extends through an opening in the housing into the second passage. The longitudinal axis of the fastener is positionable in any one of a plurality of angular positions relative to the longitudinal axis of the second passage.
A spacer received in the housing is engageable with the fastener and the longitudinal member. A clamping member threadably engages the housing to clamp the longitudinal member, the spacer, and the housing to the fastener to prevent movement of the fastener relative to the housing. When the longitudinal member is disengaged from the spacer, the housing may not remain in position relative to the fastener until the longitudinal member is clamped to the spacer. Accordingly, the housing must be held in position relative to the fastener by a surgeon while the longitudinal member is clamped to the spacer.
SUMMARY OF THE INVENTION
The present invention is an apparatus which is used to retain bone portions in a desired spatial relationship. The apparatus includes a longitudinal member connectable with a bone portion. A fastener having a longitudinal axis is engageable with the bone portion to connect the longitudinal member to the bone portion. A housing has a first passage configured to receive the longitudinal member. The housing has a second passage with a longitudinal axis extending transverse to the first passage. The fastener extends through an opening in the housing into the second passage and is movable relative to the housing. The longitudinal axis of the fastener is positionable in any one of a plurality of angular positions relative to the longitudinal axis of the second passage.
A spacer received in the second passage of the housing is engageable with the fastener and the longitudinal member. A member applies a force to prevent relative movement between the fastener and the housing when the longitudinal member is disengaged from the spacer and the spacer engages the fastener. The fastener and the housing are manually movable relative to each other against the force when the longitudinal member is disengaged from the spacer and the member applies the force. A clamping mechanism clamps the longitudinal member, the spacer, and the housing to the fastener to prevent movement of the fastener relative to the housing. Accordingly, the housing and the fastener can be positioned relative to each other and the member will hold the fastener and the housing in the relative positions before the longitudinal member is connected to the housing.



BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and other features of the present invention will become apparent to one skilled in the art to which the present invention relates upon consideration of the following description of the invention with reference to the accompanying drawings, wherein:
FIG. 1 is a perspective view of an apparatus constructed in accordance with the present invention with portions removed for clarity;
FIG. 2 is a sectional view of the apparatus of FIG. 1;
FIG. 3 is a part sectional view of the apparatus of FIG. 1;
FIG. 4 is an enlarged sectional view of a portion of the apparatus of FIG. 1;
FIG. 5 is a plan view of a spring member of the apparatus of FIG. 1; and
FIG. 6 is a side view of the spring member.



DESCRIPTION OF THE INVENTION
The present invention is directed to an apparatus for retaining bone portions, such as vertebrae of a spinal column, in a desired spatial relationship. FIGS. 1-4 illustrate an apparatus 10 constructed according to the present invention. The apparatus 10 includes a surgically implantable longitudinal member or rod 12 for maintaining bone portions, such as vertebrae of a spinal column, in a desired spatial relationship. The member 12 is connected with vertebrae of the spinal column by fasteners 16.
The rod 12 is made of a suitable biocompatible material and has a length which is at least sufficient to enable the rod to span at least two vertebrae. Of course, the length of the rod 12 in any particular installation will depend upon the condition to be corrected and the number of vertebrae to be held in a desired spatial relationship relative to each other by the rod.
The rod 12 (FIGS. 1-3) is connected to a respective vertebra by the fastener 16 made of a suitable biocompatible material. The fastener 16 has a longitudinal axis 18 and a threaded end portion 22 having a course thread convolution 24 which engages the vertebra. A second end portion 26 of the fastener 16 is provided with a first part spherical surface 28. The second end portion 26 of the fastener 16 also includes a second part spherical surface 30 having a diameter less than a diameter of the first part spherical surface 28. A radially extending shoulder 31 extends between the part spherical surfaces 28 and 30. A recess 32 (FIG. 2) is provided on the end portion 26 of the fastener 16. The recess 32 receives a tool (not shown) that applies torque to the fastener 16 to turn the thread convolution 24 into the vertebra.
The fastener 16 (FIGS. 1-4) extends into a housing 40 that interconnects the rod 12 and the fastener 16. The housing 40 (FIG. 2) has a first passage 42 through which the rod 12 extends. The housing 40 has a second passage 44 with a longitudinal axis 46 that extends transverse to the first passage 42. The fastener 16 extends through an opening 50 in the housing 40 and into the second passage 44. The first part spherical surface 28 of the fastener 16 engages a concave part spherical surface 52 of the housing 40. Accordingly, the fastener 16 is universally pivotable relative to the housing 40 so that the longitudinal axis 18 of the fastener 16 is positionable in any one of a plurality of angular positions relative to the longitudinal axis 46 of the passage 44.
A spacer 60 is housed in the second passage 44 of the housing 40. The spacer 60 (FIGS. 2-4) has a concave part spherical surface 62 that engages the part spherical surface 30 of the fastener 16. The shoulder 31 on the fastener 16 is engageable with the spacer 60 to limit the relative movement between the fastener and the housing 40. The spacer 60 also has a concave part cylindrical surface 64 that engages the rod 12. The spacer 60 has an opening 66 through which the tool (not shown) extends to engage the recess 32 in the fastener 16. The tool extends through the opening 66 to apply torque to the fastener 16 and connect the fastener to the vertebra.
The spacer 60 (FIG. 4) has a circumferential groove 68 for receiving a compressible member such as a spring member 70. The groove 68 is defined by an axially extending cylindrical surface 71. An upper surface 72 extends radially outward from the cylindrical surface 71. A lower surface 74 extends radially outward from the cylindrical surface 71 and generally parallel to the upper surface 72.
The housing 40 includes a circumferential groove 76 for receiving the spring member 70 so that the spring member extends from the groove 68 in the spacer 60 to the groove in the housing. The groove 76 is defined by an axially extending cylindrical surface 78. An upper surface 80 extends radially inward from the cylindrical surface 78. A lower surface 82 extends radially inward from the cylindrical surface 78 and generally parallel to the upper surface 80.
The spring member 70 (FIGS. 5 and 6) is a ring having a gap 82. The gap 82 permits the spring member 70 to radially contract and expand. The spring member 70 has an arched shape, as viewed in FIG. 6, when the spring member 70 is disengaged from the spacer 60 and the housing 40. When the spring member 70 is received in the grooves 68 and 76 (FIG. 4), the spring member engages the lower surface 74 on the spacer 60 and the upper surface 80 on the housing 40.
The spring member 70 applies an axial force to the spacer 60 to prevent relative movement between the fastener 16 and the housing 40 when the rod 12 is disengaged from the spacer and the spacer engages the fastener. The spring member 70 urges the spacer 60 axially toward the fastener 16 and the part spherical surface 52 of the housing 40 against the part spherical surface 28 of the fastener. The part spherical surface 62 of the spacer 60 frictionally engages the part spherical surface 30 of the fastener 16 and the part spherical surface 28 of the fastener frictionally engages the part spherical surface 52 of the housing 40. The fastener 16 and the housing 40 are manually movable relative to each other by a surgeon when the rod 12 is disengaged from the spacer 60 and the spring member 70 applies the axial force. The force applied by the spring member 70 may be overcome by the surgeon to move the housing 40 relative to the fastener 16. Accordingly, the housing 40 can be positioned relative to the fastener 16 and held in position relative to the fastener by the spring member 70 without the rod 12 engaging the spacer 60. It is contemplated that any compressible member could be used to apply the force to the fastener 16 to prevent relative movement between the fastener and the housing 40 when the rod 12 is disengaged from the spacer 60.
The spacer 60 has four axially extending slots 86, one of which is shown in FIG. 1. The slots 86 intersect the groove 68. A tool (not shown) has four prongs that extend through the slots 86 and into engagement with the spring member 70. The tool grasps the spacer 60 and the spring member 70 for inserting the spacer and the spring member into the housing 40. The prongs of the tool engage the spring member 70 to radially contract the spring member into the groove 68 in the spacer 60. The prongs hold the spring member 70 in the radially contracted condition in the groove 68 while the spacer 60 and spring member are being inserted into the housing 40. Once the spacer 60 engages the fastener 16, the prongs are removed from the slots 86 and the spring member 70 radially expands into the groove 71 in the housing 40. Although the spacer 60 is described as having four slots 86, the spacer could have any number of slots and the tool would have the same number of prongs as the spacer has slots.
A clamping mechanism or set screw 90 (FIGS. 1-4) threadably engages the housing 40. The set screw 90 and the housing 40 have a German standard DIN513 buttress thread. It is contemplated that the set screw 90 and the housing 40 could have any desired thread formation. The set screw 90 engages and applies a force to the rod 12 to press the rod against the spacer 60 and the spacer against the fastener 16. The set screw 90 clamps the rod 12, the spacer 60, and the housing 40 to the fastener 16 to prevent movement of the fastener relative to the housing. The force applied by the set screw 90 cannot be overcome by the surgeon to move the housing 40 relative to the fastener 16.
The apparatus 10 is assembled by inserting the fastener 16 through the opening 50 in the housing 40 so that the part spherical surface 28 of the fastener engages the part spherical surface 52 of the housing. The spacer 60 and the spring member 70 are inserted into the housing 40 by radially compressing the spring member into the groove 68 in the spacer. The spacer 60 and the spring member 70 are inserted into the second passage 44 until the part spherical surface 62 of the spacer engages the part spherical surface 30 of the fastener 16. The spring member 70 is released and expands radially into the groove 76 in the housing 40.
A tool is inserted through the opening 66 in the spacer 60 and into the recess 32 in the fastener 16. Torque is applied to the fastener 16 to turn the thread convolution 24 into the vertebra. Once the fastener 16 is connected with the vertebra, the housing 40 can be positioned relative to the fastener. The spring member 70 maintains the position of the housing 40 relative to the fastener 16 while the rod 12 is disengaged from the spacer 60. Once the housing 40 is positioned relative to the fastener 16, the rod 12 is placed into the passage 42 and in engagement with the spacer 60. The set screw 90 is threaded into the housing 40 and into engagement with the rod 12. The set screw 90 clamps the rod 12, the spacer 60, and the housing 40 to the fastener 16 to prevent movement of the fastener relative to the housing. Alternatively, the fastener 16 may be connected to the vertebra prior to the spacer 60 and the spring member 70 being inserted into the housing 40.
From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes and modifications within the skill of the art are intended to be covered by the appended claims.

## Claims

1. A method of producing an apparatus for retaining bone portions in a desired spatial relationship, comprising:
providing a fastener having a longitudinal axis, a first threaded end portion engageable with a bone portion and a second end portion;
providing a housing having a first passage configured to receive a longitudinal member and a second passage for receiving the fastener, the second passage having a longitudinal axis extending transverse to the first passage, the second passage having an indentation comprising an axially extending surface and an upper surface extending transverse to the axially extending surface;
extending the fastener through an opening in the housing into the second passage so that the fastener is pivotable relative to the housing and the longitudinal axis of the fastener is positionable in any one of a plurality of angular positions relative to the longitudinal axis of the second passage; and
inserting a spacer and spring member arrangement into the second passage of the housing such that a radial surface of the spacer is positioned below the upper surface of the indentation and the spring member contacts the upper surface of the indentation and the radial surface of the spacer, thereby limiting relative movement between the fastener and the housing by creating a frictional engagement that holds the position of the housing relative to the fastener when the longitudinal member is not received in the first passage of the housing.

2. The method of claim 1, wherein the first passage and second passage intersect.

3. The method of claim 1, wherein the frictional engagement is created between the second end portion of the fastener and an inner surface of the housing.

4. The method of claim 1, wherein after the fastener, spacer, and spring members are inserted into the housing, the method further comprises manually moving the fastener and housing relative to each other, maintaining the position of the fastener and housing relative to each other, and then inserting the longitudinal member.

5. A method of producing an apparatus for retaining bone portions in a desired spatial relationship, comprising:
providing a fastener having a longitudinal axis, a first threaded end portion engageable with a bone portion and a second end portion;
providing a housing having a first passage capable of receiving a longitudinal member and a second passage, the second passage having a longitudinal axis extending transverse to the first passage, the housing having an indentation in the second passage, the indentation having an upper surface;
extending the fastener through an opening in the housing into the second passage so that the second end portion of the fastener engages an inner surface of the housing and the fastener is pivotable relative to the housing so that the longitudinal axis of the fastener is positionable in any one of a plurality of angular positions relative to the longitudinal axis of the second passage; and
inserting a spacer and member into the housing, the spacer having a groove configured to receive the member, the spacer configured to engage the longitudinal member, wherein inserting the spacer and member includes positioning the member such that it contacts the upper surface of the indentation in the housing and a lower surface of the groove in the spacer, thereby applying an axial force toward the fastener to create a frictional engagement between the second end portion of the fastener and the inner surface of the housing;
wherein the frictional engagement holds the position of the housing relative to the fastener when the longitudinal member is disengaged from the spacer, and the fastener and the housing are manually moveable relative to each other when the longitudinal member is disengaged from the spacer and the spacer applies the axial force.

6. The method of claim 5, wherein the second end portion of the fastener comprises a part spherical surface.

7. The method of claim 6, wherein the part spherical surface of the fastener engages a concave part spherical surface of the housing.

8. The method of claim 5, wherein the spacer engages the fastener.

9. The method of claim 8, wherein the member is a spring member and the inserting step includes compressing the spring member to urge the spacer axially toward the fastener to prevent relative movement between the fastener and the housing when the longitudinal member is disengaged from the spacer and the spacer engages the fastener.

10. The method of claim 8, wherein the spacer has a concave part spherical surface that engages a part spherical surface of the fastener.

11. The method of claim 5, further comprising providing a cap screw, the cap screw configured to threadably engage the housing and apply a force to a longitudinal member positioned in the first passage of the housing to press the longitudinal member against the spacer.

12. A method of producing an apparatus for retaining bone portions in a desired spatial relationship, comprising:
providing a fastener having a longitudinal axis, a first threaded end portion engageable with a bone portion and a second end portion;
providing a housing having a first passage capable of receiving a longitudinal member and a second passage for receiving the fastener, the second passage having a longitudinal axis, the housing having a proximal end, a distal opening, and a circumferential groove, inserting the fastener through the second passage and the distal opening in the housing so that the second end portion of the fastener is received within the housing and is pivotable relative to the housing and the longitudinal axis of the fastener is positionable in any one of a plurality of angular positions relative to the longitudinal axis of the second passage;
providing a frictional engagement assembly, a first portion of the frictional engagement assembly configured to engage the second end portion of the fastener and a second portion of the frictional engagement assembly configured to engage the circumferential groove in the housing, wherein engagement of the second portion of the frictional engagement assembly with the groove maintains the axial position of the fastener and the frictional engagement assembly within the housing;
connecting the fastener that has been received through the distal opening of the housing to a vertebra, wherein the frictional engagement assembly holds the position of the housing relative to the fastener prior to the longitudinal member being received in the first passage of the housing;
positioning the longitudinal member in the first passage of the housing; and
threadably engaging a set screw in the housing, the set screw engaging and applying a force to the longitudinal member.

13. The method of claim 12, wherein frictional engagement is created between the second end portion of the fastener and an inner surface of the housing.

14. The method of claim 13, wherein the frictional engagement assembly includes a spacer positioned within the second passage, and the longitudinal member engages the spacer.

15. The method of claim 14, wherein the frictional engagement assembly further includes a spring member that is received in the groove and urges the spacer axially toward the fastener and the inner surface of the housing against the second end portion of the fastener.

16. The method of claim 12, wherein the first passage is transverse to and intersects the second passage.

17. The method of claim 12, wherein the second end portion of the fastener is part spherical, and the part spherical end portion of the fastener engages a concave inner surface of the housing.