SYSTEMS AND METHODS FOR USING A FEMORAL ARRAY CLAMP
20240358411 ยท 2024-10-31
Assignee
- Smith & Nephew, Inc. (Memphis, TN, US)
- SMITH & NEPHEW ORTHOPAEDICS AG (Zug, CH)
- SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED (Singapore, SG)
Inventors
Cpc classification
A61B17/6466
HUMAN NECESSITIES
A61B34/20
HUMAN NECESSITIES
International classification
A61B17/64
HUMAN NECESSITIES
A61B34/20
HUMAN NECESSITIES
Abstract
Systems and methods for using a femoral array clamp can include sliding a first throughbore of a first femoral array clamp on a first bone pin having a distal end disposed within a bone: inserting an array arm through a second throughbore of the first femoral array clamp; and locking a physical relationship between the first bone pin and the array arm by actuating a first fastener of the first femoral array clamp.
Claims
1. A method for using a femoral array clamp, the method comprising the steps of: (a) providing a first femoral array clamp with a second throughbore having an array arm slidably mounted in the second throughbore; (b) sliding a first throughbore of a first femoral array clamp around a first bone pin having a distal end disposed within a bone; and (c) locking a physical relationship between the first bone pin and the array arm by actuating a first fastener of the first femoral array clamp.
2. The method of claim 1, wherein the step of locking the physical relationship further comprises engaging a swage assembly that is coupled to the array arm, and the swage assembly is disposed in the second throughbore.
3. The method of claim 2, wherein the engaging the swage assembly further comprises clamping the swage assembly between the first bone pin and an inner surface of the second throughbore.
4. (canceled)
5. The method of claim 4, wherein (a) the swage assembly comprises: (i) a first swage member having an outer portion and an inner portion; and (ii) a second swage member having an outer surface and an inner portion; and the engaging the swage assembly further comprises (b) (i) engaging the bone pin against the outer portion of the first swage member; and (ii) engaging the outer portion of the second swage member against an inner surface of the second throughbore.
6. The method of claim 1 wherein, after inserting the array arm and before locking, the method further comprises adjusting an angle between a longitudinal central axis of the array arm and an axis of the first bone pin, wherein the angle is adjustable with at least two degrees of freedom.
7. The method of claim 1, further comprising the steps of: (a) sliding a first throughbore of a second femoral array clamp around a second bone pin having a distal end disposed within the bone; (b) inserting the array arm through a second throughbore of the second femoral array clamp; and (c) locking a physical relationship between the second bone pin and the array arm by actuating a second fastener of the second femoral array clamp.
8. The method of claim 7 further comprising, prior to locking the physical relationships, adjusting a distance between the first femoral array clamp and the second femoral array clamp along the array arm.
9. A femoral array clamp, comprising: a housing; a pin channel extends through the housing and has a pin channel axis; a throughbore extends through the housing; a passageway couples the pin channel and the throughbore, and the passageway has a passageway axis; a counterbore extends in the housing and has a counterbore axis, wherein the counterbore intersects the pin channel a fastener disposed in the counterbore; and a swage assembly disposed in the throughbore, a portion of the swage assembly protrudes through the passageway into the pin channel.
10. The femoral array clamp of claim 9, further comprising: a bone pin disposed in the pin channel, wherein the bone pin defines a bone pin axis, the femoral array clamp comprises a relaxed configuration in which the housing is capable of translating along the bone pin axis and the swage assembly is capable of rotating within the throughbore; and the femoral array clamp comprises a locked configuration in which the fastener engages the bone pin against the swage assembly to prevent translation of the housing along the bone pin and prevent rotation of the swage assembly in the throughbore.
11. The femoral array clamp of claim 9, wherein the counterbore axis and the passageway axis are offset from each other where they intersect the pin channel.
12. The femoral array clamp of claim 9, wherein the pin channel axis is perpendicular to the counterbore axis.
13. The femoral array clamp of claim 9, wherein the pin channel axis is perpendicular to the passageway axis.
14. The femoral array clamp of claim 13, wherein the pin channel axis is perpendicular to the counterbore axis.
15. The femoral array clamp of claim 9, wherein the throughbore comprises an inner surface having a semi-spherical shape.
16. The femoral array clamp of claim 9, wherein the counterbore comprises internal threads, the fastener is a set screw that engages the internal threads, and the counterbore axis is parallel to the passageway axis.
17. The femoral array clamp of claim 9, wherein the swage assembly comprises: a first swage member having a semi-spherical outer surface and an inner surface, and a second swage member having a semi-spherical outer surface and an inner surface.
18. The femoral array clamp of claim 17, wherein: the semi-spherical outer surface of the first swage member is operatively positioned within the throughbore to receive a force, the force stabilizes the first swage member, the force stabilizes the second swage member, and the second swage member receives a reciprocal force.
19. A system for surgical repair of a femur, the system comprising: a femoral array clamp comprising a housing; a pin channel extends through the housing and comprises a pin channel axis; a throughbore extends through the housing; a passageway extends between the pin channel and the throughbore, and the passageway has a passageway axis; a counterbore in the housing with a counterbore axis, wherein the counterbore intersects the pin channel and the counterbore axis is parallel to the passageway axis; a fastener disposed in the counterbore; and a swage assembly in the throughbore, wherein a portion of the swage assembly protrudes through the passageway into the pin channel; a bone pin configured to be located in the pin channel; and an array is configured to traverse the throughbore.
20. The system of claim 19, wherein the swage assembly comprises a first swage member with a semi-spherical outer surface and an inner surface, and a second swage member with a semi-spherical outer surface and an inner surface.
21. The femoral array clamp of claim 20, wherein: the semi-spherical outer surface of the first swage member is operatively positioned in the throughbore to receive a force, the force stabilizes the first swage member, the force stabilizes the second swage member, and the second swage member receives a reciprocal force.
22. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] For a detailed description of the various embodiments, reference will now be made to the accompanying drawings.
[0007]
[0008]
[0009]
[0010]
[0011]
[0012]
[0013]
[0014]
[0015]
[0016]
[0017]
[0018]
DEFINITIONS
[0019] Various terms are used to refer to particular system components. Different companies may refer to a component by different namesthis document does not intend to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms including and comprising are used in an open-ended fashion, and thus should be interpreted to mean including, but not limited to . . .
[0020] The term couple or couples is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other devices and connections.
[0021] Throughbore shall mean an aperture or passageway through an underlying device. However, the term throughbore shall not be read to imply any method of creation. Thus, a throughbore may be created in any suitable way, such as drilling, boring, laser drilling, or casting.
[0022] Counterbore shall mean an aperture or passageway into an underlying device. In cases in which the counter bore intersects another aperture (e.g., a throughbore), the counter bore may thus define an internal shoulder. However, the term counterbore shall not be read to imply any method of creation. A counterbore may be created in any suitable way, such as drilling, boring, laser drilling, or casting.
DETAILED DESCRIPTION
[0023] The following discussion is directed to various embodiments of the invention. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.
[0024]
[0025] Embodiments of the system 500 can include a clamp assembly having one or more clamps 100 (e.g., a femoral array clamp) that can be rigidly attached to bone pins 102 to support and lock a fiducial or tracking array for navigation with minimal impact on the many varied surgical workflows. The clamp assembly of system 500 can provide a rigid bridge between the bone pins 102 and the tracking array.
[0026] In an example, the system 500 can enable a surgeon to determine the location of bone pins 102 without having a preset configuration or location of the bone pins 102 relative to the array arm 104. In some cases a single clamp 100 may be used in the system 500. In other cases, and as shown in
[0027]
[0028] Some example clamps and related systems are designed and constructed such that, once the correct orientation between the clamp, the pin, and the array is achieved, that orientation can be fixed by way of the completion of one operation (e.g., tightening a single screw or inserting a single pin on each clamp).
[0029] As shown in
[0030] Embodiments of the clamp 100 can include component pieces that may fit with and within the clamp 100. For example, the clamp 100 may include a housing or clamp body with channels that can be operatively coupled. In some versions, the clamp 100 may include pin channel 101 that extends through the clamp 100 in a z-axis direction (
[0031] Furthermore, the clamp 100 may include an array throughbore 103 (
[0032] Moreover, the clamp 100 may include a third opening such as throughbore 105. The throughbore 105 may include threads on an interior thereof. The threads can be complementary to and interact with an example fastener 106. The fastener 106 may be disposed within throughbore 105.
[0033] In the example shown, the array arm 104 can have a hexagonal cross-sectional shape. The cross-section is taken perpendicular to a longitudinal central axis of the array arm 104. Other cross-sectional shapes may be used. For example, the array arm 104 may have a round cross-sectional shape and still be capable of being locked in a physical relationship with bone pins 102. Further, the array arm 104 may be composed of a variety of high modulus materials. For example, the array arm 104 may be composed of metals, carbon fiber, reinforced plastic, etc.
[0034] Embodiments of the pin channel 101 can have a respective bone pin 102 that can extend substantially perpendicular to the array throughbore 103 containing array arm 104. Further, throughbore 105 within which the fastener 106 can reside can be substantially perpendicular to both pin channel 101 and array throughbore 103.
[0035]
[0036] In addition, the clamp 100 may include an overlap or a passageway (
[0037] The passageway may include passageway axis (see vertical arrows on left side of
[0038]
[0039] The array arm 104, in turn, can push against the inner surface of the second swage member 107B. The outer surface of the second swage member 107B may then push against the inner surface of the array throughbore 103 and thereby complete the locking chain. Further, the array throughbore 103 may push back against the array arm 104 via reacting, normal forces. Such reacting, normal forces point radially inward relative to the array throughbore 103. As a result of these reacting, normal forces, the array arm 104 may push back against the inner surface of first swage member 107A via a second reacting, normal force. As a result of this second reacting, normal force, the outer surface of the first swage member 107A can push back against bone pin 102. These forces, acting together, lock the bone pin 102 and the array arm 104 securely into place. The separate and distinct swage members 107A and 107B have gaps between them to enable slight relative movement therebetween, thus directing the locking force through the array arm 104.
[0040] The swage members 107A and 107B may be designed and constructed such that they may be initially loosely assembled and/or installed in array throughbore 103 for greater range of motion, and then held in place by way of the array arm 104 inserted therethrough until they are ready to be locked in place.
[0041] Embodiments of the clamp 100 can enable the bone pin 102 to be oriented in a manner such that an axis of bone pin 102 is not parallel with that of the bone pin channel 101. Specifically,
[0042] In some embodiments, the longitudinal central axis of the pin channel 101 can be parallel to the z axis (
[0043]
[0044] The system 500 enables the surgeon to determine the location of bone pins 102 without having preset configurations or locations for the bone pins 102 relative to the array arm 104. While in some cases a single femoral array clamp 100 may be used, in other cases two or more clamps 100 can be used. In an instance where more than one clamp 100 is used, a method for using the clamps 100 can include sliding the pin channels 101 of the clamps 100 over the bone pins 102 that are installed within the underlying bone; and, optionally, inserting the array arm 104 through the array throughbores 103 of the clamps 100 (this step may be pre-established or pre-assembled, prior to surgery, in some embodiments); and locking a physical relationship between the bone pins 102 and the array arm 104 by actuating fasteners 106 in the clamps 100.
[0045] In some examples, bone pins 102 within the system 500 may be tapered (e.g., tapered outwards) from the threaded portion of bone pin 102 threaded portion on distal end 108. This tapering outwards can increase the stiffness of bone pin 102. The distal ends 108 of bone pins 102 may be disposed within the bone (
[0046] In these examples, the first swage member 107A may include a feature that can operably mate with a respective bone pin 102 to further lock the components of femoral array clamp 100. In some examples, first swage member 107A and second swage member 107B may each define a semi-spherical or hemispherical outer surface. In such examples, first swage member 107A and second swage member 107B may still be used concurrently within the femoral array clamp 100.
[0047] In certain configurations of system 500, the system may further include frictional components within the pin channel 101. The frictional components may add friction to restrict the motion of bone pin 102 while it is disposed within pin channel 101. Examples of frictional components include an O-ring, a ball plunger, a spring loaded device, packing, a mechanical gasket, or combinations thereof. Similarly, frictional components can be included between the array arm 104 and the array throughbore 103, and/or between the array arm 104 and one or both swage members 107A, 107B to reduce any extraneous free play or movement of the femoral array clamp 100 when the user is engaging the bone pins 102.
[0048] In certain configurations of system 500, the system may further include a stabilizer to hold fastener 106 in place within counterbore 105. In some examples, counterbore 105 may include threads on an inner diameter. From this, fastener 106 may interlock with the threads upon rotation of fastener 106. In certain examples, fastener 106 may be a set screw.
[0049]
[0050] In some examples, the first clamp 601 may be linearly situated at one portion of the array and the second clamp 602 may be situated at another portion of the array.
[0051] Since surgeons have wide variations in their practices for placing and situating bone pins, the flexibility of the various degrees of freedom in the system can present a benefit for those in the profession. For example, with the possible different positions illustrated, medical professionals may be cognizant and proactive about concerns such as soft tissue damage, bone fracture, workflow interference, and combinations of the like. This design allows surgeons and other medical professionals to variably install the bone pins in positions along three-dimensional axes based upon their preferred techniques. In some embodiments, a tubular spacer or separator 130 (
[0052]
[0053] Embodiments of femoral bone clamp 700 can include a wedge 701 in a pin housing 702. In some examples, wedge 701 may move along a wedge axis 703 (
[0054] In some examples, the pairs of intersecting pin channels 705 can allow the femoral bone clamp 700 to be fitted with bone pins that are parallel or skewed in various ways.
[0055] In some examples, moving a fastener 806 (
[0056] Wedge 701 can include a counterbore 805 for fastener 806. Fastener 806 can apply force against movable wedge 701 to lock wedge 701 in a physical relationship within femoral array clamp 700. In the locked position, wedge 701 reduces the amount of clearance space through the pin channels 808. In doing so, wedge 701 applies force to the bone pins located in respective ones of the pin channels 808.
[0057]
[0058]
[0059] In the embodiment of
[0060] In addition to the clamp 700, system 1000 (
[0061] In some examples of system 1000, the pin channels can be non-round in shape and/or larger than standard-size bone pins to accommodate various brands, types, and styles of bone pins.
[0062] In other examples of system 1000, the bone pins within clamp 700 may be in a locked position that is perpendicular to C-bracket array 1001. In certain examples, the C-arm array 1001 can be non-planar, such as the curved C shape that is shown.
[0063]
[0064] Example method 1100 can then include inserting an array arm through a second throughbore of the first femoral array clamp (step 1104). During this step 1104, a portion of an array may be rotated into its vertical position. The example method 1100 also can include locking a physical relationship between the first bone pin and the array arm by actuating a first fastener of the first femoral array clamp (step 1106). In this locking step 1106, the position of the external array can be locked with respect to the femoral array clamp.
[0065]
[0066] The disclosed embodiments have an advantage since the largest bone mass on the femur near the surgical site is the greater trochanter region. Placing bone pins in the greater trochanter allows the bone pins to be introduced with low precision and with minimal fear of iatrogenic damage. The greater trochanter is also close to the skin surface which reduces soft tissue damage, reduces pin deflection, and provides ease of imaging for hip surgery.
[0067] Various examples are directed to methods and systems for using a femoral array clamp. In particular, various examples are directed to using a femoral array clamp by sliding a first throughbore of a first femoral array clamp around a first bone pin having a distal end disposed within a bone, inserting an array arm through a second throughbore of the first femoral array clamp, and locking a physical relationship between the first bone pin and the array arm by actuating a first fastener of the first femoral array clamp. The locking of the physical relationship may include compressing a swage assembly. The swage assembly may surround the array arm, and the swage assembly may be disposed within the second throughbore. In other examples, the swage assembly may include a first swage member defining a hemispherical outer surface and an inner surface, and a second swage member defining a hemispherical outer surface and an inner surface. In such an example, the compressing of the swage assembly may further include pressing the bone pin against the hemispherical outer surface of the first swage member, the pressing by the first fastener. The compressing of the swage assembly may further include pressing the hemispherical outer surface of the second swage member against an inside surface of the second throughbore, the pressing by force provided from the first fastener.
[0068] Prior to inserting the pins into the bone, it is beneficial to orient the pins with respect to the bone and array to reflect the orientation that the pins will have upon being inserted into the bone. Such oriented inserting of the bone pins and holding the array in place is especially beneficial in computer-assisted procedures.
[0069] The above discussion is meant to be illustrative of the principles and various embodiments of the present invention. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.