WO2007073537A1

WO2007073537A1 - Vertebral implant inserter and method of use

Info

Publication number: WO2007073537A1
Application number: PCT/US2006/061919
Authority: WO
Inventors: John S. Young; Eric S. Heinz
Original assignee: Warsaw Orthopedic, Inc.
Priority date: 2005-12-20
Filing date: 2006-12-12
Publication date: 2007-06-28
Also published as: US20070161989A1; US20100131020A1; US7678114B2

Abstract

A surgical installation tool (10, 120, 220, 30) to insert a vertebral implant, into a patient hi eludes an elongated handle (12) and a head (20) attached to one end. The vertebral implant may be attached to the head. The head, may- include an engagement member (22, 122, 222) that is movable between engaged, and released positions. The engagement member may be outwardly biased so that it naturally rests in the released position. The engagement member may be inwardly movable from the released position to the engaged position- A reactive force caused by the inward deflection may supply the attachment force between the installation tool and the vertebral implant. The attachment between the vertebral implant to the installation tool may be maintained while the engagement member is in the engaged position.

Description

VERTEBRAL JMFLANT INSERTER AND METHOD OF USE

Background

Vertebra! implants such as spinal books are sometimes used in spinal implant systems for the treatment of spinal deformities and fractures. Conditions for which spinal implants may be indicated include degenerative disc diseases vertebral fractures, scoliosis, or other conditions that cause instability of the spine. One type of spinal implant comprises hooks and/or pedicle screws attached to rods on one or each lateral side of the vertebrae. As surgical techniques advance, minimally intrusive procedures requiring smaller incisions are more commonly used lo attach spinal implants such as these. As such, the surgical insertion tools that are used to hold and insert the implant components are a part of this improving trend

Many conventional insertion tools grasp the spinal implant components about the exterior of the component. Fuπϊier, some conventional insertion tools may not provide an optimal angle of approach for inserting the component, particularly with small surgical incisions. Accordingly, improvements in surgical insertion tools may help advance the trend towards less intrusive surgical procedures.

Summary

Embodiments of a surgical installation tool are disclosed. The installation tool may be used to insert a vertebral implant into a patient, "The vertebral implant may be attached to one end of the installation tool. The attachment end of the installation tool may include an engagement member that is movable between engaged and released positions. The engagement member may be outwardly biased so that It naturally rests in the released position. The engagement member may be inwardly movable from the released position to the engaged position. A reactive force caused by the inward deflection may supply the attachment force between the installation tool and the vertebral implant. The attachment between the vertebral implant to the installation tool may be maintained while the engagement member is in the engaged position. Brief Description of the Drawings

Figure 1 is a perspective view of an insertion, tool hoidi.πg an implant device according to one embodiment;

Figure 2 is an exploded assembly view of an insertion tool and an Implant device according to one embodiment;

Figures 3 A-3B are side views of an insertion tool holding an imp! gut device according to one embodiment;

Figure_* 4 is a frontal view of a retainer of an insertion tool according to one embodiment; Figure 5 is a fop view of a retainer of an insertion tool according to one embodiment;

Figure 6 is an exploded assembly view of an insertion tool according to one embodiment;

Figure 7 is a perspective view of an insertion tool according to one embodiment; Figure 8 is a top view of a retainer of an insertion tool according to one embodiment; Figure 9 is a top view of a retainer of an insertion tool and an attached implant device according to one embodiment;

Figure 10 is a top view of a retainer of an insertion too! according to one embodiment; Figure 11 is a top view of a retainer of an insertion tool and an attached implant device according to one embodiment;

Figure 12 is a top view of a retainer of an insertion tool according to one embodiment; and Figure 13 is a top view of a retainer of an insertion tool and an attached implant device according to one embodiment.

Detailed Description

The various embodiments disclosed herein are directed to a low profile surgical implant insertion tool. An exemplary embodiment of the insertion tool 10 is illustrated in Figure 1. In this particular embodiment, the insertion tool 10 is illustrated holding a hook implant 50, The hook 50 may be a conventional distraction hook or other hook implant such as that belonging to the CD HORIZON® LEGACY™ Spinal System available from Medtronic Sofamor Danek in Memphis, Tennessee. Various types of hooks may be held and positioned using the insertion tool 1O₅ including for example pedicle hooks, sup.ralami.oar hooks, mfraiammar hooks, and transverse process hooks. In Figure 1, the hook 50 is held by the exemplary insertion tool 10, in contrast. Figure 2 shows the hook 50 separated from the insertion tool. 10. The insertion tool 10 includes an elongated bar 12 having a head or retainer 20 disposed at an end of the elongated bar 12. The insertion tool 10 may be manipulated during surgery by maneuvering the elongated bar 12 to place the hook 50 in a desired position relative to a vertebral, member (not shown). The retainer 20 is configured to hold the hook 50 In a releasabie manner. Thus, once the hook 50 is positioned, the insertion tool 10 may be extracted, leaving the hook 50 substantially in the desired position.

The retainer 20 is shaped to fill much of the saddle portion 52 of the hook 50. In the embodiment shown, the saddle portion 52 comprises spaced apart side walls 54 having a substantially U-shaped open channel therebetween. It. is between these side walls 54 that a. spinal rod 60 of a spinal, implant system is inserted, In the illustrated embodiment of a hook 50, the side walls 54 include a threaded central portion 56 into which a retaining member 70 is inserted to secure the rod 60 within the saddle portion 52 of the hook 50. The retainer 20 has a generally U-shaped configuration, which permits insertion of the retainer 20 into the saddle portion 52 of the hook 50. The retainer 20 further comprises a plurality of biasing members 22. In this embodiment, the biasing members 22 are configured as canttlevered leaf springs and operate as engagement elements that contact the hook 50. Furthermore, in the embodiment shown, the retainer 20 has four biasing members 22, though, a different number may be used. The insertion tool 1.0 is configured such that, when the retainer 20 is inserted into the saddle 52 of the hook 50 as shown in Figure 1, the biasing members 22 frictionaiiy engage inner faces 58 of the side wails 54 on either side of the threaded portion 56, The biasing force applied by the biasing members 22 against the inner side walls 58 of the hook 50 is sufficient to support the weight of the hook 50. However, as suggested above, the retainer 20 and the biasing members 22 hold the hook 50 in a re-leasable manner. Thus, the biasing members 22 should not create so large a retaining force that the insertion too! 10 cannot be extracted frαrø the hook 50 as needed.

The exemplary insertion tool 10 also includes an enlarged flange 14 adjacent to the retainer 20. The flange 1.4 serves to limit the depth to which the hook 50 may be inserted onto the retainer 20. In addition, the flange 14 permits the application of axi insertion force in the direction indicated by the letter F in Figure 1. For instance, it may be necessary to apply an insertion force m the direction of arrow F during surgical installation of the hook 50. However, ooce the hook 50 is positioned as desired, the arrangement σf the retainer 20 and flange 14 allow the .insertion tool 10 to be removed in the directions indicated by arrow A. or arrow P or some vector combination thereof. These arrows F, A, and P are shown relative to an X-Y-Z coordinate system. Note also that the direction of deflection of the biasing members 22 caused by installation of the hook 50 onto the retainer 20 in one or more embodiments may be substantially aligned with the Y-coordinate, Figure 3 A shows arrows A and P relative to the same X-Y-Z coordinate system and to the entire insertion tool 10 and hook 50. Notably, the elongated bar 12 is substantially aligned with the direction of removal along arrow P. This direction P is towards the open part of the U-shaped channel m the saddle 52 {see Figure 2). This direction I? is also substantially perpendicular to the rod 60 that lies within the U-shaped channel in saddle 52, The ability to remove the insertion tool in this direction may help preserve the desire to maintain small surgical incisions and may also prevent interference with vertebrae or other anatomy (not shown}- Furthermore, since the retainer 20 fits substantially within the interior of the saddle 52, the extent to which the insertion, tool. 10 is a limiting factor in guiding and placing the hook 50 in a desired position may be minimized. Also, the size of the insertion tool 10 in the direction of arrow A may be minimized by adjusting the size of the bend .16 in the elongated bar 12 and die distance between the bend 16 and the distal end at which the hook 50 is attached.

As described above and shown in Figure 2, the retainer 20 uses friction to grasp the inner surfaces 58 of side walls 54 of the hook 50. Consequently, there is some amount of flexibility in orienting the hook 50 onto the retainer 20. That is. as Figure 3B shows, the hook.50 may be rotated slightly up and down in the X-Z plane as indicated by the arrows H relative to the insertion tool 10. This additional degree of flexibility may further improve approach angles during surgical installation as well as in removing the insertion tool 1.0 from the hook 50.

The U-shaped configuration of the retainer 20 is more clearly visible in the frontal view shown in Figure 4. This particular view is aligned with a longitudinal axis labeled D- The bottom surface 24 is curved to fit within the saddle 52 of hook 50. In one embodiment, the bottom surface 24 of retainer 20 has a radius of curvature that matches that of the bottom of saddle 52 (see Figure 2). This same radius of curvature may also correspond to a diameter of rod 60 (also shown in Figure 2). Figure 4 also illustrates a small outward bow of the biasing members 22 relative to the width of the bottom surface 24. The biasing members 22 are resilient and deflect, inward, conforming to the size of the saddle 52 of hook 50 (as shown, hi Figure .1). The reaction force caused by this inward deflection supplies the friction that holds the hook 50 onto the retainer 20.

Figure 5 shows a top view of the exemplary retainer 20, including the biasing members 22, in relation to the flange 14 and elongated bar 12. Notably, the middle portion 26 between the biasing members 22 extends wider than the biasing members 22 (also visible in Figure 3). When the retainer 20 is inserted into the saddle 52 of the hook SG as shown in Figure 1 , these middle portions 26 fit within the threaded portion 56 of the hook 50. A dose fit between the middle portions 26 of retainer 20 and the threaded portions 56 of hook 50 may contribute to a more robust retention, reducing unwanted motion between the two parts iθ, 50. A widened middle portion 26 may omitted in cases where the hook 50 or other vertebral implant does not have the threaded portions 56.

Figure 5 also shows that the retainer 20 is oriented along the longitudinal axis labeled D. The biasing members 22 are positioned in a free state and are spaced apart a first width Wl in a direction substantially perpendicular to the longitudinal axis D. When the hook 50 is attached as illustrated in Figure I₁ the biasing members 22 deflect inward towards an engaged state where the biasing members are space apart a second width illustrated by the dimension labeled W2. This inward deflection of lhe biasing members 22 creates the outward retention force thai keeps the hook 50 attached to the retainer 20. Note that the length of the retainer in the left to right direction of Figure 5 remains substantially constant.

An alternative embodiment of a retainer 120 is illustrated in Figures 6-9. Figure 6 shows an exploded view of components in this particular embodiment The retainer 120 uses a biasing member 122 to apply a retaining force to a hook 50. In the embodiment shown, the biasing member 122 is a compression ring. The biasing member 122 fits within a recess 126 formed between retaining walls 128 of a substantially U-shaped retainer body 124 protruding from flange 1 14. In one embodiment this retainer body 124 is sized to fit within the saddle 52 of the hook 50 shown in Figure 2. The biasing member 123 is captured within (he recess 126 by a substantially cylindrical plug .130. The plug .130 includes three portions 132, 134, 136 defined by different diameters. A flange portion 132 has a diameter that is larger than the inner diameter of the biasing member 122. The body portion 134 has a diameter thai is smaller than the inner diameter of the biasing member 1.22, Further, & plug portion 136 has a diameter that is sized to fit within a corresponding aperture .138 in the retainer body 124. The plug portion .136 may be threaded to fit. -within a corresponding threaded aperture .138. Alternatively, the plug portion 136 may be press fitted into the aperture 138. In. other embodiments;, the plug portion 136 may be loosely fit into aperture 13$, but retained using an adhesive compound. As configured, the plug 130 may retain the biasing member 122 as shown in Figure 7.

The biasing member 122 further comprises a gap 123 that, is larger than a corresponding orienting feature .133 in the body portion 134 of the plug 130. This relationship among these features is more readily visible in Figure S, which shows a top view of the exemplary retainer 120. The gap 123 in biasing member 122 is aligned with the orienting feature 133. The gap 123 is wider than the orienting feature 133 as evidenced by the existence of gaps 123 on either side of the orienting feature 133. Also as indicated, the body portion 134 (see Figure 6) has a diameter that, is smaller than the biasing member \ 22. This difference in size allows resilient compression of the biasing member 122 in the direction indicated by the arrows labeled C in Figure S- which is substantially perpendicular to the longitudinal axis D.

Figure 8 also shows that the biasing member 122 is marginally wider than the retaining walls 12S of the retainer body 124. Figure 9 illustrates that this configuration mates with a corresponding configuration in a hook 50. Specifically, the biasing member 122 in the present embodiment engages the threaded portion 56 of the sidewalls 54 of hook 50. Figure 9 also shows that upon inserting the retainer 120 into the hook 50, the biasing member 122 compresses slightly, creating a reaction force that frictioitally engages the hook 50. The compression of the biasing member 122 is visible in the vicinity of the orienting feature 133, where the amount of gap 123 on either side of the orienting feature .133 is reduced as compared to Figure S.

In yet another embodiment of a retainer 220 illustrated in Figures 10 and l ϊ, a biasing member 222 ϊs used to apply a Motional retaining force when compressed in the direction of arrows C. A single biasing member 222 is illustrated though a plurality may be vised. However, in contrast with previously described embodiments, the biasing member 222 in this embodiment does not directly contact a hook 50 of the type shown in the various Figures, Instead, the biasing member 222 imparts a reactive force on complementary plungers 226 disposed within a head 224 and that are configured to fit within the threaded portion 56 of the sidewails 54 of hook 50, Figure 11 shows this same embodiment with the hook SO attached to the retainer 220 and the plungers 226 compressed as compared to the position shown in Figure 10.

As with the embodiment of the retainer 20 shown in Figures 1-2, and 4-5, the retention mechanism created by biasing members 122 and 222 provides some flexibility in attaching a hook SO. That, is, the adjustability represented by the arrows labeled H in Figure 3B is equally applicable to these embodiments of the retainer 120, 220. Accordingly, the hook 50 may be rotated slightly up and down in the X-Z plane as indicated by the arrows H relative to the insertion too! 10, This additional degree of flexibility may further improve approach angles during surgical installation as well as in removing the insertion tool IQ from the hook 50.

In another embodiment of a retainer 320 illustrated in Figures 12 and 13, a biasing member 222 similar to that shown in Figures 10 and i I is used to apply a functional retaining force when compressed in the direction of arrow C. A single biasing member 222 is illustrated though a plurality may be used. In contrast with the embodiment shown in Figures 10 and 11 , the biasing member 222 imparts a reactive force oti a single plunger 226 that is disposed within a head 324 and is also configured to fit within the threaded portion 56 of sidewails 54 of hook 50. Figure .12 shows this same embodiment with the hook 50 attached to the retainer 320 and the single plunger 226 compressed as compared to the position shown in Figure 12.

The present invention may be carried out in other specific ways than those herein set forth without departing from the scope and essential characteristics of the invention. For example, while certain embodiments described above have contemplated engaging a threaded portion 56 on the interior of the sidewall 54 of hook 5O₅ other hooks may have threaded portions on the exterior of the sidewall 54 or transversely formed through the sidewails 54. However_* the friction forces applied by the various biasing members 22, 122, 222 may be generally applied to the inner surface 58 of the sidewails 54, regardless of the positioning or existence of threads.

Furthermore, while a hook 50 has been used as an exemplary implant that may be placed with the insertion tool 10, other implant devices may be positioned using the insertion tool. For instance, pedicle screws, clamps for securing a rod to a plate, and other items featuring & rod damp similar to the illustrated saddle 52 of hook 50 .may be inserted and positioned using the insertion tool 10 disclosed herein. The present embodiments are, therefore, to be considered in. all respects as illustrative and .not. restrictive, aad all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein,

Spatϊaiiy relative terms such as "under" , "below^*5, "lower",, "over ; "upper", '^''distal", "proximal", and the like, are αsed for ease of description to explain the positioning of one element relative to a second element. Further, the terms "down'^", "downward", "up", "upward";, and the like, are used to explain the positioning of the elements as viewed in the Figures, 'ϊhese terras are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures. Further, terras such as "first", "second", and the like, are also used to describe various elements- regions, sections, etc and are also not intended to be limiting.

Claims

What is claimed AS:

I.. A device to insert a vertebra! implant, into a patient, the device comprising: an elongated handle having a distal end and a proximal end; a head attached to the distal end, the head having a longitudinal axis; and an engagement element operatϊvely connected to the head and movable between an engaged position and a released position, the engagement element disposed in closer proximity to the longitudinal axis in the engaged position than in the released position, the engagement, element biased towards the released position.

2. The device of claim 1 wherein the engagement element is a compression ring,

3. The device of claim 2 wherein the compression ring comprises a slot that is aligned with an orienting feature on the head.

4. The device of claim 1 wherein the engagement element is a cantilevered spring element.

5. The device of claim I wherein the engagement element is biased by a resilient biasing member.

6. The device of claim 1 wherein the engagement element moves between the engaged and released positions in a direction that is substantially lateral to the handle.

7. The device of claim 1 further cam prising an enlarged flange disposed adjacent to the head.

8. A device to insert a vertebral implant into a. patient, the device comprising-, an elongated handle having a distal end and a proximal end; and a retainer attached to the distal and, the retainer having a free configuration with a. first width and an engaged configuration with a second width that is smaller tlian the first width, the retainer biased towards the free configuration.

9, The device of claim & wherehi the retainer further comprises a compression ring that is elasticaiiy compressible between the free configuration and the engaged configuration.

1.0. The device of claim. 9 wherein the compression ring comprises $. slot that is aligned with, an orienting feature on the retainer.

11. The device of claim S wherein the retainer further comprises a cantilevered spring element that is elasticaily movable between the free configuration and the engaged configuration.

12. The device of claim 8 wherein the retainer further comprises an engagement element that is movable between the free configuration and the engaged configuration snd further biased towards the free configuration by a resilient biasing member.

13. The device of claim 8 wherein the retainer further comprises a length, the length being the same i.n the engaged and free configurations.

14. A device to insert a vertebra! implant into a patient, the device comprising: an elongated handle having a distal end and a proximal end; a head attached to the distal, end; and an outwardly biased engagement member operatively connected to the head and inwardly movable from a free configuration to an engaged configuration.

15. The device of claim 14 wherein the outwardly biased, engagement element is a compression ring.

16. The device of claim 15 wherein the compression ring comprises a slot that is aligned with an orienting feature on the head. H

17. The device of claim 14 wherein the outwardly biased engagement element is a cant! levered spring element,

.

18. The device of claim 14 wherein the outwardly biased engagement element is biased by a resilient biasing member.

19, The device of claim 14 wherein moving the outwardly biased engagement member from the free configuration to the engaged configuration induces an outwardly directed engagement force.

20, A. method of attaching a vertebral implant to aa insertion tool, the method comprising: aligning a retainer attached to an end of the insertion tool with the vertebral implant; contacting the retainer with the vertebral implant; moving the vertebral implant relative to the retainer thereby moving the retainer from a released position having a first width to an engaged position having a second width that is smaller than the first width; and applying an attachment force between the retainer and the vertebral implant while the retainer is in the engaged position and maintaining attachment of the vertebral implant to the insertion tool.

21 , The method of claim 20 wherein the vertebral implant is a hook.

22, The method of claim 20 wherein moving the retainer from a released position having a first width to an engaged position having a second width that is smaller than the first width further comprises compressing a slotted ring.

23, The method of claim 20 wherein moving the retainer from a released position having a first width to an engaged position having a second width that is smaller than the first width further comprises deflecting a leaf spring.

24. The method of claim 20 wherein moving the retainer from a released position having a first width to an engaged position having a second width that is smaller than, the first width further comprises moving the engagement element against a biasing force applied by a resilient biasing member.

25. The method of claim 20 wherein moving the vertebral implant relative to the retainer comprises rotating the vertebral implant about an axis that is substantially perpendicular to the first and second widths.

26. The method of claim 20 wherein moving the vertebral implant relative to the retainer comprises sliding the vertebral Implant onto the retainer.

27. A method of attaching a vertebral implant, to an insertion tool_* the method comprising: aligning a head attached to an end of the insertion tool with the vertebra! implant; the head having a longitudinal axis; contacting the vertebral implant with an engagement element that is øperati vely coupled to the head; moving the vertebral implant relative to the engagement element thereby moving the engagement element from a released position to an engaged position, the engagement element disposed in closer proximity to the longitudinal axis in the engaged position than in the released position, the engagement element biased towards the released position; and applying an attachment force between the engagement element and the vertebral implant while the engagement element is in the engaged position and maintaining attachment of the vertebral implant to the insertion tool.

28. The method of claim 27 wherein the vertebral implant is & hook.

The method of claim 27 wherein moving the engagement element from a released position to ait engaged position further comprises compressing a slotted ring.

29. The method of claim 27 wherein moving the engagement element from a released position to an engaged position further comprises deflecting a leaf spring.

30. The method of claim 2? wherein moving the engagement element from a released position to an. engaged position further comprises moving the engagement element against a biasing force applied by a resilient biasing member,

31. The method of claim 2? wherein moving the vertebral implant relative to the engagement element comprises sliding the vertebral implant onto the engagement element.

32. The method of claim 27 wherein moving tlie vertebral irapbnt relative to the engagement clement comprises rotating the vertebral implant about a plane in which the longitudinal axis lies, the plane being substantially perpendicular to a direction of movement of the engagement element from the released position to the engaged position.