US20060036251A1 - Systems and methods for the fixation or fusion of bone - Google Patents

Systems and methods for the fixation or fusion of bone Download PDF

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Publication number
US20060036251A1
US20060036251A1 US10/914,629 US91462904A US2006036251A1 US 20060036251 A1 US20060036251 A1 US 20060036251A1 US 91462904 A US91462904 A US 91462904A US 2006036251 A1 US2006036251 A1 US 2006036251A1
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United States
Prior art keywords
stem
bone
bone fixation
fixation device
device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
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US10/914,629
Inventor
Mark Reiley
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SI Bone Inc
Original Assignee
Reiley Mark A
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Reiley Mark A filed Critical Reiley Mark A
Priority to US10/914,629 priority Critical patent/US20060036251A1/en
Publication of US20060036251A1 publication Critical patent/US20060036251A1/en
Priority claimed from US11/653,504 external-priority patent/US20070156241A1/en
Assigned to INBONE TECHNOLOGIES, INC. reassignment INBONE TECHNOLOGIES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: REILEY, MARK A.
Priority claimed from US12/315,559 external-priority patent/US9662158B2/en
Priority claimed from US12/924,782 external-priority patent/US8986348B2/en
Priority claimed from US12/960,831 external-priority patent/US8414648B2/en
Priority claimed from US12/960,811 external-priority patent/US8444693B2/en
Priority claimed from US12/960,857 external-priority patent/US8470004B2/en
Priority claimed from US12/960,798 external-priority patent/US8425570B2/en
Assigned to SI-BONE INC. reassignment SI-BONE INC. TECHNOLOGY TRANSFER AGREEMENT Assignors: INBONE TECHNOLOGIES, INC.
Priority claimed from US15/195,955 external-priority patent/US9949843B2/en
Abandoned legal-status Critical Current

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Abstract

A stem-like bone fixation device allows for bony in-growth on its surface and across fracture fragments or between bones that are to be fused.

Description

    FIELD OF THE INVENTION
  • This application relates generally to the fixation of bone.
  • BACKGROUND OF THE INVENTION
  • Many types of hardware are available both for fracture fixation and for the fixation of bones that are to fused (arthrodesed).
  • Metal and absorbable screws are routinely used to fixate bone fractures and osteotomies. It is important to the successful outcome of the procedure that the screw is able to generate the compressive forces helpful in promoting bone healing.
  • SUMMARY OF THE INVENTION
  • The invention provides bone fixation devices and related methods for stabilizing bone segments. The systems and methods include a stem-like structure adapted for passage between adjacent bone segments. At least a portion of the stem-like structure includes a surface that enhances bony in-growth. Boney in-growth into the stem-like structure helps speed up the fusion process or fracture healing time.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a perspective view of a bone fixation stem having a boney in-growth surface of a mesh configuration.
  • FIG. 2 is a perspective view of an alternative embodiment of a bone fixation stem having a boney in-growth surface of a beaded configuration.
  • FIG. 3 is a perspective view of an alternative embodiment of a bone fixation stem having a boney in-growth surface of a trabecular configuration.
  • FIG. 4 is a schematic view of a bone fixation stem of the type shown in Fig. being inserted into bone across a fracture line or bone joint.
  • FIG. 5 is a schematic view of a bone fixation stem positioned within bone and illustrating a boney in-growth surface of the stem extending across a fracture line or bone joint.
  • FIG. 6 is a front plan view of an alternative embodiment of a bone fixation stem having a boney in-growth surface in which the stem has a conical configuration.
  • FIG. 7 is front plan view of an alternative embodiment of a bone fixation stem having a boney in-growth surface in which the stem has a beveled distal tip.
  • FIGS. 8A and 8B are schematics illustrating the insertion of a conical bone fixation stem of the type shown in FIG. 6 to reduce the gap between bone segments.
  • FIG. 9 is a schematic illustrating a guidewire being introduced into bone across bone segments.
  • FIG. 10 is a schematic similar to FIG. 9 and illustrating a drill bit being introduced over the guidewire.
  • FIG. 11 is a schematic similar to FIG. 10 and illustrating a bore formed in the bone remaining after withdrawal of the drill bit.
  • FIG. 12 is a schematic similar to FIG. 11 and illustrating insertion of a bone fixation stem into the pre-formed bore.
  • FIG. 13 is an exploded front plan view illustrating the coupling of a pair of bone fixation stems by threaded engagement.
  • FIG. 14 is a schematic illustrating a pair of bone fixation stems coupled together and inserted into bone across multiple bone segments.
  • FIG. 15 is a front plan view illustrating passage of a bone fixation stem through a fenestration in another bone fixation stem.
  • FIG. 16 is a schematic illustrating the placement of a series of bone fixation stems in bone.
  • DESCRIPTION OF THE PREFERRED EMBODIMENT
  • Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention that may be embodied in other specific structure. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
  • FIG. 1 shows a device 10 sized and configured for the fixation of bone fractures or for the fixation of bones which are to be fused (arthrodesed). The device 10 comprises an elongated, stem-like structure. The device 10 can be formed—e.g., by machining, molding, or extrusion—from a material usable in the prosthetic arts, including, but not limited to, titanium, titanium alloys, tantalum, chrome cobalt, surgical steel, or any other total joint replacement metal and/or ceramic, sintered glass, artificial bone, any uncemented metal or ceramic surface, or a combination thereof. Alternatively, the device 10 may be formed from a suitable durable biologic material or a combination of metal and biologic material, such as a biocompatible bone-filling material. The device 10 may be molded from a flowable biologic material, e.g., acrylic bone cement, that is cured, e.g., by UV light, to a non-flowable or solid material.
  • The device 10 can take various shapes and have various cross-sectional geometries. The device 10 can have, e.g., a generally curvilinear (i.e., round or oval) cross-section, or a generally rectilinear cross section (i.e., square or rectangular), or combinations thereof. As will be described in greater detail later, the device 10 can be conical or wedge shaped.
  • The structure 10 includes surface texturing 12 along at least a portion of its length to promote bony in-growth on its surface. The surface texturing 12 can comprise, e.g., through holes, and/or various surface patterns, and/or various surface textures, and/or pores, or combinations thereof. The device 10 can be coated or wrapped or surfaced treated to provide the surface texturing 12, or it can be formed from a material that itself inherently possesses a surface conducing to bony in-growth, such as a porous mesh, hydroxyapetite, or other porous surface. The device 10 may further be covered with various other coatings such as antimicrobial, antithrombotic, and osteoinductive agents, or a combination thereof. The surface texturing 12 may be impregnated with such agents, if desired.
  • The configuration of the surface texturing 12 can, of course, vary. By way of examples, FIG. 1 shows the surface 12 as an open mesh configuration; FIG. 2 shows the surface 12 as beaded configuration; and FIG. 3 shows the surface 12 as a trabecular configuration. Any configuration conducive to bony in-growth will suffice.
  • In use (see FIGS. 4 and 5), the device 10 is inserted into a space between two adjacent bone surfaces, e.g., into a fracture site or between two bones (e.g., adjacent vertebral bodies) which are to be fused together. In FIG. 4, the device 10 is shown being tapped into bone through bone segments 14 (i.e., across a fracture line or between adjacent bones to be fused) with a tap 16. The bone may be drilled first to facilitate insertion of the device 10. The bony in-growth surface 12 along the surface of the device 10 accelerates bony in-growth into the device 10. Boney in-growth into the device 10 helps speed up the fusion process or fracture healing time.
  • The bony in-growth surface 12 may cover the entire outer surface of the device 10, as shown in FIG. 4, or the bony in-growth surface 12 may cover just a specified distance on either side of the joint surface or fracture line, as shown in FIG. 5.
  • The size and configuration of the device 10 can be varied to accommodate the type and location of the bone to be treated as well as individual anatomy.
  • As FIG. 6 shows, the device 10 can be angled or tapered in a conical configuration. The degree of angle can be varied to accommodate specific needs or individual anatomy. A lesser degree of angle (i.e., a more acute angle) decreases the risk of splitting the bone as the device 10 is tapped into the bone or the fracture segments 14. The device 10 may also include a beveled distal tip 18 to further add in insertion of the device 10 into bone, as shown in FIG. 7. As shown in FIGS. 8A and BB, the conical shape also helps drive the joint surfaces or fracture fragments together, reducing the gap (G) between the bone segments 14.
  • In FIGS. 9 to 12, the device 10 is cannulated, having a central lumen or throughbore 20 extending through it, to assist in the placement of the device 10 within bone.
  • In use, the physician can insert a conventional guide pin 22 through the bone segments 14 by conventional methods, as FIG. 9 shows. A cannulated drill bit 24 can then be introduced over the guide pin 22, as seen in FIG. 10. A single or multiple drill bits 24 can be employed to drill through bone fragments or bone surfaces to create a bore 26 of the desired size and configuration. In the illustrated embodiment, the drill bit 24 is sized and configured to create a conical bore 26 similar in size and configuration to the device 10. The bore 26 is desirably sized and configured to permit tight engagement of the device 10 within the bore 26 and thereby restrict movement of the device 10 within the bore 26. The pre-formed bore 26 may be slightly smaller than the device 10, while still allowing the device 10 to be secured into position within the bore 26 by tapping. As seen in FIG. 11, the drill bit 24 is then withdrawn. The device 10 is then inserted into the bore 26 over the guide pin 22, as FIG. 12 shows. The guide pin 22 is then withdrawn.
  • Alternatively, the device 10 itself can include screw-like threads along the body for screwing the device into place. In the arrangement, the device 10 be self-tapping. Also in this arrangement, the device 10 can be cannulated for use with a guide pin 22, or it need not be cannulated.
  • Multiple devices 10 may be employed to provide additional stabilization. While the use of multiple devices 10 will now be described illustrating the use of multiple devices 10 of the same size and configuration, it is contemplated that the devices 10 may also be of different size and/or configuration, e.g., one device 10 is of a cylindrical configuration and a second device 10 is of a conical configuration.
  • In many cases, it may be desirable to couple a series of devices 10 together, e.g., to provide stabilization over a larger surface area. A series of devices 10 may be coupled together be any suitable means, e.g., by a snap fit engagement or a groove and tab key arrangement. In one embodiment, a series of devices 10 are coupled by threaded engagement. As illustrated in FIG. 13, a first device 10A includes a recess 28 at one end providing a series of internal threads 30. In the illustrated embodiment, the first device 10 is of a cylindrical configuration, but may be of any desired configuration. The internal threads 30 couple with a series of complementary external threads 32 on a second device 10B of a similar or of a different configuration to couple the first and second devices 10A and 10B together.
  • The devices 10A and 10B are desirably coupled together prior to being inserted into the pre-formed bore 26. The series of internal and external threads 30 and 32 provide an interlocking mechanism that permits a series of devices 10 to be stacked and connected to cover a larger area or multiple bone segments 14 (e.g., a bone having multiple fractures) and thereby provides additional stabilization, as seen in FIG. 14.
  • FIG. 15 illustrates another embodiment in which a device 10′ includes an opening or fenestration 34 to allow another device 10 to pass through, thereby providing additional stabilization. The fenestration 34 can be sized and configured to permit another device 10 to be passed through the device 10′ at virtually any angle. The fenestration 34 can also be sized and configured to limit movement of the second device 10 relative to the second device 10′.
  • In use, and as shown in FIG. 16, the physician taps a first device 10′ having a fenestration 34 through the bone segments. A second device 10 is then inserted (e.g., by tapping) through the fenestration 34 of the first device 10′ into place.
  • It is further contemplated that device 10′ may also be adapted for coupling with another device 10A (e.g., by a series of external and internal threads), permitting the devices 10′ and 10A to be additionally stacked and connected, as also shown in FIG. 16.
  • The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.

Claims (13)

1. A bone fixation device for stabilizing bone segments
comprising a stem adapted for passage between bone segments, at least a portion of the stem including a surface permitting bony in-growth.
2. A bone fixation device as in claim 1
wherein the stem structure is of a cylindrical configuration.
3. A bone fixation device as in claim 1
wherein the stem is of a conical configuration.
4. A bone fixation device as in claim 1
wherein the stem is cannulated.
5. A bone fixation device as in claim 1
wherein the stem includes a threaded end portion for coupling with another stem.
6. A bone fixation device as in claim 1
wherein the stem comprises a prosthetic material.
7. A bone fixation device as in claim 1
wherein the stem comprises a biologic material.
8. A bone fixation device as in claim 1
wherein the stem includes a fenestration permitting passage of another stem.
9. A bone fixation device as in claim 1
wherein the stem is cannulated.
10. A bone fixation device as in claim 1
wherein the stem is threaded.
11. A bone fixation device according to claim 1
further comprising a coupling to couple the stem with another stem:
12. A method for bone fracture fixation using the bone fixation device as defined in claim 1.
13. A method for bone fixation using the bone fixation device as defined in claim 1.
US10/914,629 2004-08-09 2004-08-09 Systems and methods for the fixation or fusion of bone Abandoned US20060036251A1 (en)

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US10/914,629 US20060036251A1 (en) 2004-08-09 2004-08-09 Systems and methods for the fixation or fusion of bone
US11/136,141 US7922765B2 (en) 2004-08-09 2005-05-24 Systems and methods for the fixation or fusion of bone
AU2005274042A AU2005274042A1 (en) 2004-08-09 2005-08-03 Systems and methods for the fixation or fusion of bone
PCT/US2005/027464 WO2006020463A1 (en) 2004-08-09 2005-08-03 Systems and methods for the fixation or fusion of bone
EP05782575.4A EP1791480B1 (en) 2004-08-09 2005-08-03 Bone fixation/fusion device
DE05782575T DE05782575T8 (en) 2004-08-09 2005-08-03 Systems and method for fixing or connecting bones
ES05782575T ES2706005T3 (en) 2004-08-09 2005-08-03 Bone fixation / fusion device
JP2007525662A JP5144261B2 (en) 2004-08-09 2005-08-03 System and method for bone fixation or fusion
US11/653,504 US20070156241A1 (en) 2004-08-09 2007-01-16 Systems and methods for the fixation or fusion of bone
US11/981,009 US20080065215A1 (en) 2004-08-09 2007-10-31 Systems and methods for the fixation or fusion of bone
US12/072,153 US8308779B2 (en) 2004-08-09 2008-02-25 Systems and methods for the fixation or fusion of bone
US12/315,559 US9662158B2 (en) 2004-08-09 2008-12-04 Systems and methods for the fixation or fusion of bone at or near a sacroiliac joint
US12/804,516 US8202305B2 (en) 2004-08-09 2010-07-22 Systems and methods for the fixation or fusion of bone
US12/924,782 US8986348B2 (en) 2004-08-09 2010-10-05 Systems and methods for the fusion of the sacral-iliac joint
US12/924,784 US8388667B2 (en) 2004-08-09 2010-10-05 Systems and methods for the fixation or fusion of bone using compressive implants
US12/960,798 US8425570B2 (en) 2004-08-09 2010-12-06 Apparatus, systems, and methods for achieving anterior lumbar interbody fusion
US12/960,831 US8414648B2 (en) 2004-08-09 2010-12-06 Apparatus, systems, and methods for achieving trans-iliac lumbar fusion
US12/960,811 US8444693B2 (en) 2004-08-09 2010-12-06 Apparatus, systems, and methods for achieving lumbar facet fusion
US12/960,857 US8470004B2 (en) 2004-08-09 2010-12-06 Apparatus, systems, and methods for stabilizing a spondylolisthesis
US12/930,791 US9622783B2 (en) 2004-08-09 2011-01-18 Systems and methods for the fixation or fusion of bone
US13/078,530 US9561063B2 (en) 2004-08-09 2011-04-01 Systems and methods for the fixation or fusion of bone
JP2011175425A JP5830301B2 (en) 2004-08-09 2011-08-10 System and method for bone fixation or fusion
JP2013532916A JP5771277B2 (en) 2004-08-09 2011-10-05 System and method for fixation or fixation of compression implants using bone
CN201180058533.XA CN103237514B (en) 2004-08-09 2011-10-05 Compressibility implant is utilized to fix or the system of fused bone
BR112013008227A BR112013008227A2 (en) 2004-08-09 2011-10-05 systems and methods for bone attachment or fusion using compressible implants
EP11831524.1A EP2624772B1 (en) 2004-08-09 2011-10-05 Systems for the fixation or fusion of bone using compressive implants
PCT/US2011/054935 WO2012048008A1 (en) 2004-08-09 2011-10-05 Systems and methods for the fixation or fusion of bone using compressive implants
US13/674,764 US8840651B2 (en) 2004-08-09 2012-11-12 Systems and methods for the fixation or fusion of bone
US13/786,037 US8734462B2 (en) 2004-08-09 2013-03-05 Systems and methods for the fixation or fusion of bone using compressive implants
US13/858,814 US9375323B2 (en) 2004-08-09 2013-04-08 Apparatus, systems, and methods for achieving trans-iliac lumbar fusion
US13/867,941 US9492201B2 (en) 2004-08-09 2013-04-22 Apparatus, systems and methods for achieving anterior lumbar interbody fusion
US13/898,415 US8858601B2 (en) 2004-08-09 2013-05-20 Apparatus, systems, and methods for achieving lumbar facet fusion
US13/925,678 US8920477B2 (en) 2004-08-09 2013-06-24 Apparatus, systems, and methods for stabilizing a spondylolisthesis
JP2013140489A JP5775548B2 (en) 2004-08-09 2013-07-04 System and method for bone fixation or fusion
US14/162,689 US8840623B2 (en) 2004-08-09 2014-01-23 Systems and methods for the fixation or fusion of bone
US14/245,759 US9743969B2 (en) 2004-08-09 2014-04-04 Systems and methods for the fixation or fusion of bone
JP2014082662A JP2014147820A (en) 2004-08-09 2014-04-14 Systems and methods for fixation or fusion of bone
US14/274,486 US9486264B2 (en) 2004-08-09 2014-05-09 Systems and methods for the fixation or fusion of bone using compressive implants
US14/280,360 US9675394B2 (en) 2004-08-09 2014-05-16 Systems and methods for the fixation or fusion of bone at or near a sacroiliac joint
US14/280,436 US9039743B2 (en) 2004-08-09 2014-05-16 Systems and methods for the fusion of the sacral-iliac joint
US14/488,144 US9820789B2 (en) 2004-08-09 2014-09-16 Systems and methods for the fixation or fusion of bone
US14/707,817 US9662128B2 (en) 2004-08-09 2015-05-08 Systems and methods for the fusion of the sacral-iliac joint
JP2015111540A JP2015211849A (en) 2004-08-09 2015-06-01 System and method for fixation or fusion of bone using compressive implants
US15/195,955 US9949843B2 (en) 2004-08-09 2016-06-28 Apparatus, systems, and methods for the fixation or fusion of bone
JP2016128376A JP2016190065A (en) 2004-08-09 2016-06-29 Systems and methods for fixation or fusion of bone
US15/461,304 US9956013B2 (en) 2004-08-09 2017-03-16 Systems and methods for the fixation or fusion of bone
US15/620,752 US10004547B2 (en) 2004-08-09 2017-06-12 Systems and methods for the fixation or fusion of bone at or near a sacroiliac joint
US15/952,102 US20180228621A1 (en) 2004-08-09 2018-04-12 Apparatus, systems, and methods for the fixation or fusion of bone

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US11/136,414 Continuation US20060266492A1 (en) 2005-05-25 2005-05-25 Method for manufacturing crankshafts
US12/072,153 Division US8308779B2 (en) 2004-08-09 2008-02-25 Systems and methods for the fixation or fusion of bone

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US10/914,629 Abandoned US20060036251A1 (en) 2004-08-09 2004-08-09 Systems and methods for the fixation or fusion of bone
US11/136,141 Active 2025-12-13 US7922765B2 (en) 2004-08-09 2005-05-24 Systems and methods for the fixation or fusion of bone
US11/981,009 Abandoned US20080065215A1 (en) 2004-08-09 2007-10-31 Systems and methods for the fixation or fusion of bone
US12/072,153 Active 2027-01-27 US8308779B2 (en) 2004-08-09 2008-02-25 Systems and methods for the fixation or fusion of bone
US12/804,516 Active US8202305B2 (en) 2004-08-09 2010-07-22 Systems and methods for the fixation or fusion of bone
US13/078,530 Active US9561063B2 (en) 2004-08-09 2011-04-01 Systems and methods for the fixation or fusion of bone
US13/674,764 Active US8840651B2 (en) 2004-08-09 2012-11-12 Systems and methods for the fixation or fusion of bone
US14/162,689 Active US8840623B2 (en) 2004-08-09 2014-01-23 Systems and methods for the fixation or fusion of bone
US14/245,759 Active US9743969B2 (en) 2004-08-09 2014-04-04 Systems and methods for the fixation or fusion of bone
US14/488,144 Active 2025-10-12 US9820789B2 (en) 2004-08-09 2014-09-16 Systems and methods for the fixation or fusion of bone

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US12/072,153 Active 2027-01-27 US8308779B2 (en) 2004-08-09 2008-02-25 Systems and methods for the fixation or fusion of bone
US12/804,516 Active US8202305B2 (en) 2004-08-09 2010-07-22 Systems and methods for the fixation or fusion of bone
US13/078,530 Active US9561063B2 (en) 2004-08-09 2011-04-01 Systems and methods for the fixation or fusion of bone
US13/674,764 Active US8840651B2 (en) 2004-08-09 2012-11-12 Systems and methods for the fixation or fusion of bone
US14/162,689 Active US8840623B2 (en) 2004-08-09 2014-01-23 Systems and methods for the fixation or fusion of bone
US14/245,759 Active US9743969B2 (en) 2004-08-09 2014-04-04 Systems and methods for the fixation or fusion of bone
US14/488,144 Active 2025-10-12 US9820789B2 (en) 2004-08-09 2014-09-16 Systems and methods for the fixation or fusion of bone

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ES2706005T3 (en) 2019-03-27
US20080154316A1 (en) 2008-06-26
US8840623B2 (en) 2014-09-23
JP5144261B2 (en) 2013-02-13
JP2016190065A (en) 2016-11-10
US20080065215A1 (en) 2008-03-13
JP5830301B2 (en) 2015-12-09
WO2006020463A1 (en) 2006-02-23
JP2012005848A (en) 2012-01-12
US20110184478A1 (en) 2011-07-28
JP5775548B2 (en) 2015-09-09
US8308779B2 (en) 2012-11-13
US20140222150A1 (en) 2014-08-07
US20140142644A1 (en) 2014-05-22
US9820789B2 (en) 2017-11-21
US9743969B2 (en) 2017-08-29
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US8840651B2 (en) 2014-09-23
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US20100292738A1 (en) 2010-11-18
EP1791480A4 (en) 2011-07-27
AU2005274042A1 (en) 2006-02-23
EP1791480A1 (en) 2007-06-06
US20060036322A1 (en) 2006-02-16
US7922765B2 (en) 2011-04-12
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US9561063B2 (en) 2017-02-07
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US20130131739A1 (en) 2013-05-23
US8202305B2 (en) 2012-06-19
JP2013226433A (en) 2013-11-07
US20150005832A1 (en) 2015-01-01

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