Source: http://patents.com/us-10188440.html
Timestamp: 2019-02-21 09:55:47
Document Index: 229330939

Matched Legal Cases: ['Application No. 16180626', 'Application No. 11250603', 'Application No. 11250603', 'Application No. 04757057', 'Application No. 04757057', 'Application No. 04757057', 'Application No. 11250603']

US Patent # 1,018,8440. Method and device for delivering medicine to bone - Patents.com
United States Patent 10,188,440
Sweeney; Patrick J. (Flossmoor, IL)
Spinal Generations, LLC (Mokena, IL)
Family ID: 1000003784592
14/864,290
US 20160008044 A1 Jan 14, 2016
13270072 Oct 10, 2011 9445852
12822022 Jun 23, 2010 8062270
12427520 Apr 21, 2009 8808337
10704526 Nov 7, 2003 7527611
10620287 Jul 15, 2003 7575572
10682307 Oct 9, 2003 7608062
Current CPC Class: A61B 17/864 (20130101); A61B 17/7061 (20130101); A61B 17/8685 (20130101); A61B 17/8819 (20130101); A61B 17/8841 (20130101); A61M 37/00 (20130101); A61B 17/3472 (20130101); A61M 2210/10 (20130101); A61B 17/7098 (20130101); A61B 17/72 (20130101); A61B 17/7258 (20130101); A61B 17/744 (20130101); A61B 2017/00004 (20130101); A61F 2002/30677 (20130101); A61M 25/00 (20130101); A61M 2039/025 (20130101); A61M 2202/10 (20130101)
Current International Class: A61B 17/86 (20060101); A61M 37/00 (20060101); A61B 17/88 (20060101); A61B 17/70 (20060101); A61B 17/34 (20060101); A61F 2/30 (20060101); A61M 39/02 (20060101); A61B 17/00 (20060101); A61B 17/74 (20060101); A61B 17/72 (20060101); A61M 25/00 (20060101)
4399814 August 1983 Pratt et al.
4464178 August 1984 Dalton
5122114 June 1992 Miller et al.
5203770 April 1993 Wigness et al.
5252301 October 1993 Nilson et al.
5372583 December 1994 Roberts et al.
5380319 January 1995 Saito et al.
5562625 October 1996 Stefancin, Jr.
5586821 December 1996 Bonitati et al.
5618286 April 1997 Brinker
5681289 October 1997 Wilcox et al.
5749883 May 1998 Halpern
5752941 May 1998 Romano' et al.
5800407 September 1998 Eldor
5842785 December 1998 Brown et al.
5951160 September 1999 Ronk
6019761 February 2000 Gustilo
6077265 June 2000 Werding et al.
6228088 May 2001 Miller et al.
6387098 May 2002 Cole et al.
6461327 October 2002 Addis et al.
6669059 December 2003 Mehta
6679890 January 2004 Margulies et al.
7527611 May 2009 Sweeney
7575572 August 2009 Sweeney
7608062 October 2009 Sweeney
8057090 November 2011 Saha et al.
8808337 August 2014 Sweeney
2002/0169507 November 2002 Malone
2003/0139751 July 2003 Evans et al.
2003/0212426 November 2003 Olson et al.
2005/0015059 January 2005 Sweeney
2005/0015060 January 2005 Sweeney
2005/0059972 March 2005 Biscup
2006/0111767 May 2006 Olson et al.
2007/0073295 March 2007 Biedermann et al.
2007/0083265 April 2007 Malone
2007/0233123 October 2007 Ahmad et al.
2008/0039846 February 2008 Lee et al.
2008/0039855 February 2008 Lambert
2008/0086143 April 2008 Seaton, Jr.
2009/0164016 June 2009 Georgy et al.
2009/0204158 August 2009 Sweeney
2010/0042213 February 2010 Nebosky et al.
2010/0042214 February 2010 Nebosky
2010/0106199 April 2010 Sawa et al.
2010/0131014 May 2010 Peyrot et al.
2010/0262089 October 2010 Sweeney
2011/0046682 February 2011 Stephan et al.
2012/0029432 February 2012 Sweeney
2012/0041395 February 2012 Sweeney
0 858 775 Aug 1998 EP
1 749 490 Feb 2007 EP
1 653 869 Jun 2011 EP
WO-88/06023 Aug 1988 WO
WO-02/098307 Dec 2002 WO
WO-2005/009258 Feb 2005 WO
WO-2010/019788 Feb 2010 WO
WO-2011/063240 May 2011 WO
European Search Report for European Application No. 16180626.0, dated Sep. 27, 2016, 8 pages. cited by applicant .
Communication received in European Patent Application No. 11250603.5, dated Mar. 11, 2016, 6 pages. cited by applicant .
Cecil, M.L. et al., "Projection of the S2 Pedicle Onto the Posterolateral Surface of the Ilium--A Technique for Lag Screw Fixation of Sacral Fractures or Sacroiliac Joint Dislocations," Spine 1996, vol. 21, pp. 875-878, www.kalindra.com/project.htm, 6 pages. cited by applicant .
Communication received in European Patent Application No. 11250603.5, dated Feb. 20, 2015, 5 pages. cited by applicant .
European Office Action for Application No. 04757057.7, dated Jan. 26, 2010, 5 pages. cited by applicant .
European Search Report for European Patent Application No. 04757057.7, dated Jul. 2, 2010, 4 pages. cited by applicant .
European Search Report for European Patent Application No. 04757057.7, dated Nov. 30, 2009, 3 pages. cited by applicant .
European Search Report for European Patent Application No. 11250603.5-2310, dated Sep. 29, 2011, 6 pages. cited by applicant .
Instratek Inc., "Titanium Cannulated Bone Screws Minimize Surgery Time by Eliminating Complicated Procedure Steps," www.instratek.com/bone_screw/, 5 pages. cited by applicant .
International Search Report and Written Opinion for International Application No. PCT/US2014/035542, dated Sep. 22, 2014, 14 pages. cited by applicant .
International Search Report and Written Opinion for PCT Application No. PCT/US2015/014216, dated Apr. 22, 2015, 14 pages. cited by applicant .
International Search Report and Written Opinion for PCT Application PCT/US2013/052853, dated Jan. 14, 2014, 15 pages. cited by applicant .
Press release from Spine Center Atlanta, "New Screw Debut First-time Use for New Spinal Surgery Device," 2002, Orthopaedic & Spine Surgery of Atlanta, LLC. www.SpineCneterAtlanta.com, 2 pages. cited by applicant .
Sato, T. et al., "Calcium Phosphate Augmentation of Screw Fixation in Femoral Neck Fracture," 47th Annual Meeting, Orthopaedic Research Society, Feb. 25-28, 2001, San Francisco, CA, 1 page. cited by applicant .
SunMedica--Orthopaedic Surgery Products, "orthoPLUG.RTM. Hard Bone Design," Redding, CA 96002; www.xunmedica.com, 1 page. cited by applicant.
This application is a continuation-in-part of U.S. application Ser. No. 13/270,072, filed Oct. 10, 2011, now U.S. Pat. No. 9,445,852, which is a continuation of U.S. application Ser. No. 12/822,022, filed Jun. 23, 2010, now U.S. Pat. No. 8,062,270, which is a continuation-in-part of U.S. application Ser. No. 12/427,520, filed Apr. 21, 2009, now U.S. Pat. No. 8,808,337, which is a continuation of U.S. application Ser. No. 10/704,526, filed Nov. 7, 2003, now U.S. Pat. No. 7,527,611, which is a continuation-in-part of U.S. application Ser. No. 10/682,307, filed Oct. 9, 2003, now U.S. Pat. No. 7,608,062, which is a continuation-in-part of U.S. application Ser. No. 10/620,287, filed Jul. 15, 2003, now U.S. Pat. No. 7,575,572. U.S. application Ser. Nos. 13/270,072, 12/822,022, 12/427,520, 10/704,526, 10/682,307, and Ser. No. 10/620,287 are incorporated herein by reference in their entireties.
1. A method for delivering multiple substances in a delayed fashion to a bone of a patient, comprising: providing a cannulated bone screw, wherein the bone screw comprises first and second fenestrations disposed along a shaft of the bone screw and connecting to a cannulation of the bone screw; inserting an insert into the bone screw; creating an aperture in skin of a patient; inserting the bone screw into the bone of the patient through the aperture; delivering a first substance into the bone through the bone screw, wherein the first substance changes over time into an at least partially solid hardened material; and delivering a second substance into the bone through the bone screw and through the first substance after the first substance has changed into the at least partially solid hardened material; wherein the first and second substances are delivered into the bone through the insert; and wherein the insert is moveable within the cannulation of the bone screw to deliver the first substance through at least one of the first and second fenestrations and to deliver the second substance through at least one of the first and second fenestrations.
6. The method of claim 1, further comprising: removing the insert without removing the bone screw before delivering the second substance; treating the insert with a treatment intended to reduce infection in the bone and clean a cannulation of the insert; and recoupling the treated insert to the bone screw.
7. The method of claim 1, further comprising providing a second insert and coupling the second insert to the bone screw.
8. The method of claim 1, wherein the insert is moveable within the cannulation of the bone screw between a first position to deliver the first substance through the first fenestration and a second position to deliver the second substance through the second fenestration.
9. The method of claim 1, wherein the first substance includes bone cements and the second substance includes at least one of bone morphogenic proteins, osteoprogenitor cells, calcium phosphate, antibiotics, and anti-cancer drugs.
10. A method for delivering multiple substances in a delayed fashion to a bone of a patient, comprising: providing a cannulated bone screw, wherein the bone screw comprises first and second fenestrations disposed along a shaft of the bone screw and connecting to a cannulation of the bone screw; inserting an insert into the bone screw; creating an aperture in skin of a patient; inserting the bone screw into the bone of the patient through the aperture; delivering a first substance into the bone through the bone screw, wherein the first substance changes over time into an at least partially solid hardened material; delivering a second substance into the bone through the bone screw and through the first substance after the first substance has changed into the at least partially solid hardened material; wherein the first and second substances are delivered into the bone through the insert; removing the insert without removing the bone screw before delivering the second substance; treating the insert with a treatment intended to reduce infection in the bone and clean a cannulation of the insert; and recoupling the treated insert to the bone screw.
In another aspect of the invention, a first substance is delivered to a desired location in the bone through a bone screw. The first substance changes over time into a solid hardened material. For example, the first substance is bone void filler, such as bone cements. After the first substance changed into a solid state, a second substance is delivered into the bone through the bone screw. In some embodiments, the solid hardened material of the first substance is permeable material. The second substance can transport through the permeable material. In some embodiments, the second substance can reach to a desired location in the bone through pores or cracks in the solid hardened material of the first substance. In some other embodiments, the second substance can be in a liquid state, in a gaseous state or in a mixed state. The second substance may pass through the solid state of the first substance and reach to a desired location of the bone by diffusion. In another embodiment, the second substance may be delivered through the bone screw while the first substance is changing into a solid hardened material.
Another embodiment of the invention relates to a system for treating a bone, which includes an insert for a bone screw or a fixation nail. The insert includes a shaft that extends between proximal and distal ends of the insert and a cap. The shaft includes an opening in the proximal end and a cannulation extending from the opening through at least a portion of the shaft. The shaft further includes a fenestration disposed along the cannulation such that the cannulation is configured to provide a pathway for a substance between the opening and the fenestration. The cap is fastened to and seals the opening in the proximal end of the shaft and adjoins the cannulation. The cap is configured to provide a needle access through the cap to the cannulation following implantation of the system within the bone, and is further configured to self-seal after the needle is removed.
Another embodiment of the invention relates to a system for removing material from a bone, which includes an insert, a bone screw, and an expandable portion. The insert includes a shaft extending between proximal and distal ends of the insert, a cannulation extending through at least a portion of the length of the shaft, and a fenestration disposed along the shaft and connecting to the cannulation. The bone screw includes a shaft extending between first and second ends of the bone screw. The shaft of the bone screw is cannulated. Furthermore, the bone screw is configured to receive the insert in the cannulation of the bone screw. The expandable portion is coupled to the insert and extends laterally from the insert to contact an interior surface of the cannulation of the bone screw, which forms a seal extending between the exterior of the insert and the interior of bone screw in the cannulated portion of the bone screw.
Another embodiment of the invention relates to a system for treating a bone, which includes a fastener and an insert. The fastener includes a rigid shaft extending lengthwise between first and second ends of the fastener. The first end includes an opening, and the shaft of the fastener includes a cannulation extending from the opening to the second end of the fastener. The fastener is fenestrated with an elongate slot extending lengthwise along the shaft. The insert includes a shaft extending between proximal and distal ends of the insert, a conduit extending from the proximal end and through at least a portion of the shaft, and a fenestration disposed along the shaft and connecting to the conduit. The insert is configured to be inserted through the opening in the first end of the fastener and is movable within the cannulation of the fastener.
FIG. 34 shows a schematic cross-sectional view of a bone screw inserted into a bone during delivery of multiple substances in a delayed fashion.
The device of the present invention further comprises a bone-screw insert. For the purposes of this invention, the term "insert" is used to refer to one or more cannulated members which are disposed within the cannulated portion of a bone screw. Referring now to FIG. 3(a), the insert 300 comprises a cannulated portion 310 which consists of a hollow cavity 320 surrounded by the insert wall 330, where the cavity and wall dimensions may be suitably chosen in order to carry out the practice of the invention disclosed herewith. In certain embodiments, the insert may comprise a single piece, as disclosed in FIG. 3(a). Alternatively, the insert may comprise two or more pieces or sections that, when taken together, form the insert of the present invention. Referring now to FIG. 3(b), when the insert 300 is a single piece, the insert comprises two ends, 302 and 304, connected by a shaft 306. The shaft may be cannulated along its entire length, creating openings at each end of the insert. Alternatively, the cannulation may extend only partially into the shaft so long as the cannulation is sufficient to allow for delivery of a substance from one end of the insert to one or more bone-screw fenestrations. One end 302 of the insert 300 may comprise threads 340 which interlock with bone screw threads 140 of FIG. 1 to help fix an insert 300 into a bone screw 100. When the insert comprises two or more pieces or sections, only one of the sections need be cannulated such that the insert sections, when taken together, allow for delivery of a substance from one end of the insert to one or more bone-screw fenestrations.
In accordance with the present invention, the insert is disposed within the bone screw to provide for a directed or controlled delivery of a desired substance to a bone. For the purposes of this invention, the term "substance" is used to refer to one or more chemical compounds that are useful when delivered to the vicinity of a bone. Substances may be chosen to help treat diseased bone as well as fractured or otherwise injured bones. Alternatively, the substance may be delivered to otherwise healthy bone to help maintain overall bone health, for example. Representative example substances include medicants or therapeutics such as antibiotics, chemotherapeutics, angiogenic factors, bone morphogenic proteins, bone cements and bone growth factors. Other desirable substances may be known or hereinafter determined by one skilled in the art, which are to be included within the scope of this invention.
In other embodiments, fenestrations, such as fenestrations 3040, 3050 and 3060, may be of other lengths relative to shaft 3010 (e.g., 1/8 of the length of shaft 3010, 1/4 of the length of shaft 3010, 1/2 of the length of shaft 3010, and 3/4 of the length of shaft 3010, etc.). In the embodiment shown in FIG. 31, threads 3020 are shown including gaps or spaces at the location of fenestrations 3040, 3050 and 3060. In other embodiments, threads 3020 may be contiguous threads that extend above or overlap fenestrations 3040, 3050 and 3060.
Referring to FIG. 34, another aspect of the invention is disclosed. The bone screw 3400 coupled with an insert 3402 can include any feature in any embodiment discussed above. In some embodiments, the bone screw 3400 is used for delivering multiple substances into a bone 3408 in a delayed fashion. In some embodiments, a first substance 3404 may be delivered to a desired location in the bone 3408. The first substance 3404 changes over time into an at least partially solid hardened material. For example, the first substance 3404 is bone void filler, such as bone cements. After the first substance 3404 changed into a semi-solid or fully solid state, a second substance 3406 may be delivered into the bone 3408. In some embodiments, the substance may be delivered through an insert 3402 positioned in the bone screw 3400. In one embodiment, the first and second substances are delivered through the same insert 3402. In another embodiment, the first and second substances are delivered through different inserts. In some embodiments, the solid hardened material of the first substance 3404 is permeable material and allows the second substance 3406 to transport through. In some embodiments, the second substance 3406 may transport through the solid hardened material by diffusion. In some other embodiments, the second substance 3406 may reach to a desired location in the bone through pores or cracks of the solid hardened material of the first substance 3404. In some embodiments, the second substance 3406 can be in a liquid state, in a gaseous state or in a mixed state. In some other embodiments, the second substance 3406 may be delivered into the bone while the first substance 3404 is changing into a solid state. Additional substances, such as a third substance or medicant may be delivered the bone in the same fashion, through the first and/or second substance.
Previous Patent US 10,188,439 | Next Patent US 10,188,441