The present invention relates generally to the field of devices and methods for delivering substances to bone. More particularly, the present invention concerns devices and methods for mixing and delivering substances to the interior of fractured or otherwise injured bones, especially to the fracture interface.
Present methods of preparing a viscous surgical substance, such as a bone void filler, to be introduced to fractured or injured bones involve cumbersome, multi-step processes. The process to form such a surgical substance requires mixing a bulking agent with a reacting agent to form the substance at the time of use, such as at the time of delivery to the targeted area of the bone. Such methods may require mixing the elements in a separate mixing container and manually transferring the material to a delivery container, such as a syringe. Not only is this method laborious, but can also create a mess at the mixing site. The amount of time used to mix the elements and make this transfer can also add to the increased viscosity of the substance, and make compression of the syringe or delivery device for delivering the substance to a cannula or other delivery apparatus more difficult. Syringes can fail, which may result in waste of the substance therein, or require a further transfer and additional clean-up. Furthermore, the compressive forces necessary to make the transfer from the syringe can be difficult for many users and preparers of the material.
Various embodiments of the invention described herein allow for mixing and delivery of a substance (e.g., medication or bone void filler) to be delivered to a target area of the body, such as a fracture site after stabilization of the bone.
One embodiment of the invention relates to method of mixing and delivering a substance to a bone including providing a compressible tube having a reservoir and using a mixing apparatus to mix a particulate solid and a mixing liquid to form the substance within the reservoir of the compressible tube. The method further includes using a compressing device to move the substance through an exit port in the compressible tube for delivery to the bone.
The method may also include providing the particulate solid in the reservoir of the compressible tube, or alternatively, introducing the particulate solid into the reservoir of the compressible tube. The method may also include introducing the mixing liquid into the reservoir of the compressible tube. The mixing liquid may be introduced to the reservoir through a sealable inlet portion. The compressible tube may include a portal serving as the inlet portion and the exit port.
The method may also include moving the substance through the exit port and into a delivery apparatus for delivery directly to the bone. The delivery apparatus may be a cannula positioned within the body and having a distal portion position near the target portion of the anatomy.
The substance may be a bone void filler. The compressing device may be positioned on the compressible tube and the method may further include moving the compressing device along the compressible tube to empty the substance from the compressible tube. The compressing device may include a rolling key to roll the compressible tube to empty the substance from the compressible tube.
Another embodiment of the invention relates to a mixing and delivery system including a compressible tube having a reservoir configured for mixing and holding a surgical substance. The compressible tube includes an inlet portion for accommodating the introduction of an element of the surgical substance into the compressible tube. The compressible tube also includes an exit port for enabling the delivery of the surgical substance to a target portion of an anatomy. The system further includes a mixing apparatus configured to be received through the inlet portion of the compressible tube for mixing the elements of the surgical substance to form the surgical substance.
The mixing and delivery system may also include a compressing device configured to move along the compressible tube and force the surgical substance through the exit port. The exit port may be configured to engage with a delivery apparatus which delivers the surgical substance to the anatomy. The delivery apparatus may be a cannula positioned within the body and having a distal portion position near the target portion of the anatomy. The inlet portion may be sealable. The compressible tube may further include a portal serving as the inlet portion and the exit port.
The reservoir of the compressible tube may contain a particulate substance and the fluid introduced through the inlet portion may be a mixing liquid. The surgical substance may be a bone void filler.
Yet another embodiment of the invention relates to a kit for mixing and delivering a surgical substance to an anatomy including a compressible tube having a reservoir configured for mixing and holding the surgical substance, the compressible tube containing a particulate solid. The compressible tube includes a portion capable of being opened to receive a mixing liquid introduced into the reservoir. The compressible tube also includes an exit port for enabling the delivery of the surgical material to a target portion of an anatomy. The kit further includes a mixing apparatus configured to be inserted into the compressible tube for mixing the particulate solid and the mixing liquid. The kit may include a plurality of compressible tubes. The kit may also include at least one compressing device configured to ride along the compressible tube and force the surgical substance through the exit port.
Alternative exemplary embodiments relate to other features and combinations of features as may be generally recited in the claims.
The disclosure will become more fully understood from the following detailed description, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements, in which:
Before turning to the figures, which illustrate the exemplary embodiments in detail, it should be understood that the application is not limited to the details or methodology set forth in the description or illustrated in the figures. It should also be understood that the terminology is for the purpose of description only and should not be regarded as limiting. For example, a femur is illustrated in the drawings, but the devices and methods described herein may be used in connection with any bone in the body, including but not limited to bones in the spine, arms, hands, legs, and feet. Furthermore, it should be understood that the exemplary embodiments described herein can also be used for the storage and mixing of other materials and substances. For example, though the description is directed to storing, mixing, and delivery of bone void fillers and similar substances, the delivery system disclosed herein may also be used for the storage of stem cells or bone marrow aspirate, and may accommodate mixing with other substances upon harvesting or at the time of delivery.
Referring to
Various delivery apparatuses can be introduced over the stabilizing wire 4 to deliver a surgical substance, such as a bone void filler to the fractured area of the bone, or other target area of the anatomy. Such delivery apparatuses may be elongated cannulas that carry the surgical substance from the fluid/substance source, to the target area of the anatomy, and may be such cannulas as described in U.S. patent application Ser. No. 13/270,072, titled “Method and Device for Delivering Medicine to Bone,” filed Oct. 10, 2011, and hereby incorporated by reference herein in its entirety.
Referring to
The cannulas described herein can be made of any material suitable for placement into a bone without harmful effects on the patient. In one embodiment, the cannula is made of stainless steel or other type of metal. In another embodiment, the cannula is made of a rigid plastic, such as polyethylketone, that cannot be easily bent or manipulated into alternative configurations. A rigid cannula may be advantageous to provide stability when introducing the cannula into a hole 6 in a bone 10. Furthermore, a rigid cannula provides stability for various procedures that a more flexible cannula may not provide. For example, if a surgeon desires to use a plunger or other device to push a substance from the cannula and into the bone, a rigid cannula may be more desirable. As another example, a rigid cannula is able to withstand more significant forces than a flexible cannula (e.g., forces applied to the cannula by a delivery device or a suction device, and the forces resulting from movement of substances through the channels and through any open portals in the cannula).
The cannulae that may be used to deliver the substance to the bone are substantially elongated structures with, in preferred embodiments, two or more channels. The multichannel cannula 200 depicted in
The multichannel cannula shown in
As shown in
Various delivery systems can be coupled to the delivery portal 322 to assist in delivering substances to the second channel 202 of multichannel cannula 200, and ultimately to the bone. Tubing may be used to connect the delivery system to the delivery portal 322. The type of delivery system selected by a user may depend on the type of substance to be delivered to the bone.
One such delivery system is a mixing and delivery system 400, as depicted in
As shown in
In an exemplary embodiment, the portal 404 is both the inlet and the exit portal. In an alternative exemplary embodiment, the portal 404 serves as an exit portal only, and the opposing end 405 is open, or able to be opened and resealed, such that introduction of the mixing liquid and performance of the mixing (described below) can be accomplished through the opposing end 405.
In certain embodiments, the compressible tube 401 has a false bottom, wherein the tube has an internal partition constituting a wall of the reservoir 402 portion of the compressible tube 401. In other embodiments, the reservoir 402 comprises the entirety of the area within the compressible tube 401 structure. The compressible tube 401, in preferred embodiments, is made of a transparent material to enable visualization of the mixing of the surgical substance. In this way, a practitioner is able to witness and guide the progress of the mixing and determine when the surgical substance is appropriately formed.
Referring to
Mixing and delivery system 400 may also include a compressing device, such as the compressing device 420 shown in
One method of mixing and delivering a surgical substance to bone, such as a bone void filler, according to an exemplary embodiment includes providing a compressible delivery tube, such as compressible tube 401, wherein the compressible tube 401 has a reservoir 402. The compressible tube 401 may be provided with a first element therein, such as particulate solid or a prepared paste or fluid, or the first element may be introduced into the reservoir 402 through the portal 404. A mixing apparatus 410, such as a blender, mixing, or agitator, is introduced to the reservoir 402 of the compressible tube 401 after or during introduction of a second element, such as the mixing liquid to the reservoir 402. As described above, the second element, such as the mixing liquid, may be introduced through the portal 404 or through an alternative inlet portion of the compressible tube 401. The mixing apparatus 410, likewise, may be introduced through the portal 404 or through an alternative inlet portion of the compressible tube 401. The method further includes moving the surgical substance through the exit port of the compressible tube 401 for delivery to the body. Delivery to the body may take place through a cannula as described above, or may alternatively take place through a catheter, delivery needle, or other delivery apparatus. Moving the surgical substance through the exit port of the compressible tube 401 may use a compressing device 420 which moves along the length of the compressible tube 401 to force the surgical substance through the portal 404 of the compressible tube 401.
The construction and arrangement of the devices and methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, use of materials, orientations, etc.). For example, the position of elements may be reversed or otherwise varied and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.
This is a divisional of U.S. patent application Ser. No. 14/184,478, filed Feb. 19, 2014, which is incorporated herein by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
3310051 | Schulte | Mar 1967 | A |
3870198 | Cohen | Mar 1975 | A |
4015945 | Frankel | Apr 1977 | A |
4277184 | Solomon | Jul 1981 | A |
4399814 | Pratt et al. | Aug 1983 | A |
4464178 | Dalton | Aug 1984 | A |
4653487 | Maale | Mar 1987 | A |
4653489 | Tronzo | Mar 1987 | A |
4760844 | Kyle | Aug 1988 | A |
4772261 | Von Hoff et al. | Sep 1988 | A |
4976692 | Atad | Dec 1990 | A |
5047030 | Draenert | Sep 1991 | A |
5122114 | Miller et al. | Jun 1992 | A |
5133755 | Brekke | Jul 1992 | A |
5203770 | Wigness et al. | Apr 1993 | A |
5252301 | Nilson et al. | Oct 1993 | A |
5372583 | Roberts et al. | Dec 1994 | A |
5380319 | Saito et al. | Jan 1995 | A |
5425723 | Wang | Jun 1995 | A |
5562625 | Stefancin, Jr. | Oct 1996 | A |
5586821 | Bonitati et al. | Dec 1996 | A |
5618286 | Brinker | Apr 1997 | A |
5681289 | Wilcox et al. | Oct 1997 | A |
5702372 | Nelson | Dec 1997 | A |
5749883 | Halpern | May 1998 | A |
5752941 | Romano' et al. | May 1998 | A |
5769899 | Schwartz et al. | Jun 1998 | A |
5800407 | Eldor | Sep 1998 | A |
5842785 | Brown et al. | Dec 1998 | A |
5871484 | Spievack et al. | Feb 1999 | A |
5876116 | Barker et al. | Mar 1999 | A |
5951160 | Ronk | Sep 1999 | A |
6019761 | Gustilo | Feb 2000 | A |
6048343 | Mathis et al. | Apr 2000 | A |
6077265 | Werding et al. | Jun 2000 | A |
6210376 | Grayson | Apr 2001 | B1 |
6214012 | Karpman et al. | Apr 2001 | B1 |
6220888 | Correa | Apr 2001 | B1 |
6228088 | Miller et al. | May 2001 | B1 |
6286670 | Smith | Sep 2001 | B1 |
6364856 | Ding et al. | Apr 2002 | B1 |
6387098 | Cole et al. | May 2002 | B1 |
6461327 | Addis et al. | Oct 2002 | B1 |
6669059 | Mehta | Dec 2003 | B2 |
6679890 | Margulies et al. | Jan 2004 | B2 |
7018089 | Wenz et al. | Mar 2006 | B2 |
7527611 | Sweeney | May 2009 | B2 |
7575572 | Sweeney | Aug 2009 | B2 |
7608062 | Sweeney | Oct 2009 | B2 |
8057090 | Saha et al. | Nov 2011 | B1 |
8062270 | Sweeney | Nov 2011 | B2 |
8808337 | Sweeney | Aug 2014 | B2 |
20010021852 | Chappius | Sep 2001 | A1 |
20020138146 | Jackson | Sep 2002 | A1 |
20020169507 | Malone | Nov 2002 | A1 |
20030045885 | Margulies et al. | Mar 2003 | A1 |
20030083662 | Middleton | May 2003 | A1 |
20030139751 | Evans et al. | Jul 2003 | A1 |
20030212426 | Olson et al. | Nov 2003 | A1 |
20040225292 | Sasso et al. | Nov 2004 | A1 |
20050015059 | Sweeney | Jan 2005 | A1 |
20050015060 | Sweeney | Jan 2005 | A1 |
20050059972 | Biscup | Mar 2005 | A1 |
20050111300 | Nies et al. | May 2005 | A1 |
20060079905 | Beyar et al. | Apr 2006 | A1 |
20060111767 | Olson et al. | May 2006 | A1 |
20070073295 | Biedermann et al. | Mar 2007 | A1 |
20070083265 | Malone | Apr 2007 | A1 |
20070233123 | Ahmad et al. | Oct 2007 | A1 |
20080039846 | Lee et al. | Feb 2008 | A1 |
20080039855 | Lambert | Feb 2008 | A1 |
20080086143 | Seaton et al. | Apr 2008 | A1 |
20080154229 | Lambert | Jun 2008 | A1 |
20090164016 | Georgy et al. | Jun 2009 | A1 |
20090204158 | Sweeney | Aug 2009 | A1 |
20100042213 | Nebosky et al. | Feb 2010 | A1 |
20100042214 | Nebosky et al. | Feb 2010 | A1 |
20100106199 | Sawa et al. | Apr 2010 | A1 |
20100131014 | Peyrot et al. | May 2010 | A1 |
20100262089 | Sweeney | Oct 2010 | A1 |
20110046682 | Stephan et al. | Feb 2011 | A1 |
20120029432 | Sweeney | Feb 2012 | A1 |
20120041395 | Sweeney | Feb 2012 | A1 |
Number | Date | Country |
---|---|---|
0 858 775 | Aug 1998 | EP |
1 749 490 | Feb 2007 | EP |
1 653 869 | Jun 2011 | EP |
WO-8806023 | Aug 1988 | WO |
WO-9001364 | Feb 1990 | WO |
WO-02098307 | Dec 2002 | WO |
WO-2005009258 | Feb 2005 | WO |
WO-2010019788 | Feb 2010 | WO |
WO-2011063240 | May 2011 | WO |
WO-2013150476 | Oct 2013 | WO |
Entry |
---|
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. |
Communication received in European Patent Application No. 11250603.5, dated Feb. 20, 2015, 5 pages. |
European Search Report on EP 04757057.7, dated Nov. 30, 2009, 3 pages. |
European Search Report on EP 11250603.5-2310, dated Sep. 29, 2011, 6 pages. |
Instratek Inc., “Titanium Cannulated Bone Screws Minimize Surgery Time by Eliminating Complicated Procedure Steps,” www.instratek.com/bone_screw/, 5 pages. |
International Search Report and Written Opinion for PCT Application No. PCT/US2014/035542, dated Sep. 22, 2014, 14 pages. |
International Search Report and Written Opinion for PCT Application No. PCT/US2015/014216, dated Apr. 22, 2015, 14 pages. |
International Search Report and Written Opinion for PCT Application PCT/US2013/052853, dated Jan. 14, 2014, 15 pages. |
Office Action on EP 04757057.7, dated Jan. 26, 2010, 5 pages. |
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. |
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. |
SunMedica—Orthopaedic Surgery Products, “orthoPLUG® Hard Bone Design,” Redding, CA 96002; www.xunmedica.com, 1 page. |
Number | Date | Country | |
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20200275962 A1 | Sep 2020 | US |
Number | Date | Country | |
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Parent | 14184478 | Feb 2014 | US |
Child | 16876547 | US |