This invention relates to surgical impactors for aiding in installing orthopedic prostheses, and more specifically, to an improved grasping mechanism for installing acetabular implants in the acetabular socket.
A double mobility prosthetic cup is a type of acetabular implant that is designed to increase a patient's range of hip mobility. Unlike other types of acetabular implants, double mobility prosthetic cups do not have an opening through the cup portion which allows for easy manipulation during implantation. For example, a rod is typically threaded through the cup opening to the apex of the cup dome where there is typically a threaded hole. This rod is used like a handle with which to control and guide the implant during implantation. Double mobility implants, on the other hand, do not have such an opening and therefore create a challenge in controlling them during implantation. The present invention solves this problem and provides an effective novel means of manipulating the double mobility implant during implantation.
Complicated mechanical devices have crevices and recesses that are difficult, if not almost impossible to clean with ease. Devices that are not properly cleaned and sterilized run the risk of disease transfer from patient to patient following the emergence of certain “prions” that are not killed by normal hospital sterilization and need to be physically removed by washing and rinsing.
During implantation of the prosthetic cup, a great amount of mechanical force is delivered to the cup implant. Generally, an impacting force is delivered to the proximal end of the impactor which is then imparted to the prosthetic cup at the distal end. The application of such mechanical impacting forces could damage the implant cup, particularly a double mobility prosthetic cup implant since these types of cup implants generally lack the mechanical strength to withstand the application of impaction forces throughout the prosthetic cup. Furthermore, these double mobility prosthetic cups are precisely machined with smooth surfaces. As such, the machined surfaces of these implants could become structurally deformed, cracked or scratched during implantation. In addition, many double mobility prosthetic cups may comprise an insert liner, commonly made of a ceramic material, that is positioned along the interior surface within the cavity of the prosthetic cup. These inserts provide a protective barrier that allows for smooth movement between a metallic joint and the metallic prosthetic cup. Like the prosthesis cup, these inserts could also become structurally deformed, cracked or scratched during implantation. Such damage to the cup and/or cup insert could result in a decrease of mobility for the patient or the need to repeat the prosthetic cup implantation process. Damage could also increase the risk of higher wear rates for the bearing components leading to possible earlier device failure.
Further, in surgical procedures in which access to the treatment site is limited, it is difficult to use current impactors without subjecting the patient to repeated abrasion and tissue trauma when inserting, operating and extracting surgical instruments.
Still further, once the appropriate position of the implant is selected, it is often difficult to ensure that the position does not change upon insertion of the assembly through the incision.
What is needed, therefore, is a double mobility implant impactor that minimizes the potential of damaging the cup implant during implantation. Further, the present invention provides an impactor that is easily adjustable, operatable, disassemblable, and cleanable. Still further, what is needed is an impactor that enables the surgeon to better maneuver, position and install the double mobility implant in a particular angular orientation.
The present invention relates to an acetabular impactor that aids a surgeon in controlling the installation of a double mobility acetabular prosthesis cup. The impactor has a housing which encloses a drive train having, at a far end, a double mobility prosthetic engaging subassembly, and at the opposite end, a handle which facilitates activation of the drive train and movement of the subassembly. The impactor enables easy orientation of a double mobility prosthesis attached to its end. This is important because precise control of the prosthetic is critical in implantation of the prosthetic in a patient.
The subassembly comprises a series of components, an impaction plate having a plurality of cup contacting members positioned on an exterior surface of the plate and a wedging assembly attached to a drive rod. The wedging assembly further comprises a first conical body positioned adjacent a second conical body, a conical bias member and an end cap member. The wedging assembly is designed to lock the cup contacting members in direct contact with the prosthesis cup at differing depths within the cup's interior surface, thereby providing a secure fit therebetween. Once positioned within the body, the wedging assembly can be released and the impactor removed, thus leaving the prosthetic cup positioned within the body.
An objective of the invention is to provide a novel design by which the double mobility cup prosthesis is manipulated and inserted into the body with minimum stresses imparted to the cup. The present invention provides an impactor by which potential damage to the cup during the implantation procedure is minimized.
A further objective is to provide an impactor that can be “easily cleaned”. Quick and modular disassembly of the impactor enables access to all surfaces that should be cleaned. The reduction in the number of small radius internal corners, crevices and small gaps and the absence of blind holes also aids in sterilization of the instrument.
Referring now to
The prosthesis cup engaging subassembly 20, as illustrated in
As shown in
As shown in
As shown in
As previously mentioned, the lower body portion 30 of the primary cup contacting member 26 extends below the upper body portion 32. The lower body portion 30 comprises opposing lower body portion sidewalls that form a lower body portion having a length, a width and a depth. In a preferred embodiment, a lip 50, as shown in
As shown in
As shown in
As shown in
Furthermore, as illustrated in
In addition, the impaction plate 24 may comprise a primary member channel 96 that resides within the thickness 84 of the impaction plate 24. More specifically, as illustrated in
As shown in
As shown in
An embodiment of the wedging assembly 33 is shown in
As shown in
In a preferred embodiment, an annular gasket 130 circumferentially extends around the proximal end of the first body 116. As shown, the gasket 130 protrudes outwardly from the outer perimeter of the annular sidewall 126. As shown, in
A first cone band 136 extends circumferentially around the proximal end of the first body 116. As shown, the first cone band 136 forms an exterior sidewall surrounding the gasket 130 and having a band frustro-conical shape that extends from the proximal end of the body 116 to a point distal of the cone's proximal end. In a preferred embodiment, the first cone band 136 may have an angled or ramped orientation with respect to the annular sidewall 126 of the first body 116. In an embodiment, the first band 136 may be positioned in an angled relationship ranging from about 5° to about 50° with respect to the exterior surface of the annular sidewall 126. As shown in
In a preferred embodiment, as illustrated in
The second conical body 118 resides distal of the first conical body 116. The second conical body 118 is of a general cone shape having an annular second conical body sidewall 142 extending from a second conical body distal end 144 to a second conical body proximal end 146. A second conical body throughbore 148 extends longitudinally therethrough. A second cone end sidewall 150 resides at the proximal end of the secondary conical body 118. In a preferred embodiment, the end sidewall 150 extends circumferentially around the throughbore opening 148 in a perpendicular relationship therewith. The second conical body sidewall 142 has a frusto-conical shape such that the diameter of the distal end 144 of the secondary conical body 118 is greater than the diameter at the proximal end 146 of the secondary conical body 118. In an embodiment, the annular second conical body sidewall 142 may be positioned at an angled relationship ranging from about 5° to about 50° with respect to longitudinal axis C-C as shown in
In a preferred embodiment, the wedging assembly 33 is constructed such that the annular sidewall 126 of the first conical body 116 is positioned through the throughbore 148 of the second conical body 118. In a preferred embodiment, a ledge 154 of the gasket portion 130 of the first body 116 is positioned on an exterior surface of the end sidewall portion 150 of the second conical body 118. The wedging assembly 33 is constructed such that the diameter at the distal end 111 of the assembly 33 is greater than the diameter at the proximal end 109 of the assembly 33 (
The annular wave-shaped bias member 120 is preferably positioned between the second conical body 118 and the end cap 122 of the wedging assembly 33. The bias member 120 provides a bias force against the first and second conical bodies 116, 118. As shown, the end cap 122 comprises a cylindrical sidewall 156 that extends from a proximal end to an enlarged gripping portion 158. An end cap throughbore 160 resides perpendicularly through the annular sidewall 156. The throughbore 160 is dimensioned such that the locking pin 124 may be positioned therethrough. The locking pin 124 received in throughbores 140 and 160 connects the end cap 122 to the first body 116 with the second conical body 118 and the bias member 120 positioned therebetween.
In operation, a prosthetic cup implant 12 is initially positioned at the distal end of the prosthesis engaging subassembly 20. As shown in
A prosthesis cup 12 is positioned over the distal end portion 38 of the primary cup contacting members 26A, 26B. Specifically, a prosthetic cup 12 is positioned over the distal end portion 38 of the primary cup contacting members 26A, 26B such that a distal end surface 40 or ridge 44 of the members 26A, 26B resides within the groove 72 of the cup 12. In addition, a portion of a front surface 76 of the distal end portion 38 of the primary cup contacting members 26A, 26B contacts a proximal end surface 78 of the prosthetic cup insert 14.
Once the prosthetic cup implant. 12 is initially positioned at the distal end of the prosthesis engaging subassembly 20, the wedging assembly 33 is utilized to lock the prosthesis cup 12 in position. Specifically, a downward movement of a lever 164 of the drive train 18 (
Proximal movement of the second cone sidewall 142 causes the distal end surface 70 of the secondary cup contacting members 28A, 28B into contact with the interior surface 34 of the cup 12, particularly an interior surface 42 of the insert 14 positioned within the cup 12. As shown in
In a preferred embodiment, when the lever 164 is moved in a downward direction towards the exterior surface 166 of the housing 16, the wedging assembly 33 begins to move in a proximal direction towards the central opening 86 of the impaction plate 24. Continued proximal movement of the wedging assembly 33 causes the second band 142 of the second cone 118 to first come into contact with the proximal end surfaces 68 of the second cup contacting members 28A, 28B. As shown in
As shown in
When the lever 164 reaches its full downward position and the wedging assembly 33 is positioned in its full proximal position, as shown in
The second cone 118 is biased against the bias member 120 such that impaction forces applied to the cup insert 14 by the secondary cone members 28A, 28B are primarily absorbed by the bias member 120. Thus, when an impaction force is applied to the end of the handle 22, the magnitude of the force is primarily absorbed by the bias member 120. In addition, some of the impaction force is absorbed by the first bias members 104 before that force is transferred to the primary cup contacting member 26. Furthermore, the use of the respective distal end surfaces 40 and 70, with a minimum amount of surface area, reduces the magnitude of the impaction force transmitted to the cup 12 or insert 14. This helps prevent damage to the cup 12 and insert 14 during their installation into an acetabulum.
In a preferred embodiment, the prosthesis engaging subassembly 20 is connected to the distal end 90 of the housing 16. The cylindrical drive rod 114, which is connected to a cylindrical piston 168, slides through the central axial bore 86 that penetrates through the impaction plate 24. The cylindrical drive rod 114 is preferably threaded. The cylindrical rod 114 is threaded into a corresponding threaded groove of the axial through-bore 128 of the primary body 116 of the wedging assembly 33 securing it in place as shown in
In a preferred embodiment, the impaction plate 24 may be made of a metallic material such as stainless steel, MP35N, aluminum or the like. The primary and secondary cup contacting members 26A, 26B, 28A, 28B are preferably made of a polymeric material such as, but not limited to synthetic rubber, neoprene, nylon, poly vinyl chloride (PVC), polystyrene, polyethylene, polypropylene, polyacrylonitrile, polyvinyl butyral (PVB), silicone, polyether ether ketone (PEEK), and the like.
With respect to the drive train 18, the piston 168 is connected by way of a first U-joint 170 to a lever 172 which slides in a pivoting sleeve 174 fixed to the housing 16 via a pivot 176. The lever 172 is connected via a second. U-joint 178 to a second pivoting lever 180 which is fixed to pivot in a catch 182 (
A slideable sleeve 186 slides over the lever 180 and has a trunnion 188 to which a rod 190 is pivotally attached. The rod 190 passes through a one-way catch 192 in the housing 16. The one-way catch 192 can be a captured split wedge sleeve 194 having an inner diameter that just matches the outer diameter of the rod 190. The split wedge sleeve 194 is captured in a recess having a matching conical surface that surrounds the sleeve so as to allow the rod 190 to slide into the housing 16, but to prevent the rod 190 from sliding out of the housing 16 unless an unlock lever (not show) is activated. Manipulation of the lever lifts the sleeve 186 out of engagement with the conical surface into an unlocked position to permit the rod 190 to back out of the housing 16. Any number of alternative one-way lock devices may be used, however, the selection of which being within the skill of a person of ordinary skill in this field. For greater detail regarding the drive train 18 supported by the housing 16, reference is made to U.S. Pat. No. 7,682,363 to Burgi et al., which is assigned to the assignee of the present invention and incorporated herein by reference.
Once correctly positioned within the body, impaction forces are delivered to the proximal end of the impactor 10. These impaction forces are intended to drive the prosthetic cup implant 12 to the desired location within the body. Once the cup implant 12 is securely in place, the tension between distal end surfaces 40, 70 of the members 26A, 26B and 28A, 28B against the respective primary and secondary cup contacting members 26A, 26B, 28A and 28B are released. A release button not shown) for the one-way catch 192 is depressed allowing the rod 190 to move in a reverse direction, thereby relieving the applied pressure of the distal end surfaces 40, 70 to the prosthetic cup 12 and/or insert 14. The operator may then pulls back on the handle 22 thereby retracting the impaction plate 24 and wedging assembly 33 of the prosthesis engaging subassembly 20 from the body. The inserter 10 is removed from the body leaving the double mobility prosthetic cup 12 behind within the body.
The inserter 10 is designed to be disassembled for cleaning by simply sliding the slide back so as to release the pivot. 182 and then lifting the drive train 18 out of the housing, but allowing the drive train to remain pivotally connected at pivot 176. As the drive train 18 is pivoted, the piston 168 is drawn out of the housing cavity. To reassemble after cleaning, the piston 168 is reinserted into the housing cavity and the drive train 18 is rotated back into position, with the one way locking mechanism entering its receiver and the pivot 176 again entering into the catch 182. The slide is then slid over the pivot 176 and the inserter 10 is again ready for use.
The present invention can be packaged in a kit offering a variety of double mobility prosthetic implants 12 of different sizes and diameters. The inserter 10 and assorted double mobility implants 12 and subassemblies 20 can be packaged in a case with recesses which conveniently hold the components in a convenient, easy to access manner.
The attached drawings represent, by way of example, different embodiments of the subject of the invention. Multiple variations and modifications are possible in the embodiments of the invention described here. Although certain illustrative embodiments of the invention have been shown and described here, a wide range of modifications, changes, and substitutions is contemplated in the foregoing disclosure. In some instances, some features of the present invention may be employed without a corresponding use of the other features. Accordingly, it is appropriate that the foregoing description be construed broadly and understood as being given by way of illustration and example only, the spirit and scope of the invention being limited only by the appended claims.
This application claims priority to U.S. provisional application Ser. No. 61/538,313, filed on Sep. 23, 2011.
Number | Name | Date | Kind |
---|---|---|---|
1942422 | Hanna | Jun 1931 | A |
D272648 | Bolesky et al. | Feb 1984 | S |
D273806 | Bolesky et al. | May 1984 | S |
4475549 | Oh | Oct 1984 | A |
4520511 | Gianezio et al. | Jun 1985 | A |
4528980 | Kenna | Jul 1985 | A |
4587964 | Walker et al. | May 1986 | A |
4632111 | Roche | Dec 1986 | A |
4716894 | Lazzeri et al. | Jan 1988 | A |
4765328 | Keller et al. | Aug 1988 | A |
4904267 | Bruce et al. | Feb 1990 | A |
4919679 | Averill et al. | Apr 1990 | A |
4921493 | Webb, Jr. et al. | May 1990 | A |
5019105 | Wiley | May 1991 | A |
5037424 | Aboczky | Aug 1991 | A |
5059196 | Coates | Oct 1991 | A |
5061270 | Aboczky | Oct 1991 | A |
5062854 | Noble et al. | Nov 1991 | A |
5089003 | Fallin et al. | Feb 1992 | A |
5116339 | Glock | May 1992 | A |
5124106 | Morr et al. | Jun 1992 | A |
5133766 | Halpern | Jul 1992 | A |
5169399 | Ryland et al. | Dec 1992 | A |
5171313 | Salyer | Dec 1992 | A |
5190549 | Miller et al. | Mar 1993 | A |
5234432 | Brown | Aug 1993 | A |
5261915 | Durlacher et al. | Nov 1993 | A |
5324293 | Rehmann | Jun 1994 | A |
5342362 | Kenyon et al. | Aug 1994 | A |
5364403 | Petersen et al. | Nov 1994 | A |
5417696 | Kashuba et al. | May 1995 | A |
5443471 | Swajger | Aug 1995 | A |
5454815 | Geisser et al. | Oct 1995 | A |
5485887 | Mandanis | Jan 1996 | A |
5540697 | Rehmann et al. | Jul 1996 | A |
5658294 | Sederholm | Aug 1997 | A |
5665091 | Noble et al. | Sep 1997 | A |
5683399 | Jones | Nov 1997 | A |
5707374 | Schmidt | Jan 1998 | A |
5762391 | Sumnitsch | Jun 1998 | A |
5863295 | Averill et al. | Jan 1999 | A |
5913860 | Scholl | Jun 1999 | A |
5928287 | Keller | Jul 1999 | A |
5931518 | Pirker | Aug 1999 | A |
5954727 | Collazo | Sep 1999 | A |
5976148 | Charpenet et al. | Nov 1999 | A |
5993455 | Noble | Nov 1999 | A |
6063124 | Amstutz | May 2000 | A |
6120508 | Grunig et al. | Sep 2000 | A |
6197065 | Martin et al. | Mar 2001 | B1 |
6432141 | Stocks et al. | Aug 2002 | B1 |
6451058 | Tuke et al. | Sep 2002 | B2 |
6626913 | McKinnon et al. | Sep 2003 | B1 |
6663636 | Lin | Dec 2003 | B1 |
6811569 | Afriat et al. | Nov 2004 | B1 |
6827381 | Reichert et al. | Dec 2004 | B1 |
7192449 | McQueen et al. | Mar 2007 | B1 |
7335207 | Smith | Feb 2008 | B1 |
7341593 | Auxepaules et al. | Mar 2008 | B2 |
7396357 | Tornier et al. | Jul 2008 | B2 |
7585301 | Santarella et al. | Sep 2009 | B2 |
7591821 | Kelman | Sep 2009 | B2 |
7604667 | DeSmet et al. | Oct 2009 | B2 |
7621921 | Parker | Nov 2009 | B2 |
7727282 | Slone et al. | Jun 2010 | B2 |
7785331 | Leisinger et al. | Aug 2010 | B2 |
7922726 | White | Apr 2011 | B2 |
8021370 | Fenton et al. | Sep 2011 | B2 |
8142439 | Parker | Mar 2012 | B2 |
8236003 | Burgi | Aug 2012 | B2 |
8277457 | Burgi et al. | Oct 2012 | B1 |
8398650 | Burgi | Mar 2013 | B1 |
8475465 | Teeny et al. | Jul 2013 | B2 |
20010051830 | Tuke et al. | Dec 2001 | A1 |
20020004660 | Henniges et al. | Jan 2002 | A1 |
20020116007 | Lewis | Aug 2002 | A1 |
20020177854 | Tuke et al. | Nov 2002 | A1 |
20020193797 | Johnson et al. | Dec 2002 | A1 |
20030009234 | Treacy et al. | Jan 2003 | A1 |
20030050645 | Parker et al. | Mar 2003 | A1 |
20030083668 | Rogers et al. | May 2003 | A1 |
20030088316 | Ganjianpour | May 2003 | A1 |
20030187512 | Frederick et al. | Oct 2003 | A1 |
20030220698 | Mears et al. | Nov 2003 | A1 |
20030229356 | Dye | Dec 2003 | A1 |
20040215200 | Tornier et al. | Oct 2004 | A1 |
20050038443 | Hedley et al. | Feb 2005 | A1 |
20050075736 | Collazo | Apr 2005 | A1 |
20050137603 | Belew et al. | Jun 2005 | A1 |
20050171548 | Kelman | Aug 2005 | A1 |
20050187562 | Grimm et al. | Aug 2005 | A1 |
20050222572 | Chana | Oct 2005 | A1 |
20050228395 | Auxepaules et al. | Oct 2005 | A1 |
20050234462 | Hershberger | Oct 2005 | A1 |
20050246031 | Frederick et al. | Nov 2005 | A1 |
20060052780 | Errico et al. | Mar 2006 | A1 |
20060149285 | Burgi et al. | Jul 2006 | A1 |
20060241781 | Brown et al. | Oct 2006 | A1 |
20070010825 | Leisinger et al. | Jan 2007 | A1 |
20070156155 | Parker | Jul 2007 | A1 |
20070167952 | Burgi et al. | Jul 2007 | A1 |
20070225725 | Heavener et al. | Sep 2007 | A1 |
20070270783 | Zumsteg et al. | Nov 2007 | A1 |
20070288096 | Surma | Dec 2007 | A1 |
20070293869 | Conte et al. | Dec 2007 | A1 |
20080004628 | White | Jan 2008 | A1 |
20080021481 | Burgi | Jan 2008 | A1 |
20080033444 | Bastian et al. | Feb 2008 | A1 |
20080077249 | Gradel | Mar 2008 | A1 |
20080146969 | Kurtz | Jun 2008 | A1 |
20080154261 | Burgi | Jun 2008 | A1 |
20080243127 | Lang et al. | Oct 2008 | A1 |
20080255565 | Fletcher | Oct 2008 | A1 |
20080255568 | Tornier et al. | Oct 2008 | A1 |
20080262503 | Muller | Oct 2008 | A1 |
20090112214 | Philippon et al. | Apr 2009 | A1 |
20090182334 | Brehm | Jul 2009 | A1 |
20090192515 | Lechot et al. | Jul 2009 | A1 |
20090240256 | Smith | Sep 2009 | A1 |
20090281545 | Stubbs | Nov 2009 | A1 |
20120053592 | Burgi | Mar 2012 | A1 |
20120136361 | Aux Epaules et al. | May 2012 | A1 |
20130079785 | Burgi | Mar 2013 | A1 |
Number | Date | Country |
---|---|---|
0453694 | Oct 1991 | EP |
0470912 | Dec 1992 | EP |
0535973 | Apr 1993 | EP |
3 7302 | Jul 1994 | EP |
638299 | Dec 1995 | EP |
1308140 | May 2003 | EP |
119 687 | Jul 2004 | EP |
1438936 | Jul 2004 | EP |
1447058 | Aug 2004 | EP |
9511641 | May 1995 | WO |
0012832 | Mar 2000 | WO |
2005044153 | May 2005 | WO |
2006061708 | Jun 2006 | WO |
2007098549 | Sep 2007 | WO |
2008128282 | Oct 2008 | WO |
2009136284 | Nov 2009 | WO |
Entry |
---|
Smith & Nephew Polarcup Dual Mobility System, Dec. 2006. |
European Search Report dated Apr. 15, 2011. |
Duraloc Option, Ceramic Acetabular Cup System, DePuy, Sep. 18, 2006. |
Number | Date | Country | |
---|---|---|---|
20130079785 A1 | Mar 2013 | US |
Number | Date | Country | |
---|---|---|---|
61538313 | Sep 2011 | US |