This application is a National Stage Application filed Under 35 U.S.C. § 371 of International Application No. PCT/CN2017/088368 filed Jun. 15, 2017, published Dec. 20, 2018 as International Publication No. WO2018/227446 A1 which is hereby incorporated by reference in its entirely.
Retractors are often used for permitting access to a bone structure intended for osteotomy procedures while at the same time providing protection for various soft tissue members. The development of surgical retractors and techniques that minimize the size of incisions has yielded major improvements in recovery time and post-operative pain because by reducing the required dissection of tissue. However, visualization of the retractor may be difficult, particularly when the procedure occurs at a location deep within the body of the patient. In orthopaedic surgery, it is extremely important that surgical tools such as retractors have good reliability (i.e., strength), biocompatibility and radiolucency. Currently, retractors for use in osteotomies, for example, have generally been designed using polyether ether ketone (PEEK), aluminum or Stainless Steel (SST). However, none of these materials has the ideal combination of characteristics for use in an osteotomy. The reliability of retractors composed of PEEK has often been poor while manufacturing cost is high. Aluminum retractors may be toxic and have also displayed poor reliability, while the radiolucency of retractors composed of SST is low.
The described embodiments of the invention are directed to a radiolucent tissue retraction device. The device may generally be described as comprising a handle extending along a handle axis and a first paddle coupled to a first end of the handle, the first paddle portion including a first portion extending parallel to and offset from the handle and a second portion connecting the first portion to the handle, the first portion having at least one radiolucent feature extending into a surface thereof, wherein the first portion is curved along a longitudinal axis thereof.
The present disclosure may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present disclosure is directed to orthopedic medical devices and, in particular, relate to surgical retractors including a radiolucent feature. Those skilled in the art will appreciate that the principles of the invention apply to any handheld medical device that is inserted into a patient during a surgical procedure. It should be noted that the terms “proximal” and “distal” as used herein are intended to refer to a direction toward (proximal) and away from (distal) a user of the device.
The retractor 100 includes two paddles 102, 202 and a handle 106. The first paddle 102 is coupled to a proximal end 130 of the handle 106 while the second paddle 202 is coupled to a distal end 132 of the handle 106. The first paddle 102 includes a first part 110 extending from a proximal end 112 to a distal end 114 and a second part 116 extending from the first part distal end 114 and including a substantially 90 degree bend. The first part 110 according this embodiment is an elongated member with a rounded proximal end 112 and a length along a longitudinal axis L1. The first part 110 includes a bone-contacting first surface 118, and an opposing second surface 120 and has a width W (i.e., an extent in a direction perpendicular to the axis L1) that is, in this embodiment, shorter than its length and substantially uniform along the length of the first part 110. In this embodiment, the first part 110 is curved about a first curvature axis L2 perpendicular to the central longitudinal axis, L1, as shown in
The first part 110 includes a plurality of radiolucent features including a plurality of slots and/or grooves 122 which, in this exemplary embodiment, extend perpendicular to the longitudinal axis L1 separated from one another along the length of the first portion 110. The grooves 122 are formed in the second surface 120. As would be understood by those skilled in the art, the radiolucency of the grooves 122 depends on the density of the Stainless Steel and the attenuation of length of the structure (i.e., thickness of the material). In an exemplary embodiment using Type 1.4542 Stainless Steel, the thickness of the first part 110 at the greatest depth of the grooves 122 (i.e., the minimum thickness of the material of the first part 110) is approximately 0.3 mm. The depth of these grooves 122 enhances the radiolucency of the first part 110. However, if this minimum thickness were applied uniformly over the surface of the first part 110 may be too thin to withstand the stresses applied during surgery. Thus, the grooves 122 are concave leaving an increased thickness of material toward the lateral surfaces of the first part 110. The thicker lateral sides of the first part 110 provide the stability required to withstand the stresses applied during use enhancing the reliability of the retractor 100 which increasing the radiolucency of the device. The grooves 122 are, in this embodiment, generally oval as illustrated in
The second part 116 extends from a proximal end 124 connected to the distal end 114 of first part 110 to a distal end 126 connected to the handle 106. In this embodiment, the second part 116 includes a curved portion 117 having an approximately 90-degree bend and a tapered portion 119. The curved portion 117 curves from a plane including the first part 110 to a plane perpendicular to the first part 110. In this exemplary embodiment, the width of the curved portion 117 is approximately equal to the width of the first part 110. However, the width of the tapered portion 119 decreases from a proximal end connected to a distal end of the curved portion 117 to the distal end 126 of second part 116 to form a substantially U or V-shape. For example, in the embodiment of
The handle 106 extends from a proximal end 130 coupled to the distal end 126 of the second part 116 to a distal end 132 coupled to a proximal end 212 of the second paddle 202 along a longitudinal axis Lh. In this embodiment, the handle 106 may be substantially cylindrical about a medial portion with tapering proximal and distal ends. It will be understood that the handle 106 may take any shape providing a stable connection between the first and second paddles 102, 202 as well as a suitable surface for gripping. The handle 106 may include a plurality of slots 134 distributed radially about the outer surface of the handle 106 for enhanced gripability when in use. The handle 106 may be formed of Stainless Steel or any other suitable biocompatible material.
The second paddle 202 in this embodiment is configured substantially similarly to the first paddle 102. Specifically, the second paddle 202 includes a first part 210 extending from a proximal end 212 to a distal end 214 and a second part 216 extending from the first part proximal end 212 and including a substantially 90 degree bend. The first part 210 according to this embodiment is an elongated member with a rounded distal end 214 and a length along a longitudinal axis L5. The first part 210 includes a bone contacting first surface 218 and an opposing second surface 220 and has a width W (i.e., an extent in a direction perpendicular to the axis L5) that is, in this embodiment, shorter than its length and substantially uniform along the length of the first part 210. In this embodiment, the first part 210 is curved about a first curvature axis L6 perpendicular to the central longitudinal axis, L5, as shown in
As with first portion 110, the first portion 210 includes a plurality of radiolucent features including a plurality of grooves 222 which, in this exemplary embodiment, extend perpendicular to the longitudinal axis L5 and are separated from one another along the length of the first portion 210. The grooves 222 are formed in the same manner as grooves 122. Namely, in an exemplary embodiment using Type 1.4542 Stainless Steel, the thickness of the first part 210 at the greatest depth of grooves 222 (i.e., the minimum thickness of the material of the first part 210) is approximately 0.3 mm. The grooves 22 are also concave leaving an increased thickness of material toward the lateral surface of the first part 210. In this embodiment, the grooves 22 are generally oval however, it will be understood that the grooves 222 may take any shape or form so long as at their greatest depth, the thickness of the paddle 202 is approximately 0.3 mm while the thickness of the lateral portions of the first part 210 is at least 2 mm.
The second part 216 extends from a proximal end 224 connected to the distal end 132 of the handle to a distal end 226 connected to the proximal end 212 of the first part 210. In this embodiment, the second part 216 includes a curved portion 217 having an approximately 90-degree bend and a tapered portion 219. The curved portion 217 curves from a plane including the first part 210 to a plane perpendicular to the first part 210. In this exemplary embodiment, the width of the curved portion 217 is approximately equal to the width of the first part 210. However, the width of the tapered portion 219 decreases from a distal end connected to a proximal end 212 of the first part 210 to a distal end 132 of the handle 106 to form a substantially U or V-shape. For example, in the embodiment of
The first and second paddles 102, 202 are coupled to the handle 106 so that the tapered portions 119, 219 extend perpendicular to a plane including the longitudinal axis of the handle. The tapered portion 119 extends perpendicular to the longitudinal axis Lh of the handle 106 in a first direction while the tapered portion 219 extends perpendicular to the longitudinal axis Lh of the handle 106 in an opposing direction, as can be seen in
The material of the retractor 100 of this embodiment is stainless steel which provides a high level of strength and reliability as well as improved radiolucent qualities, especially when combined with the thinner grooved portions 122, 222 disclose above. In an exemplary embodiment, the retractor is formed of Type 1.4542 Stainless Steel. In other embodiments, the retractor may be formed of 1.4301, 1.4021, 1.4310 Stainless Steels or any other suitable Stainless Steel variation. Stainless steel also shows high levels of biocompatibility to prevent from any toxicity when in the human body. Various techniques may be used to manufacture the device at a relatively low cost. For example, the retractor may be manufactured by machining, welding, finish, or heat treating.
Referring now to
It will be appreciated by those skilled in the art that changes may be made to the embodiments described above without departing from the inventive concept thereof. It should further be appreciated that structural features and methods associated with one of the embodiments can be incorporated into other embodiments. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but rather modifications are also covered within the scope of the present invention as defined by the appended claims.
Filing Document | Filing Date | Country | Kind |
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PCT/CN2017/088368 | 6/15/2017 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2018/227446 | 12/20/2018 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
1100312 | Leino | Jun 1914 | A |
8100828 | Frey et al. | Jan 2012 | B2 |
8636654 | Protopsaltis | Jan 2014 | B2 |
10093404 | Mariansky | Oct 2018 | B1 |
10398299 | Hawk et al. | Sep 2019 | B2 |
10464102 | Akiyama et al. | Nov 2019 | B2 |
10869657 | Raymond et al. | Dec 2020 | B2 |
10966702 | Swift | Apr 2021 | B1 |
20020095139 | Keogh | Jul 2002 | A1 |
20040015173 | Irving | Jan 2004 | A1 |
20050085723 | Huebner | Apr 2005 | A1 |
20050107671 | McKinley | May 2005 | A1 |
20060052671 | McCarthy | Mar 2006 | A1 |
20070038033 | Jones et al. | Mar 2007 | A1 |
20080090207 | Rubbert | Apr 2008 | A1 |
20080146885 | Protopsaltis | Jun 2008 | A1 |
20110093075 | Duplessis | Apr 2011 | A1 |
20120265021 | Nottmeier | Oct 2012 | A1 |
20120316430 | Aldag | Dec 2012 | A1 |
20140265789 | Metzler | Sep 2014 | A1 |
20140275797 | Ibrahim et al. | Sep 2014 | A1 |
20150196289 | Ryshkus et al. | Jul 2015 | A1 |
20150313456 | Hawkins et al. | Nov 2015 | A1 |
20160030128 | Duggal | Feb 2016 | A1 |
20170311941 | Daavettila | Nov 2017 | A1 |
20200345339 | Radl | Nov 2020 | A1 |
Number | Date | Country |
---|---|---|
2006-507099 | Mar 2006 | JP |
2007-514501 | Jun 2007 | JP |
2009-254752 | May 2011 | JP |
2011-115408 | Jun 2011 | JP |
2014-534868 | Dec 2014 | JP |
2016-521997 | Jul 2016 | JP |
Entry |
---|
International Search Report and Written Opinion, International Application No. PCT/CN2017/088368, dated Mar. 15, 2018, 15 pages. |
JP2019-569458—Corresponding JP Exam Report dated Mar. 23, 2021. |
English Translation—JP2011115408A_Abstract Dated Jun. 16, 2011. |
Number | Date | Country | |
---|---|---|---|
20210145428 A1 | May 2021 | US |