Sternum closure device having locking member
A sternal closure device including impermanently joined sliding and receiving attachment structures which are adapted for intercostal positioning between at least two corresponding rib pairs and substantially surrounding a patient's sternum with each structure having a cross member, a plurality of integrated legs and foot members, a plurality of sternum engagement surfaces, and an end portion. The receiving structure further incorporates a generally bow-shaped locking member with angularly disposed teeth-like structures positioned to receive and position a plurality of receiving structure projection members when inserted therein. The locking member further serves as a stabilizing structure with stabilization facilitated via an easily removed single screw like structure markedly facilitates quick release. The projection members further embody complimenting positioned teeth-like structures providing for racheting, unidirectional entry and positioning within the receiving attachment structure.
This application is a continuation-in-part of U.S. patent application Ser. No. 10/699,208 filed Oct. 31, 2003.
TECHNICAL FIELD OF THE INVENTIONThis invention relates generally to surgical devices. More specifically, the present invention relates to improved sternum clamping devices and methods to reapproximate a patient's sternum following a partial median sternotomy.
BACKGROUND OF THE INVENTIONA partial or median sternotomy is a procedure by which a saw or other appropriate cutting instrument is used to make a midline, longitudinal incision along a portion or the entire axial length of the patient's sternum, allowing two opposing sternal halves to be separated laterally. A large opening into the thoracic cavity is thus created, through which a surgeon may directly visualize and operate upon the heart and other thoracic organs or tissues. Following such a procedure, the two severed sternal halves must be reapproximated.
Traditionally, sternal halves have been reapproximated with stainless steel wires wrapped around or through the sternal halves so as to exert medial compression thereon and twisted together to approximate the sternum. Other methods of sternum repair include the use of band or strap assemblies which typically include a locking mechanism, which secures a strap in a closed looped configuration about the sternum positions. While utilization of steel wires and strap assemblies have been widely accepted for sternum repair, these devices present a number of disadvantages. Steel wires can and do break, and provide insufficient (non-uniform) clamping force resulting in sternal nonunion. Steel wires are difficult to maneuver and place around the sternum. The cut ends of the steel wires are also sharp and can pierce through the surgeon's gloves or fingers. In addition, the small diameter of the steel wires can cause the wires to migrate into or through the tissue surrounding the sternum region or into the sternal bone itself over time and result in sternal disintegration into small segments. This can lead to significant patient pain and discomfort in addition to slowing the postoperative recovery and increasing the risk of sternal infection. Moreover, the strap mechanisms of band assemblies are often relatively structurally complex and are difficult to precisely apply about the sternum. There are also healing problems associated with the use of steel wires and band assemblies due to improper forces exerted by these devices which can cause unwanted bone movements leading to raking and rubbing of surrounding tissue or bone.
Several other techniques of sternal reapproximation have been proposed both for primary closure following a median sternotomy and for reclosure following post-operative emergency surgical procedures. One such sternal fixation device is described in U.S. Pat. No. 6,051,007 entitled External Closure Device and Instruments Therefor, the entire contents of which are incorporated herein by reference.
The sternum closure device of U.S. Pat. No. 6,051,007 however is absent some of the advantages of the present invention. Most particularly foot portions (20, 40) of the '007 device are limited to two points of contact on the posterior section of a patient's sternum and consequently lack the stability and positioning enhancement features of various embodiments of the present invention. Quite distinguishable, from the '007 patent and other devices practiced in the contemporary art is the novel structure of various embodiments of the present invention which advances the art by allowing and encouraging divided sternal plates to be tilted upward to maximize healing surfaces in apposition to each other, thus avoiding downward plate deflection and substandard healing. Also distinguishable from devices of the contemporary art, embodiments of the present invention span the width of at least two interspaces, thus eliminating the need for more than one device for tight/secured closure over the same sternal area. The four securing leg and foot structures of various embodiments of the present invention improve pulmonary mechanics by assisting in the alignment of ribs across the sternotomy allowing for simultaneous right and left rib elevation symmetrically across the sternum and chest. The projection member structures of various embodiments of the present invention leverage the tight connections provided by fascia and muscle, strengthens pulmonary compliance and allows for distribution of energy and positioning strength to be spread evenly throughout the sternum. Various embodiments of the present invention enable fragmented segments of the sternum to be held in place for healing, as opposed to single plate structures of the contemporary art which concentrate (as opposed to distribute) energy occasionally to a crushing central point thereby allowing laterally displaced fragments to further displace.
BRIEF SUMMARY OF THE INVENTIONThe present invention provides an improved device and method for re-approximating the sternal halves of a patient's sternum following a median or partial sternotomy, and facilitates ready access to the thoracic cavity during or after a medical procedure advanced the art by overcoming the sternal nonunion problems inherent in prior art devices.
A sternum closure device in accordance with an embodiment of the present invention includes a sliding attachment structure including a plurality of projection members with angularly disposed teeth-like structures inwardly positioned on the innermost edges of each the plurality of projection members, and first and second leg portions, each of the first and second leg portions including a sliding attachment structure associated integrated foot portion and a sliding attachment structure associated sternum engagement portion. The sternum closure device includes a receiving attachment structure including a securing aperture, and third and forth leg portions, each of the third and fourth leg portions including a receiving attachment structure associated integrated foot portion and a receiving attachment structure associated sternum engagement portion. The sternum closure device still further includes and a generally bow-shaped locking member attached to the securing aperture of the receiving attachment structure and including a first distal end and a second distal end, each of the first distal end and the second distal end including angularly disposed teeth-like structures. The generally bow-shaped locking member is resiliently tensioned between the plurality of projection members such that the angularly disposed teeth-like structures of the generally bow-shaped locking member engage the angularly disposed teeth-like structures of the plurality of projection members.
The following disclosure teaches the structure and practice of a method for a sternal closure device, which comprises impermanently joined, sliding and receiving attachment structures that are adapted for intercostal positioning between at least two correspondingly positioned rib pairs substantially surrounding a patient's sternum with each structure having a cross member, a plurality of integrated leg and foot portions, a plurality of sternum engagement surfaces, and an end portion.
BRIEF DESCRIPTION OF THE DRAWINGS
While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides for inventive concepts capable of being embodied in a variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific manners in which to make and use the invention and are not to be interpreted as limiting the scope of the present invention.
While the invention has been described with a certain degree of particularity, it is clear that many changes may be made in the details of construction and the arrangement of components without departing from the spirit and scope of this disclosure. It is understood that the invention is not limited to the embodiments set forth herein for purposes of exemplification, but is to be limited only by the scope of the attached claim or claims, including the full range of equivalency to which each element thereof is entitled.
Referring to the drawings like numerals indicate like elements, one embodiment of an improved sternum closure device according to the present invention is shown in
The following disclosure teaches the structure and practice of a method for a sternum closure device, which comprises impermanently jawing, sliding and receiving attachment structures that are adapted for intercostal positioning between at least two correspondingly positioned rib pairs substantially surrounding a patient's sternum with each structure having a cross member, a plurality of integrated leg and foot portions, a plurality of sternum engagement surfaces, and an end portion.
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The generally bow-shaped locking member 220 is illustrated in
The locking member 220 further includes first and second extensions 230a and 230b extending from the first and second distal ends 226 and 228, respectively. The first and second extensions 230a and 230b extend beyond the receiving chamber 213 of the receiving attachment structure 212 to allow the first and second extensions 230a and 230b to be squeezed towards one another, for example, through use of pliers. The squeezing of the first and second extensions 230a and 230b allow the teeth-like structures 222 of the locking member 222 to disengage from the teeth-like structures 210 of the projection members 209 permitting the sternum closure device to be opened.
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A significant advantage of various embodiments of the present invention is to facilitate sternum closure via two separate attachment structures from opposing sides which decreases the amount of metal needed for clamping/securing structures. An additional advantage of various embodiments of the present invention is to provide for two independently adjustable locking means which distribute the strength of a sternum closure, equally and laterally, and essentially appose opposing rib segments along the same plane.
Another advantage of various embodiments of the present invention is to provide a device wherein the width of two separate sequentially occurring rib intraspaces are associated with the invention's clamping structures to eliminate need for multiple devices to facilitate sternum closure over the same area. A further advantage of various embodiments of the present invention is to provide a small locking member and clamping apparatus which results in decreased apparatus profile and weight but not closure strength.
Yet another advantage of various embodiments of the present invention is to provide for a single locking mechanism which improves pulmonary mechanics by assisting in the alignment of the ribs across a sternotomy, thus permitting simultaneous right and left rib elevation symmetrically across the sternum and chest. A further advantage of various embodiments of the present invention is to provide for a single locking mechanism which leverages ribs connected by fascia and muscle strengthening pulmonary compliance. An additional advantage of various embodiments of the present invention is to provide a mechanism and method by which the distribution of closure energy and strength are spread evenly throughout the sternum enabling even fragmented segments of the sternum to be held in place for healing.
Yet another advantage of various embodiments of the present invention is to provide an apparatus by which the strength of the sternal closure is actually increased and distributed by means of a double clamping mechanism over a correspondingly positioned rib pair. An additional further advantage of various embodiments of the present invention is to provide an apparatus by which the alignment of apposing ribs actually increases the strength of the closure as well as pulmonary force expiratory volume. Yet another advantage of various embodiments of the present invention is to provide an apparatus in which the edges are smooth to prevent dehiscence or extrusion.
Another advantage of various embodiments of the present invention is to provide for an easily accessible and expeditious means by which sliding and receiving attachment structures may be engaged to, and disengaged from on another. Another advantage of various embodiments of the present invention is its single set screw which when removed, allows rapid, complete disarticulation of the apparatus allowing almost instantaneous surgical access in the event of an emergency procedure.
Additional advantages of the invention are set forth, in part, in the description which follows and, in part, will be apparent to one of ordinary skill in the art from the description and/or from the practice of the invention. These together with other advantages of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages attained by its uses, reference would be had to the accompanying drawings, depictions and descriptive matter in which there is illustrated preferred embodiments and results of the invention.
It will be apparent to those skilled in the art that various modifications and variations can be made in the construction, configuration, and/or operation of the present invention without departing from the scope or spirit of the invention. For example, in the embodiments mentioned above, variations in the materials used to make each element of the invention may vary without departing from the scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of the invention provided they come within the scope of the appended claims and their equivalents.
While this invention has been described to illustrative embodiments, this description is not to be construed in a limiting sense. Various modifications and combinations of the illustrative embodiments as well as other embodiments will be apparent to those skilled in the art upon referencing this disclosure. It is therefore intended that this disclosure encompass any such modifications or embodiments.
Claims
1. A sternum closure device for positioning between at least two corresponding rib pairs substantially surrounding a patients sternum, the sternum closure device comprising:
- a sliding attachment structure including: a plurality of projection members with angularly disposed teeth-like structures inwardly positioned on the innermost edges of each the plurality of projection members; and first and second leg portions, each of the first and second leg portions including a sliding attachment structure associated integrated foot portion and a sliding attachment structure associated sternum engagement portion;
- a receiving attachment structure including: a securing aperture; and third and forth leg portions, each of the third and fourth leg portions including a receiving attachment structure associated integrated foot portion and a receiving attachment structure associated sternum engagement portion; and
- a generally bow-shaped locking member attached to the securing aperture of the receiving attachment structure and including a first distal end and a second distal end, each of the first distal end and the second distal end including angularly disposed teeth-like structures; and
- wherein the generally bow-shaped locking member is resiliently tensioned between the plurality of projection members such that the angularly disposed teeth-like structures of the generally bow-shaped locking member engage the angularly disposed teeth-like structures of the plurality of projection members.
2. The sternum closure device of claim 1, wherein the receiving attachment structure further includes securing means to removable attach the generally bow-shaped locking member to the receiving attachment structure.
3. The sternum closure device of claim 1, wherein the sliding attachment structure further includes a cross member connecting the plurality of projection members with the first and second leg portions.
4. The sternum closure device of claim 3, wherein the cross member includes a cut line to facilitate the separation of the plurality of projection members from the first and second leg portions by a cutting action.
5. The sternum closure device of claim 3, wherein the cross member includes at least one cut hole to facilitate the separation of the plurality of projection members from the first and second leg portions by a cutting action.
6. The sternum closure device of claim 1, wherein at least one of the plurality of projection members is in offset alignment by a predetermined offset with a corresponding first or second leg portion of the sliding attachment structure.
7. The sternum closure device of claim 1, wherein the generally bow-shaped locking member further includes first and second extensions extending from the first and second distal ends, respectively, the first and second extensions to facilitate, wherein squeezing of the first and second extensions facilitates disengagement of the teeth-like structures of the locking member from the teeth-like structures of the plurality of projection members.
8. The sternum closure device of claim 1, wherein at least a portion of a surface of the sliding attachment structure associated sternum engagement portion is knurled.
9. The sternum closure device of claim 1, wherein the plurality of projection members includes at least one trim hole to facilitate trimming of the plurality of projection members to a desired length.
10. The sternum closure device of claim 1, wherein the sliding attachment structure and the receiving attachment structure are sized and dimensioned to engage opposite sides of a patient's severed sternum and facilitate the tilting of divided sternal plates while positioned intercostally between at least two corresponding rib pairs.
11. The sternal closure device of claim 1 wherein each of the plurality of projection members are angularly offset with respect to each other.
12. The sternal closure device of claim 1, wherein the generally bow-shaped locking member may be compressed to facilitate disengagement of the sternal closure device when previously secured intercostally between at least two corresponding positioned rib pairs.
13. The sternal closure device of claim 1, wherein at least one portion of the sliding attachment structure is scored to facilitate disengagement of the sternal closure device when previously secured intercostally between at least two corresponding positioned rib pairs.
14. The sternal closure device of claim 1, wherein the receiving attachment structure further comprises at least one receiving chamber for slidably receiving the plurality of projection members of the sliding attachment structure.
15. The sternal closure device of claim 14, wherein the generally bow-shaped locking member includes a locking member securing aperture substantially centered between the first and second distal ends to facilitate securing of the generally bow-shaped locking member to the at least one receiving chamber of the receiving attachment structure.
16. The sternal closure device of claim 1, wherein each of the sliding attachment structure and the receiving attachment structure include a clamp guide to facilitate clamping together of the sliding attachment structure and the receiving attachment structure.
Type: Application
Filed: Nov 29, 2005
Publication Date: Aug 31, 2006
Inventor: Leonard Stevens (Tulsa, OK)
Application Number: 11/289,750
International Classification: A61F 2/30 (20060101);