TECHNICAL FIELD OF THE INVENTION
This 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 INVENTION
A 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 INVENTION
The 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
FIG. 1 illustrates a frontal view of one embodiment of the present invention as practiced in its joined or associated state;
FIG. 2 illustrates a posterior view of one embodiment of the present invention as practiced in its joined or associated state;
FIG. 3 illustrates a side view of one embodiment of the present invention as practiced in its joined or associated state;
FIG. 4 illustrates a posterior view of one embodiment of the sliding attachment structure with the locking member positioned therein;
FIG. 5 illustrates distinguishable elements of one embodiment of the present invention in a disassociated state;
FIG. 6 illustrates a posterior view of the present invention intercostally positioned above and below at least two correspondingly positioned rib pairs and substantially surrounding a patient's sternum;
FIG. 7 illustrates a frontal view of the present invention intercostally positioned above and below at least two correspondingly positioned rib pairs and substantially surrounding a patient's sternum;
FIG. 8 illustrates a frontal view of another embodiment of a sliding attachment structure of a sternal closure device of the present invention;
FIGS. 9A-9D illustrate the sliding attachment structure of FIG. 8 after forming;
FIGS. 10A-10B illustrate another embodiment of a sternum closure device assembly in an open configuration; and
FIGS. 11A-11B illustrate the sternum closure device assembly of FIGS. 10A-10B in a closed configuration.
DETAILED DESCRIPTION
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 FIGS. 1 through 7.
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.
FIG. 1 illustrates a frontal view of one embodiment of the present invention when practiced in a joined or associated state. As can be seen in FIG. 1, a sliding attachment structure 3 comprises a cross member 5, a plurality of leg structures 7, and a plurality of projection members 9 with each projection member 9 further embodying a number of angularly disposed teeth-like structures 10 which are inwardly disposed and positioned on the innermost edges of each the projection members 9.
Continuing with FIG. 1, the projection members 9 are inserted through, generally u-shaped receiving chambers formed on the lower most surface of receiving attachment structure 12 (receiving chamber not shown in FIG. 1, discussed further in association with FIG. 2). Also shown in FIG. 1, is a connection means, such as but not limited to, a screw, lock, pin, or other similarly intended device 15 and a catch member (illustrated in association with FIGS. 4 and 5) which is inserted through a securing aperture 17 embodied within said receiving attachment structure 12. The connection means providing an easily accessible and expeditious means of engaging and disengaging attachment structures 3 and 12, thereby allowing rapid removal of the structure.
FIG. 2 illustrates a posterior view of one embodiment of the present invention as practiced in its joined or associated state. Referring now to FIG. 2, an embodiment of the receiving attachment structure 12 is shown further illustrating its receiving chambers 13 through which the projection members 9 of sliding attachment structure 3 are inserted. FIG. 2 further discloses a plurality of sternum engagement surfaces 8, which are located at the terminus of the integrated leg portions 7. In practice, the projection members 9 are slidably received into and through the receiving chambers 13 whereupon the projection members teeth-like structures 10 are correspondingly engaged by a generally bow-shaped locking member 20 (shown in FIGS. 4 and 5) having teeth-like structures, such that one-way traversing of said receiving chambers 13 is allowed. The teeth-like structures 10 of each projection member 9 and the locking member 20 further possess complimenting engagement surfaces which allow for secure positioning once a desired closure position has been realized. The locking member 20 and the projection members 9 form a one-way ratchet-type locking mechanism such that the sternum closure device may be ratcheted into a closed position, while opening of the sternum closure device is prevented. Further discussion and disclosure of the interaction between the locking member 20 and projection member 9 teeth-like surfaces 10 will be provided in association with FIGS. 4 and 5.
FIG. 3 illustrates a side view of one embodiment of the present invention as practiced in a joined or associated state. Referring now to FIG. 3, further distinction may be observed with respect to the foot portion 6, leg portion 7, and sternum engagement surfaces 8 of one embodiment of the present invention. A side view illustration of the engagement of the receiving chamber 13 is also provided, as is a beveled or otherwise angled projection member positioning limitation structure 18. The positioning limitation structure 18 is intended to provide the means by which a maximum projection member insertion may be observed and/or facilitated.
FIG. 4 illustrates a frontal view of one embodiment of the sliding attachment structure 3 with the locking member 20 positioned therein. The locking member 20 is a resiliently tensioned structure, typically, though not limitedly embodied of the same material as the receiving and sliding attachment structures 3 and 12. Still referring to FIG. 4, the projection members 9 are shown with inwardly positioned angularly disposed teeth-like structures 10 located on each of the projection members 9. The teeth-like structures 10 engage outwardly positioned teeth-like structures 22 located at first and second distal ends (26, 28) of the locking member 20 as the locking member 20 is housed and accommodated within the posterior of the receiving chambers 13. A securing aperture 24 is substantially centered between the first and second distal ends (26, 28) of the locking member 20. FIG. 4 allows comprehension and appreciation of the one-way insertion orientation of the slidably adjustable sternum closure device of various embodiments of the present invention.
FIG. 5 illustrates distinguishable elements of one embodiment of the present invention in a disassociated state. Still referring to FIG. 5, the locking member 20 may be observed in a state in which it is not engaged with the angularly disposed teeth-like structures 22 outwardly positioned at first and second distal ends (26, 28) of the locking member 20. FIG. 5 further provides a frontal view of the sliding attachment structure 3, as well as a posterior view of the receiving attachment structure 12.
FIG. 6 illustrates a posterior view of an embodiment of a pair of sternum closure devices of the present invention intercostally positioned above and below at least two correspondingly positioned rib pairs (31, 32) and substantially surrounding a patient's sternum (50).
FIG. 7 illustrates a frontal view of an embodiment of a pair of sternum closure devices of the present invention intercostally positioned above and below at least two correspondingly positioned rib pairs (31, 32) and substantially surrounding a patient's sternum (50).
FIG. 8 illustrates a frontal view of another embodiment of a sliding attachment structure 103 of a sternum closure device of the present invention. Still referring to FIG. 8, the sliding attachment structure 103 is illustrated in a pre-bent flat form. In various embodiments, the sliding attachment structure 103 is laser cut from a flat sheet of material. The flat form of the sliding attachment structure 103 is then shaped by bending into the form illustrated in FIG. 9. In various embodiments of the present invention, the sliding attachment structure 103 of FIG. 8 is used as an alternative to the sliding attachment structure 3 of in a sternum closure device illustrated in FIGS. 1-7.
Still referring to FIG. 8, the sliding attachment structure 103 includes two projection members 109 that have inwardly positioned angularly disposed teeth-like structures 110 located on each of the projection members 109. The teeth-like structures 110 engage outwardly positioned teeth-like structures 22 located at first and second distal ends (26, 28) of the locking member 20 of FIGS. 4 and 5 as the locking member 20 is housed and accommodated within the posterior of the receiving chambers 13. The sliding attachment structure 103 further includes a cross member 105, and a plurality of leg structures 107. Each of the plurality of leg structures 107 further includes a foot portion 106 and sternum engagement portions 108. The top surface of the sternum engagement portions 108 and a portion of the foot portions 106 are formed with a knurled or rough surface which aids in binding the sternum engagement portions 108 to the sternum of the patient to prevent movement of the sternum closure device after implantation. In various embodiments of the present invention, the leg structures 107 and the projection members 109 are offset from each other by a predetermined offset 119, whose function will be further discussed with respect to FIGS. 9A-9D.
Still referring to FIG. 8, the projection members 109 of the sliding attachment structure 103 may further include a plurality of trim holes 111 which facilitate trimming of the projection members 109 to a desired length after implementation of the sternum closure device by minimizing the amount of material that must be cut through. The cross member 105 of the sliding attachment structure 103 may further be provided with a cut line 115 and cut holes 117 which function to aid in cutting apart of the cross member 105 to allow quick release of the sternum closure device in situations in which such a quick release is necessary or desirable. In other embodiments, the cross member 105 may be scored with a line of reduced thickness to provide a snap point for quick release of the sternum closure device as an alternative to the cut line 115.
Referring now to FIGS. 9A-9D, the sliding attachment structure 103 of FIG. 8 after forming is illustrated. Referring now to FIG. 9A, a frontal view of the sliding attachment structure 103 after forming is illustrated. As discussed with respect to FIG. 8, the leg structures 107 and the projection members 109 are offset from each other by a predetermined offset 119. The function of the predetermined offset 119 is for situations in which corresponding ribs of a patient are not in alignment with each other. In one embodiment of the invention, the predetermined offset 119 is equal to three-sixteenths of an inch. It should be understood that sliding attachment structures having a number of different predetermined offsets may be provided as required by the particular alignment of the patient's ribs. In still other embodiments, the projection members 109 and the leg structures 107 may be angularly offset from each other such that they are not aligned in a parallel direction with respect to each other. In still other embodiments, each of the leg structures may be angularly offset from each other such that they are not parallel.
Referring now to FIG. 9B, an end view of the sliding attachment structure 103 after forming is illustrated. Referring now to FIG. 9C, a side view of the sliding attachment structure 103 after forming is illustrated. Referring now to FIG. 9D, a cross sectional view of the sternum engagement portions 108 of the sliding attachment structure 103 through a cross section A-A is illustrated. As illustrated in FIG. 9D, the cross section sternum engagement portion 108 is formed into a U-shape to prevent gouging of the ribs or sternum by the edges of the sternum engagement portion 108.
Referring now to FIGS. 10A-10B, another embodiment of a sternum closure device assembly in an open configuration is illustrated. FIG. 10A and FIG. 10B illustrate a frontal view and a side view, respectively, of the sternum closure device assembly in an open configuration. The sternum closure device includes a sliding attachment structure 203 and a receiving attachment structure 212. The sliding attachment structure 203 comprises a cross member 205, a plurality of leg portions 207, and a plurality of projection members 209 with each projection member 209 further embodying a number of angularly disposed teeth-like structures 210 which are inwardly disposed and positioned on the innermost edges of each the projection members 209. Each of the plurality of leg portions 207 further includes a foot portion 206.
Continuing with FIGS. 10A-10B, the projection members 209 are inserted through receiving chambers 213 formed of the receiving attachment structure 212. A connection means 215, such as but not limited to, a screw, lock, pin, or other similarly intended device and a catch member which is inserted through a securing aperture 217 embodied within the receiving attachment structure 212. The connection means 215 providing an easily accessible and expeditious means of engaging and disengaging the sliding attachment structure 203 and a receiving attachment structure 212, thereby allowing rapid removal of the sternum closure device.
FIGS. 10A-10B further illustrates a plurality of sternum engagement surfaces 208, which are located near the terminus of the leg portions 207. In practice, the projection members 209 are slidably received into and through the receiving chambers 213 of the receiving attachment structure 212 whereupon the projection members teeth-like structures 210 are correspondingly engaged by a generally bow-shaped locking member 220 having teeth-like structures, such that one-way traversing of the receiving chambers 213 is allowed. The teeth-like structures 210 of each projection member 209 and the locking member 220 further possess complimenting engagement surfaces which allow for secure positioning once a desired closure position has been realized.
The generally bow-shaped locking member 220 is illustrated in FIGS. 10A-10B as being positioned within the sliding attachment structure 203. The generally bow-shaped locking member 220 is a resiliently tensioned structure, typically, though not limitedly embodied of the same material as the receiving and sliding attachment structures 203 and 212. The locking member 220 of FIGS. 10A-10B is includes outwardly positioned teeth-like structures 222 located at each of opposed first distal end 226 and second distal end 228. The teeth-like structures 222 engage the teeth-like structures 210 of the sliding attachment structure 203 as the locking member 220 is partially housed and accommodated within the receiving chamber 213 of the receiving attachment structure 212. The locking member 220 further includes a securing aperture 224 that is substantially centered between the first and second distal ends (226, 228) of the locking member 220. The locking member 220 and the projection members 209 form a one-way ratchet-type locking mechanism such that the sternum closure device may be ratcheted into a closed position, while opening of the sternum closure device is prevented.
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.
Still referring to FIGS. 10A-10B, the projection members 209 of the sliding attachment structure 203 may further include a plurality of trim holes 211 which facilitate trimming of the projection members 209 to a desired length after implementation of the sternum closure device by minimizing the amount of material that must be cut through. The cross member 205 of the sliding attachment structure 203 may further be provided with a cut line 218 and cut holes 219 which function to aid in cutting apart of the cross member 205 to allow quick release of the sternum closure device in situations in which such a quick release is necessary or desirable. In other embodiments, the cross member 205 may be scored with a line of reduced thickness to provide a snap point for quick release of the sternum closure device as an alternative to the cut line 218.
Still referring to FIGS. 10A-10B, the receiving attachment structure 212 may be provided with a first clamp guide 232a, and the sliding attachment structure 203 may be provided with a second clamp guide 232b. In accordance with various embodiments, the first claim guide 232a is a c-shaped cut in the receiving chamber 213 of the receiving attachment structure 212, and the second clamp guide 232b is a c-shaped cut in the cross member 205 of the sliding attachment structure 203. The first clamp guide 232a and the second clamp guide 232b function to provide a guide for placement of a clamp for clamping together the sliding attachment structure and the receiving attachment structure of the sternum closure device with a greater force than may be generated by hand.
Referring now to FIGS. 11A-11B, the sternum closure device assembly of FIGS. 10A-10B is illustrated in a closed configuration. FIG. 11A and FIG. 11B illustrate a frontal view and a side view, respectively, of the sternum closure device assembly in a closed configuration. In the closed configuration of FIGS. 11A-11B, the sliding attachment structure 203 and the receiving attachment structure 212 have been slide together into a fully closed position such that the foot portions 206 of oppositely disposed leg portions 207 are in contact.
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.
Patent Application
20060195101
