# Patent

## Title
Method and Apparatus for Sternal Closure

## Abstract

A method and apparatus for securing a fractured or sectioned sternum in a patient's body is disclosed. The apparatus can include an attachment member and an adjustable flexible member construct. The attachment member can have a flexible member holder. The adjustable flexible member construct can have first and second ends and a body defining at least one passage portion. The first and second ends can be passed into and through the at least one passage portion via first and second openings associated with the at least one passage portion of the adjustable flexible member construct to form a pair of loops. The attachment member can be configured to be coupled to at least one of the formed pair of loops. The adjustable flexible member construct can be positioned about the sternum and can be reduced to compress the fractured or sectioned sternum.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a divisional of U.S. patent application Ser. No. 12/938,902 filed on Nov. 3, 2010, now U.S. Pat. No. 8,597,327, which is a continuation-in-part of U.S. patent application Ser. No. 12/915,962 filed on Oct. 29, 2010, now U.S. Pat. No. 8,562,647, which is a continuation-in-part of U.S. patent application Ser. No. 12/719,337 filed on Mar. 8, 2010, now U.S. Pat. No. 9,078,644, which is a continuation-in-part of U.S. patent application Ser. No. 12/489,168 filed on Jun. 22, 2009, now U.S. Pat. No. 8,361,113 issued on Jan. 29, 2013, which is a continuation-in-part of U.S. patent application Ser. No. 12/474,802 filed on May 29, 2009, now U.S. Pat. No. 8,088,130 issued on Jan. 3, 2012, which is a continuation-in-part of (a) U.S. patent application Ser. No. 12/196,405 filed on Aug. 22, 2008, now U.S. Pat. No. 8,128,658 issued on Mar. 6, 2012; (b) U.S. patent application Ser. No. 12/196,407 filed on Aug. 22, 2008, now U.S. Pat. No. 8,137,382 issued on Mar. 20, 2012; (c) U.S. patent application Ser. No. 12/196,410 filed on Aug. 22, 2008, now U.S. Pat. No. 8,118,836 issued on Feb. 21, 2012; and (d) a continuation-in-part of U.S. patent application Ser. No. 11/541,506 filed on Sep. 29, 2006, which is now U.S. Pat. No. 7,601,165 issued on Oct. 13, 2009.
This application is a continuation-in-part of U.S. patent application Ser. No. 13/645,964 filed on Oct. 5, 2012, which is a divisional of U.S. patent application Ser. No. 12/570,854 filed on Sep. 30, 2009, which is now U.S. Pat. No. 8,303,604 issued on Nov. 6, 2012, which is a continuation-in-part of U.S. patent application Ser. No. 12/014,399 filed on Jan. 15, 2008, which is now U.S. Pat. No. 7,909,851 issued on Mar. 22, 2011, which is a continuation-in-part of U.S. patent application Ser. No. 11/347,661 filed on Feb. 3, 2006, which is now U.S. Pat. No. 7,749,250 issued on Jul. 6, 2010.
This application is a continuation-in-part of U.S. patent application Ser. No. 13/587,374 filed on Aug. 16, 2012, which is now U.S. Pat. No. 8,777,956, which is a divisional of U.S. patent application Ser. No. 12/029,861 filed on Feb. 12, 2008, which is now U.S. Pat. No. 8,251,998 issued on Aug. 28, 2012, which is a continuation-in-part of U.S. patent application Ser. No. 11/504,882 filed on Aug. 16, 2006, which is now U.S. Pat. No. 8,998,949, which is a continuation-in-part of U.S. patent application Ser. No. 11/408,282 filed on Apr. 20, 2006, now abandoned.
This application is a continuation-in-part of U.S. patent application Ser. No. 12/702,067 filed on Feb. 8, 2010, which is now U.S. Pat. No. 8,672,968, which is a continuation of U.S. patent application Ser. No. 11/541,505 filed on Sep. 29, 2006 and is now U.S. Pat. No. 7,658,751 issued on Feb. 9, 2010.
This application is a continuation-in-part of U.S. patent application Ser. No. 13/098,927 filed on May 2, 2011, which is now U.S. Pat. No. 8,852,171, which is a continuation-in-part of U.S. patent application Ser. No. 12/196,398 filed Aug. 22, 2008, which is now U.S. Pat. No. 7,959,650 issued on Jun. 14, 2011, which is a continuation-in-part of U.S. patent application Ser. No. 11/784,821 filed Apr. 10, 2007, which is now U.S. Pat. No. 9,017,381.


The disclosures of all of the above applications are incorporated by reference herein.
FIELD
The present disclosure relates generally to methods and arrangements for securing a fractured or sectioned bone, and more particularly to methods and arrangements for sternal closure.
BACKGROUND
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
After trauma or surgical intervention, there may be a need to fix bone fragments or portions together to immobilize the fragments and permit healing. Compressive force can be applied to the bone fragments by encircling the bone fragments or bridging the fragments together across a broken, sectioned (cut) or otherwise compromised portion of the bone. The compressive forces should be applied such that upon ingrowth of new bone, the fragments will heal together and restore strength to the site of trauma or surgical intervention.
Accordingly, there is a need for apparatus and methods to apply compressive force to a bone across a fracture or section (cut) to maintain alignment and assist healing. Further, there is a need for apparatus and methods that are easy to use intraoperatively to accommodate various bone sizes or shapes, or locations of bone fractures or sections.
SUMMARY
This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
In one aspect, an apparatus for securing a fractured or sectioned bone in a patient's body is provided. The apparatus can include an attachment member and an adjustable flexible member construct. The attachment member can have a flexible member holder. The adjustable flexible member construct can have a body extending from a first end to a second end and defining at least one passage portion. The first and second ends can be passed into and through the at least one passage portion via at least first and second openings associated with the at least one passage portion of the adjustable flexible member construct to form a pair of loops. The attachment member can be configured to be coupled to at least one of the formed pair of loops.
In another aspect, a method is provided for securing a fractured or sectioned sternum in a patient's body. The method can include forming an adjustable flexible member construct, which can include providing a flexible member having first and second ends and a body defining first and second passage portions spaced apart from each other by a first portion of the flexible member. The first end can be passed into and through the second passage portion and then into and through the first passage portion to form a first loop. The second end can be passed into and through the first passage portion in an opposite direction as the first end and then into and through the second passage portion in an opposite direction as the first end to form a second loop. An attachment member can be coupled to the first and second loops. The fractured or sectioned sternum can be encircled by at least partially wrapping the formed adjustable flexible member construct about the sternum. The first portion of the flexible member construct opposite the loops can be coupled to the attachment member. The adjustable flexible member construct can be reduced to compress the fractured or sectioned sternum.
In yet another aspect, a method is provided for securing a fractured or sectioned sternum in a patient's body. The method can include providing an adjustable flexible member construct and positioning the adjustable flexible member construct across a fracture or section of the fractured or sectioned sternum. The adjustable flexible member construct can have first and second ends and a body defining at least one passage portion therebetween. The first and second ends can be passed into and through the at least one passage portion via at least first and second apertures associated with the at least one passage portion of the adjustable flexible member construct to form a pair of loops. A fixation arrangement can be provided and the pair of loops can be coupled to the fixation arrangement. The adjustable flexible member construct can be reduced to a reduced position to compress the fractured or sectioned sternum by applying tension to the first and second ends of the adjustable flexible member construct and thereby reducing the size of the pair of loops. The adjustable flexible member construct can be automatically maintained in the reduced position.
Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.



DRAWINGS
The present teachings will become more fully understood from the detailed description, the appended claims and the following drawings. The drawings are for illustrative purposes only and are not intended to limit the scope of the present disclosure.
FIG. 1 depicts an adjustable flexible member construct according to the present teachings;
FIGS. 1A and 1B depict an exemplary method of assembling the adjustable flexible construct of FIG. 1 according to the present teachings;
FIG. 2 depicts an exemplary assembly configuration of the flexible member construct of FIG. 1 having an attachment member and an insertion member according to the present teachings;
FIG. 2A depicts a side view of the attachment member of FIG. 2 according to the present teachings;
FIGS. 3, 3A and 3B depict alternative flexible member constructs according to the present teachings;
FIGS. 4 and 5 depict exemplary views of the adjustable flexible member construct of FIG. 1 in a surgical procedure for sternal closure according to the present teachings;
FIGS. 6-9 depict views of exemplary alternative attachment members associated with one or more of the adjustable flexible member constructs according to the present teachings;
FIGS. 10 and 11 depict views of the attachment members of FIGS. 6-9 in exemplary configurations for use in a sternal closure procedure according to the present teachings;
FIG. 12 depicts a view of an exemplary use of the flexible member construct of FIG. 3A in a surgical method for sternal closure according to the present teachings;
FIG. 13 depicts an exemplary alternative attachment member according to the present teachings;
FIG. 14 depicts exemplary configurations of the attachment member of FIG. 13 associated with various adjustable flexible member constructs according to the present teachings;
FIG. 15 depicts an exemplary surgical method for sternal closure according to the present teachings; and
FIG. 16 depicts an exemplary surgical method for sternal closure according to the present teachings.



DETAILED DESCRIPTION
The following description is merely exemplary in nature and is in no way intended to limit the present disclosure, its application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. While the disclosure relates to apparatus and associated methods for sternal closure, the apparatus and methods of the present teachings can be used in connection with various other fracture fixation methods and/or procedures.
Referring to FIG. 1, an adjustable flexible member construct 10 is provided according to various aspects of the present teachings. The adjustable flexible member construct 10 can be fashioned from a flexible member 14 made of any biocompatible material including, but not limited to, non-resorbable polymers, such as polyethylene or polyester, resorbable polymers, and various combinations thereof. In various aspects, the adjustable flexible member construct 10 can include a hollow material or core to allow for appropriate tensioning, as will be discussed herein. In various aspects, the adjustable flexible member construct 10 can be a suture. In such aspects, the suture can be hollow or a braided or a multiple-filament braided suture structure having a hollow core. In various aspects, the suture can be resorbable. In various aspects, the adjustable flexible member construct 10 can define a substantially tubular hollow shape.
The adjustable flexible member construct 10 can include a first end 18, a first formed passage portion 22, a second end 26, a second formed passage portion 30, and a fixed length loop portion 34 connecting the first and second passage portions 22, 30, as shown in FIG. 1. In one exemplary aspect, flexible member construct 10 can include an elongated body 32 having an exterior surface and an interior surface defining an elongated passage between the first and second ends 18, 26. The body 32 can define the first and second passage portions 22, 30 and the fixed length portion 34 therebetween. Passage portions 22, 30 can each include first apertures 38, 42 positioned proximate one end thereof, and second apertures 46, 50 positioned proximate a second opposite end thereof. The passage portions 22, 30 can be formed to have a larger width or diameter than remaining portions of flexible member 14, as shown for example in FIG. 1. Alternatively, the passage portions 22,30 can be formed initially to have the same width or diameter as the remaining portions of flexible member 14, later expanding in diameter during the construction process. In various aspects, the first and second apertures 38, 42, 46, 50 can be formed during a braiding process of flexible member 14 as loose portions between pairs of fibers defining flexible member 14, or can be formed during the construction process. Alternatively, the first and second ends can be pushed between individual fibers of the braided flexible member 14, as will be discussed herein.
To form the adjustable flexible member construct 10, first end 18 can be passed through second passage portion 30 via first and second apertures 42, 50, as generally shown in FIGS. 1A and 1B. In a similar manner, second end 26 can be passed through the first passage portion 22 via the first and second apertures 38, 46, as also shown in FIGS. 1A and 1B. Subsequently, as shown in FIG. 1B with reference to FIG. 1, first end 18 can be passed through the first passage portion 22 via second and first apertures 46 and 38, respectively. First end 18 can follow a path that is opposite in direction to a path followed by a portion 54 of the flexible member 14 that has already passed through first passage portion 22 while following second end 26 through first and second apertures 38 and 46. Similarly, second end 26 can be passed through the second passage portion 30 via second and first apertures 50 and 42, respectively. First end 26 can follow a path that is opposite in direction to a path followed by a portion 58 of the flexible member 14 that has already passed through second passage portion 30 while following first end 18 through first and second apertures 42 and 50. This results in portions 62, 64 of flexible member 14 being positioned parallel or substantially parallel to portions 54, 58 in passage portions 22, 30. Passing the first and second ends 18, 26 though passage portions 22, 30 as discussed above forms adjustable loops 66, 70, as shown in FIG. 1. The first and second ends can be passed through the same apertures in each passage portion 22, 30 or, alternatively, through separate apertures in each passage portion 22, 30.
The adjustable flexible member construct 10 can thus provide a double adjustable loop configuration via loops 66, 70 while also providing portion 34, which can have a fixed length between the passage portions 22, 30. As will be discussed in greater detail herein, this configuration can be used, for example, to couple an attachment member to loops 66, 70 and couple fixed length portion 34 to either the attachment member or another device. In this manner, the amount of friction developed within the first and second passage portions 22, 30 relative to and among portions 54, 58, 62 and 64 during adjustment of adjustable loops 66, 70 is reduced as compared to that which would occur if the attachment member were coupled to the passage portion when the loops are being adjusted or reduced in size under tension.
With additional reference to FIGS. 2 and 2A, adjustable flexible member construct 10 is shown in an exemplary assembly configuration 76 having an attachment member 80 coupled to a first side 84 of loops 66, 70 opposite a second side 88 facing fixed length portion 34. Attachment member 80 can include a generally T-shaped configuration having a first stem portion 92 defining an aperture 94 for receipt of loops 66, 70 therein at one end, and a transversely extending cross portion 96 at a second opposite end. Transversely extending portion 96 can include opposed lateral ends 104 that include arcuate or curled portions 108, as shown in FIG. 2A. In various aspects, attachment member 80 can be used to secure a flexible member loop thereto by placing the loop over first portion 92 and under arcuate portions 108, as shown for example in FIG. 4.
The assembly configuration 76 can also include an optional grab member or handle 116 and a passing or needle member 118. Handle 116 can be used to aid the surgeon in easily pulling ends 18, 26 of construct 10 to reduce the size of loops 66, 70, as will be discussed in greater detail below. Handle 116 can include a first pair of apertures 120 positioned at opposed ends 124 of handle 116, as shown in FIG. 2. The first and second ends 18, 26 can be passed or routed through apertures 120 and then through a central aperture 128, where ends 18, 26 can be secured to handle 116 by various methods, including a knot 132, as also shown in FIG. 2. The surgeon can use handle 116 to apply simultaneous tension to ends 18, 26, which can thereby evenly reduce or adjust loops 66, 70 to a desired size or tension.
Operation of the adjustable flexible member construct 10 will now be described in greater detail with reference to an exemplary configuration where adjustable flexible member construct 10 is wrapped around or encircles a bone, such as a sternum, and fixed loop 34 is connected to attachment member 80, as shown for example in FIG. 4. It should be appreciated, however, that construct 10 can be used in various attachment configurations, other than the example discussed above, wherein tension is applied to construct 10 via fixed loop 34 and attachment member 80 in connection with reducing or adjusting the size of loops 66, 70.
Upon applying tension to ends 18, 26, with or without handle 116, the loops 66, 70 can be reduced to a desired size and/or placed in a desired tension by causing translation of ends 18, 26 relative to passage portions 22, 30. Tension in fixed length loop portion 34 combined with the tension in adjustable loops 66, 70 can cause the body 32 of flexible member 14 defining the passage portions 22, 30 to constrict about the portions 54, 58 and 62, 64 of flexible member 14 passed therethrough. This constriction can reduce a width or diameter of each of the passage portions 22, 30, thereby forming a mechanical interface between exterior surfaces of the passed through portions of flexible member 14 and interior surfaces of the passage portions 22, 30. The static friction between the interior and exterior surfaces at the mechanical interface formed as a result of the constriction can prevent relative movement of portions 54, 58, and 62, 64 relative to passages 22, 30 and hence prevent relaxation of the tension in construct 10, thereby preventing an increase in the size of loops 66, 70. Thus, adjustable flexible member construct 10 provides for “automatically” locking loops 66, 70 in a reduced length or size under tension without requiring a knot.
Flexible member construct 10 can be provided in various sizes to accommodate differently sized bones, such as sternums, in different patients. In one exemplary configuration, fixed loop portion 34 can be provided in various sizes or lengths. Flexible member construct 10 can also be provided with flexible member 14 having various diameters, such as 30 thousandths of an inch or 37-40 thousandths of an inch. In one exemplary configuration, the 30 thousandths diameter flexible member 14 can be used, for example, where construct 10 is routed or passed through holes drilled in the bone so that flexible member 14 can be more easily manipulated during such routing. The larger 37-40 thousandths diameter flexible member 14 can be used, for example, where the construct 10 is wrapped around the sternum, as will be discussed herein. Forming the construct 10, as well as other constructs discussed herein, with a larger diameter flexible member provides more surface area of the tensioned flexible member to engage the sternum or other bone, and thus distribute the compressive load over a greater area of the bone.
With additional reference to FIG. 3, and FIG. 3A, an exemplary alternative adjustable flexible member construct 150 is shown. Construct 150 can include a hollow flexible member 154 having a first end 158 and a second end 162, and can include a body 164 that defines a longitudinal passage portion 168 therein between first and second ends 158, 162, as shown in FIG. 3. The passage portion 168 can define a pair of apertures 172, 176 at opposed ends thereof, similar to apertures 38, 46 discussed above. To form construct 150, the first end 158 can be passed through aperture 172 and passage portion 168 and out aperture 176 such that a portion 180 of flexible member 154 following first end 158 extends through passage portion 168. In a similar manner, second end 162 can be passed through aperture 176 and passage portion 168 and out aperture 172 such that a portion 184 of flexible member 154 following second end 162 also extends through passage portion 168. This configuration forms two loops 188 and 188′, as shown in FIG. 3. It should be appreciated that each of the first and second ends 158, 162 can alternatively be pushed through a respective space defined between adjacent individual fibers of the braided flexible member 14 such that the respective spaces defined between fibers comprise apertures 172, 176 in communication with an interior longitudinal passage.
The pulling of ends 158, 162 can cause movement of portions 180, 184 relative to passage portion 168, and the loops 188, 188′ can be reduced to a desired size or placed in a desired tension. Tension in loops 188, 188′ can cause the body 164 defining the passage portion 168 to be placed in tension and therefore cause passage portion 168 to constrict about portions 180, 184 passed therethrough. This constriction reduces the diameter of passage portion 168, thus forming a mechanical interface between the exterior surfaces of portions 180, 184 and an interior surface of passage portion 168. This constriction results in static friction between the interior and exterior surfaces at the mechanical interface, causing the adjustable flexible member 154 to “automatically” lock in a reduced size or diameter configuration in which tension is maintained. Flexible member construct 150 with adjustable loops 188, 188′ can be used to compress a fractured or sectioned bone, such as a sectioned sternum in a sternal closure procedure following open chest surgery, as will be discussed herein.
With additional reference to FIG. 3A, adjustable flexible member construct 150 is shown having attachment members or flexible anchors 196 coupled to loops 188, 188′. Each loop can include various numbers of anchors coupled thereto, including more or fewer anchors 196 than shown. Each anchor 196 can define a hollow core and can include a pair of apertures 200, 204 formed in a body 208 thereof in a similar manner as apertures 38, 46 discussed above. Flexible member 154 can pass through first aperture 204 into the hollow core and out through the second aperture 200, as shown in FIG. 3A. Apertures 200, 204 can be placed inward from respective ends 212, 216 of anchors 196 so as to form tail portions 220, 224 adjacent each aperture 200, 204. The tail portions 220, 224 can provide anchoring resistance relative to a corresponding bone or anchoring structure, as will discussed herein.
With reference to FIG. 3B and continuing reference to FIGS. 3 and 3A, an alternative adjustable flexible member construct 150A is shown. Construct 150A can be formed to include a double loop configuration having two loops 240, 240′ that each traverse a path from one end of passage portion 168 to the other end thereof, instead of each loop being disposed at respective opposite ends of passage portion 168 as in construct 150. Flexible member construct 150A can be formed by passing the first end 158 of the flexible member through aperture 176, through passage portion 168 and out aperture 172. The second end 162 can be passed through aperture 172, through the passage portion 168 and out the aperture 176. In various aspects, the first and second apertures 172, 176 can be formed during the braiding process as loose portions between pairs of fibers defining the flexible member 154, as discussed above. Passing ends 158, 162 through the apertures 172, 176 can form the loops 240, 240′. The loops 240, 240′ can define mount or summit portions 244, 244′ of the adjustable flexible member construct 150A and can be disposed generally opposite from the passage portion 168. Flexible member construct 150A can be used, for example, to compress a fractured or sectioned bone or to close a sectioned sternum in sternal closure procedures, as will be discussed herein.
The longitudinal and parallel placement of the first and second ends 158 and 162 of the flexible member 154 within the passage portion 168 resists the reverse relative movement of the first and second portions 180, 184 of the flexible member construct 150A once it is tightened. The tensioning of the ends 158 and 162 can cause relative translation of the portions 180, 184 relative to passage portion 168. Upon applying tension to the first and second ends 158 and 162, the loops 240, 240′ can be reduced to a desired size or placed in a desired tension. Tension in the loops 240, 240′ can cause the body of the flexible member 154 defining the passage portion 168 to be placed in tension and therefore cause passage portion 168 to constrict about the portions 180, 184 similarly to the constriction discussed above with respect to construct 150. This constriction can cause the adjustable flexible member construct 150A to “automatically” lock in a reduced size or smaller diameter configuration. A further discussion of the flexible member constructs 150, 150A are provided in U.S. patent Ser. No. 11/541,506 filed on Sep. 29, 2006 entitled “Method and Apparatus for Forming a Self-Locking Adjustable Suture Loop” assigned to Biomet Sports Medicine, LLC, and the disclosure is incorporated by reference.
Referring now to FIGS. 4-16, the use of flexible member constructs 10, 150 and 150A in various assembly configurations and exemplary sternal closure procedures will now be described. With particular reference to FIGS. 4 and 5, a sternum 304 is shown having a section or cut 308 separating sternal portions 312, 316, such as may be performed in connection with cardiac surgery. Flexible member constructs 10, 150, 150A alone, or in various combinations with each other or additional fixation devices, can be used to compress and secure sternal portions 312, 316 together to assist healing, as will be discussed herein.
In FIGS. 4 and 5, adjustable flexible member construct 10 is shown in various configurations to compress sternal portions 312, 316 toward each other to close section 308. In one exemplary configuration, two flexible member constructs 10 can be used in a diagonal pattern in the manubrium 320 of the sternum in connection with two pairs of diagonally opposite holes 324 formed in the manubrium 320. While the diagonal pattern of flexible member construct 10 is shown in the manubrium 320 in FIG. 4, a non-diagonal or medial-lateral configuration can alternatively be used, as generally shown in FIG. 5.
To secure flexible member construct 10 to the manubrium 320, passing member 118 can be inserted through a first hole 324a of a respective pair of holes 324a, 324b and directed towards a corresponding second hole 324b, as shown in FIG. 5. A surgeon or the like can pull the passing member through the second hole 324b thus routing at least the fixed portion 34 through the first and second holes 324a, 324b. Fixed portion 34 can then be secured to attachment member 80, as shown in FIG. 4. Once fixed portion 34 is secured to the attachment member, first and second ends 18, 26 can be pulled or tensioned to reduce the loops 66, 70 to a desired size and to place construct 10 in a desired tension to compress and close the sectioned sternum 304. Ends 18, 26 of construct 10 can be tensioned by pulling on the respective ends as discussed above, or with the use of the handle 116, as generally shown in FIG. 4. Handle 116 can provide the surgeon with an ability to easily tension ends 18, 26 simultaneously and evenly. Handle 116 can then be removed and discarded. Handle 116 can be used to evenly tension loops 66, 70 as discussed above, or can be used to tension loops 66, 70 at different rates by manipulating an angle of handle 116 so that, for example, a first loop of loops 66, 70 can be tensioned at a faster rate than a second loop of loops 66, 70. In this manner, the first loop can reach a desired final tension before the second loop. In one exemplary configuration, the smaller diameter flexible member can be used with construct 10 in manubrium 320 for easier manipulation through holes 324.
Flexible member construct 10 can also be used to compress a body 332 of sternum 304, as also shown in FIGS. 4 and 5. For the body 332, construct 10 can be wrapped around the sternum and fixed portion 34 can be secured to attachment member 80 such that ends 18, 26 extend from an anterior side 336 of body 332, as shown in FIG. 4. In the exemplary configuration shown in FIG. 4, three flexible member constructs 10 are shown securing the body 332 of the sternum 304. Nevertheless, more or fewer flexible constructs than shown can be used in the intercostal spaces between the ribs to secure the body of the sternum, as may be determined by a surgeon during a sternal closure procedure. In addition, the larger diameter flexible member construct 10 can be utilized in body area 332 of sternum 304, according to one exemplary configuration. The larger diameter flexible member can enable more tension to be applied to the bone or sternum without cutting into or damaging the bone.
The flexible member constructs 10 can be attached and tensioned or secured to the sternum 304 in various orders. For example, flexible member constructs 10 can first be attached to the manubrium 320 and then to the body 332, or vice-versa. Additionally, flexible member constructs 10 can be tensioned in various orders, such as initially tensioning each flexible member construct 10 to a snug or non-slack condition and then further tensioning each construct 10 to a final desired tension. As discussed above, constructs 10 can be tightened with or without use of handle 116. Flexible construct 10 can automatically lock under tension, as also discussed above, after which a portion of ends 18, 26 can be trimmed and removed.
Flexible member construct 10 also can be provided with an antibiotic and/or platelet concentrate coating to resist bacterial adhesion and/or promote healing. In this regard, flexible member construct 10, as well as other constructs discussed herein, can be pre-configured with such a coating or the coating can be applied intraoperatively. Further, the surgeon can also apply the platelet coating to the sectioned area during the sternal closure procedure.
With additional reference to FIGS. 6 and 10, flexible member construct 150A is shown in an assembly configuration 350 having a pair of attachment members 354 coupled to opposed sides 356 of loops 240 and 240′. Attachment members 354 can include a generally arcuate shape 358 and, in the exemplary configuration shown in FIG. 6, a generally semicircular shape or U-shape. The shape 358 of attachment members 354 can be used to secure the attachment members 354 to medial and lateral sides 362 of sternum 304, as generally shown in FIG. 10. Attachment members 354 can include an aperture 366 for receiving loops 240, 240′ therethrough, as shown in FIG. 6. In an exemplary configuration, flexible member construct 150A can be formed integrally with attachment members 354 for use in a sternal closure or other fracture reduction procedure. In this manner, attachment members 354 can be preformed and coupled to loops 240, 240′ to form assembly configuration 350, which can be provided in the assembly configuration for use in the sternal closure procedure.
With particular reference to FIG. 10, construct 150A in the assembly configuration 350 can be used to compress the sternum 304 by securing attachment members 354 to the sides 362 of sternal portions 312, 316 and then applying tension to ends 158, 162 of construct 150A. The adjustable loops of construct 150A can then be reduced to the desired size and placed in the desired tension to compress sternum 304 about section 308. Flexible member construct 150A can automatically lock under tension to maintain the reduced size of loops 240, 240′, as discussed above. It should be appreciated that while attachment members 354 are described above in connection with flexible member construct 150A, the attachment members 354 can also be used with alternative flexible member constructs, such as construct 150.
Turning now to FIG. 7 and with reference to FIG. 10, flexible member construct 150 is shown in an assembly configuration 376 operatively associated with an attachment member or frame 380. Frame 380 can be used to facilitate securing flexible member construct 150 around a fractured bone or the sectioned sternum 304 to compress the fracture or section and affect healing. Frame 380 can include a pair of attachment portions 384 at opposed ends 388 of the frame. In the exemplary configuration shown, frame 380 can include a generally rectangular plate 392 and the attachment portions 384 can be in the form of V-shaped apertures extending through plate 392 from a top surface 396 to a bottom surface 400, as shown in FIG. 7. Bottom surface 400 can optionally include a pair of fixation members 404 to prevent movement of frame 380 relative to the sternum 304 upon placement thereon. Fixation members 404 can include spikes, posts, screws, adhesive or the like that are coupled to or pass through or extend from the bottom surface 400.
With additional reference to FIG. 10, flexible member construct 150 in the assembly configuration 376 is shown with the bottom surface of frame 380 positioned on the anterior side 336 of sternum 304. Flexible member construct 150 can then be wrapped around sternum 304 and opposed ends 412 of loops 188, 188′ can be secured to frame 380 via attachment portions 384. In this configuration, passage portion 168 can be positioned on a posterior side of sternum 304, as generally shown in FIG. 10. Ends 158, 162 of construct 150 can then be tensioned to reduce the loops 188, 188′ to the desired size and tension to compress and close section 308 and assist healing of sternum 304. Flexible member construct 150 can automatically lock and maintain the reduced size of loops 188, 188′ under tension, as discussed above. It should be appreciated that frame 80 can also be used with flexible member construct 10.
Referring now to FIGS. 8 and 10, flexible member construct 150 is shown in an assembly configuration 420 operatively associated with an attachment member or frame 430. Frame 430 can include a base 434, a post 438 extending from an upper surface 442 of base 434, and at least one optional fixation member 446 extending from a lower surface 448 of base 434. Fixation member 446 can include spikes, posts, screws, adhesive or the like that are coupled to or extend from lower surface 448. Post 438 can include a reduced diameter neck portion 450 coupled to the base and a larger diameter or head portion 454 coupled to the neck portion 450 and configured to retain loops 188, 188′ of construct 150, as discussed below. Frame 430 can be placed on sternum 304 with lower surface 448 engaging the anterior side 336 of sternum 304, as shown in FIG. 10. Flexible member construct 150 can be wrapped around sternum 304 in one of the intercostal spaces and each loop 188, 188′ can be secured to the frame 380 via post 438, as also shown in FIG. 10.
In this exemplary configuration, passage portion 168 can be positioned on the posterior side of sternum 304. Once frame 430 is positioned and construct 150 is wrapped around the sternum and secured to post 438, ends 158 and 162 extending from the posterior side of sternum 304 can be tensioned. Applying tension to ends 158, 162 can reduce loops 188, 188′ to a desired size and tension to compress sectioned sternal portions 312, 316 together to assist healing at section 308, as generally shown in FIG. 10. Flexible construct 150 can automatically lock loops 188, 188′ under tension to maintain the reduced size of loops 188, 188′ and compression of sternal portions 312, 316 together, as discussed above.
It should be appreciated that while reference to FIG. 10 has been made with respect to the assembly configurations 350, 376 and 420, these assembly configurations have been combined in one figure for illustration purposes only and need not be used together. In this regard, an exemplary sternal closure procedure could utilize only one of the assemblies shown in the intercostal spaces, or combinations thereof, as may be desired by a particular surgeon performing a sternal closure procedure. It should also be appreciated that assemblies 350, 376 and 420 could be used individually or in various combinations with flexible member constructs 10 secured to the manubrium 320, as discussed above with reference to FIG. 4.
Referring now to FIGS. 9 and 11, adjustable flexible member construct 150 is shown in an assembly configuration 468 operatively associated with a frame 472. As shown in FIG. 9, frame 472 can include a generally rectangular body 476 with attachment portions 480 positioned at one pair of diagonally opposed corners 484 and a groove or channel 486 extending diagonally across a top surface of frame 472 from a second pair of opposed corners 488. While frame 472 is shown having rectangular body 476, it should be appreciated that frame 472 can be configured in other shapes, such as various polygonal shapes for use in coupling frame 472 to flexible member construct 150, as will be described below. Attachment portions 480 can each include a recess 492 at least partially surrounding a post 496. Post 496 can include a neck portion 500 and a cap or head portion 504 having a width dimension 508 greater than a corresponding width of neck portion 500 such that at least a portion of head portion 504 overhangs neck portion 500, as shown in FIG. 9. At least one optional fixation member 512 can extend from a bottom surface 516 of frame 472.
With particular reference to FIG. 11, frame 472 can be positioned in various configurations relative to sternum 304, as illustrated by the two exemplary configurations shown in FIG. 11. Frame 472 can be positioned on sternum 304 such that the bottom surface 516 engages the anterior side 336 of sternum 304. Flexible member construct 150 can be wrapped around sternum 304 within an intercostal space thereof and loops 188, 188′ can be coupled to respective attachment portions 480. More specifically, flexible construct 150 can be placed in channel 486 such that passage portion 168 is positioned within channel 486, as shown in FIG. 11. Positioning construct 150 in channel 486 can provide a low profile closure arrangement that can be more conformable or provide less discomfort to a recipient patient. Loop portion 188 can then be wrapped around the posterior side of sternum 304 in one direction and coupled to attachment portion 480A of the pair of attachment portions 480. Similarly, loop portion 188′ can be wrapped around the posterior side of sternum 304 in an opposite direction of loop 188 and then be coupled to attachment portion 480B. Tension can then be applied to ends 158, 162 to reduce the size of loops 188, 188′ to compress sternal portions 312, 316 together to assist healing of sectioned sternum 304 at section 308. Flexible member construct 150 can automatically lock loops 188, 188′ at the desired reduced size under tension, as discussed above. In addition, placing frame 472 over the section can also stabilize the sternum to align sternal portions 312, 316 to be co-planar.
Flexible member construct 150 in the assembly configuration 468 can be used alone or in various combinations with flexible member constructs 10 and 150A and/or assembly configurations 350, 376 and 420 discussed above. For example, flexible member constructs 10 can be used in the manubrium 320 as shown in FIG. 4 and assembly 468 can be used alone or in various combinations with assemblies 350, 376 and 420 in the body 332 to compress sternal portions 312, 316, as discussed above.
Referring now to FIG. 12, adjustable flexible member construct 150 is shown operatively associated with anchors 196 and an orthopedic mesh 550 for use in a sternal closure procedure. More particularly, orthopedic mesh 550 can be positioned on the anterior side 336 of sternum 304 such that portions 554 extend around the lateral sides 362 in the intercostal spaces, as shown in FIG. 12. The orthopedic mesh 550 can be, for example, a product sold by Biomet Sports Medicine, LLC under the name SportMeshTM. With the orthopedic mesh 550 positioned on sternum 304 as discussed above, construct 150 with anchors 196 can be used in various configurations to compress the sectioned sternum 304 at section 308, as generally shown in FIG. 12.
The orthopedic mesh 550 can be coated with the platelet concentrate discussed above, and/or antibiotics, bone growth agents, etc. to aid in soft tissue healing. The mesh 550 can provide a barrier between the flexible member constructs and the bone to aid in transferring load from the flexible member construct to the mesh 550, which can decrease the pressure applied to the bone by the tensioned flexible member construct. The mesh 550 can be particularly useful, for example, in patients with soft bone tissue. It should also be appreciated that load distribution in the intercostal spaces can be provided by the portions 554 that extend around the medial and lateral sides. Moreover, the orthopedic mesh can aid in the retention of anchors 196, particularly where the bone tissue may be soft.
In one exemplary configuration, four holes 558 can be formed through the mesh 550 and the manubrium 320. Flexible anchors 196 associated with two flexible member constructs 150 can be inserted through respective diagonal pairs of holes 558 through the manubrium, as shown in FIG. 12. The constructs 150 can be in diagonal overlapping pattern and be disposed primarily on top of the orthopedic mesh 550. Upon tensioning the free ends 158, 162 of each construct 150, the tail portions 220, 224 of anchors 196 can engage the posterior manubrium adjacent holes 558 and provide anchoring resistance to retain the anchors 196 outside of holes 558 on the posterior side of the sternum 304. The loops 188, 188′ subsequently can be reduced to the desired size or tension to compress sternal portions 312, 316 and assist closure and healing of the sectioned sternum. The orthopedic mesh 550 can work to distribute the load placed on the anterior side 336 of the sternum by the constructs 150 under tension. A similar configuration 562 can be used at a lower portion 566 of the sternum 304 adjacent the Xiphoid process, as also shown in FIG. 12. It should be appreciated that configuration 562, as well as the configuration discussed immediately above with respect to the manubrium, can alternatively be in a parallel transverse pattern as opposed to the illustrated diagonal patterns.
Continuing with FIG. 12, adjustable flexible construct 150 having a pair of anchors 196 attached to respective loops 188, 188′ can be inserted through transverse bores 586 formed in sternum 304. In particular, the constructs 150 can be positioned in bores 586 such that the passage portions 168 are each aligned in a respective bore 586, as shown in FIG. 12. The constructs 150 can be pierced or routed through the portions 554 of orthopedic mesh 550 that extend around the lateral sides of sternum 304 so as to provide additional anchoring resistance and load distribution for flexible anchors 196, as shown in FIG. 12. Ends 158, 162 can be tensioned to compress sternal portions 312, 316, as discussed herein. It should be appreciated that while orthopedic mesh 550 is shown in FIG. 12 with reference to construct 150 and flexible anchors 196, orthopedic mesh 550 can be used in various other sternal closure configurations disclosed herein, for example, to distribute a load applied by the various disclosed flexible member constructs relative to the sternum 304.
Referring now to FIGS. 13 and 14, adjustable flexible member construct 150 is shown in exemplary assembly configurations 600 and 604 operatively associated with attachment members 608. Each attachment member 608 can include a body 612 having a substantially U-shaped configuration and can be sized for positioning about the lateral sides 362 of sternum 304 such that top and bottom portions 616, 620 extend about the respective anterior and posterior sides of the sternum, as shown in FIG. 14. In one exemplary configuration, attachment member 608 can include an aperture 624 positioned within a side portion 628 connecting the top and bottom portions 616, 620. In another configuration, attachment member 608 can include an aperture 632 in the top portion 616, as shown in FIG. 14. Aperture 632 can be in lieu of or in addition to aperture 624.
With reference to assembly configuration 600, flexible member construct 150 with anchors 196 can be positioned through transverse bore 636 in sternum 304 such that passage portion 168 is positioned within the bore. Each respective loop 188, 188′ with anchors 196 can be passed through aperture 624 in attachment member 608 such that the anchors 196 are on a first side of portion 628 opposite a second side adjacent the sternum 304. Ends 158, 162 can then be tensioned thereby reducing a size of loops 188, 188′ so as to draw attachment members 608 against the lateral sides of sternum 304 and compress sternal portions 312, 316 together. Flexible member construct 150 can automatically lock the loops in the reduced diameter configuration under tension, as described herein. Attachment members 608 can facilitate distributing a compression load applied to the sternum by the tensioned construct 150, which can enable more tension to be applied.
With continuing reference to FIG. 14, assembly configuration 604 can include attachment members 608 integrally formed or pre-assembled with flexible member construct 150A such that loops 240, 240′ are coupled to apertures 632. In this configuration, attachment members 608 can be positioned against the respective lateral sides of sternum 304, similar to assembly configuration 600 discussed above. Flexible member construct 150A can be positioned relative to the anterior side 336 of sternum 304 such that it does not wrap around or extend through sternum 304. It should be appreciated that assembly configurations 600, 604 can be used alone or with various other flexible member construct and assembly configurations disclosed herein to compress sternal portions 312, 316 to assist healing of sectioned sternum 304.
Turning now to FIG. 15, an alternative configuration 650 for compression of sternum 304 in a sternal closure procedure is provided. Configuration 650 can include two flexible member constructs 10 in a transverse orientation in the manubrium 320, as generally discussed above with reference to FIGS. 4 and 5. Configuration 650 can also include flexible member construct 150A coupled around the two constructs 10 before fixed portion 34 of each construct 10 is coupled to the respective attachment member 80, as shown in FIG. 15. Construct 150A can be positioned generally in a superior-inferior orientation perpendicular to the transverse orientation of constructs 10. Construct 150A can be tensioned after tensioning constructs 10 to draw any remaining tension from the system. In this configuration, constructs 10 can provide cross-tensioning generally perpendicular to section 308 and construct 150A can provide tensioning generally parallel to section 308. Configuration 650 can also be utilized to compress the body 332 of sternum 304, where constructs 10 are wrapped around the sternum 304 instead of through holes 324, as also shown in FIG. 15.
Referring now to FIG. 16, another alternative configuration 670 for compression of sternum 304 in a sternal closure procedure is provided. Configuration 670 can include two separate continuous suture or flexible member loops 674 having a fixed length. Alternatively, a flexible member construct, such as construct 150, can be used in place of fixed loops 674 to provide additional adjustment and tensioning capability. Flexible member construct 150A can be provided with four attachment members 80 integrally coupled to loops 240, 240′. In the manubrium area, loops 674 can be routed or passed along the posterior side of sternum 304 in a transverse orientation such that opposed ends 678 of loops 674 extend through a respective pair of holes 324, as shown in FIG. 16. The opposed ends 678 of each of loops 674 can be coupled to a respective two of the four attachment members 80. The ends 158, 162 of flexible member construct 150A can then be tensioned to compress sternal portions 312, 316, as discussed herein. Additional configurations 670 can be used to compress body 332 of sternum 304 where the fixed loops are wrapped around the sides of sternum 304 as opposed to being passed through holes 324, as also shown in FIG. 16. It should be appreciated that configurations 650 and 670 can be used alone or with various combinations of the flexible member constructs and assembly configurations discussed herein.
While one or more specific examples have been described and illustrated, it will be understood by those skilled in the art that various changes may be made and equivalence may be substituted for elements thereof without departing from the scope of the present teachings as defined in the claims. Furthermore, the mixing and matching of features, elements and/or functions between various examples may be expressly contemplated herein so that one skilled in the art would appreciate from the present teachings that features, elements and/or functions of one example may be incorporated into another example as appropriate, unless described otherwise above. Moreover, many modifications may be made to adapt a particular situation or material to the present teachings without departing from the essential scope thereof.

## Claims

1. A method for securing a fractured or sectioned sternum in a patient's body, comprising:
forming an adjustable flexible member construct including:
providing a flexible member having first and second ends and a body defining first and second passage portions spaced apart from each other by a first portion of the flexible member;
passing the first end into and through the second passage portion and then into and through the first passage portion to form a first loop;
passing the second end into and through the first passage portion in an opposite direction as the first end and then into and through the second passage portion in an opposite direction as the first end to form a second loop; and
coupling an attachment member to the first and second loops;

encircling the fractured or sectioned sternum by at least partially wrapping the formed adjustable flexible member construct about the sternum;
coupling the first portion of the adjustable flexible member construct opposite the loops to the attachment member; and
reducing the adjustable flexible member construct to compress the fractured or sectioned sternum.

2. The method of claim 1, wherein reducing the adjustable flexible member construct to compress the fractured or sectioned sternum comprises applying tension to the first and second ends of the adjustable flexible member construct such that a size of the first and second loops is decreased thereby compressing the fractured or sectioned sternum; and wherein the adjustable flexible member construct automatically remains in a reduced position about the sternum.

3. The method of claim 2, further comprising:
forming first and second pairs of holes through a manubrium of the sternum, each pair of holes being on opposed sides of a section or fracture of the sternum; wherein forming a flexible member construct includes forming a plurality of flexible member constructs;
passing a first flexible member construct of the plurality of formed flexible member constructs through the first pair of holes and a second flexible member construct of the plurality of formed flexible member constructs through the second pair of holes such that the attachment members and passing portions of the first and second flexible member constructs are on an anterior side of the sternum;
coupling first portion of the first and second flexible member constructs opposite the loops to their respective attachment members; and
reducing the first and second constructs to compress the fractured or sectioned sternum.

4. The method of claim 3, further comprising passing the first and second flexible member constructs through the first and second pairs of holes such that the first and second constructs overlap each other so as to form an X-shaped pattern.

5. The method of claim 3, further comprising:
encircling the sternum with a third flexible member construct of the plurality of formed flexible member constructs adjacent an intercostal space;
coupling the first portion of the third flexible member construct opposite the loops to its respective attachment member; and
reducing the third adjustable flexible member construct to compress the fractured or sectioned sternum.

6. The method of claim 3, further comprising:
providing a single passage portion adjustable flexible member construct;
coupling the single passage portion adjustable flexible member construct to the first and second adjustable flexible member constructs before coupling the first portion of the first and second adjustable flexible member constructs to their respective attachment members; and
tensioning the single passage portion adjustable flexible member construct to a reduced size after reducing the first and second constructs to reduce the fractured or sectioned sternum, the single passage portion adjustable flexible member construct automatically maintaining the reduced size.

7. The method of claim 6, wherein the single passage portion adjustable flexible member construct is orientated substantially perpendicular to the first and second adjustable flexible member constructs.

8. The method of claim 1, wherein encircling the fractured or sectioned sternum further comprises passing the adjustable flexible member construct around the posterior side of the sternum with a needle passing member detachably coupled to the first portion of the adjustable flexible member construct.

9. The method of claim 1, wherein forming an adjustable flexible member construct includes coupling the first and second ends to a tensioning member; and
wherein reducing the adjustable flexible member construct to compress the fractured or sectioned sternum includes engaging the tensioning member to simultaneously decrease a size of the first and second loops to compress the fractured or sectioned sternum.

10. The method of claim 1, further comprising applying an orthopedic mesh to at least an anterior side of the fractured or sectioned sternum such that at least a portion of the adjustable flexible member construct rests on the orthopedic mesh.

11. The method of claim 10, further comprising applying a platelet concentrate, antibiotic concentrate, or combinations thereof, to the adjustable flexible member construct, the orthopedic mesh, or combinations thereof.