Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
  • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
  • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
  • A61B17/1691—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the sternum
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
  • A61B17/823—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage for the sternum
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
  • A61B17/8861—Apparatus for manipulating flexible wires or straps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
  • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
  • A61B17/1606—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other
  • A61B17/1608—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other the two jaw elements being linked to two elongated shaft elements moving longitudinally relative to each other
  • A61B17/1611—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other the two jaw elements being linked to two elongated shaft elements moving longitudinally relative to each other the two jaw elements being integral with respective elongate shaft elements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
  • A61B17/8863—Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
  • A61B17/8869—Tensioning devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
  • A61B2017/00407—Ratchet means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/03—Automatic limiting or abutting means, e.g. for safety

Definitions

• the locking head can have a housing, a strap receiving slot that extends through the housing, and a locking member that is connected to the housing and includes at least one complementary tooth that extends into the strap receiving slot such that when the distal end of the strap is inserted through the strap receiving slot along a second direction that is transverse to the first direction the at least one complementary tooth of the locking member engages the teeth of the strap to thereby prevent the strap from translating through the strap receiving slot along a direction that is opposite to the second direction.
• the housing can be tapered along the first direction such that a distal end of the housing has a thickness measured along the second direction that is greater than the thickness of a proximal end of the housing.
• the leader portion can be elongate along the first direction, and is configured to be more flexible than the strap.
• the leader portion can be made of at least a second material that is different than the first material.
• Fig. 3F is an enlarged cross-sectional view of a portion of the bone fixation member illustrated in Fig. 3D, showing the strap inserted through the locking head so as to secure the bone fixation member about an underlying bone;
• FIG. 4 is a perspective view of a bone fixation instrument constructed in accordance with an embodiment, the bone fixation instrument configured to tighten and subsequently cut the strap of the bone fixation member shown in Fig. 1 ;
• Fig. IOC is a bottom plan view of the cap shown in Fig. 10B coupled to the locking head;
• Fig. 10D is a cross-sectional view of the cap shown in Fig. IOC coupled to the locking head through the line 10D-10D.
• the teeth 42 extend from the body 38 along a common surface and are spaced apart from each other along the longitudinal direction L.
• the strap 22 is made from a first flexible biocompatible material such as PEEK or PEKK.
• the strap 22 is configured to have a first length Li measured from the proximal strap end P to the distal strap end D that is between about 200 mm and about 300 mm, and preferably is about 270 mm. It should be appreciated, however, that the strap 22 can include any length Li as desired.
• the strap body 38 defines a first or bone contact surface or end 66 and a second or outer surface or end 67 spaced apart from the first end 66 along the transvers direction.
• the strap body 38 further defines a recess 46 that extends into the outer bone contacting surface or end 66 of the body 38 along the transverse direction T so as to be defined by opposed inner side surfaces 50 of the body 38 and an inner bottom surface 54 of the body 38.
• the trailing edges 62 extend from the inner bottom surface 54 along the transverse direction and are substantially perpendicular to the inner bottom surface 54 such that the trailing edges 62 are configured to engage complementary trailing edges of the locking teeth of the locking head 26. It should be appreciated, however, that the teeth 42 can have other configurations as desired. For example, the trailing edges 62 can also extend from the inner bottom surface 54 at an angle so long as the trailing edges 62 can engage complementary trailing edges of the locking teeth of the locking head 26.
• the strap 22 can have an overall width W2 that extends along the lateral direction A and a height 3 ⁇ 4 that extends along the transverse direction T and is measured between adjacent teeth 42.
• the width W2 and the height 3 ⁇ 4 can be configured such that a cross-section of the strap 22 taken between adjacent teeth 42 has an area that is between about 4.0 mm 2 and about 8.0 mm 2 .
• the strap 22 can have any cross-sectional area as desired, so long as the strap 22 is flexible enough to be placed about the target bone 18 without breaking.
• the width W2 of the strap 22 can also vary depending on the target bone 18 that the bone fixation member 14 is to be placed.
• space between adjacent ribs may vary thereby limiting the width W 2 . That is, if the space between adjacent ribs is narrow, the width W2 of the strap 22 will also have to be narrow so that the bone fixation member 14 can be placed about the bone. Moreover, by providing the strap 22 or at least the strap body 38 with a greater width W 2 , the outer bone contacting surface 66 can be increased so as to reduce complications such as sternal non-union or sternal infection sometimes caused when using wires. Therefore, a greater width W2 provides a greater bone contacting surface 66 for the bone fixation member 14 so as to further reduce any complications typically associated with bone fixation.
• the locking head 26 is configured to receive the distal strap end D of the strap 22. As shown, the locking head 26 includes a housing
• the molding process can be configured to prevent the PEEK polymer from crystallization during the cooling process. This can be accomplished by quenching the hot polymer melt by injection molding the PEEK polymer melt into a cool mold.
• the mold temperature can be between about 10°C and about 120°C, and preferably between about 25°C and 80°C.
• the cool molds can reduce the crystallization of the PEEK polymer thereby increasing the strength and flexibility of the part.
• the leader portion 30 extends from the distal strap end D of the strap 22 and is elongate along the first direction L.
• the leader portion 30 is made of a second material that is different than the first material that the strap 22 is made from.
• the leader portion 30 can be made from a metal such as stainless steel.
• a stainless steel leader portion 30 may allow the leader portion 30 to be bent or twisted, rendering it easy to handle.
• the leader portion 30 can be made from other materials, such as non-PEEK or non-PEKK materials, for example a suture material. As shown in Fig.
• the bone fixation member 14 can have cross-sectional areas such that the ratio falls outside of the stated range, as desired.
• the material choice, the cross-sectional area, the shape, and the length of the leader portion 30 can all provide for greater flexibility as compared to the strap 22, so as to allow the bone fixation member 14 to be more easily implanted.
• the proximal end of the leader portion 30 may be coupled to the distal strap end D of the strap 22 either after or during the molding of the strap 22.
• the proximal end of the leader portion 30 may be overmolded onto the distal strap end D of the strap 22 when the strap 22 is being formed in the mold.
• the distal strap end D of the strap 22 can include a metal insert and the proximal end of the leader portion 30 can be coupled to the metal insert by a weld. It should be appreciated, however, that the leader portion 30 can be coupled to the strap 22 by other connections, for example by a knot.
• the strap 22 is placed about the first and second bone segments 16a and 16b of the target bone 18, and the needle 34 is inserted through the slot 74 and pulled through the slot 74 so as to cause the strap 22 to subsequently translate through the slot
• the fixation instrument 110 can include a tension assembly 1 14 that is configured to secure the fixation instrument 110 to the strap 22, and is further configured to further pull the strap 22 through the locking head 26 thereby further inducing tension in the strap 22 until the strap 22 has securely compressed the first and second bone segments 16a and 16b of the target bone 18 together at the fracture location.
• the fixation instrument 1 10 further includes a cutter assembly 120 that is configured to cut a free end 124 of the strap 22 that has passed through the locking head 26 once a desired tension has been induced in the strap 22 about the first and second segments 16a and 16b of the target bone 18.
• the desired tension can be within a range defined by and between a lower end that can be approximately 50 Newtons or approximately 80 Newtons, and an upper end that can be approximately 150-160 Newtons or 200 Newtons. It should be appreciated that the desired tension can depend on the bone quality and the preference of the surgeon, and can for instance be any tension as desired that reliably secures the target bone 18 without over tightening the strap 22. It should further be appreciated, that the bone fixation assembly 10 can include other bone fixation instruments that are configured to provide tension to the bone fixation members 14. Moreover it should be appreciated that the bone fixation assembly 10 can be void of a bone fixation instrument and tension can be applied manually by an individual.
• the fixation instrument 1 10 further includes a trigger 138 that extends down from the body 126 at a location spaced forward from the handle 134, and a nose 140 disposed at the front end 130a of the body
• the tension assembly 1 14 includes a grip 160 that is movable between a disengaged position, whereby the grip 160 is configured to loosely receive the strap 22, such as the portion of the strap that has passed through the locking head 26, and an engaged position whereby the grip 160 is configured to be secured to the received strap 22.
• the tension assembly 1 14 further includes a traveler 168 that is operably coupled to the grip 160 and extends rearward from the grip 160, such that rearward movement of the traveler 168 causes the grip 160 to move rearward in the secured configuration, thereby inducing tension in the strap 22.
• the tension assembly 114 can further include a tension limiter 172 that is connected between the trigger 138 and the traveler 168.
• the tension limiter 172 can be configured to apply a force that is greater than, but corresponds to, the tension in the loop 76 about the target bone 18.
• the maximum force applied by the tension limiter 172 can correspond to the maximum desired tension in the loop 76, it being appreciated that once the teeth 42 and 82 ride over and past each other, the tension in the loop 76 can decrease somewhat as the teeth 42 and 82 interlock.
• the tension limiter 172 can apply a maximum force as desired that corresponds to a desired maximum tension in the loop 76 about the target bone 18.
• the bone fixation member 214 can be placed about any location of the sternum as desired or about another bone as desired.
• the bone fixation member 214 is substantially similar to the bone fixation member 14 and includes like features unless otherwise described. Therefore, it should be appreciated that the bone fixation member 214 can include a strap 22, a leader portion 30, and a needle 34 as described with respect to the bone fixation member 14 shown in Figs. 3A-3G.
• the upper surface 276 is convex along the longitudinal direction L and the lower surface 277 is concave along the longitudinal direction L.
• the convex upper surface 276 and the concave lower surface 277 converge toward each other as they extend from the distal head end 279 toward the proximal head end 280 along the longitudinal direction L.
• the convex upper surface 276 provides a smooth outer surface for the locking head 226 to reduce irritation to the surrounding tissue.
• the concave lower surface 277 provides clearance for the strap 22 when the strap 22 is translated through the strap receiving slot 274.
• the locking head 226 is constructed as a single monolithic unit. It should be appreciated, however, that the locking head 226 can include a cap that is placed over the housing 270 such that the cap at least partially defines the first end 271. Therefore, the cap can define the convex upper surface 276 of the locking head 226.
• the locking head 226 further includes a toothed locking member 281 that is connected to the housing 270 and has at least one, such as three complementary teeth 282 that extend into the strap receiving slot 274.
• the locking member 281 is configured to flex as the strap 22 is passed through the slot 274 so as to allow the strap 22 to incrementally pass through the slot along the insertion direction.
• the locking teeth 282 define a beveled leading edge 290 that is configured to cam over the complementary beveled leading edges 60 of the locking teeth 42 when the strap 22 is translated through the slot 274 along the insertion direction B.
• the locking teeth 282 further define trailing edges 294 that are sloped less than the beveled leading edges 290, such that the trailing edges 294 engage the trailing edges 62 of the teeth 42 to prevent the strap 22 from translating through the slot 274 along a direction opposite the insertion direction B to thereby prevent the loop from increasing. Therefore, the locking head 226 is configured to allow the strap 22 to translate uni-directionally through the slot 274 along the insertion direction B so as to reduce the size of the loop about the first and second segments 16a and 16b of the target bone 18.
• the bone fixation member 214 can be placed transsternally about the bone segments 16a and
• the locking head 326 includes a housing 370 that defines a first or upper end 371 and a second or lower end 372 that is spaced from the first end 371 along the transverse direction.
• the locking head further includes a strap receiving slot 374 that extends through the housing 370 from the lower end 372 to the upper end 371 along a second direction.
• the slot 374 can extend along the second direction which can be along the transverse direction T or a direction having a directional component that extends along the transverse direction T.
• the strap receiving slot 374 is configured to receive the distal strap end D of the strap 22 such that the strap 22 is configured to translate through the slot 374 uni-directionally along an insertion direction B which can be the second direction so as to define a loop about the target bone 18.
• the lower surface 377 defines a shallow curve such that a maximum distance diA measured between the lower surface 377 and a plane P defined by the locking head 326 that extends linearly through or otherwise liner tangential to a distal end of the lower surface 377 and a proximal end of the lower surface 277 is between about 3 mm and about 5 mm. It should be appreciated, however, that the lower surface can have a deeper curve as desired, or even be void of a curve as desired.
• the upper surface 376 of the locking head 326 merges into the upper surface or end 67 of the strap 22 such that a substantially no portion of the upper surface 376 protrudes above the upper surface 67.
• a maximum distance d2A measured along the second direction between the upper most portion of the first end 371 of the locking head 326 and a lower most portion of the second end 372 is no more than 2 times a maximum distance or height d3 measured between the upper surface or end 67 and the bone contacting surface or end 66 of the strap 22 along the second direction. Therefore, the geometry of the locking head 326 provides a lower profile and/or a smoother transition for the locking head 326 when in use.
• the bone fixation assembly 10 can further include a bone punch 400 that is configured to form holes in the bone segments 16a and 16b, for example in respective manubrium portions 228.
• a bone punch 400 that is configured to form holes in the bone segments 16a and 16b, for example in respective manubrium portions 228.
• One of the bone fixation members, such as the bone fixation member 214 can be configured to extend through the holes so that the bone fixation member 214 can compress the manubrium portions 228 together to an approximated position.
• the bone punch 400 can be configured to form holes in any portion of the sternal portions 16a and 16b, and can be further configured to form holes in any anatomical structure as desired.
• the body 404 defines a boom arm
• the distal punch housing 428 can include a support member 450 that defines an aperture 454 that receives the punch 416 when the punch 416 has passed through the bone receiving gap 432.
• the support member 450 is configured to shield surround tissue from a tip of the punch 416.
• the support member 450 can be configured to limit the translation of the punch 416. It should be appreciated, however, that the support member 450 can have any configuration as desired. For example, the support member 450 can define a recess rather than an aperture as illustrated.
• the bone receiving gap 432 can be defined between a first support member 440a of the proximal punch housing 424 and the support member 450 of the distal punch housing 428 as illustrated.
• the bone receiving gap 432 can define a length LQ measured along the punch direction Dp that is sufficient to receive a target bone. For example, in the illustrated
• the boom arm 420 further defines a bridge 462 that couples the proximal punch housing 424 to the distal punch housing 428.
• the bridge 462 can have a length that is substantially equal to the length LQ.
• the bridge 462 can define a stop surface 464 that is configured to abut the bone portion when the bone receiving gap 432 has fully received the bone portion.
• the bone receiving gap 432 can have a depth H measured along a bone receiving direction DB that is perpendicular to the punch direction Dp from a central axis of the punch 416 to the stop surface 464.
• the depth H can be between 15 mm and 25 mm preferably about 20 mm. It should be appreciated, however, that the bone receiving gap 432 can have any depth H as desired.
• the punch 416 is translatably coupled to the body 404 such that the punch 416 is translatable along the punch direction Dp between a first position whereby a tip of the punch 416 is proximal to the bone receiving gap 432 and a second position whereby the tip of the punch 416 extends into the support member 450 of the distal punch housing 428.
• the punch 416 can include a punch body 469 that is elongate along the punch direction D P and defines a proximal end 470 and a distal end 472 spaced from the proximal end 470 along the punch direction Dp.
• the punch 416 can further include a trigger housing 474 coupled to the proximal end 470 of the punch body 469 and a needle 478 coupled to the distal end 472 of the punch body 469.
• the needle 478 can be removably coupled to the punch body 469 so that the needle 478 can be replaceable.
• the trigger housing 474 defines a slot 480 that is elongate along the bone receiving direction DB.
• the trigger housing 474 can include a pin 482 that is slidable within the slot 480 and is configured to couple the trigger 412 to the trigger housing 474.
• the trigger 412 is rotatably coupled to the body 404 at a pivot Pi and pivotally coupled to the trigger housing 474 by the pin 482.
• the trigger housing 474 is moved forward along the punch direction Dp.
• the pin 482 moves within the slot 480 away from the body 404 so that the rotational motion of the trigger 412 is converted into translational motion of the punch 416.
• the needle 478 is configured to move along the punch direction Dp and through the bone receiving gap 432 when the punch 416 is translated from the first position to the second position.
• the bone engaging tip 488 is proximal to the bone receiving gap 432 when the punch is in the first position and is distal to the bone receiving gap 432 when the punch is in the second position.
• the bone engaging tip 488 extends into the aperture 454 of the support member 450 when the punch 416 is in the second position. It should be appreciated, however, that the bone engaging tip 488 can stop short of the support member 450 when the punch 416 is in the second position as desired. [0087] Now in reference to Figs.
• the bone punch 400 can be configured to approach the bone segments 16a and 16b from an anterior approach.
• the bone punch 400 can be moved so that the bone receiving gap 432 extends into the fracture location 20.
• the bone punch 400 can then be rotated, such as rotated 90 degrees, so that the bone receiving gap 432 receives the target bone segment.
• the bone punch 400 can be positioned in the fracture location 20 such that the bone receiving gap receives the bone segment by moving the bone punch 400 toward the target bone segment. In either, case it can be said that the bone receiving gap 432 receives the bone segment along the bone receiving direction DB.
• a cap 500 that is separate from the locking head can be configured to overlie and be coupled to the locking head 26 of the bone fixation element 14 to thereby transform the locking head 26 into a locking head that is similar to the locking head 226. Therefore, the cap 500 can be configured to remove sharp edges from and/or provide a low profile to the locking head 26 when coupled to the locking head 26. It should be appreciated, that while the cap 500 is described as being configured to overlie the locking head 26, the features of the cap 500 can be incorporated into caps that define the first ends 271 and 371 of the locking heads 226 and 326.
• the cap 500 can further include at least one, such as a pair of attachment members 590 that are configured to couple the cap 500 to the locking head 26.
• each attachment member 590 can extend from the cap body 504 such as from the inner shell 574.
• Each attachment member 590 can extend inward from a respective one of the side walls 554 into the cavity 516 from a location that is proximate to the lower end 512.
• a bone fixation members 14 may be placed about the bone segments and of the sternum between adjacent ribs and the strap 22 can be pulled through the slot 74. As the strap 22 is translated through the slot 74 of the locking head 26 the locking teeth
• the bone fixation kit can include any combination of bone fixation members 14, bone fixation members 214, bone fixation members 314, caps 500, a bone fixation instrument 1 10, and a bone punch 400.
• the bone fixation kit can include all bone fixation members 14, all bone fixation members 214, or some combination of bone fixation members 14 and bone fixation members 214 with or without the bone fixation instrument 110, with or without the bone punch, and with or without the caps 500.

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• 2013
  • 2013-03-13 IN IN7751DEN2014 patent/IN2014DN07751A/en unknown
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