JP2012510852A - System and method for bone fixation or adhesion at or near the sacroiliac joint - Google Patents

Abstract

  At least one bone fixation device comprising a stem having a maximum outer diameter traverses the sacroiliac joint into the iliac, approximately sized to the maximum outer diameter or about the maximum outer diameter of the stem in soft tissue And then through a minimally invasive incision path into the sacrum and into the sacroiliac joint. Without invasive joint formation, cartilage removal or removal at or near the sacroiliac joint, the stem is inserted through the incision path and into the sacroiliac position between the iliac and sacrum And fusing the sacroiliac joint. Desirably, at least a portion of the stem includes a surface that allows bone growth.

Description

FIELD OF THE INVENTION This application relates generally to bone fixation.

BACKGROUND OF THE INVENTION Many types of hardware are commercially available for both fracture fixation and fixation of bone to be fused (joint fixation).

  Metal and resorbable screws are usually used to fix fractures and osteotomy. For the successful outcome of the procedure, it is important that the screw be able to generate a compression force that helps to promote bone healing.

SUMMARY OF THE INVENTION The present invention provides a bone fixation device and associated method for stabilizing bone fragments. The system and method includes a stem-like structure that is suitable for passage between adjacent bone fragments. At least a portion of the stem-like structure includes a surface that promotes bone growth. Bone growth on the stem-like structure serves to speed up the adhesion process or fracture healing time.

  In accordance with one aspect of the present invention, at least one bone fixation device comprising a stem having a maximum outer diameter is generally defined by a size of the maximum outer diameter of the stem or about the maximum outer diameter in soft tissue. It is inserted into the sacroiliac joint through a minimally invasive incision path into the bone, across the sacroiliac joint and into the sacrum. The stem is inserted through the incision path at a location within the sacroiliac joint between the iliac and sacrum for invasive arthroplasty, cartilage removal, or removal at or near the sacroiliac joint ( Adherent sacroiliac joints without scraping. Desirably, at least a portion of the stem includes a surface that allows bone growth.

FIG. 1 is a perspective view of a bone fixation stem having a mesh shaped bone growth surface. FIG. 2 is a perspective view of another embodiment of a bone fixation base having a beaded bone growth surface. FIG. 3 is a perspective view of another embodiment of a bone fixation stem having a trabecular bone growth surface. FIG. 4 is a schematic view of a bone fixation stem of the type shown being inserted into a bone across a fracture line or bone joint. FIG. 5 is a schematic view of a bone fixation stem disposed in bone, illustrating that the bone growth surface of the stem extends across the fracture line or bone joint. FIG. 6 is a front view of another embodiment of a bone fixation stem having a bone growth surface, the stem having a conical shape. FIG. 7 is a front view of another embodiment of a bone fixation stem having a bone growth surface, the stem having an angled distal tip. 8A and 8B are schematic diagrams illustrating the insertion of a conical bone fixation stem of the type illustrated in FIG. 6 to reduce the gap between bone fragments. FIG. 9 is a schematic diagram illustrating that a guide wire has been introduced into the bone across the bone fragment. FIG. 10 is a schematic view similar to FIG. 9 illustrating that a drill bit has been introduced over the guide wire. FIG. 11 is a schematic view similar to FIG. 10 illustrating the bore formed in the bone remaining after the drill bit has been withdrawn. FIG. 12 is a schematic view similar to FIG. 11 illustrating the insertion of a bone fixation stem into the preformed bore. FIG. 13 is an exploded front view illustrating the connection by threaded engagement of a pair of bone fixation stems. FIG. 14 is a schematic diagram illustrating a pair of bone fixation stems connected and inserted across a plurality of bone fragments into a bone. FIG. 15 is a front view illustrating passing a bone fixation stem through a perforation in another bone fixation stem. FIG. 16 is a schematic diagram illustrating the placement of a series of bone fixation stems within the bone. FIG. 17 is a lateral anterior anatomical view of the bone in the human lumbar region, illustrating the iliac, sacrum, and sacroiliac joints therebetween. 18 is a posterior anatomical view of the lumbar region illustrated in FIG. 17, with one or more bone anchoring devices traversed into the iliac, across the sacroiliac joint, and into the sacrum. Figure 2 illustrates an incision path for insertion through a soft tissue and into the sacroiliac joint. FIG. 19 is a posterior anatomical view after insertion of one or more bone fixation devices into the sacroiliac joint, as illustrated in FIG. 18, to fuse the sacroiliac joint.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Although the disclosure herein is detailed and precise for those skilled in the art to practice the invention, the disclosed physical embodiments are not limited to other specific structures. It is merely illustrative of the invention that may be embodied. While preferred embodiments have been described, details may be changed without departing from the invention, which is defined by the claims.

  FIG. 1 shows a device 10 sized and shaped for fixation of a fracture or for fixation of a bone to be fused (joint fixed). Device 10 comprises an elongated stem-like structure. Device 10 can be formed from materials that can be used in prosthetic technology, such as by machining, molding or extrusion, including, but not limited to, titanium, titanium alloys, tantalum, Cobalt chromium, surgical stainless steel, or any other total joint replacement metal and / or ceramic, sintered glass, artificial bone, any unbonded metal or ceramic surface, or combinations thereof. In another embodiment, device 10 may be formed from a suitable durable biological material, or a combination of metal and biological material, such as a biocompatible bone filler material. Device 10 may be molded from a flowable biological material that is hardened to a non-flowable or solid material, for example by UV light, such as acrylic bone cement.

  Device 10 can take a variety of external shapes and can have a variety of cross-sectional shapes. The device 10 can have, for example, a generally curvilinear (ie, circular or elliptical) cross section, or a generally straight cross section (ie, square or rectangular), or a combination thereof. As will be described in more detail later, the device 10 can be conical or V-shaped.

  The structure 10 includes surface texturing 12 along at least a portion of its length to promote bone growth on its surface. The surface texturing 12 can have, for example, through holes and / or various surface patterns and / or various surface textures and / or holes, or combinations thereof. To provide surface texturing 12, device 10 can be coated or wrapped or surface treated, or it results in bone growth, such as a porous mesh, hydroxyapatite, or other porous surface. The surface can be formed from a material that itself inherently possesses. Device 10 may be further covered with a variety of other coatings, such as antimicrobial agents, antithrombotic agents, and osteoinductive agents or combinations thereof. If desired, the surface texturing 12 may be impregnated with such agents.

  Of course, the shape of the surface texturing 12 can vary. By way of example, FIG. 1 illustrates the surface 12 as a perforated mesh shape; FIG. 2 illustrates the surface 12 as a beaded shape; and FIG. 3 illustrates the surface 12 as a trabecular shape. Any shape that results in bone growth is sufficient.

  In use (see FIGS. 4 and 5), the device 10 is inserted into a gap between two adjacent bone surfaces, for example into a fracture site, or between two bones to be fused together (eg adjacent The matching vertebral body is inserted. In FIG. 4, the device 10 is driven into the bone by a tap 16 through the bone fragment 14 (ie, across the fracture line or between adjacent bones to be fused). Is shown. To facilitate insertion of the device 10, a hole may first be drilled in the bone. Bone growth surface 12 along the surface of device 10 accelerates bone growth into device 10. Bone growth into device 10 helps to speed up the adhesion process or fracture healing time.

  The bone growth surface 12 may cover the entire outer surface of the device 10, as illustrated in FIG. 4, or the bone growth surface 12 may be on either side of the joint surface or fracture line, as illustrated in FIG. You may cover a specific distance.

  The size and shape of the device 10 can be varied to accommodate the type and location of bone and individual anatomy to be treated.

  As FIG. 6 illustrates, the device 10 can be conical in shape, angled or tapered. The angle can vary to accommodate specific needs or individual anatomy. When the device 10 is driven into a bone or bone fragment 14, a smaller angle (ie, a sharper angle) reduces the risk of tearing the bone. As further illustrated in FIG. 7, the device 10 may include a beveled distal end 18 to further add insertion of the device 10 into the bone. As illustrated in FIGS. 8A and 8B, the conical shape also helps to reduce the gap (G) between the bone fragments 14 to fit the articular surface or fracture piece.

  9-12, to assist in placement of device 10 within the bone, device 10 has a lumen or through hole 20 that is tubularized and extends therethrough.

  In use, as FIG. 9 illustrates, a physician can insert a conventional guide pin 22 through the bone fragment 14 in a conventional manner. Next, as can be seen in FIG. 10, a cannulated drill bit 24 can be introduced over the guide pin 22. Single or multiple drill bits 24 can be used to drill holes in bone fragments or bone surfaces to form bores 26 of the desired size and shape. In the illustrated embodiment, the drill bit 24 is sized and shaped to form a conical bore 26 that is similar in size and shape to the device 10. The bore 26 is preferably sized and shaped to allow firm engagement of the device 10 within the bore 26 and thereby limit movement of the device 10 within the bore 26. The pre-formed bore 26 may be slightly smaller than the device 10 while at the same time allowing the device 10 to be locked in position within the bore 26 by driving. Next, as can be seen in FIG. 11, the drill bit 24 is pulled out. Next, the device 10 is inserted over the guide pin 22 and into the bore 26, as FIG. 12 illustrates. Next, the guide pin 22 is pulled out.

  In another embodiment, the device 10 itself may include a screw thread that follows the human body to screw the device into place. In the arrangement, the device 10 is self-tapping. Further, in this arrangement, the device 10 can be tubularized for use with the guide pin 22, or it need not be tubularized.

  Multiple devices 10 may be used to provide further stabilization. Although the use of multiple devices 10 of the same size and shape is illustrated to illustrate the use of multiple devices 10, it is contemplated that the devices 10 may be of different sizes and / or different shapes. For example, one device 10 has a cylindrical shape and the second device 10 has a conical shape.

  In many cases, it may be desirable to couple a series of devices 10, for example to provide stabilization over a larger surface area. The series of devices 10 may be coupled by any suitable means, such as snap-fit engagements or groove and tab key arrangements. In one embodiment, the series of devices 10 are coupled by threaded engagement. As illustrated in FIG. 13, the first device 10 </ b> A includes a recess 28 at one end that provides a series of internal threads 30. In the illustrated embodiment, the first device 10 is cylindrical, but may be any desired shape. The internal thread 30 is connected to a series of complementary external threads 32 on a second device 10B of similar or different shape to connect the first device and the second devices 10A and 10B.

  Devices 10A and 10B are preferably coupled prior to being inserted into preformed bore 26. As can be seen in FIG. 14, the series of internal threads and external threads 30 and 32 provide an internal linkage mechanism that allows the series of devices 10 to be stacked and connected to provide a larger area or multiple bones. Allows to cover the piece 14 (eg, bone with multiple fractures), thereby providing further stabilization.

  FIG. 15 illustrates another embodiment in which the device 10 'includes an opening or perforation 34 that allows another device 10 to pass through thereby providing further stabilization. The perforations 34 can be sized and shaped to allow another device 10 to pass through the device 10 'at substantially any angle. The perforations 34 can also be sized and shaped to limit the movement of the second device 10 relative to the second device 10 '.

  In use, as illustrated in FIG. 16, the physician drives a first device 10 'having a perforation 34 through the bone fragment. Next, the second device 10 is inserted into place through the perforation 34 of the first device 10 '(eg, by driving in).

  Similarly, as illustrated in FIG. 16, device 10 ′ is suitable for coupling with another device 10A (eg, by a series of external and internal threads), and devices 10 ′ and 10A are further stacked. It is further conceivable that it may be possible to be connected.

Sacroiliac Joint Fixation As shown in FIG. 17, the lumbar region of the human body is made up of three large bones connected by three relatively stationary joints. One of the bones is called the sacrum, which is located at the bottom of the lumbar spine, where it connects with the L5 vertebra. The other two bones are commonly referred to as “the hipbone” and technically referred to as the right and left iliac bones. The sacrum connects to both hipbones at the sacroiliac (SI) joint.

  The sacroiliac joint has a function of transmitting force from the spine to the lower limbs, and vice versa. Sacroiliac joint adhesion is typically a surgical treatment for degenerative sacroiliac, inflammatory sacroiliac, iatrogenic instability of the sacroiliac joint, iliac sclerosing osteopathy or traumatic dislocation fracture of the pelvis Indicated.

  Currently, screws with screws and plates are used for sacroiliac joint adhesion. At the same time, cartilage needs to be removed from the “synovial joint” portion of the SI joint. This requires a large incision to gain access to a damaged, sub-dislocated, dislocated, fractured or deformable joint.

  FIGS. 18 and 19 illustrate one or more devices 100, for example as previously described and illustrated in FIG. 1, each of which has a sacroiliac joint adhesion (joint fixation). Therefore, the size and shape are determined. As explained above, each device 100 comprises an elongated stem-like structure. Each device 100 can be formed from materials available in the art of prosthesis, such as, but not limited to, machining, molding or extrusion, including, but not limited to, titanium, Titanium alloy, tantalum, cobalt chromium, surgical stainless steel, or any other joint replacement metal and / or ceramic, sintered glass, artificial bone, any cemented metal or ceramic surface, or their A combination is included. In another embodiment, each device 100 may be formed from a suitable durable biological material, such as a biocompatible bone filler material, or a combination of metal and biological material. Device 100 may be molded from a flowable biological material that is hardened to a non-flowable or solid material, for example, by UV light, such as acrylic bone cement.

  A given device 100 can have a variety of external shapes and can have a variety of cross-sectional shapes. The given device 100 can have, for example, a generally curvilinear (ie, circular or elliptical) cross section, or a generally rectilinear cross section (ie, square or rectangular), or a combination thereof. The given device 100 can be conical or V-shaped. The device 100 used for a given arthrodesis can be of various sizes and shapes depending on the anatomical condition encountered.

  As previously described, one or more devices 100 (see FIG. 18) include surface texturing 120 along at least a portion of its length to promote bone growth on that surface. It is desirable. Surface texturing 120 can include, for example, through holes and / or various surface patterns and / or various surface textures and / or holes, or combinations thereof. The device 100 can be coated or wrapped or surface treated to provide surface texturing 120, or it can be a porous mesh, hydroxyapatite or other porous surface, It can be formed from a material that itself inherently possesses a surface that results in bone growth. Device 100 may be further covered with a variety of other coatings, such as antimicrobial agents, antithrombotic agents, and osteoinductive agents, or combinations thereof. If desired, the surface texturing 120 may be impregnated with such agents.

  As FIG. 18 and FIG. 19 illustrate, one or more devices 100 can pass through the respective iliac, across each sacroiliac joint, and into the sacrum in the soft tissue. 140 and inserted individually in a minimally invasive form. Conventional tissue access tools, obturators, cannulas, and / or drills can be used for this purpose. Arthroplasty, cartilage removal, or deletion is not required prior to formation of the insertion path or insertion of the device 100, where there is a minimally invasive path approximately determined by the maximum outer diameter or about the maximum outer diameter size of the device 100. Need to be formed.

  In a typical procedure, depending on the patient's physique and the size of the device 100, 1-6, or perhaps eight devices 100 may be required.

  The described method includes providing at least one device 100 comprising a stem having a maximum outer diameter. The method forms a minimally invasive path approximately sized to the maximum outer diameter or about the maximum outer diameter through soft tissue, into the iliac, across the sacroiliac joint, and into the sacrum. The method involves placing the stem through the incision path and in the sacroiliac joint between the iliac and sacrum without further arthroplasty, cartilage removal or removal at or near the sacroiliac joint. Including insertion and adhesion of the sacroiliac joint. Preferably, at least a portion of the stem includes a surface that allows bone growth.

  After attachment, the patient will be advised not to stress the sacroiliac joint while the adhesion occurs. This can be 6-12 weeks or more, depending on the patient's health and adherence to his or her post-operative protocol.

  The foregoing is considered to be just one example of the principles of the present invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desirable to limit the present invention to the construction and operation as shown and described. While preferred embodiments have been described, the details may be changed without departing from the invention, which is defined by the claims.

Claims (2)

Providing at least one bone fixation device comprising a stem having a maximum outer diameter;
Forming an incision path into the iliac, across the sacroiliac joint, and into the sacrum, approximately determined by the maximum outer diameter or about the maximum outer diameter of the stem in soft tissue; Without further arthroplasty, cartilage removal or removal near the joint or sacroiliac joint, the stem is inserted through the incision path and into the sacroiliac position between the iliac and sacrum. A method comprising adhering an intestinal joint.   The method of claim 1, wherein at least a portion of the stem includes a surface that allows bone growth.

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