Tissue fixation system and method

• US 10,238,378 B2
• Filed: 05/24/2016
• Issued: 03/26/2019
• Est. Priority Date: 10/26/2004
• Status: Active Grant

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter M., Phillips, Glen A.
• Primary Examiner(s): Lawson, Matthew
• Application Number:
  US15/163,425
• Publication Number:
  US 20170049487A1
• Time in Patent Office: 1,036 Days
• Field of Search: 606 79- 90, 606139-150, 606157, 606228-233, 606247, 606248, 606279, 623 1311- 1317
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/683 comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
• CPC Class Codes: A61B 17/685 Elements to be fitted on the end of screws or wires, e.g. protective caps
• CPC Class Codes: A61B 17/7053 with parts attached to bones or to each other by flexible wires, straps, sutures or cables
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 17/82 : for bone cerclage apparatus for manipulating wires or straps A61B17/8861; wires, bands or straps other than cerclage A61B17/842
• CPC Class Codes: A61B 17/842 : Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61B 17/844 : with expandable anchors or anchors having movable parts
• CPC Class Codes: A61B 17/8861 : Apparatus for manipulating flexible wires or straps devices for inserting Kirschner wires A61B17/1697
• CPC Class Codes: A61B 17/8863 : Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 17/8869 : Tensioning devices
• CPC Class Codes: A61B 2017/00004 : (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00398 : using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00477 : Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00818 : Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00876 : magnetic
• CPC Class Codes: A61B 2017/00893 : pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 : expandable upon contact with fluid
• CPC Class Codes: A61B 2017/00951 : adhesive
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 : having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 2090/035 : preventing further rotation
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2/0063 : Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/08 : Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 : Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/28 : Bones joints A61F2/30
• CPC Class Codes: A61F 2/30749 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/4405 : for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/441 : made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 : Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/2817 : Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body

Abstract

Methods and devices for stabilizing spinal anatomical structures. Some example methods may include introducing a curved segment of an elongate fastener placement rod adjacent to a bone, providing a fastener at the leading end of the curved segment, and/or securing the fastener in place with respect to the bone.

Claims

1. A method for stabilizing a bone in a body of a subject, comprising:

introducing, into the body of the subject, a curved segment of an elongate, fastener placement rod, such that a leading end of the curved segment at least partially circumnavigates the bone;

providing, at the leading end of the curved segment of the fastener placement rod, a fastener at the bone;

securing the fastener with respect to the bone, wherein the fastener is secured with respect to the bone utilizing at least one flexible line;

passing the flexible line from the fastener through at least a portion of the bone to a separate securing point within the body, wherein the passing step is performed utilizing a gripper at a leading end of an elongate gripper rod which pulls the flexible line from the fastener and at least through the portion of the bone to the separate securing point within the body, wherein the elongate fastener placement rod and elongate gripper rod extend from a hand-held guidance and positioning device; and

forming a hole through the portion of the bone prior to the pulling step, wherein the hole forming step is performed by an elongate drill rod extending from the hand-held guidance and positioning device,

wherein;

the bone is a first bone,

the flexible line is provided attached to the fastener at the first bone, and

the method includes a step of passing the flexible line from the fastener and at least through the portion of the first bone, through at least a portion of a second bone to a separate securing point within the body, thereby stabilizing at least the first and second bones with respect to each other.

2. The method of claim 1, further comprising securing the at least one flexible line at the separate securing point by a second fastener.

3. The method of claim 2, wherein the step of securing the at least one flexible line at the separate securing point by the second fastener comprises crimping the second fastener to the flexible line.

4. The method of claim 3, wherein the crimping step comprises introducing a crimping mechanism extending from an elongate rod of a crimping tool through an incision in the body and adjacent to the second fastener.

5. The method of claim 1, wherein the at least one flexible line comprises a suture.

6. The method of claim 1, wherein the at least one flexible line comprises a cable.

7. The method of claim 1, wherein the elongate gripper rod and elongate drill rod are guided by a guide tube extending from the hand-held guidance and positioning device.

8. The method of claim 1, wherein the elongate gripper rod extends from the hand-held guidance and positioning device along an axis that runs adjacent to or through the leading end of the curved segment of the fastener placement rod.

9. The method of claim 1, wherein the first bone is a first vertebra and the second bone is a second vertebra.

10. The method of claim 1, wherein the first bone is a first spinous process and the second bone is a second spinous process.

11. The method of claim 1, wherein the method includes a step of passing the flexible line from the fastener and at least through the portion of the first bone, through at least a portion of a second bone, and through at least a portion of a third bone to the separate securing point within the body, thereby stabilizing at least the first, second and third bones with respect to each other.

12. The method of claim 1, wherein the passing step further comprises passing the flexible line through an implant.

13. The method of claim 1, wherein the first bone is a first side of a cervical spine and the second bone is a second side of the cervical spine.

14. The method of claim 1, wherein the method further comprises passing the flexible line through a tubular implant positioned between the first and second bones.

15. The method of claim 1, further comprising a step of tensioning at least a portion of the flexible line extending between the fastener and the separate securing point.

16. The method of claim 1, wherein the flexible line extends to or through a stabilization rod or plate.

17. A method for stabilizing a bone in a body of a subject, comprising:

connecting a flexible line and a fastener;

introducing a curved segment of an elongate, fastener placement rod into the body of the subject, such that a leading end of the curved segment at least partially circumnavigates the bone;

providing, at the leading end of the curved segment of the fastener placement rod, the fastener and the flexible line at a fastener placement point that is at the bone, the providing step including passing the fastener and attached flexible line through the curved segment of the elongate fastener placement rod to the leading end;

passing the attached flexible line from approximate the fastener placement point through at least a portion of the bone to a securing point, wherein the passing step is performed utilizing a gripper at a leading end of an elongate gripper rod to pull the attached flexible line from approximate the fastener placement point through at least the portion of the bone to the securing point, wherein the elongate fastener placement rod and the elongate gripper rod extend from a hand-held guidance and positioning device;

forming a hole through the portion of the bone prior to the passing step, wherein the hole forming step is performed by an elongate drill rod extending from the hand-held guidance and positioning device;

tensioning the flexible line between the fastener placement point and the securing point; and

securing the flexible line at the securing point.

18. The method of claim 17 wherein the elongate gripper rod and the elongate drill rod are guided by a guide tube extending from the hand-held guidance and positioning device.