Tissue fixation system and method

• US 9,980,761 B2
• Filed: 09/25/2015
• Issued: 05/29/2018
• 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., Crainich, Lawrence
• Primary Examiner(s): Boles, Sameh
• Application Number:
  US14/866,001
• Publication Number:
  US 20160008043A1
• Time in Patent Office: 977 Days
• Field of Search: None
• 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 17/0487 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 17/683 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 17/82 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 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• 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 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• 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: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/08 : Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/28 : Bones joints A61F2/30
• 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 2002/30677 : 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

Abstract

A tissue fixation system is provided for dynamic and rigid fixation of tissue. A fastener connected with an elongate fastening member, such as a cable, wire, suture, rod, or tube, is moved through a passage between opposite sides of tissue. The fastener is provided with a groove that accommodates at least a portion of the fastening member to reduce the profile during the movement through the passage. The fastener is then pivoted to change its orientation. A second fastener can then be connected with the fastening member. While tension is maintained in the fastening member, the fasteners are secured against relative movement. This may be done by deforming the fastening member, either the first or second fasteners, or a bushing placed against the second fastener.

Claims

1. A tissue fixation system comprising:

an elongate member;

an anchor positionable on the elongate member and movable from a first orientation to a second orientation, the anchor having a body with a surface configured to contact a first tissue;

a fastener positionable along the elongate member and having a body with a surface configured to contact a second tissue;

a cannulated drill system comprised of a removably connected drill and an attached outer sleeve configured to pass together through the first tissue and the second tissue as the drill creates a passage through the first tissue and the second tissue, wherein the removably connected drill is configured to be removed from the outer sleeve, wherein the anchor positioned in the first orientation on the elongate member is configured to be inserted into and advanced through the outer sleeve;

a pushrod, configured to advance the anchor positioned on the elongate member in the outer sleeve through the outer sleeve, wherein the anchor is configured to pivot from the first orientation to the second orientation and contact the first tissue after passage through the outer sleeve; and

a medical instrument configured to secure the fastener to the elongate member, the medical instrument comprising;

a handle;

a tubular member coupled to the handle, the tubular member including first and second ends and defining a longitudinal passage along a central longitudinal axis through which the elongate member is configured to be passed through the tubular member;

a tensioning mechanism disposed in the handle for tensioning the elongate member to a desired tension by actuating the tensioning mechanism when the elongate member is secured in the tensioning mechanism, wherein the tensioning mechanism is comprised in part of a pivotably attached lever to apply tension to the elongate member, and a sensor and a spring element to measure and control the tension in the elongate member;

a crimping mechanism positionable in at least a portion of the first end on the tubular member for securing the fastener about the elongate member, wherein the fastener is positionable in the crimping mechanism;

a trigger mechanism disposed in the handle for activating the crimping mechanism, the trigger mechanism comprised in part by a pivotably attached trigger, wherein actuation of the trigger activates the crimping mechanism,

wherein the pivotably attached lever of the tensioning mechanism and the pivotably attached trigger of the trigger mechanism pivot about parallel axes; and

a cutting mechanism configured to cut off the excess elongate member simultaneous to the crimping mechanism securing the fastener about the elongate member,

wherein securing the fastener about the elongate member secures the anchor against the first tissue.

2. The tissue fixation system of claim 1, wherein at least a portion of one of the elongate member, anchor, fastener, cannulated insertion device, and medical instrument are passed through at least one of tube, delivery catheter, sheath, cannula or expandable cannula in a minimally invasive incision.

3. The tissue fixation system of claim 1, wherein surgery utilizing at least a portion of the system can be performed with a surgical robot.

4. The tissue fixation system of claim 1, wherein the system can be used in at least one of repair, reconstruction, augmentation, and securing of at least one of a tissue or an implant.

5. The tissue fixation system of claim 4, wherein the implant includes harvested, configured, and implanted tissue.

6. The tissue fixation system of claim 1, wherein at least one of the first tissue and second tissue includes at least one of bone, muscle, ligament, tendon, cartilage, joint, capsule, organ, skin, nerve, vessel, or stomach tissue.

7. The tissue fixation system of claim 1, wherein the system is utilized in at least one of minimally invasive joint replacement surgery, intervertebral disc surgery, knee surgery, hip surgery, organ transplant surgery, bariatric surgery, spinal surgery, anterior cruciate ligament surgery, tendon-ligament surgery, rotator cuff surgery, capsule repair surgery, fractured bone surgery, pelvic fracture surgery, avulsion fragment surgery, and hernia repair surgery.

8. The tissue fixation system of claim 1, wherein the elongate member is at least one of a suture, a thread, a cable, a wire, and a pin.

9. The tissue fixation system of claim 1, wherein the drill system is configured to drill through bone tissue.

10. The tissue fixation system of claim 1, wherein the system is configured to be used with at least one of endoscopic guidance, computer assisted navigation, magnetic resonance imaging, CT scan, ultrasound, fluoroscopy, and X-ray indirect visualization techniques.

11. The tissue fixation system of claim 1, wherein the fastener is comprised of an anchor and a bushing.

12. The tissue fixation system of claim 1, wherein the system is configured to secure at least one of a plate and rod within or on a fractured bone.

13. A tissue fixation system for fixation of a first tissue member to a second tissue member, comprising:

an elongate member positionable though the first and second tissue members and including first and second ends, such that the first and second tissue members are interposed between the first and second ends of the elongate member;

an anchor positionable on the first end of the elongate member, adjacent to the first tissue member;

a fastener positionable on the second end of the elongate member, adjacent to the second tissue member;

a medical instrument configured to secure the fastener to the elongate member, the medical instrument comprising;

a handle;

a tubular member coupled to the handle, the tubular member including first and second ends and defining a longitudinal passage along a central longitudinal axis through which the elongate member is configured to be passed through the tubular member;

a tensioning mechanism disposed in the handle for tensioning the elongate member to a desired tension by actuating the tensioning mechanism when the elongate member is secured in the tensioning mechanism, wherein the tensioning mechanism is comprised in part of a pivotably attached lever to apply tension to the elongate member, and a sensor and a spring element to measure and control the tension in the elongate member;

a crimping mechanism positionable in at least a portion of the first end on the tubular member for securing the fastener about the elongate member, wherein the fastener is positionable in the crimping mechanism;

a trigger mechanism disposed in the handle for activating the crimping mechanism, the trigger mechanism comprised in part by a pivotably attached trigger, wherein actuation of the trigger activates the crimping mechanism; and

a cutting mechanism configured to cut off the excess elongate member,

wherein the pivotably attached lever of the tensioning mechanism and the pivotably attached trigger of the trigger mechanism pivot about parallel axes, and

wherein the tension provided through the elongate member between the anchor and fastener, affixes the first tissue member to the second tissue member.

14. A tissue fixation system of claim 13, wherein the system is configured to secure a plate on a fractured bone.

15. The tissue fixation system of claim 13, wherein surgery utilizing at least a portion of the system can be performed with a surgical robot.

16. The tissue fixation system of claim 13, wherein the system can be used in at least one of repair, reconstruction, augmentation, and securing of at least one of tissue or an implant.

17. The tissue fixation system of claim 13, wherein at least one of the first tissue and second tissue includes at least one of bone, muscle, ligament, tendon, cartilage, joint, capsule, organ, skin, nerve, vessel, or stomach tissue.

18. The tissue fixation system of claim 13, wherein the system is utilized in at least one of minimally invasive joint replacement surgery, intervertebral disc surgery, knee surgery, hip surgery, organ transplant surgery, bariatric surgery, spinal surgery, anterior cruciate ligament surgery, tendon-ligament surgery, rotator cuff surgery, capsule repair surgery, fractured bone surgery, pelvic fracture surgery, avulsion fragment surgery, and hernia repair surgery.

19. The tissue fixation system of claim 13, wherein the cutting of the excess elongate member occurs simultaneous to the crimping mechanism securing the fastener about the elongate member.

20. The tissue fixation system of claim 13, wherein the elongate member is at least one of a suture, a thread, a cable, a wire, and a pin.