Deformable fastener system

• US 9,814,453 B2
• Filed: 04/26/2013
• Issued: 11/14/2017
• 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): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US13/871,892
• Publication Number:
  US 20130274769A1
• Time in Patent Office: 1,663 Days
• Field of Search: 606 99
• 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, resorptive for implantable prostheses A61F2210/0004
• 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 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 2017/0464 : for soft tissue
• 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: 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

The guidance and positioning device may be a system for creating a passage in tissue, positioning fasteners or other implants, and tensioning an elongated fastening member, like a suture, thread, wire, or pin. In some embodiments, the device may allow for the implantation of multiple sutures and fasteners in tissue. A fastener may be positioned at the distal end of a flexible pushrod. The fastener may be connected with the pushrod or may be loosely fitted with the distal end of the pushrod. A suture may be looped through or connected with the fastener such that one, two, or more sections, legs, strands, or portions of the suture extend from the fastener.

Claims

1. A deformable fastener system comprising:

a flexible hollow fastener fabricated solely from a plurality of biocompatible fibers;

a suture extending through the hollow fastener such that two legs of the suture extend from the hollow fastener to enable a user to tension the suture, wherein at least a portion of the suture is fabricated with polyethylene; and

an introducer having a pushrod configured to engage the fastener and position the fastener relative to a body tissue, wherein the hollow fastener and suture are positioned on the distal end of the pushrod, and

wherein the hollow fastener is configured to deform from a first configuration to a second configuration to provide an anchor for the suture as the suture is tensioned relative to the body tissue; and

wherein the hollow fastener includes a polymeric material.

2. The system of claim 1, wherein the suture includes at least a portion of polyester.

3. The system of claim 1, wherein the hollow fastener is knotless.

4. The system of claim 1, wherein the suture is positionable through proximal and distal portions of body tissue.

5. The system of claim 1, wherein the pushrod is flexible.

6. The system of claim 1, wherein the introducer has at least one of a linear configuration and a curved configuration.

7. The system of claim 1, wherein the distal portion of the introducer is configured to penetrate an imperforate surface of the body.

8. A deformable fastener system comprising:

a suture;

a flexible hollow fastener fabricated solely from a plurality of fibers comprised of a biocompatible polymeric material, wherein at least a portion of the suture extends through the hollow fastener such that two legs of the suture extend from the hollow fastener to enable a user to tension the suture to deform the hollow fastener from a first configuration to a second configuration to anchor the suture within the body; and

an introducer with a pushrod configured to engage the fastener, wherein the hollow fastener and suture are positioned on the distal end of the pushrod.

9. The system of claim 8, wherein the suture is at least one of braided and interlaced.

10. The system of claim 8, wherein the suture includes polyethylene.

11. The system of claim 8, wherein the suture includes at least a portion of polyester.

12. The system of claim 8, wherein the pushrod is flexible.

13. The system of claim 8, wherein the introducer has at least one of a linear configuration and a curved configuration.

19. The system of claim 8, wherein the hollow fastener is knotless.

14. A method of using a deformable fastener system, said method comprising:

inserting a deformable hollow fastener into a passage in a bone, the deformable hollow fastener being flexible and fabricated solely from a plurality of flexible biocompatible fibers, and having a suture extending through the deformable hollow fastener such that two legs of the suture extend from the deformable hollow fastener to enable a user to tension the suture, wherein the deformable hollow fastener and suture are positioned on the distal end of a pushrod during insertion;

tensioning the suture to anchor the deformable hollow fastener into the bone;

deforming the deformable hollow fastener from a first configuration to a second configuration in the bone; and

wherein inserting a deformable hollow fastener further comprises inserting a deformable hollow fastener that includes a polymeric material.

15. The method of claim 14, wherein inserting a deformable hollow fastener having a suture further comprises inserting a deformable hollow fastener having a suture that is at least one of braided and interlaced.

16. The method of claim 14, wherein inserting a deformable hollow fastener having a suture further comprises inserting a deformable hollow fastener having a suture that includes at least one of polyethylene and polyester.

17. The method of claim 14, wherein inserting a deformable hollow fastener further comprises inserting a deformable hollow fastener with a pushrod that is flexible.

18. The method of claim 14, wherein inserting a deformable hollow fastener further comprises inserting a deformable hollow fastener with an introducer that has at least one of a linear configuration and a curved configuration.

20. The method of claim 14, wherein inserting a deformable hollow fastener further comprises inserting a deformable hollow fastener that is knotless.