Systems, device, and methods for joint fusion

• US 10,363,140 B2
• Filed: 07/12/2016
• Issued: 07/30/2019
• Est. Priority Date: 03/09/2012
• Status: Active Grant

• Current Assignee: SI-Bone, Incorporated
• Original Assignee: SI-Bone, Incorporated
• Inventors: Mauldin, Richard G., Rashbaum, Ralph F., Reiley, Mark A., Yerby, Scott A., Sand, Paul, Schneider, Bret W., Rodriguez, Jose, Domingo, Nicanor, Leung, Joanne
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): Gabr, Mohamed G
• Application Number:
  US15/208,588
• Publication Number:
  US 20170007409A1
• Time in Patent Office: 1,113 Days
• 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 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1664 for the hip
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/7055 connected to sacrum, pelvis or skull
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/84 Fasteners therefor or fasteners being internal fixation devices
• CPC Class Codes: A61B 17/846 Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface A61B17/72, A61B17/86 take precedence
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61B 17/92 Impactors or extractors, e.g. for removing intramedullary devices insertion or extraction of artificial joints A61F2/4603
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/3433 with different outer diameters of the cannula
• CPC Class Codes: A61F 2/30988 Other joints not covered by any of the groups A61F2/32 - A61F2/4425
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/30156 : triangular
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/3093 : for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30995 : for sacro-iliac joints

Abstract

The present invention relates generally to implants and tools for the fixation or fusion of joints or bone segments. These tools include tissue dilators and protectors. Other tools include broaches used to shape bores in bone. The tools can also include a system for removing an implant from bone. Implants can include assemblies of one or more implant structures that make possible the achievement of diverse interventions involving the fusion and/or stabilization of lumbar and sacral vertebra in a non-invasive manner, with minimal incision, and without the necessitating the removing the intervertebral disc. Implants for fusing both sacroiliac joints of a patient include a long implant that extends across both sacroiliac joints.

Claims

1. A system for the fusion of the sacroiliac joint, the system comprising:

a guide pin configured to have a length greater than a mediolateral side to side width of an adult human patient'"'"'s pelvis, the guide pin having a proximal end with a first alignment feature and a distal end with a second alignment feature;

a broach having a lumen for receiving the guide pin, the lumen having a complementary alignment feature that is configured to interact with the first alignment feature and the second alignment feature to register the broach with the guide pin in a predetermined orientation, the broach configured to form a rectilinear cavity in bone; and

an implant having a rectilinear cross-section transverse to a longitudinal axis of the implant, the implant configured to have a length greater than the width between a surface of the patient'"'"'s right ilium and a surface of the patient'"'"'s left ilium, the implant sized to fit through the cavity formed by the broach,

wherein the broach further comprises;

an elongate body with a proximal end, a distal end, at least three faces between the distal end and the proximal end, a plurality of apices formed at the junctions between adjacent faces, and a longitudinal axis, the lumen extending throughout the elongate body about the longitudinal axis, wherein the lumen is sized and shaped for receiving the guide pin;

a plurality of cutting surfaces spaced apart along the longitudinal axis of the elongate body and located on the distal end of the elongate body for shaping the cavity to receive the implant, wherein the plurality of cutting surfaces are oriented along the plurality of apices and become progressively smaller in size towards the distal end; and

a plurality of additional cutting surfaces aligned with the plurality of apices for cutting channels in the cavity to receive a bone graft material.

2. The system of claim 1, further comprising a soft tissue protector, the soft tissue protector comprising:

a longitudinal body having a distal end, a proximal end and a wall with an inner surface that defines a passage extending through the longitudinal body, wherein the passage is configured to receive the implant;

at least one port located on the inner surface of the wall proximal the distal end of the longitudinal body; and

at least one channel in fluid communication with the at least one port, wherein the at least one channel is configured to contain a biologic aid.

3. The system of claim 1, wherein the implant has a rough surface.

4. The system of claim 1, wherein the implant has a triangular cross-section transverse to the longitudinal axis of the implant.

5. The system of claim 1, wherein the implant has a rectangular or square cross-section transverse to the longitudinal axis of the implant.

6. The system of claim 1, wherein the first alignment feature and the second alignment feature are selected from the group consisting of lines, ridges, slots, and pins.

7. A system for the fusion of the sacroiliac joint, the system comprising:

a guide pin configured to have a length greater than a mediolateral side to side width of an adult human patient'"'"'s pelvis;

a broach having a lumen for receiving the guide pin, the broach configured to form a rectilinear cavity in bone; and

an implant having a rectilinear cross-section transverse to a longitudinal axis of the implant, the implant configured to have a length greater than the width between a surface of the patient'"'"'s right ilium and a surface of the patient'"'"'s left ilium, the implant sized to fit through the rectilinear cavity formed by the broach,

wherein the broach further comprises;

an elongate body with a proximal end, a distal end, at least three faces between the distal end and the proximal end, a plurality of apices formed at the junctions between adjacent faces, and a longitudinal axis, the broach lumen extending throughout the elongate body about the longitudinal axis, wherein the broach lumen is sized and shaped for receiving the guide pin;

a plurality of cutting surfaces spaced apart along the longitudinal axis of the elongate body and located on the distal end of the elongate body for shaping the rectilinear cavity to receive the implant, wherein the plurality of cutting surfaces are oriented along the plurality of apices and become progressively smaller in size towards the distal end; and

a plurality of additional cutting surfaces aligned with the plurality of apices for cutting channels in the rectilinear cavity to receive a bone graft material.

8. The system of claim 7, wherein the implant length is configured to be greater than the width between a surface of the patient'"'"'s right ilium and a surface of the patient'"'"'s left ilium by about 2 to 20 mm.

9. The system of claim 7, wherein the implant length is configured to be between about 100 mm to 300 mm.

10. The system of claim 7, wherein the guide pin has an alignment feature that extends across the length of the guide pin.