|Publication number||USRE40796 E1|
|Application number||US 09/922,555|
|Publication date||Jun 23, 2009|
|Filing date||Aug 3, 2001|
|Priority date||Apr 20, 1998|
|Also published as||US5954671|
|Publication number||09922555, 922555, US RE40796 E1, US RE40796E1, US-E1-RE40796, USRE40796 E1, USRE40796E1|
|Inventors||Michael J. O'Neill|
|Original Assignee||Paradigm Biodevices, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (21), Non-Patent Citations (7), Referenced by (13), Classifications (15), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims benefit of provisional application Ser. No. 60/082,340 filed Apr. 20, 1998.
A percutaneous, closed, or mini-open bone harvesting method for orthopedic, neurosurgical, ear nose & throat (ENT), oral, maxillo-facial, rheumatology, and bone marrow aspiration procedures.
Orthopedic, neurosurgical, spinal, ear-nose-throat, oral-maxillo-facial, and rheumatology procedures require the removal of bone or bone cells to culture or place in other parts of the body to permit fusion or bone formation. The current method for bone harvesting requires an open surgical procedure involving wide exposure of the iliac crests, ulna, radius, or femur. These areas are exposed with an incision over the donor sites, followed by the stripping of muscle to expose the donor site area. The removal of the bone is performed utilizing curettes, drills, or free-hand bone coring devices.
These open procedures usually cause very frequent donor site pain and morbidity as they involve significant incisional scarring, vast muscle stripping, damage to surrounding tissues, and over harvesting of the donor site. This has become one of the greatest complaints and problems of patients recovering from surgeries involving bone and bone marrow harvesting procedures.
Recently, inventors have begun creating “minimally invasive” methods to harvest bone. U.S. Pat. No. 5,556,399 to Huebner (1995) discloses a “coring drill used to harvest bone from a donor area of the human body.” This stainless steel device is the first device of its nature, and it is used freehand, under power, without guided controls and requires an open incision with wide muscle re-section.
In 1997, Spinetech, Inc. (Minneapolis, Minn.) released a patent pending “minimally invasive” cylindrical bone harvester that is used through a mini-open procedure, but without guided control. This device is not applicable to a percutaneous technique because it requires a large incision and muscle stripping to expose the donor site. The cutter is inserted into the donor site bone freehand. More importantly, the cutter tip is a uni-directional threaded two piece unit which must be disassembled to remove bone tissue from the collection tube. This makes the device unsuitable to a closed or percutaneous procedure due to the potential for disassembly inside the patient. Bi-directional cutting action will dislodge the cutter tip from the shaft.
Biomedical Enterprises, Inc. (San Antonio, Tex.) created the patent pending Bone & Marrow Collection System (BMCS), which utilizes a manual or motor driven drill bit and a disposable collection tube. This technique provides limited initial drill stabilization, but does not guide or control the direction of the tip after cutting action begins. In addition, it still utilizes an open procedure and vast muscle resection. The BMCS is an auger-drill type that is lacking an adequate delivery system for placing the guidance tube through a percutaneous or closed technique. Also, the BMCS does not prevent the drill cutter from advancing too far into the donor site, thus violating the surrounding bony architecture, tissue, and muscle. The BMCS also does not provide an accurate and easy method to measure the amount of material captured by the drill and collection tube, and is extremely susceptible to frequent clogging during repositioning of the tip.
This invention relates to a disposable or reusable bone harvester specifically designed to operate through percutaneous, closed, or mini-open incisions during orthopedic, neurosurgical, ENT, oral-maxillofacial, rheumatology, and bone marrow aspiration procedures.
The present invention discloses a manual, cylindrical, multi-directional coring device utilizing a guided delivery system that can be inserted through a percutaneous or closed approach to extract precisely measured amounts of bone or bone marrow. The invention requires only a small incision, less that 2 cm above the donor site, and utilizes a guided delivery system of guide wires, obturators, dilators, and cannulas. The present invention makes a very small incision that gradually splits the muscle and tissue. The result is less blood loss, less tissue damage, and less donor site morbidity.
All other techniques including Huebner's, Spinetech's, and BME's require an open or mini-open incision. The first two techniques do not possess a method for guided control of the cutter tip, and the last gives only limited direction prior to the coring procedure. The disadvantages of the above techniques are:
Accordingly, it is an object of the present invention to provide a method which permits bone to be harvested in precise quantities via a percutaneous or closed technique utilizing a series of guide wires, obturators, dilators, and cannulas as the exposure and delivery instrumentation for the cutting tool.
It is another object of the present invention to provide a multi-directional cutting tip with six cutting edges, which can be used to cut in clockwise, counterclockwise, or both directions, as well as with a downward force for rapid cutting action and morselization of graft material.
It is still another object of the present invention to provide multiple cannula sizes and shapes to accommodate different anatomic sites for a more precise fit, control, and tissue protection.
A further object of the present invention is to provide distal arms, or “teeth”, on the cannulas for stabilization and lateral control, which permit the cannula to move in an arc on the bony surfaces, facilitating multi-directional coring or sweeping of bone through the same incision.
Another object of the present invention is to provide a precise measurement system visible and calibrated along the proximal cylinder shaft to indicate depth of insertion and amount of material collected.
It is still another object of the present invention to provide a transparent, or translucent, bio-compatible, plastic cylindrical cutter shaft with a bonded, mechanically fastened, or ultrasonically welded permanently affixed stainless steel cutting tip forming a one-piece coring unit.
It is a further object of the present invention to provide a detachable and re-attachable T-Handle and/or Teardrop Handle.
It is also an object of the present invention to provide a calibration system on the proximal end of cutter shaft and a depth stop system to prevent the cutter from over harvesting bone, and advancing too far in the body.
Further objects of the invention may be provided with multiple sized cutting tips ranging in sizes from 8 mm, 10 mm, 12 mm, and 14 mm. These cutters can be utilized via laparoscopic techniques in addition to percutaneous, closed, and mini-open approaches.
These together with other objects of the invention, along with various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed hereto and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated a preferred embodiment of the invention.
Referring to the drawings in detail wherein like elements are indicated by like numerals, there is shown a bone harvesting method and apparatus used therein. As may be most clearly seen from
The guide wire 10 is elongated and preferably made from stainless steel and has nominal dimensions of 3.2 mm×25 cm. The guide wire 10 has a pointed distal end 11 and a blunt proximal end 12. The distal end 11 is defined as that end engaging a harvest site 3. The obturator 20 is also preferably made from stainless steel and has a generally cylindrical shape. The obturator 20 has a dome-shape distal end 22 and a cross-hatched proximal end 23. The proximal end 23 is cross-hatched to provide a better grip. The distal end 22 is used to split tissue for cannula placement as described below. A generally cylindrical channel 21 is centrally formed within the obturator 20 along its central, elongated axis extending from the distal end 22 to the proximal end 23. The obturator 20 is placed over the guide wire 10 by positioning the obturator 20 so that its channel 21 is slid over the wire 10. The dilator/toothed cannula 30 is also preferably made from stainless steel and has a cylindrical channel 31 is formed therein along its central, elongated axis extending from an open distal end 32 to an open proximal end 33. There may be several dilators 30 having varied lengths, outer diameters and inner diameters. Each distal end 32 is beveled with teeth at its distal tip 34 similar to a hole saw. The forked cannula 40 is hollow and has a distal end 42 and a proximal end 41. The distal end 42 is longitudinally notched resulting in two protruding arms 43 parallel to the central axis of the cannula 40. The proximal end 41 terminates in two, parallel, block-like elements 44. The forked cannula 40 is also preferably made from stainless steel and may have various inner and outer diameters and lengths. The cutter cylinder 50 has a proximal end 54 and distal end 55 with a hollow, transparent, or translucent, cylindrical biocompatible plastic tube 51 between. The distal end 55 has an attached stainless steel cutting tip 60. The cutting tip 60 may be permanently attached by bonding means of mechanically fastened or ultrasonically welded. The cutter cylinder proximal end 54 has a groove 56 for mating with a T-handle 70. The cutter cylinder 50 is nominally twenty-two centimeters in length, and comes in nominal eight, ten, twelve and fourteen centimeter diameters.
The cutting tip 60 has a proximal end 68 which attached to the cutter cylinder distal end 55. The distal end 61 of the cutter tip 60 has two, protruding, generally triangular blades 62 with four cutting edges 63 to facilitate bi-directional cutting action. The protruding blade tips 64 are connected to each other. The cutter tip distal end 61 also terminates in two cutting edges 65 positioned between the protruding cutting blades 62 for multi-directional and downward cutting action. See, especially,
Referring specifically to
Referring again to
As may be most clearly seen from
Although the iliac crest is the most popular area harvested, other anatomical sites may be indicated. For these areas, a small incision above the harvest site is made and the guide wire 10 inserted into cortical bone. An obturator 20 and dilator/toothed cannula 30 are placed over the wire guide 10. The wire guide 10 and obturator 20 are removed and an impactor cap 45 is placed over the cannula 30 and tapped gently into the cortical surface. The methodology of using the cutter cylinder 50 as described above is the same. Basically the only difference between methods is the use or non-use of the forked cannula 40.
It is understood that the above-described embodiment is merely illustrative of the application. Other embodiments may be readily devised by those skilled in the art which will embody the principles of the invention and fall within the spirit and scope of the invention thereof.
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|U.S. Classification||600/567, 606/179|
|International Classification||A61B19/00, A61B17/16, A61B10/00, A61B10/02, A61B17/14|
|Cooperative Classification||A61B17/1604, A61B2090/062, A61B10/025, A61B17/1635, A61B17/1688, A61B17/1637|
|European Classification||A61B17/16H, A61B17/16G|