Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
1999-09-29
2001-11-20
Schaetzle, Kennedy (Department: 3762)
Surgery
Instruments
Orthopedic instrumentation
C606S142000, C227S175100
Reexamination Certificate
active
06319258
ABSTRACT:
FIELD OF THE INVENTION
The field of art to which this invention relates is surgical instruments, in particular an applier for delivering an absorbable orthopaedic fastener. Specifically, a multi-shot rivet applier that drives an absorbable polymer rivet and pin for fixating a plate to bone, especially hard tissue of the cranium or face, for plastic or reconstructive surgical procedures.
BACKGROUND OF THE INVENTION
There are currently a variety of metallic fasteners and appliers or drivers to deliver the fastener for attaching bone plates to fracture and surgery repair sites; spinal, cranial, and maxillo-facial plates have all been fastened using metal screws. The disadvantage of metal screws and other fasteners is that they are permanent and may need to be removed through a second surgical procedure. If they remain in the body, tissue atrophy and subsequent loosening of the device may occur. In addition, metallic and especially plastic screws, including absorbable polymer screws, quite often require tapping threads into the bone; a laborious task that slows the surgical procedure and can lead to poor fixation from stripping of the threaded bone.
Metallic wire or suture can be used to attach plates to bone. This technique requires a tedious method of drilling numerous holes, guiding the wire through the holes, tying and bending the wire and then cutting excess wire away to prevent irritation of soft tissues.
Furthermore, several rivet patents relate to devices which are inserted into a hole and then deployed by driving a member upwards, or proximally, through or into a radially flexible portion of the device. This requires that the hole be deeper than the depth of the deployed device in order to leave enough room to fully insert the device with some type of driver before deployment. Such designs are undesirable for surgical applications where only a thin layer of bone is available for attachment or it is not possible to drill beyond the depth of the thin bone layer for fear of damaging underlying soft tissues, such as in cranial and maxillo-facial surgical procedures. In such cases, the required length of the fastener for adequate fastening strength is very close to the total thickness of the bone.
U.S. Pat. No. 4,590,928 describes an anchor consisting of an elongated cylindrical body with a tapered coaxial channel and radially flexible legs and a pin insertable into the end having the head, the proximal end. The body is placed into a hole formed in bone and the pin is inserted into the channel to expand the legs radially into the surrounding bone. The body and pin are of biocompatible material and the body contains carbon fibers embedded in and extending longitudinally along its interior. Since carbon fibers are not absorbed by or resorbed within the body, this fastener is only partially absorbable.
This patent U.S. Pat. No. 4,590,928, describes a fastener having a solid pin. It is well known that the material properties, such as Young'modulus of elasticity and the material yield stress, of bone tissue change significantly with age and vary significantly among individuals of the same age and sex. Having a solid pin therefore limits the fastening ability of the device since the pin cannot deform if the surrounding bone is stiff that the legs cannot expand radially outwards.
In such a case where the surrounding bone is stiffer than that for which the device was designed and the pin is solid, the large force required to drive the rigid pin into the tapered hole will be such that either the legs will be deformed and rendered useless or the pin will be crushed. A radially compressible or flexible pin that could deform radially inwards to fit the internal passage under high insertion load conditions would give the fastener better performance over a wider range of bone material properties.
U.S. Pat. No. 5,268,001 describes an apparatus for emplacement of a single bone fastener in a bone. The apparatus consists of holder for holding an expandable sleeve in position within a pre-drilled hole in bone. A plunger moveable in relation to the holder forces a pin into the bore of the expandable sleeve. An attached means for separating the expandable sleeve from the holder (i.e. annular cutter) then cuts the expandable sleeve, thereby releasing the sleeve from the holder. Typical procedures require more than one fastener and varying amounts of application force. This apparatus lacks the ability to apply multiple fasteners and to change the level of force required to embed the pins into the above-mentioned expandable sleeve.
Therefore, what is needed in the art is a novel absorbable fastener for cranial, maxillo-facial, and other reconstructive surgical applications in which the fastener is inserted into a hole having the same depth as the fastener and is deployed by driving a radially compressible member downwards, or distally, into a flexible body of the fastener from above. The current invention discloses an applier for such a device wherein the applier can fire multiple rivet fasteners with little force thereby speeding and simplifying the procedure. The multiple applier consists of a cartridge, which will contain multiple rivet fasteners. The cartridge utilizes a loading mechanism which loads single rivets. The applier also consists of a firing mechanism that can produce varying degrees of force required for different surgical applications.
SUMMARY OF THE INVENTION
We have discovered a rivet applier comprising a housing with a horizontal axis, an applier barrel, a passage substantially parallel to the horizontal axis and a trigger. The applier barrel having a central chamber with a proximal chamber opening, a distal chamber opening and a slot. The proximal end of the applier barrel is attached to the housing and aligned with the horizontal axis of the applier barrel. A loader is slidably mounted within the central chamber of the applier barrel having a loader handle attached thereto and extending substantially perpendicular to the horizontal axis. A firing pin extends through said housing and the central chamber of the applier barrel. The firing pin is biased to extend through the applier barrel to the proximal chamber opening, the firing pin extending through the proximal chamber into the housing. The firing pin is mechanically linked to a trigger mechanism for restraining the firing pin in a first position and being capable of releasing the firing pin in cooperation with the movement of the trigger to allow the firing pin to move to a second position.
We have also discovered a rivet clip assembly, which is composed of a clip barrel and clip body. The clip barrel has a barrel opening on its distal end and a barrel groove adjacent to the proximal end. The clip body is attached to the barrel and extends substantially perpendicular thereto. The clip body is adapted to contain at least one rivet (and preferably a plurality), which is supported by a clip guide and biased by a clip spring. The rivet enters the barrel through a clip slot. The forward movement of the loader moves the rivets from the chamber of the clip barrel to the end of the clip barrel prior to placement in the patient. Firing the trigger advances the rivet out of the rivet applier and pushes the rivet pin into the rivet thereby securing the rivet in the patient.
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Cooper Kevin L.
McAllen, III John
Overaker David W.
Droesch Kristen L.
Ethicon Inc.
Schaetzle Kennedy
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