Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-04-08
2001-04-03
Yasko, John B. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C606S075000, C606S075000
Reexamination Certificate
active
06210376
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to devices for delivering medication and other fluids through a patient's bone, and in particular to a delivery pin for introducing fluids into bone.
BACKGROUND OF THE INVENTION
There are a number of surgical procedures which involve the delivery of medication and other fluids into the bone of a patient. One example is intraosseous infusion, a procedure for administering fluids into a patient's bloodstream through the medullary cavity of a patient's bones, typically the long bones, jaw bone or pelvis. This procedure allows the medication or other fluids to enter the bloodstream from the medullary cavity within seconds without requiring access to a suitable blood vessel of the patient. In other applications, medication or other fluids are delivered to the cortical plate of patients' bones.
A type of device which is used to deliver fluids into bone is a delivery pin or needle. A delivery needle is used in intraosseous infusion for accessing the medullary cavity of the bone. The needle has a passageway and a number of orifices in communication with the passageway for delivering the fluids into the bone. For boring through bone, the needle has a pointed end and a number of threads spaced longitudinally along the needle. The pointed end may include a self-cutting tip for tapping into and boring into bone. A drill may be used to drill a hole in the bone prior to inserting the needle, if no self-cutting tip is provided. The needle is inserted by rotating the needle with either a drill operated at a low speed, or manually. The needle is inserted until the orifices are appropriately positioned within the patient's bone.
The orifices of delivery pins have a tendency to become clogged with tissue during the advancement of the needle through the bone. U.S. Pat. No. 5,601,559 to Melker et al., the disclosure of which is hereby incorporated by reference herein, discloses orifices which are sized and positioned with respect to threads on the needle to avoid such clogging. Clogging of the orifices of the pin prevents the administration of fluids and may present a possibly life-threatening situation for a patient in dire need of the administration of such fluids.
Threaded pins are also used as fixation devices anchoring other devices to bone. For example, one device for anchoring prostheses in bone includes cutting edges for boring into bone, as well as orifices for providing space into which bone tissue can grow. Such a device is disclosed by Bränemark, U.S. Pat. No. 5,725,581, the disclosure of which is hereby incorporated by reference herein. In these devices as well, bone tissue tends to clog the orifices as the pin advances through the bone. Thus, improvements in needles or pins for delivering medication and other fluids to the bone of a patient are desirable.
SUMMARY OF THE INVENTION
A delivery pin for administering fluids to the bone of a patient comprises a shaft having a connection end and a pointed end. The shaft defines a conduit for communication of fluids and a plurality of delivery holes in communication with the conduit. At least a portion of the delivery holes has a central axis tilted in a direction toward the connection end of the shaft. In preferred embodiments, the pin includes threaded portions for boring through bone. The pin, for example, may include at least a first threaded portion of the shaft which includes threads for boring through bone. The threads are longitudinally spaced along the threaded portion of the shaft. In certain embodiments, at least a portion of the delivery holes are disposed between the spaced threads and distributed on the threaded portion. In other embodiments, the shaft includes a perforated portion disposed in an unthreaded portion of the shaft and the delivery holes are disposed in the perforated unthreaded portion.
The tilted delivery holes of the delivery pin substantially discourages clogging of the delivery pin. The delivery pin may be used in procedures infusing fluids into the medullary cavity or cortical plates of bones and the delivery holes are preferably positioned accordingly. The delivery pin may be also used as a fixation device to fix another device to bone while delivering fluids to the bone.
In certain preferred embodiments, the threaded and perforated portions are positioned along the shaft so that the pin may be positioned as desired. For example, the delivery holes may be spaced from the pointed end so that a threaded portion adjacent the pointed end engages the cortical plate of the bone and the delivery holes are disposed within the medullary cavity. In certain preferred embodiments, the first threaded portion comprises a portion of the shaft adjacent the pointed end of the shaft. The threaded portion may, for example, extend from the pointed end of the shaft to a first intermediate point on the shaft comprising a second end of the first threaded portion. Thus, the pin may include an unthreaded portion adjacent the pointed end and a portion extending from the connection end to the first intermediate point which does not include threads. In certain embodiments, the perforated portion may comprise the unthreaded portion extending from the connection end to the first threaded portion. In other embodiments, the pin includes a second threaded portion adjacent the connection end of the shaft. The second threaded portion extends from the connection end to a second intermediate point so that the perforated portion extends from the second intermediate point to the first intermediate point, between the first and second threaded portions.
In preferred embodiments, the delivery pin further comprises curved segments between the threads. The curved segments may include, for example, surfaces facing the connection end and surfaces facing the pointed end. The delivery holes are desirably defined by the surfaces facing the connection end.
Preferred embodiments also include a trocar for slidable engagement with the conduit of the pin to block the conduit. Preferably, the trocar substantially fills the conduit and prevents the ingrowth of bone. Additionally, the trocar leaves little stagnant area within the conduit for bacterial infection to develop.
Another aspect of the invention provides a delivery pin for administering fluids to the bone of a patient, comprising a shaft having a connection end and pointed end and defining a conduit for the communication of fluids, the shaft including a first threaded portion and an unthreaded portion. The first threaded portion is a portion of the shaft adjacent the pointed end, including threads longitudinally spaced along the first threaded portion for boring through bone and the shaft defines a plurality of delivery holes in communication with the conduit. In preferred embodiments, the delivery pin further comprises a second threaded portion adjacent the connection end and the delivery holes are disposed in the unthreaded portion. At least a portion of the plurality of delivery holes has a central axis tilted in a direction toward the connection end of the delivery pin in preferred embodiments, as discussed above.
Another aspect of the invention is a method of installing the delivery pin to administer fluids to the medullary cavity of a patient's bone by providing a cut in the cortical bone surrounding the medullary cavity and turning the delivery pin so that the threads bore through the cortical bone until the first and second threaded portions are disposed within the cortical bone and the delivery holes are disposed within the medullary cavity of the bone.
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patent: 3821956 (1974-07-01), Gordhamer
patent: 4175555 (1979-11-01), Herbert
patent: 4236520 (1980-12-01), Anderson
patent: 4573448 (1986-03-01), Kambin
patent: 4653489 (1987-03-01), Tronzo
patent: 4670008 (1987-06-01), Von Albertini
patent: 4769005 (1988-09-01), Ginsburg et al.
patent: 4784638 (1988-11-01), Ghajar et al.
patent: 4950270 (1990-08-01), Bowman et al.
patent: 4968306 (1990-11-01), Huss et al.
patent: 5047030 (1991-09-01), Draenert
paten
Browdy and Neimark
New York University
Yasko John B.
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