Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-05-13
2001-10-16
Yasko, John D. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S506000
Reexamination Certificate
active
06302866
ABSTRACT:
RELATED APPLICATIONS
This application claims the priority of German Patent Application No. 198 21 723.4, filed May 14, 1998, which is incorporated herein by reference.
BACKGROUND
The invention relates to a catheter head for subcutaneous administration of substances, including medically active substances, such as insulin and the like.
A catheter head as known from U.S. Pat. No. 5,522,803 comprises a cannula housing with a cannula and a needle holder, to be connected to the cannula housing, including a feed line for feeding a substance to the catheter head. The cannula projects from the cannula housing and is placed in tissue. In the cannula housing a passage channel to the cannula is formed for the active substance. The cannula housing is designed to allow flush, conforming or mould (or molded) positioning on the surface of the tissue into which the cannula is placed, and it is prepared for being fixed on or attached to the tissue.
A connecting needle is rigidly attached to the needle holder. The connecting needle is introduced into the passage channel of the cannula housing for obtaining a connection. Both the cannula and the cannula housing will stay on the site of attachment in and on the tissue, whereas the needle holder may be repeatedly connected to the cannula housing and separated from the same again. During assembly, the cannula housing and the needle holder are automatically engaging into each other, due to the needle holder detachably anchoring itself to the cannula housing. Guide means are provided for positioning the connecting needle in relation to the passage channel of the cannula housing and for introducing the connecting needle into the passage channel, with the guide means guiding the needle holder at the cannula housing.
The guide means of this known catheter head are formed by a pair of guide pins projecting on either side of the connecting needle and parallel to the same from the needle holder. Accordingly, the cannula housing is provided with guide shafts on either side of an inlet into the passage channel into which one each of the guide pins for introducing the connecting needle is inserted. The connecting needle is positioned in relation to the inlet by the interaction of the guide pins with the guide shafts and guided in centered position during introduction into the passage channel. In the course of advancement of the connecting needle in the passage channel, the needle holder is anchored by an automatically engaging snap-on connection to the cannula housing.
SUMMARY
It is an object of the invention to provide a catheter head for subcutaneous administration of a substance comprising a cannula housing and needle holder which may be simply and correctly connected to each other, and which is easy to manufacture.
In one embodiment, the present invention provides a catheter head comprising a cannula housing, a needle holder connectable to the cannula housing and a guide sleeve associated with the needle holder for positioning and guiding a connecting needle, and for being narrowly slide-guided over a portion of said cannula housing.
In one embodiment the catheter head to which the invention relates comprises a cannula housing with a cannula and a needle holder, to be connected to the cannula housing, including a feed line for feeding an active substance to the catheter head. The cannula projects from the cannula housing and is placed in tissue. The cannula may be an integral part of the cannula housing. In another embodiment, the cannula may be attached and/or anchored inside the cannula housing. It may be designed as a rigid element, such as a steel cannula, or it may be flexible, or pliable. In the cannula housing a passage channel to the cannula is formed for the active substance. The cannula housing is designed to allow flush positioning on the tissue, into which the cannula is placed, and it is prepared for being fixed on to the tissue.
A connecting needle is rigidly attached to the needle holder. The connecting needle is introduced into the passage channel of the cannula housing for obtaining a connection. Both the cannula and the cannula housing will stay on the site of attachment in and on the tissue, whereas the needle holder may be repeatedly connected to the cannula housing and separated from the same again. During connection or assembly, the cannula housing and the needle holder are preferably automatically engaging with each other, in particular due to the needle holder being detachably anchored to the cannula housing. Guide means are provided for positioning the connecting needle in relation to the passage channel of the cannula housing and for introducing the connecting needle into the passage channel, with the guide means guiding the needle holder at the cannula housing.
According to the invention, the guide means of the needle holder is a guide sleeve axially surrounding the connecting needle, said guide sleeve being pushed narrowly slide-guided over a cylindrical extension of the cannula housing upon the needle holder and the cannula housing being connected, i.e. upon the connecting needle being introduced. The cylindrical extension surrounds the inlet and a section of the passage channel of the cannula housing connected to the same. The invention ensures secure introduction of the connecting needle without the need of forming additional guide pins. In addition, the guide sleeve represents a means of protection for handling, both for the needle and the user. The guide sleeve may have openings, but is preferably designed as a closed sleeve body.
In one preferred embodiment, the cannula housing comprises a compact front section, from the underside of which the cannula projects and from the rear of which a disc-shaped section and the cylindrical extension project, the disc-shaped section extending the underside of the cannula housing placed on the tissue. An upper side of the disc-shaped rear section of the cannula housing facing the cylindrical extension and an underside of the needle holder are acting as additional guide means upon the cannula housing and the needle holder are being connected, preventing rotation of the needle holder in relation to the cannula housing around the longitudinal axis of the connecting needle.
Preferably, an additional passage is formed in the cannula housing for a piercing needle for the cannula. When the cannula housing and the needle holder are connected, this passage points at an angle in relation to the connecting needle. The passage channel for the connecting needle leads into this additional passage which extends the passage channel up to the cannula after the cannula has been placed and the piercing needle retracted. Owing to the fact that a piercing needle need not be retracted from the passage channel, into which the connecting needle is introduced after placing the cannula and fixing the cannula housing, complete precharging of the catheter head up to the cannula, i.e. priming, is possible in the state of the cannula housing and the needle holder being connected.
In another embodiment, a flexible cannula extends the passage channel, but flush. In a third embodiment, the cannula may be formed by the piercing needle itself.
In one manufacturing process, the prefabricated cannula is moulded into the cannula housing when injection-moulding the cannula housing. For this purpose, a rear section of the cannula is preferably provided with a widened section, anchoring the cannula in the cannula housing during injection. The cannula may be made of a soft plastic material, in particular Teflon. A thermoplastic material may be used both as a material for the cannula housing and for the needle holder.
Other objects, features, embodiments and advantages of the device and method of the present invention will become more fully apparent and understood with reference to the following description and appended drawings and claims.
REFERENCES:
patent: 3783868 (1974-01-01), Bokros
patent: 4436519 (1984-03-01), O'Neill
patent: 4475548 (1984-10-01), Muto
patent: 4537593 (1985-08-01), Alchas
patent: 4682981 (1987-07
Disetronic Licensing AG
Dorsey & Whitney LLP
Yasko John D.
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