Delivery apparatus, nozzle, and removable tip assembly

Fluent material handling – with receiver or receiver coacting mea – Filling means with receiver or receiver coacting means – With receiver and supply securing means

Reexamination Certificate

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Details

C141S383000, C141S384000, C141S391000, C141S392000, C604S082000, C606S092000

Reexamination Certificate

active

06502608

ABSTRACT:

TECHNICAL FIELD
This invention pertains in general to bone cement dispensing and delivery apparatus for flowable materials. More particularly, this invention relates to dispensing tips and nozzles for use in conjunction with a dispensing apparatus or container for binding materials such as surgical bone cement.
BACKGROUND OF THE INVENTION
Reconstructive bone surgery is a common procedure to replace bone structures. For example, replacement hip surgery uses a prosthetic hip joint to replace a patient's hip joint. Such surgical procedures include removing the hip joint from a femur, packing bone cement within an inner canal of the femur, and positioning the prosthetic hip joint into the bone cement inside the femur. Subsequently, the cement is allowed to harden, thereby securing the hip joint in place. A tip that is secured to a bone cement dispensing apparatus or container is commonly used to issue bone cement into a bone canal of the femur.
For example, to apply bone cement, the bone canal is cleaned out and the dispensing tip is introduced into the canal extending to a distal end of the canal which has previously been blocked with a canal plug. As bone cement issues from the tip into the canal, the tip is withdrawn from adjacent the canal plug in a retrograde fashion to the proximal end of the canal, thereby filling the canal with cement.
One technique to enhance filling of the proximal end of the bone canal is to shorten the tip, after first filling the proximal end, by snapping off an end of the tip using a score line provided for this purpose. However, this technique has disadvantages. First, snapping off the end can leave particulates of the tip structure in the surgical area and on the newly shortened end of the tip. When the tip is reintroduced into the canal to finish filling the proximal end of the bone canal, the particulates can contaminate the surgical site. The contamination can lead to infection in the bone and/or weakening of the bone cement once the cement hardens. Secondly, even the best score line can leave minute jagged edges after the tip end is broken away. Such jagged edges can cause injury to canal tissue upon reintroducing the tip in the bone, or can cut through protective surgical gloves used by surgical personnel during manipulation of the bone cement dispensing apparatus and delivery tip. In the latter case, a health risk is presented to the personnel, such as a risk of transmitting acquired immune deficiency syndrome (AIDS).
Typically, for the case of a bone cement delivery system having multiple interchangeable tips, a single tip is sealed in a package and stored in an area which may not be as sterile as the surgical room. Before or during the surgical procedure, a surgical nurse or assistant makes a determination as to the size of tip needed and secures the tip to a bone cement dispensing container, typically by threaded cooperation, either in the surgical room or in a less sterile environment. If during the surgical procedure a different sized tip is needed, the surgical nurse/assistant then has to venture to the less sterile area in order; to retrieve another tip and then rethread the new tip onto the cement dispensing container. The retrieval of another tip by personnel wastes time where time is typically important because bone cement is relatively fast setting and a predetermined time frame is provided by the bone cement in which a surgical procedure has to be performed, else the bone cement hardens and is wasted. Since bone cement is expensive, it is important that any delays (expected or unexpected) be minimized once the bone cement has been prepared. Additionally, for the case where a nurse/assistant is required to leave the sterile environment of a surgical room in order to retrieve a different tip, potential for contamination of the surgical area is increased.
Therefore, there exists a need for an improved bone cement delivery apparatus, including a tip, to be used with bone cement dispensing apparatus or containers, a need to provide access to a plurality of tips each with unique dimensions suited for a particular use, and a single, common nozzle, and a need for the tips to be located in the most sterile environment possible.
SUMMARY OF THE INVENTION
One or more tips are constructed for use in a bone cement delivery apparatus. The tips are quickly and easily attached and detached from a bone cement dispensing apparatus, or container. A bone cement delivery apparatus includes one or more interchangeable tubular dispensing tips and a dispensing apparatus, or container. Additionally, the delivery apparatus can include a nozzle that communicates with the bone cement dispensing apparatus. According to one construction, the dispensing tip and nozzle are removably secured together with a pair of complementary, mating connectors. According to other aspects, a plurality of individually unique, such as variously sized; dispensing tips, are interchangeably mated with a single, common nozzle. Each tip has a delivery tube and a connector, and according to one construction, the connector is integrally formed from the delivery tube. According to one package configuration, the tips are stored in a first hermetically sealed tub that is removable from a second hermetically sealed tub.
According to one aspect, a bone cement delivery apparatus is provided. The delivery apparatus includes a delivery tube and a connector. The delivery tube has an inner wall providing an axial bore. The connector is provided at a proximal end of the delivery tube. The connector includes at least one receiving slot in the inner wall. The receiving slot includes a transverse portion comprising an override surface and a local recess which cooperate to removably mate the delivery tube and the connector with a bone cement dispensing apparatus.
According to another aspect, a fluent material delivery apparatus is provided. The delivery apparatus includes a tip and a nozzle. The tip has a delivery tube and a delivery tube connector. The delivery tube connector includes at least one receiving slot provided in the delivery tube, and having a transverse portion including an override surface and a local recess. The nozzle has a nozzle connector. The nozzle communicates with a fluent material dispensing apparatus, and the nozzle connector is configured to removably mate with the delivery tube connector. The nozzle connector includes at least one node sized for slidable engagement with the receiving slot. The node is operative to mate in interlocking engagement with the local recess of the transverse portion responsive to circumferential manipulation of the nozzle and the at least one node over the override surface of the at least one receiving slot.
According to yet another aspect, a nozzle is provided for connecting a delivery tube with a bone cement dispensing apparatus. The nozzle includes a first portion and a second portion. The first portion has an outer surface configured to be received in a delivery tube. The outer surface defines at least one node configured to secure the delivery tube in interlocking engagement with the nozzle. The second portion communicates with the supply of bone cement.
According to even another aspect, a removable tip assembly is provided in conjunction with a bone cement dispenser. The removable tip assembly includes a converging section, a cylindrical portion, and a tubular body. The cylindrical portion integrally extends from a smaller diameter of the converging section. The cylindrical portion comprises an outer wall defining an aperture. The tubular body has: a proximal and a distal end. The proximal end integrally extends from the cylindrical portion to the distal end. The converging section, the cylindrical portion, and the tubular body define an axial bore, and the aperture of the cylindrical portion extends through the outer wall to the axial bore.


REFERENCES:
patent: 4466435 (1984-08-01), Murray
patent: 4671263 (1987-06-01), Draenert
patent: 5265956 (1993-11-01), Nelson et al.
patent: 5344232 (1994-09-01), Nelson et al.
patent: 5415474 (199

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