Surgery – Means for inserting fibrous or foraminous resident packing,...
Reexamination Certificate
2000-02-02
2003-02-11
Lewis, Aaron J. (Department: 3761)
Surgery
Means for inserting fibrous or foraminous resident packing,...
C604S904000
Reexamination Certificate
active
06517509
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to facilitating insertion of packing material into a cavity in the human body and, in particular, to treating nose hemorrhages.
BACKGROUND OF THE INVENTION
Nasal cavity or sinus cavity hemorrhaging is commonly treated by packing such a cavity with an absorbent foam material. The absorbent foam material serves two primary purposes. First, it absorbs the blood to prevent possible aspiration of the blood by the patient. Second, it averts the flow of blood by applying pressure to the ruptured blood vessel due to expansion of the absorbent foam material thereby acting as a hemostat.
At present, there are a number of devices that apply hemostatic pressure to control a hemorrhage in the nose and absorb blood associated with the hemorrhage. However, several of these devices require manual insertion of the absorbent material. For example, U.S. Pat. No. 4,030,504 to Doyle issued Jun. 21, 1977 and entitled “Nasal Hemostat and Method of Construction of Nasal Hemostat” uses an expandable absorbent material contoured to conform to the nasal cavity that must be inserted and positioned by hand.
Other known devices are typically formed or adapted at the time of use. For example, a physician will typically trim a piece of expandable absorbent material to the appropriate size, attach a suture to the absorbent material to facilitate retrieval, and manually insert the device into the patient's nasal or sinus cavity. The absorbent material then expands upon contact with blood. This expansion results in hemostatic pressure being applied to the ruptured blood vessel resulting in the arrest of blood flow. The absorbent material is then retrieved from the cavity by means of the attached suture.
Other body fluid-absorbing devices are also known. For example, catamenial devices that are used in a different application are described in U.S. Pat. No. 3,015,332 to Brecht issued Jan. 2, 1962 and entitled “Applicator,” U.S. Pat. No. 3,103,929 to Brecht issued Sep. 17, 1963 and entitled “Catamenial Device,” U.S. Pat. No. 3,101,713 to Sargent issued Aug. 27, 1963 and entitled “Tampon Applicator,” and U.S. Pat. No. 3,433,225 to Voss issued Mar. 18, 1969 and entitled “Hygenic Devices and Methods of Making The Same.” These catamenial devices, however, would be inappropriate for use in a nose cavity. For example, the absorbent material used in these catamenial devices is meant to merely absorb blood flow and is not meant to apply hemostatic pressure to stop blood flow. In addition, the circular cross section of the barrel and absorbent material used in the catamenial devices would be inappropriate for use in a nose cavity since the bone and cartilage structures of the cavity define a non-circular cross-section.
Therefore, these known nose and catamenial devices might require a significant amount of manual manipulation, may be time consuming to use, can result in a significant amount of patient discomfort, or are inappropriate for use in the nose. A syringe type applicator that inserts absorbent packing material into nose cavities has been developed by the inventor of the present invention to overcome the drawbacks associated with these other prior art devices. This syringe type device is disclosed in U.S. Pat. No. 4,895,559 to Shippert, issued Jan. 23, 1990 and entitled “Nasal Pack Syringe.” However, this syringe type applicator may at times have difficulty expelling the packing material from the syringe, particularly when the contents are moisture sensitive causing the material to swell inside a syringe. Additionally, syringe type applicators can be more costly to make and assemble because of the number of parts.
Accordingly, a need exists for non-syringe type devices (i.e., no syringe plunger) that have fewer parts, are inexpensive to manufacture and can effectively insert an absorbent material into a human body cavity, including a hemorrhaging nose cavity that has a severely deviated canal, with a minimum amount of manual manipulation. The present invention satisfies such needs and provides related advantages.
SUMMARY OF THE INVENTION
The present invention provides an efficient, relatively painless and inexpensive way of delivering absorbent packing material to a patient's body cavity to absorb blood or other fluids and to apply hemostatic pressure to inhibit blood flow if present. The invention has a desirable containment feature in that contact with any blood that is present can be limited to the invention components and not spread to the operator or user thereof or elsewhere. The insertion device of the present invention can be characterized as having two components: (a) a single unit introducer member, and (b) a liquid absorption assembly.
The introducer member has a hollow volume and an outlet for the liquid absorption assembly to exit when expelled into the nasal or sinus cavity. In one embodiment, the hollow volume is closed in that it is defined by a single body member or shaft having two parallel wide sides and two parallel narrow sides to create a substantially rectangular cross section. The cross section defines the outlet, which is located at the distal end of the introducer member and is sized to hold the proximal end of the liquid absorption assembly securely in place until the absorbent member is expelled into the nose cavity as explained in more detail below. The walls are sufficiently strong (i.e. stiff) to hold the liquid absorption assembly in place. However, the narrow side walls can, but not necessarily, be made of thicker material than the wide side walls to provide a more solid platform for the absorbent member.
Alternatively, the introducer member has an open hollow volume defined by an elongated opening. In one embodiment, the introducer member includes a main body section and a pivotal body section formed by cut-out portions in the first and second side walls, an intermediate or connecting wall, and an elongated opening opposite the intermediate wall. In a further embodiment, the introducer member includes a single body having first and second side walls, an intermediate wall and an elongated opening opposite the intermediate wall without cut-out portions in the side walls.
The side and intermediate walls of the open volume embodiments are sufficiently strong to hold the liquid absorption assembly in place. However, the intermediate wall can, but not necessarily, be made of thicker material than the side walls to provide a more solid platform for the liquid absorption assembly as it is disengaged from the introducer member. In the embodiment having a pivotal body section, the intermediate wall beneath the cut-out portions is sufficiently flexible to allow pivotal movement of the pivotal body section relative to the main body section during the expulsion of the liquid absorption assembly into the nose cavity as explained in more detail below.
The elongated opening of the open volume embodiments has a length at least substantially corresponding to the lengths of the first and second side walls. The first and second side walls can be parallel or taper inwardly towards the elongated opening for a more secure holding of the liquid absorption assembly in the introducer member. Particularly in the embodiment in which the walls taper inwardly, different widths of absorption or packing material can be utilized in the same introducer member since such walls can be spread apart to accommodate reception of packing material of different widths. In addition, the height of the side walls of the introducer member can be lower than the height of the absorbent member to reduce the risk of cutting nose tissue and/or to make the introducer member less intrusive during the insertion process.
The introducer member is particularly useful when constructed of one piece and made of inexpensive disposable plastic material. The introducer can also be made of reusable plastic or metal materials.
The liquid absorption assembly includes an absorbent member having a proximal end, a distal end and a terminating section that is located closer to the proximal end t
Anderson C L
Lewis Aaron J.
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