Surgery – Means or method for facilitating removal of non therapeutic... – Wound or abscess
Reexamination Certificate
1997-09-12
2001-01-16
Kennedy, Sharon (Department: 3763)
Surgery
Means or method for facilitating removal of non therapeutic...
Wound or abscess
C604S540000
Reexamination Certificate
active
06174306
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention concerns a device for vacuum sealing an injury.
2. Description of the Related Art
For care of large surface area injuries with larger tissue defects it is known from WO93/09727 that the injury is covered over its surface with a film and closed off in an airtight manner. A drainage tube is introduced under the film and connected via a secretion-collecting container to a vacuum system. Thereby and under-pressurization or vacuum is produced in the wound area under the film, which beneficially influences the tissue regeneration and prevents the growth of bacteria. In larger injuries it is preferred that a porous foam insert be placed into the wound, into which the drainage tube is inserted, whereby the wound secretion can be siphoned or suctioned off over the overall wound surface area in a more even manner.
Until now a vacuum of approximately 80 kPa has been employed in this known device. In order to produce this vacuum, a vacuum pump is connected to the container for collection of the wound secretion, so that a suction effect of the pump continuously acts upon the container. Another possibility is comprised therein, that an evacuated container is employed which is changed out as soon as the vacuum in the container falls below a pre-determined value.
The research which underlies the present invention has shown, that this hitherto conventional vacuum is too high, in particular for chronic injuries. Pressures which are less than approximately ⅙ of the hitherto conventionally employed pressures, that is, approximately 10 kPa, appear to have a more beneficial effect on the healing process. The employment of continuously operating vacuum pumps is restricted to the patients at residence in a stationary clinical state. The employment of evacuated secretion collection containers is associated with significant problems at these low vacuums. Even small amounts of secretion, which are collected in the container, are sufficient to cause a substantial pressure drop in the container. Likewise, any breech or compromise of the seals, which in practice is difficult to avoid, results in an abrogation of the vacuum in the system.
DESCRIPTION OF THE RELATED ART
The invention is concerned with the problem of providing a device for vacuum sealing of a wound in which even a small under-pressurization in the range of 10 kPa or less can be maintained and which in particular can be employed ambulatory independent of a stationary clinical residence.
The essential concept of the invention is comprised therein, that the container for the collection of the wound secretion is associated with a pump, with which the under-pressurization or vacuum in the container and therewith the sealing of the wound is accomplished. The combination of the container and the pump makes the patient independent of the stationary vacuum system of the hospital, so that an ambulatory care of the acute and the chronically injured is possible. By means of the pump combined with a container, the under-pressurization of the container can at any time be maintained at a desired value. The patient can himself monitor the actual under-pressurization by means of a pressure gauge provided on the container and can as needed also correct the pressure to the desired pressure value.
The pump can be integrated completely into the container, so that the container and the pump are constructed as single use articles and after use can be collectively disposed of.
As an alternative possibility the pump can be releasably mounted on the container, which in certain cases simplifies the construction. Thereby there results a greater flexibility since the pump can be constructed or designed as a single use or as a multi-use article independent of whether the container itself is employed as a single or multi-use article. Finally, there is also the possibility that the pump is constructed as an independent component, which is coupled mechanically on the outside of the container and is in communication with the container via a connection hose.
Since the container with its pump is employed in an ambulatory manner and since the pump as a rule is employed only once or a few times, it is preferred to construct the pump in a simple, space saving and economical manner. These requirements are in harmony with the fact, that the pump need only be capable of providing small under-pressurizations, so that only minimal demands must be placed upon the capacity and quality of the pump. There can be employed, for example, a motorized pump, wherein simple and economical embodiments can be utilized, such as for example the so-called aquarium pumps.
Manual pumps can also be employed to advantage, for example, simple piston pumps. These manual pumps in addition have the advantage, that they are independent of an electrical power supply (current supply, battery).
In order that the vacuum in the container can be monitored and adjusted to the desired value, the container is equipped for example with a manometer. Here also, in consideration of the preferred single use construction and in consideration of the minimal precision requirements, a simple as possible and economical manometer is preferred. The manometer can for example be a spring bellows formed on the container which is drawn together or collapsed by the under-pressurization in the container and which correspondently expands upon the release of the vacuum.
In the case of a piston pump, the piston can be biased by a spring in the direction of its suction movement. Thereby an equilibrium condition is established between the spring force acting on the piston and the under-pressurization which acts in the opposite direction on the piston. If the under-pressurization relents, then the piston moves as a result of the spring force so far, until the equilibrium condition is again established. The under-pressurization is in this manner essentially made constant over the entire displacement space of the piston and can be pre-determined by selecting the spring force. A manual operation of the pump is only necessary at the time, when the piston has traveled back along its entire displacement space. The piston rod of the piston thereby can simultaneously serve as an indicator which makes a special manometer superfluous.
In a further embodiment, the container itself can fulfill the function of the pump. The container exhibits therefore a flexible outer wall, so that it can be compressed in the axial direction, in order to achieve an under-pressurization corresponding to its volumetric expansion. The axial volume increase can be achieved by a spring force, in which either the walls of the containers themselves are designed to function as spring bellows or a pressure spring is provided in the container. It is also possible to expand the container pneumatically. The force which expands the container volume, for example the spring force or, as the case may be, the pneumatic pressure, determine the under-pressurization produced in the container. Here also is produced a pre-determined vacuum corresponding to the mechanical spring force or, as the case may be, corresponding to the pneumatic pressure, which increases the container volume, and which is maintained constant by the cumulative expanding space of the container. A correcting of the under-pressurization is only necessary then when the container has traveled over its entire expansion displacement.
The film for covering and sealing the wound, the foam material insert, the drainage tube and the container with the pump are preferably provided as a complete set, so that the doctor has all the necessary components for care of the wound.
REFERENCES:
patent: 2276098 (1942-03-01), Saunders
patent: 3779243 (1973-12-01), Tussey et al.
patent: 3809086 (1974-05-01), Schachet et al.
patent: 3875941 (1975-04-01), Adair
patent: 5279550 (1994-01-01), Habib et al.
patent: 5636643 (1997-06-01), Argenta et al.
patent: 93/09727 (1993-05-01), None
Kennedy Sharon
Pendorf & Cutliff
Rodriguez Cris L.
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