Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-01-29
2001-03-13
Ruhl, Dennis (Department: 3761)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S057000, C604S048000, C604S311000, C604S514000, C604S218000
Reexamination Certificate
active
06200288
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an everting device for delivering a drug, absorbent, or other preparation in powder, liquid, gel, cream, or aerosol form to an internal body cavity or other cavity. More particularly this invention relates to an everting toroid device and methods for delivering a drug or the like to the will lumen or interior wall, vagina, or other lumen or internal mucosal or absorptive so. Application to inmate or artificial surfaces, e.g., inner tubular walls and the like, is also contemplated.
BACKGROUND OF INVENTION
Everting sleeve devices for probing internal body cavities, for delivering drugs in powder form to the surfaces of those cavities, and for taking samples from within the cavity are well known in the medical arts. Attention is directed to U.S. Pat. Nos. 3,168,092 issued Feb. 2, 1965, No. 3,500,819 issued Mar. 17, 1970 and No. 3,589,356 issued Jun. 29, 1971, all to Daniel Silverman, which are typical of the prior art everting sleeve devices. Essentially, a cylindrical external casing is provided with a long thin walled plastic tubing which is anchored at one end thereof to the inside wall of the casing and extends along the inside of the casing. The tubing may be open- or closed-ended. By application of external gas pressure between the casing and the tubing, the tubing is forced to turn on itself, or evert, and extend outwardly beyond the end of the casing. Powdered drugs may be applied to the everting surfaces before use and these will be deposited on the mucosa or walls of the body cavity as the tubing extends. If an open-ended tubing is employed, samples of body fluids or the like may be withdrawn through the extended tubing. Withdrawal of the tubing may be effected by withdrawing the tubing in its extended condition or by re-everting the tubing by pulling on an internally mounted withdrawal cord or the like. These prior art devices, while relatively effective, suffer from several serious disadvantages. Firstly, considerable pressure is required to evert the tubing and in the event that the tubing should fail during eversion considerable damage to sensitive and delicate body tissues may result. Secondly, withdrawing an extended tubing from a body cavity may cause considerable friction and hence discomfort or pain to the patient. Everting the extended tubing by means of an internal withdrawal cord or the like is cumbersome and not very practical in the case of very thin long tubes. There is a need, therefore, for an improved everting sleeve device for delivering drugs, absorbents and the like to body cavities, including long narrow body passages, such as, but not limited to, the urethra, bladder, vagina, anus, rectum, and colon in both human and animal patients.
OBJECT OF THE INVENTION
An object of the present invention is to provide an improved everting toroidal low-pressure sleeve device for delivering drugs and the like to internal body cavities or other cavities. Another object of this invention is to provide an everting toroidal sleeve device in combination with an aerosol delivery device for delivery of drugs, absorbents and the like to internal body cavities or other cavities.
Yet another object is to provide novel methods for delivery of pharmaceutical compositions, such as drugs, to internal body cavities, or for absorption of secretions and the like from such cavities.
BRIEF STATEMENT OF THE INVENTION
By one aspect of this invention there is provided an apparatus for delivering a composition to an internal wall or lumen of a cavity, comprising: a housing member having a first open end and a second end; an elongated flexible toroidal member contained within said housing member and having an outer surface portion thereof secured to said housing adjacent said first open end thereof; and means adjacent said second end, contacting a surface portion of said toroidal member, and movable through said housing member towards said first open end thereof so as to cause said toroidal member to evert and extend outwardly from said first open end of said housing member.
By another aspect of this invention there is provided an apparatus for delivering a pharmaceutical or other composition to an internal wall or lumen of a cavity, comprising in combination a housing member having a first open end and a second end; an elongated flexible toroidal member contained within said housing member and having an outer surface portion thereof secured to said housing adjacent said first open end thereof; means adjacent said second end, contacting a surface portion of said toroidal member, and movable through said housing member towards said first open end thereof so as to cause said toroidal member to evert and extend outwardly from said first open end of said housing member; a tubular housing member having a proximal end and an open distal end; a tube contained within said tubular housing having an open distal end and an aerosolized composition delivery chamber at a proximal end thereof; means to extend said tube longitudinally outwardly from said open distal end of said tubular housing and to retract said extended tube back into said tubular housing; and a valve adjacent said delivery chamber to dispense an aerosolized composition contained in said delivery chamber through said tube to said distal end thereof when said tube is extended from said tubular housing member and while it is retracting therein to; wherein said housing member and said toroidal member axially receive said tubular member when in said extended position from said tubular housing member.
By yet another aspect of this invention there is provided an apparatus wherein said means to extend said tube includes a slider cooperating with said tubular housing member to extend said tube longitudinally therefrom.
According to an alternative aspect of this invention, there is provided a method for delivering a pharmaceutical or other composition to an internal wall or lumen of a cavity, comprising: providing a housing member having a first open end and a second end, an elongated flexible toroidal member contained within said housing member and having an outer surface portion thereof secured to said housing adjacent said first open end, and means adjacent said second end, contacting a surface portion of said toroidal member, and movable through said housing member towards said first open end thereof, wherein a selected said composition is disposed on an inner surface of said toroidal member, and advancing said means adjacent said second end through said housing member so as to cause said toroidal member to evert into said internal body cavity and deposit said composition therein.
The cavity may be, but is not necessarily a body cavity such as the urethra, bladder, vagina, anus, rectum, colon, pharynx, nostril, ear canal, or other suitable cavity of a subject in need of drug delivery thereto. The body cavity may also be a non-natural cavity, such as a wound or an infection, or it may be a cavity created during, for example, a surgical procedure. Preferably, the body cavity is the urethra, and more preferably, the adult male or female urethra. Other cavities include inanimate or artificial surfaces su as the inside of tubes, bores, and the like.
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Adams Michael A.
Banting James D.
Heaton Jeremy P. W.
Hicks Richard J.
Miernicki Steeg Carol
Queen's University at Kingston
Ruhl Dennis
Scribner Stephen J.
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