Surgery – Instruments – Sutureless closure
Reexamination Certificate
2002-11-01
2003-10-28
Jackson, Gary (Department: 3731)
Surgery
Instruments
Sutureless closure
C606S214000, C604S180000
Reexamination Certificate
active
06638296
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to medical devices for hemostasis, and methods of using the medical devices for hemostasis. More particularly, the present invention relates to medical devices for effecting hemostasis at a puncture wound with an indwelling tubular element extending therethrough.
BACKGROUND OF THE INVENTION
Puncture of blood vessels is a necessary stage in many of the minimally invasive approaches to diagnosis and treatment, including interventional radiology and cardiology. Therefore, a need to create hemostasis as rapidly as possible following the procedure becomes an important priority.
Various hemostatic agents, such as synthetic or natural cationic polymers, hydrogels, collagen based products, oxidized cellulose, gelatin derivatives, topical thrombin, astringents, vasoconstrictors, etc. have been and are being utilized. Most conventional devices and methods of application are designed as a pad or dressing, incorporating these hemostatic agents to the bleeding site, puncture site or wound site.
Certain medical procedures require insertion of a tubular element, such as catheter, introducer or tube in an artery or other vessel of a patient. The insertion of such tubular element makes it difficult to provide an effective hemostasis at a puncture wound because the hemostatic substances can not be applied directly and intimately under pressure to the bleeding or wound site. Also, an immediate hemostasis is often needed during surgery while a tubular element is still in the vessels of the patient or after the tubular element is removed. Therefore, what is needed is a simple, safe and effective device and method for providing more directly and intimately hemostasis to the bleeding site with an indwelling tubular element, such as catheter, introducer or tube, and allowing the tubular element to be easily removed thereafter.
SUMMARY OF THE INVENTION
The present invention provides a device and method for effecting hemostasis at a wound site with an indwelling tubular element, such as catheter, introducer or tube disposed therein.
Many hemostasis methods have been utilized or attempted, including suture-based devices, collagen plugs, pressure applying devices, and the like. The situation is complicated further by the use of anticoagulants in these procedures, which prolongs clotting times. Substances such as heparin, aspirin, coumadin, and other anticoagulants are used with regularity and affect the normal blood coagulation cascade. The use of cationic substances in flocculation and coagulation in non-medical situations such as water treatment, paper production, industrial sludge treatment, and the like has been effectively used in the past and is well documented. The method of action is by precipitating, coagulating or flocculating suspended particles which are negatively charged by virtue of using positively charged materials, which attract the oppositely charged ions.
It has been clearly demonstrated that the charge on blood cells and components (platelets, etc.) is negative. By using a positively charged biocompatible substance, it is possible to agglomerate these cells creating coagulation through a system other than by virtue of the normal clotting cascade. Innocuous polymers are positively charged (cationic substances) as the initiator of coagulation in clinical situations. Additionally, positive charges can be applied via iontophoretic methods using electrode pads and positively charged treatment sites to accomplish the same thing.
The use of a positive charge administered by either cationic substances or by iontophoretic means to quickly create a coagulation process and hemostasis until the normal clotting cascade can take over. This can occur even in the face of significant anticoagulation since the process is ionic and not effected by the anticoagulants, which operate on the normal blood cascade. This approach can be revolutionary in the after treatment of patients with minimally invasive or invasive procedures since rapid hemostasis and mobilization of the patient are desirable endpoints.
The cationic substance can be incorporated into many forms, such as woven and non-woven pads, fibers, gels, pastes, waxes, foams, sprays, liquids of varying viscosities, packings, membranes, sheets, and the like. Additionally, these forms can be incorporated and utilized with iontophoretic types of equipment that create a positive charge at the bleeding site to effect coagulation.
Utilizing colloidal chemistry for effecting coagulation ionically in suspensions or colloidal substance by providing cationic charges, has enormous value in the diagnosis and treatment of conditions such as cardiovascular disease, interventional radiological procedures, and the like. The cationic charge can be provided by a substance with a positively charged surface, or electronically by utilizing electrophoretic type equipment and electrode pads specifically designed to be disposable, conductive and sterile, designed to fit the required anatomical site. Many cationic substances are available, such as polymers, polysaccharides and starches, aluminum salts, magnesium salts, natural polymers such as chitosan, and the like.
The use of ionic charges to create hemostasis is a new and important process in the treatment of disease processes. This novel approach can be administered by applying sterile, biocompatible, positively charged materials directly in contact with the blood column, accompanied by pressure, or provided electronically by utilizing controlled direct current on the positive side with iontophoretic type approaches and specially constructed, disposable, sterile electrodes to the bleeding site
According to one aspect of the present invention, a hemostatic pad defines an opening at a proximally central point of the pad. The opening is sized to allow egress of the indwelling tubular element through the pad. The pad further comprises an application surface, which contains hemostatic agent used for effecting hemostasis at the wound site associated with an indwelling tubular element. The hemostatic agent preferably is a cationic substance, such as cationic polymer, or a cationic protein. The hemostatic substance on the pad, therefore, may be applied evenly, directly and intimately around the tubular element, also providing an even application of pressure for hemostasis. It also allows the indwelling tubular element to be easily removed from the wound site through the pad. In a preferred embodiment, the opening of the pad is a slit extending from an approximate center to an edge of the pad. In another preferred embodiment, the opening is constructed as an aperture with a slit extending from the aperture to an edge of the pad.
According to another aspect of the present invention, the hemostatic pad may have a non-slip etched area on a top surface of the pad, in order to achieve more friction between the finger of a surgeon and the surface of the pad. The non-slip etched area make it easier to apply a pressure to a puncture site, and make the hemostasis more efficiently and quickly.
According to another aspect of the present invention, the hemostatic device comprises an adhesive bandage which preferably has a “Band Aid™”-like shape. The adhesive bandage includes a non-adhesive central portion and an adhesive peripheral portion, preferably two adhesive ends, extending from two opposite side of the non-adhesive central portion. The adhesive bandage defines an aperture at an approximately central point of the central portion and an elongated cut extending from the aperture to an edge of the non-adhesive central portion. The aperture is sized to allow passage of the tubular element, for example, catheter or introducer. The bandage may further include two peelable films covering the two adhesive ends of the bandage. A hemostatic effective amount of hemostatic agent or a hemostatic pad with the hemostatic agent attached thereon is attached to the non-adhesive central portion for effecting a hemostasis at a puncture wound where the adhesive bandage is applied.
According to another
Jackson Gary
McDermott & Will & Emery
Scion Cardiovascular, Inc.
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