Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-07-13
2004-03-30
Denion, Thomas (Department: 3748)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S160000, C604S246000, C604S256000
Reexamination Certificate
active
06712789
ABSTRACT:
TECHNICAL FIELD
The present invention generally relates to introducers and introducing assemblies. Specifically, it relates to an introducer with a hemostatic valve.
BACKGROUND
Introducer devices are employed for inserting catheters, guidewires, or other medical devices into patients. A typical procedure provides for insertion of a needle into the vasculature of a patient. After insertion of the needle, a guide wire is inserted through the needle, and the needle is removed. The dilator and the sheath are inserted over the guidewire, and the dilator and guidewire may be removed leaving the sheath protruding from the patient's vein. A diagnostic or therapeutic catheter (e.g. a central venous access catheter) or guide wire or other medical device, is then inserted through the sheath into the patient.
Peelable sheaths are available, where the sheath can be peeled off of a catheter, for example, as that shown in U.S. Pat. No. 4,345,606 to Littleford on Aug. 24, 1982. However, once a sheath is inserted, and the dilator and guidewire have been removed, the sheath provides a passage for a flow of blood, where such uncontrolled blood loss can have a negative affect on a patient. Another problem with the sheath is that the sheath allows for the introduction of air into the vein of the patient. If air is inadvertently introduced into the vein, an air embolism may result with negative effects. One solution is found in U.S. Pat. No. 5,304,142 issued to Liebl on Apr. 19, 1994, and assigned to Medamicus, Inc. Another approach is described in U.S. Pat. No. 5,125,904, issued to Lee in Jun. 30, 1992. However, the sheath in the '904 Patent may experience resistance to pulling apart, and separating the sheath may prove to be difficult. In addition, the technician may experience difficulty in inserting an instrument or medical device through the valve. One solution is to lubricate the valve with silicone. However this results in silicone becoming inadvertently transferred to other medical instruments, or technicians.
Accordingly, what is needed is an introducer and dilator which seals an introducer to a catheter or other medical instruments. What is also needed is a sealing device which does not distract or interfere with the implantation process.
SUMMARY
An introducing apparatus includes an elongate tubular sheath having an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough, where the sheath is separable. The sheath includes at least one tab extending away from a longitudinal axis of the sheath. A sliding valve assembly is slidingly engaged with the tab, where the sliding valve is adapted to slide from a first position to a second position. In the first position the sliding valve is disposed through the longitudinal axis of the sheath. In the second position the sliding valve assembly is disposed away from the longitudinal axis of the sheath.
Options for the above introducing apparatus include as follows. In one option, the sliding valve assembly includes a membrane coupled with a sliding member, where the membrane optionally includes a slit therein. Alternatively, the tab is defined in part by a tab longitudinal axis, and the sliding valve assembly is adapted to slide along the tab longitudinal axis. In another option, the sliding valve assembly is adapted to rotate about a hinge point on the at least one tab. Optionally, the introducing apparatus includes a removable side port. In yet another option, the sliding valve assembly includes a valve support member coupled with a seal, and the valve support member extends only partially around the seal.
An introducing apparatus includes an elongate tubular sheath having an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough. The sheath includes at least one tab extending away from a longitudinal axis of the sheath. A movable valve assembly is movably engaged with the tab, where the movable valve is adapted to move from a first position to a second position. In the first position the movable valve is disposed through the longitudinal axis of the sheath. In the second position the movable valve assembly is disposed away from the longitudinal axis of the sheath.
Options for the above introducing apparatus include as follows. One example of an option is that the movable valve assembly is adapted to slide relative to the tab. In another example of an option, the sheath is optionally separable. In another option, the sliding valve assembly includes a membrane coupled with a moving member, where the membrane optionally includes a slit therein. Alternatively, the tab is defined in part by a tab longitudinal axis, and the movable valve assembly is adapted to slide along the tab longitudinal axis. In another option, the movable valve assembly is adapted to rotate about a hinge point on the at least one tab. Optionally, the introducing apparatus includes a removable side port. In yet another option, the movable valve assembly includes a valve support member coupled with a seal, and the valve support member extends only partially around the seal.
A method includes inserting an introducing apparatus into a body. The introducing apparatus includes an elongate tubular sheath which has an external diameter, and the sheath has a bore including an internal diameter sized to receive a dilator therethrough. The sheath includes at least one tab which extends away from a longitudinal axis of the sheath. A movable valve assembly is movably coupled with the at least one tab. The method further includes moving the valve assembly from a first position to a second position. In the first position, the movable valve assembly is disposed through the longitudinal axis of the sheath. In the second position the movable valve assembly is disposed away from the longitudinal axis of the sheath. Optionally, the method further includes flexing the valve assembly as an instrument is inserted therethrough.
An introducing apparatus is also described which includes an elongate, separable tubular sheath that is defined in part by an external diameter. The sheath includes a bore which has an internal diameter sized to receive a dilator therethrough. The sheath further includes at least one tab that extends away from a longitudinal axis of the sheath. The introducing apparatus further includes a side port assembly removably coupled with the sheath. The side port assembly is adapted to be removed from the sheath without damage or separation of the sheath. In one option, the side port assembly is coupled with the sheath with a snap-fit connection. Alternatively, the side port assembly is threadingly coupled with the sheath. In another option, the side port assembly includes a valve disposed between the sheath and the side port.
The present introducing assembly requires fewer parts, and is cheaper to make. In addition, since the valve is optionally moved away from the longitudinal axis prior to splitting of the sheath, the splitting of the sheath is easier to do. The implanter has more options in sealing the introducing apparatus, including the option of having the valve moved out of the way during a procedure. A further benefit is that a more effective seal is made around the catheter or medical instrument since the device which retains or supports the valve optionally flexes, for example, as instruments are inserted therethrough. Furthermore, the introducing assembly allows for more flexible instruments to be inserted therethrough, where no damage occurs to the distal end of the flexible instruments which might occur with prior valve designs.
These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the in
Kraus Mark C.
Lange Michael
Chang Ching
Denion Thomas
MedAmicus, Inc.
Schwegman Lundberg Woessner & Kluth P.A.
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