Vascular infusion device

Details Vascular infusion device Vascular infusion device

1998-04-24

2001-01-30

Stright, Ronald (Department: 3762)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S173000, C604S264000, C604S523000

Reexamination Certificate

active

06179813

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates generally to medical devices suitable for use in delivering fluids to a patient. More particularly, the invention relates to an introducer sheath which will include side holes configured such that the holes appear longitudinally and circumferentially along the sheath tubing to provide an outlet for medications injected into the sidearm of the sheath. The holes will allow medication to be directed to specific locations rather than to have the entire volume of medication exit the distal end of the sheath tube.
The clinical utility of the infusion sheath relates to the ability to infuse medications, specifically medications intended to counteract vasospasm. Vasospasm is a common problem, particularly in the transradial catheterization technique. The result of vasospasm is difficulty in sheath removal and accompanying patient discomfort at the end of a catheterization procedure. To minimize or eliminate vasospasm, physicians will commonly administer a ‘cocktail’ of medications. An example of such a cocktail would be a mixture of Verapamil, Nitroglycerine, and Xylocaine, Verapamil being an antispasmotic agent. This mixture would be injected through the sideport of the sheath, often prior to withdrawing the sheath, to minimize vasospasm and discomfort. With current sheath designs, the fluid will exit in its entirety out the end of the sheath. With a 21 cm sheath, this presents the potential for the drugs to be significantly distant from where the spasming may be taking place. The tendency of the medications will be to flow in the direction of the blood flow which will be back towards the proximal end of the sheath tubing (for example, flowing from the elbow area back towards an insertion site in the wrist). However, the sheath tubing is large in relation to the radial artery lumen size and therefore may obstruct the medications from getting to the specific portion of the radial artery which is spasming. It is important to note that prior to performing a radial artery procedure, the physician must first ascertain whether the patient has good collateral blood flow into the hand. This is so that if the radial artery is not providing sufficient flow due to sheath obstruction, the ulnar artery can continue to provide sufficient circulation.
The infusion sheath design of the present invention overcomes these clinical problems. By providing infusion ports along a significant portion of the sheath tubing, the drugs can exit the sheath at the point where spasming may be occurring and have a quicker, and perhaps, more effective response. Some prior art teachings disclose side holes or slits which communicate with specifically designated lumens within the wall of the sheath. The present invention allows for a sheath which maintains the critical aspects of being able to have appropriate wall thickness such that insertability and the size of the puncture are not compromised. The design of the sheath and a dilator, which, in some instances, will be used in combination with the sheath, to accommodate this objective is significantly different than other known configurations in sheaths or catheters.
SUMMARY OF THE INVENTION
The present invention is directed toward a vascular device adapted for infusion of fluids into a patient comprising an elongated tubular member having a proximal end, a distal end and a wall extending between the proximal end and the distal end, the wall having an inner surface and an outer surface, at least one lumen extending between the proximal end and the distal end and communicating with the inner surface, with the at least one lumen being adapted to receive a fluid, and one or more apertures disposed in the wall along a length between the proximal end and the distal end for providing fluid communication between the inner surface and the outer surface and adapted for conveying the fluid between the at least one lumen and an environment surrounding the outer surface. The apertures might be disposed circumferentially about the wall, as for example, in a helical pattern, or the apertures might be disposed longitudinally along the wall, as for example, in one or more rows. The apertures may have a diameter in a range of from about 0.025 mm to about 0.600 mm. Preferably, the apertures might have a diameter of about 0.125 mm. The apertures might be spaced from about 1 mm to about 200 mm apart. Preferably, the apertures might be spaced about 10 mm apart. The tubular member might have a length in a range of from about 10 cm to about 25 cm. Further included is a means for delivering the fluid to the lumen.
The invention further embodies a vascular device for infusion of fluids into a patient comprising a first elongated tubular member having a proximal end, a distal end, a first lumen extending therethrough and a first wall having an outer surface and extending between the proximal end and the distal end, a second tubular member having a second wall and being positioned within the lumen to define a space between the first wall and the second wall, the space being adapted to receive a fluid, the second tubular member being sized and configured to create a fluid seal proximate the distal end of the first tubular member, and one or more apertures disposed in the first wall between the proximal end and the distal end for providing fluid communication between the space and an environment surrounding the outer surface of the first wall, wherein fluid introduced into the space exits the device substantially only through the one or more apertures along the length of the outer surface of the first wall. The apertures might be disposed circumferentially about and longitudinally along the first wall. The second tubular member is preferably a dilator which comprises a first portion having a first cross section and a second portion having a second cross section, with the first cross section being greater than the second cross section. The first cross section at a first predetermined location has a cross section being at least equal to the lumen at the first predetermined location. The second cross section at a second predetermined location has a cross section being less than the lumen at the second predetermined location. The dilator might include at least one groove disposed in an outer surface along a length of the dilator. The dilator might further comprise a closed distal end and a second lumen therein communicating with the space, the second lumen being adapted to receive the fluid and delivering the fluid to the space. The second wall of the dilator might comprise one or more second lumens disposed in the second wall communicating with the space, the one or more second lumens being adapted to receive the fluid and delivering the fluid to the space.
The invention still further embodies a vascular device for infusion of fluids into a patient comprising a first elongated tubular member having a proximal end, a distal end and a lumen extending therethrough, a first wall extending between the proximal end and the distal end, with the first tubular member having a through opening at the distal end, a second tubular member having a second wall and being positioned within the lumen to define a space between the first wall and the second wall, the space being adapted to receive a fluid, with a portion of the second member extending through the opening at the distal end of the first tubular member, and one or more apertures disposed in the first wall between the proximal end and the distal end for providing fluid communication between the space and an environment external of the device, wherein a portion of the fluid introduced into the space exits the device through the one or more apertures along the length of the first wall. Preferably the second tubular member is a catheter and the apertures are disposed circumferentially about and longitudinally along the first wall.
In yet another embodiment of the invention embraces a vascular device for infusion of fluids into a patient comprising a first elongated tubular member having a proximal en

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