Hemostatic agent delivery device having built-in pressure sensor
First Claim
1. A device for indicating pressure variations due to systolic and diastolic phases of the cardiac cycle comprising:
- (a) an elongated tubular member having a proximal end, a distal end and a lumen extending therebetween, the elongated tubular member including a port extending to the lumen proximate the distal end; and
(b) an indicator device affixed to the proximal end of the tubular member, the indicator device including an elongated convoluted track formed therein, a transparent, fluid tight seal member covering said track, and a compliant sealing means positioned between said track and said lumen, the track containing a quantity of a liquid therein whereby the liquid reciprocally moves in said track under influence of systolic and diastolic pressure when the distal end is inserted through a puncture wound into a blood vessel.
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Accused Products
Abstract
An instrument for achieving rapid hemostasis at the conclusion of a catheterization procedure comprising a hemostatic agent injection device for use with a conventional introducer sheath used to gain access to the blood vessel. The injection device includes an elongated tubular member having ejection ports proximate its distal end. A hub member includes an elongated groove or track located in its surface with a transparent cover. The enclosed track is sealed from the lumen extending through the tubular member with a compliant membrane and filled with a predetermined amount of fluid. After the catheterization procedure, the device is inserted into the introducer sheath. Blood flows into the lumen of the device and pulsates against the compliant membrane. The fluid in the track pulsates within the enclosed track, clearly indicating that the ports are located in the blood vessel and subjected to variations in blood pressure. The instrument and introducer sheath are then slowly retracted as a unit in the puncture wound. The blood flow will stop pulsating against the compliant membrane when the ports have exited the blood vessel wall. A hemostatic agent is then injected by the instrument adjacent the vessel wall.
120 Citations
29 Claims
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1. A device for indicating pressure variations due to systolic and diastolic phases of the cardiac cycle comprising:
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(a) an elongated tubular member having a proximal end, a distal end and a lumen extending therebetween, the elongated tubular member including a port extending to the lumen proximate the distal end; and
(b) an indicator device affixed to the proximal end of the tubular member, the indicator device including an elongated convoluted track formed therein, a transparent, fluid tight seal member covering said track, and a compliant sealing means positioned between said track and said lumen, the track containing a quantity of a liquid therein whereby the liquid reciprocally moves in said track under influence of systolic and diastolic pressure when the distal end is inserted through a puncture wound into a blood vessel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A device for indicating pressure variations due to systolic and diastolic phases of the heart comprising:
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(a) a tubular member having a proximal end, a closed distal end, and a lumen extending therebetween;
(b) a port located at a predetermined distance proximal of said closed distal end of said tubular member, said port providing a fluid passageway from said lumen of said tubular member to an exterior of said tubular member;
(c) pressure indicating means including a fluid tight track of a predetermined length affixed to said proximal end of said tubular member, said fluid tight track including a transparent cover, a compliant membrane between said track and said lumen and a predetermined volume of fluid partially filling said track, whereby said tubular member is adapted to be inserted into a puncture in blood vessel wall whereby blood enters the lumen and pulsates against said compliant membrane causing said predetermined volume of fluid to pulsate. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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17. An apparatus for sealing percutaneous punctures in a blood vessel wall following a catheterization procedure, said apparatus adapted for use in conjunction with a tubular introducer of the type having a sheath whose distal end is insertable into a wound resulting from percutaneous puncture of said blood vessel wall, said sealing apparatus comprising:
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(a) a tubular member having a closed distal end, a proximal end and a lumen extending therebetween, said tubular member sized to slide into said tubular introducer and of a length whereby its distal end will extend out of said distal end of said tubular introducer sheath when fully inserted therein;
(b) a port positioned proximate said distal end of said tubular member, said port providing fluid passageway from said tubular member lumen to an exterior of said tubular member;
(c) a hub member affixed to said tubular member, the hub member having a groove of a predetermined length formed in a surface thereof, said groove having a first end and a second end, a first fluid passageway extending between said lumen and said first end of said groove and a transparent member over-lying the groove and cooperating with the groove to create a sealed track, a compliant sealing means positioned between said first fluid passageway and said lumen and a predetermined volume of fluid trapped in said fluid passageway and said sealed track; and
(d) a hemostatic seal at said proximal end of said lumen. - View Dependent Claims (18, 19, 20, 21, 22)
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23. A method of sealing percutaneous punctures in the blood vessel of a patient following a catheterization procedure and adapted for use with a vascular introducer of the type having a sheath whose distal end is inserted into a wound resulting from the percutaneous puncture, said method comprising the steps of:
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(a) providing a tubular member having a closed distal end, a proximal end and a lumen extending therebetween, said tubular member having a port located a predetermined distance proximal of its closed distal end, said port extending between said lumen and an exterior of said tubular member and an observable fluid tight track positioned proximate said proximal end of said tubular member, said fluid tight track being sealed from said lumen with a compliant membrane;
(b) inserting said tubular member into said tubular introducer sheath until blood movement against said compliant membrane causes movement of fluid to be observed in said fluid tight track;
(c) retracting as a unit from said puncture wound said tubular member and said tubular introducer sheath until blood movement in said fluid tight track ceases; and
(d) injecting a hemostatic agent into said tubular member lumen whereby said hemostatic agent exits said port adjacent said blood vessel wall. - View Dependent Claims (24, 25, 26, 27, 28, 29)
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Specification