Splittable hemostatic valve and sheath and the method for using the same
DC CAFCFirst Claim
1. A sheath assembly for use with a lead or catheter comprising:
- an introducer sheath;
a hemostatic valve coupled to said introducer sheath, said hemostatic valve and introducer sheath being arranged and configured to permit introduction of at least one lead or catheter therethrough;
means for permitting removal of said hemostatic valve and introducer sheath from said lead or catheter disposed therethrough without requiring said introducer sheath and hemostatic valve to be removed from an end of said lead or catheter,wherein said means for permitting removal of said hemostatic valve comprises a two-part body, said two-part body being made in two separate body portions, said body portions defining means for sealing said body portions together when said two body parts are joined with each other to form said hemostatic valve,whereby said assembly may remain in a vein throughout an operation with the advantage of free lead exchange and easier lead manipulation without substantial bleeding, risk of air embolism, clotting or repeated sheath insertion causing related trauma from lead exchange,
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Abstract
A splittable hemostatic valve and introducer sheath is provided for introductions of leads or catheters through the valve and sheath combination into a vein or artery. Because of the hemostatic valve, this sheath can remain in the vein throughout the operation with the advantage of free lead exchange possibility and easier lead manipulation, especially in dual lead insertions, without bleeding, risk of air embolism or repeated sheath insertion related trauma for lead exchange. A side arm to the hemostatic valve cage provides continuous fluid drip in order to prevent clot formation in the lumen of the sheath. At the point in the operation where the introducer sheath and hemostatic valve must be removed from the lead or catheter, which must remain implanted, a device is employed to split or separate the introducer sheath and valve apart so that the sheath and valve are removed from the implanted lead or catheter without the necessity of sliding either the sheath or valve over the free end of the lead or catheter. The hemostatic valve is made in two separate parts which include a fluid-tight seal to facilitate splitting of the valve. In this manner, any termination which may be provided on the free end of the lead or catheter, such as a terminal for connection to a pacemaker, will not interfere with the optimal use of the introducer sheath and hemostatic valve.
348 Citations
33 Claims
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1. A sheath assembly for use with a lead or catheter comprising:
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an introducer sheath; a hemostatic valve coupled to said introducer sheath, said hemostatic valve and introducer sheath being arranged and configured to permit introduction of at least one lead or catheter therethrough; means for permitting removal of said hemostatic valve and introducer sheath from said lead or catheter disposed therethrough without requiring said introducer sheath and hemostatic valve to be removed from an end of said lead or catheter, wherein said means for permitting removal of said hemostatic valve comprises a two-part body, said two-part body being made in two separate body portions, said body portions defining means for sealing said body portions together when said two body parts are joined with each other to form said hemostatic valve, whereby said assembly may remain in a vein throughout an operation with the advantage of free lead exchange and easier lead manipulation without substantial bleeding, risk of air embolism, clotting or repeated sheath insertion causing related trauma from lead exchange, - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method of percutaneous catherterization comprising the steps of:
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disposing an introducer sheath and hemostatic valve coupled to said introducer sheath into a body lumen; disposing at least one lead or catheter through said valve and introducer sheath into said body lumen; sealing said lead or catheter within said hemostatic valve to prevent bleeding and introduction of air into said body lumen with disposition of said lead or catheter therein; and later removing said hemostatic valve and introducer sheath while leaving said lead or catheter in place within said body lumen without sliding either said introducer sheath or hemostatic valve over an end of said lead or catheter, where in said step of removing said hemostatic valve, said hemostatic valve is comprised of two body portions, said body portions being separately provided to form said hemostatic valve and being temporarily joined together to form a complete body of said hemostatic valve, wherein said body portions are pulled apart to split said hemostatic valve; whereby implanted leads or catheters may be disposed into said body lumen without bleeding, risk of air embolism, clotting or repeated sheath insertion related to trauma for lead exchange or requiring said into said lead or catheter to a have structure to permit removal of said sheath and valve thereover. - View Dependent Claims (15, 16)
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- 17. The method of claim 17 where said step of tearing said sheath and prying valve along a score line further comprises tearing said sheath and prying valve along a pair of longitudinally defined score lines in said sheath and valve.
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19. A sheath assembly for use with a lead or catheter, comprising:
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an introducer sheath; a hemostatic valve coupled to said introducer sheath, said heomstatic valve and introducer sheath being arranged and configured to permit introduction of at least one lead or catheter therethrough; means for permitting removal of said hemostatic valve and introducer sheath from said lead or catheter disposed therethrough without requiring said introducer sheath and hemostatic valve to be removed from an end of said lead or catheter; wherein said means for permitting removal of said heomstatic valve comprises a multiple-part body, said body being made in at least two separate body portions, said body portions defining means for sealing said body portions together when said body parts are joined with each other to form said heomstatic valve; whereby said assembly may remain a vein throughout an operation with the advantage of free lead exchange and easier lead manipulation without substantial bleeding, risk of air embolism, clotting or repeated sheath insertion causing related trauma from lead exhange. - View Dependent Claims (20, 21, 22, 23, 32, 33)
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- 24. The sheath assembly of clam 23 wherein said sealing lip on one body portion is an inner circumferential sealing lip and said sealing lip on said another body portion is an outer circumferential sealing lip, said inner and outer circumferential sealing lips conforming with each other to seal said hemostatic valve.
Specification