US7025746B2 — Vascular access device

Claim 1

Independent Claim 167 words

A preassembled vascular access device, the device comprising: a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip; a guidewire preloaded in the needle; a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space; and a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle; wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that blood, if any, in at least one of the annular spaces, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a blood vessel; and wherein the dilator is slideably displaceable relative to the sheath.

Claim 2

Dependent Claim 167 words

A preassembled vascular access device, the device comprising: a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip; a guidewire preloaded in the needle; a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space; and a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle; wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that blood, if any, in at least one of the annular spaces, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a blood vessel; and wherein the dilator is slideably displaceable relative to the sheath.

Claim 3

Dependent Claim 22 words

A device as defined by claim 1 , wherein the sharpened distal tip of the hollow needle protrudes distally from the dilator.

Claim 4

Dependent Claim 33 words

A device as defined by claim 2 , where the sharpened distal tip of the hollow needle so protrudes distally from the dilator as to reach a central blood vessel of a patient.

Claim 5

Dependent Claim 50 words

A device as defined by claim 1 , wherein the dilator defines a dilator side hole, and wherein the first annular space communicates with the second annular space through the dilator side hole, so that blood, if any, exiting the dilator side hole may flow to the second annular space.

Claim 6

Dependent Claim 26 words

A device as defined by claim 4 , wherein the dilator is at least partly semi-opaque, and the sheath is at least partly clear or translucent.

Claim 7

Dependent Claim 20 words

A device as defined by claim 1 , wherein the dilator and sheath are slideably displaceable together over the needle.

Claim 8

Dependent Claim 21 words

A device as defined by claim 1 , wherein the needle, dilator, and sheath are slideably displaceable together over the guidewire.

Claim 9

Dependent Claim 32 words

A device as defined by claim 1 , wherein the dilator is slideably displaceable over the needle to a position in which it covers the needle's sharpened distal tip, thereby protecting it.

Claim 10

Dependent Claim 40 words

A device as defined by claim 1 , wherein the dilator is clear, semi-opaque, or translucent, so that blood, if any, in the first annular space, may be visualized to confirm proper placement of the needle in the blood vessel.

Claim 11

Dependent Claim 50 words

A device as defined by claim 1 , wherein the sheath is clear, semi-opaque, or translucent, the second annular space communicates with the first annular space, so that blood, if any, in the second annular space, may be visualized to confirm proper placement of the needle in the blood vessel.

Claim 12

Dependent Claim 89 words

A device as defined by claim 1 , wherein the dilator comprises a discontinuous structure having a solid distal section connected to a solid proximal section by at least one longitudinal member, so that the second annular space is defined between the sheath and the needle and the second annular space communicates with the hollow needle bore through the needle side hole, so that blood, if any, in the second annular space, may be visualized through the sheath to confirm proper placement of the needle in the blood vessel.

Claim 13

Dependent Claim 61 words

A device as defined by claim 1 , wherein the dilator comprises a continuous tube structure, so that the second annular space is defined between the sheath and the dilator, and so that blood, if any, in the second annular space, may be visualized through the dilator and the sheath to confirm proper placement of the needle in the blood vessel.

Claim 14

Dependent Claim 15 words

A device as defined by claim 1 , wherein the sheath comprises a side port.

Claim 15

Dependent Claim 31 words

A device as defined by claim 1 , wherein the hollow needle is so stiff as to support the dilator and sheath during advancement of the device into the blood vessel.

Claim 16

Dependent Claim 29 words

A device as defined by claim 1 , wherein a distal end of the guidewire is preloaded in the needle, and the guidewire further comprises a proximal free end.

Claim 17

Dependent Claim 21 words

A device as defined by claim 1 , wherein the dilator comprises a distal dilation section having a double cone configuration.

Claim 18

Dependent Claim 15 words

A device as defined by claim 1 , wherein the sheath is a peelable sheath.

Claim 19

Dependent Claim 18 words

A device as defined by claim 1 , further comprising a seal disposed between the dilator and sheath.

Claim 20

Dependent Claim 15 words

A device as defined by claim 1 , wherein the sheath comprises a hemostatic valve.

Claim 21

Dependent Claim 39 words

A device as defined by claim 1 , wherein the needle is attached to a proximal needle hub, the dilator is attached to a proximal dilator hub, and the needle hub and dilator hub are interlockable with one another.

Claim 22

Dependent Claim 16 words

A device as defined by claim 1 , wherein the dilator is affixed to the needle.

Claim 23

Independent Claim 186 words

A method of gaining access to a patient's blood vessel, comprising: providing a preassembled vascular access device, the device comprising: a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip; a guidewire preloaded in the needle; a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space; and a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle; introducing the distal tip of the hollow needle into the patient's blood vessel; threading the preloaded guidewire though the distal tip of the needle into the blood vessel; advancing the dilator and sheath together over the needle into the blood vessel; and removing the guidewire, the needle, and the dilator, thereby leaving the sheath in place to provide access to the patient's blood vessel.

Claim 24

Independent Claim 186 words

A method of gaining access to a patient's blood vessel, comprising: providing a preassembled vascular access device, the device comprising: a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip; a guidewire preloaded in the needle; a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space; and a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle; introducing the distal tip of the hollow needle into the patient's blood vessel; threading the preloaded guidewire though the distal tip of the needle into the blood vessel; advancing the dilator and sheath together over the needle into the blood vessel; and removing the guidewire, the needle, and the dilator, thereby leaving the sheath in place to provide access to the patient's blood vessel.

Claim 25

Dependent Claim 70 words

A method as defined by claim 22 , wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that blood, if any, in at least one of the annular spaces, may be visualized through the dilator and/or sheath, and the method further comprises confirming proper placement of the needle by visualizing blood in at least one of the annular spaces through the dilator and/or sheath.

Claim 26

Dependent Claim 35 words

A method as defined by claim 23 , wherein the dilator is clear, semi-opaque, or translucent, and the method further comprises confirming proper placement of the needle by visualizing blood in the first annular space.

Claim 27

Dependent Claim 48 words

A method as defined by claim 23 , wherein the sheath is clear, semi-opaque, or translucent, the second annular space communicates with the first annular space, and the method further comprises confirming proper placement of the needle by visualizing blood in the second annular space through the sheath.

Claim 28

Dependent Claim 78 words

A method as defined by claim 23 , wherein the dilator comprises a discontinuous structure having a solid distal section connected to a solid proximal section by at least one longitudinal member, so that the second annular space is defined between the sheath and the needle and the second annular space communicates with the hollow needle bore through the side hole, and the method further comprises confirming proper placement of the needle by visualizing blood through the sheath.

Claim 29

Dependent Claim 49 words

A method as defined by claim 23 , wherein the dilator comprises a continuous tube structure, so that the second annular space is defined between the sheath and the dilator, and the method further comprises confirming proper placement of the needle by visualizing blood through the dilator and sheath.

Claim 30

Dependent Claim 29 words

A method as defined by claim 23 , wherein proper placement is confirmed, before advancing the dilator and sheath, by observing a blood flash through the dilator and/or sheath.

Claim 31

Dependent Claim 17 words

A method as defined by claim 22 , wherein the blood vessel is a central blood vessel.

Claim 32

Dependent Claim 32 words

A method as defined by claim 29 , wherein introducing comprises introducing the distal tip of the hollow needle into the patient's central blood vessel without the dilator penetrating the patient's skin.

Claim 33

Dependent Claim 29 words

A method as defined by claim 22 , wherein advancing further comprises advancing the needle together with the dilator and sheath in to the blood vessel over the guidewire.

Claim 34

Dependent Claim 28 words

A method as defined by claim 22 , wherein the sheath comprises a side port, and the method further comprises sampling the patient's blood through the side port.

Claim 35

Dependent Claim 21 words

A method as defined by claim 22 , further comprising supporting the dilator and sheath with the hollow needle during advancement.

Claim 36

Dependent Claim 20 words

A method as defined by claim 22 , further comprising observing a blood flash before advancing the dilator and sheath.

Claim 37

Dependent Claim 33 words

A method as defined by claim 22 , wherein the dilator is so advanced over the needle as to contain the needle distal tip within the dilator to protect the needle distal tip.

Claim 38

Dependent Claim 168 words

A preassembled vascular access device, the device comprising: a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip; a guidewire preloaded in the needle; a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space, the dilator comprising a distal dilation section having a double cone configuration; and a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle; wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that blood, if any, in at least one of the annular spaces, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a blood vessel.

Claim 39

Dependent Claim 168 words

A preassembled vascular access device, the device comprising: a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip; a guidewire preloaded in the needle; a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space, the dilator comprising a distal dilation section having a double cone configuration; and a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle; wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that blood, if any, in at least one of the annular spaces, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a blood vessel.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2009-04-10	2009-10-10	2010-04-11	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2013-04-10	2013-10-10	2014-04-11	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2017-04-10	2017-10-10	2018-04-11	$7700.00	Window Closed / Lapsed

Vascular access device

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