US6459917B1 — Apparatus for access to interstitial fluid, blood…

Claim 1

Independent Claim 89 words

A transcutaneous implant comprising: an access component to provide a stable dermal interface; a central housing disposed within the access component, the central housing having a first end for external access and a second end; a first septum disposed within the central housing; and a filtration membrane disposed at the second end of the central housing to allow analyte in bodily fluid to enter a reservoir formed by the filtration membrane, the first septum and the central housing, wherein the filtration membrane includes a first material to promote neovascularization.

Claim 2

Dependent Claim 89 words

A transcutaneous implant comprising: an access component to provide a stable dermal interface; a central housing disposed within the access component, the central housing having a first end for external access and a second end; a first septum disposed within the central housing; and a filtration membrane disposed at the second end of the central housing to allow analyte in bodily fluid to enter a reservoir formed by the filtration membrane, the first septum and the central housing, wherein the filtration membrane includes a first material to promote neovascularization.

Claim 3

Dependent Claim 40 words

The implant of claim 1 wherein the access component includes a neck having a first end and a second end, and skirt that extends outwardly from the second end of the neck to anchor the access component in subcutaneous tissue.

Claim 4

Dependent Claim 26 words

The implant of claim 2 wherein the central housing is formed integrally with the access component and is defined by an inner surface of the neck.

Claim 5

Dependent Claim 40 words

The implant of claim 2 wherein the central housing extends beneath the skirt of the access component and is adapted to be secured to a wall of an arterio-venous shunt such that the filtration membrane resides within the arterio-venous shunt.

Claim 6

Dependent Claim 37 words

The implant of claim 2 wherein the access component includes a porous material disposed on at least a portion of the skirt of the access component wherein the porous material encourages cell infiltration and formation of tissue.

Claim 7

Dependent Claim 12 words

The implant of claim 5 wherein the porous material includes polyester velour.

Claim 8

Dependent Claim 18 words

The implant of claim 2 wherein the skirt and neck are integrally formed of a flexible, biocompatible material.

Claim 9

Dependent Claim 46 words

The implant of claim 7 wherein the flexible biocompatible material is a member of a group of materials that includes flexible medical grade polyurethane, polymethyl methacrylate (PMMA), polyethylene (PE), polyvinyl chloride (PVC), polycarbonate, polypropylene (PP) polydimethyl siloxane (PDMS), ethylene glycol dimethacrylate (EGDM), polytetrafluoroethylene PTFE), and nylon.

Claim 10

Dependent Claim 35 words

The implant of claim 2 wherein the skirt includes recessed regions containing a material that encourages growth of fibrous collagen, wherein the fibrous collagen promotes a stable seal between the access component and the skin.

Claim 11

Dependent Claim 32 words

The implant of claim 1 wherein the filtration membrane includes a material that allows passive diffusion of the analyte in the bodily fluid and substantially prevents transport of cells or larger proteins.

Claim 12

Dependent Claim 33 words

The implant of claim 1 wherein the first material is at least one of cellulose acetate, mixed esters of cellulose, polysulfone, polyester, polypropylene, cellulose nitrate, polycarbonate nylon, polyethylene, and vinyl acetate ethylene copolymers.

Claim 13

Dependent Claim 13 words

The implant of claim 1 wherein the first material includes polyvinylidene fluoride (PVDF).

Claim 14

Dependent Claim 34 words

The implant of claim 1 wherein the filtration membrane further includes a second material which allows passive diffusion of the analyte in the bodily fluid and substantially prevents transport of cells or larger proteins.

Claim 15

Dependent Claim 14 words

The implant of claim 13 wherein the second material includes polymerized polyethylene glycol (PEG).

Claim 16

Dependent Claim 21 words

The implant of claim 13 wherein the second material is laminated on the first material to form a two-layer filtration membrane.

Claim 17

Dependent Claim 25 words

The implant of claim 13 wherein a portion of the second material penetrates into the first material to form a partially embedded two-layer filtration membrane.

Claim 18

Dependent Claim 25 words

The implant of claim 13 wherein the second material is contained within a layer of the first material to form an embedded two-layer filtration membrane.

Claim 19

Dependent Claim 37 words

The implant of claim 13 wherein the filtration membrane further includes a third material, which is more rigid than at least one of the first material and the second material, to provide support to the filtration membrane.

Claim 20

Dependent Claim 20 words

The implant of claim 1 wherein the first material has a pore size ranging from 0.05 μm to 40 μm.

Claim 21

Dependent Claim 31 words

The implant of claim 1 wherein the first septum forms a liquid-tight seal between the reservoir and a side of the first septum nearest the first end of the central housing.

Claim 22

Dependent Claim 44 words

The implant of claim 20 wherein the first septum is formed of a self-sealing material such that, after the first septum has been penetrated by a fluid sampling/delivery device and the fluid sampling/delivery device removed, the first septum self-seals to reestablish the liquid-tight seal.

Claim 23

Dependent Claim 18 words

The implant of claim 21 wherein the first septum is formed from a material that includes silicone rubber.

Claim 24

Dependent Claim 50 words

The implant of claim 1 wherein the central housing includes a conduit disposed within the lumen of the central housing and wherein the first septum is disposed within the conduit and the filtration membrane is disposed at an end of the conduit adjacent the second end of the central housing.

Claim 25

Dependent Claim 27 words

The implant of claim 23 wherein the conduit is formed integrally with the central housing, the conduit being defined by an inner surface of the central housing.

Claim 26

Dependent Claim 15 words

The implant of claim 23 wherein the conduit is formed of a rigid biocompatible material.

Claim 27

Dependent Claim 24 words

The implant of claim 23 further comprising a cap disposed over an end of the conduit adjacent the first end of the central housing.

Claim 28

Dependent Claim 37 words

The implant of claim 23 further comprising a second septum disposed within the conduit nearer the first end of the central housing than the first septum, the first and second septa defining a chamber within the conduit.

Claim 29

Dependent Claim 31 words

The implant of claim 23 further comprising a support member disposed within the conduit to support the first septum, the first septum being disposed within the conduit adjacent the support member.

Claim 30

Dependent Claim 18 words

The implant of claim 1 further comprising a cap disposed over the first end of the central housing.

Claim 31

Dependent Claim 35 words

The implant of claim 1 further comprising a second septum disposed within the central housing nearer the first end than the first septum, the first and second septa defining a chamber within the central housing.

Claim 32

Dependent Claim 32 words

The implant of claim 30 where in the second septum forms a liquid-tight seal between the chamber and a side of the second septum nearest the first end of the central housing.

Claim 33

Dependent Claim 20 words

The implant of claim 1 wherein the filtration membrane is attached to the central housing using a medical grade adhesive.

Claim 34

Dependent Claim 32 words

The implant of claim 1 wherein the filtration membrane extends outwardly to form a surface area that exceeds an area of a cross section of the second end of the central housing.

Claim 35

Dependent Claim 21 words

The implant of claim 1 further comprising a safety stop to prevent a fluid sampling/delivery device from contacting the filtration membrane.

Claim 36

Dependent Claim 34 words

The implant of claim 34 wherein the safety stop is disposed within the reservoir, the safety stop including an aperture to permit the analyte to pass between the reservoir and the fluid sampling/delivery device.

Claim 37

Dependent Claim 19 words

The implant of claim 1 wherein at least a portion of the reservoir is lined with an antibacterial coating.

Claim 38

Dependent Claim 11 words

The implant of claim 36 wherein the antibacterial coating includes silver.

Claim 39

Dependent Claim 19 words

The implant of claim 1 wherein the first septum is removable from the central housing to allow replacement thereof.

Claim 40

Dependent Claim 39 words

The implant of claim 1 further comprising a sampling stop disposed at the first end of the central housing to limit the insertion of a fluid sampling/delivery device such that the device is prevented from contacting the filtration membrane.

Claim 41

Dependent Claim 68 words

The implant of claim 39 wherein the sampling stop includes a stop wall adapted to engage a flange of the fluid sampling/delivery device, the stop wall including an aperture to receive a narrower portion of the fluid sampling/delivery device such that a tip of the narrower portion of the fluid sampling/delivery device rests within the reservoir when the flange of the fluid sampling/delivery device engages the stop wall.

Claim 42

Dependent Claim 14 words

The implant of claim 39 wherein the sampling stop is removable from the implant.

Claim 43

Dependent Claim 62 words

The implant of claim 1 wherein the central housing is adapted to engage an analyte measurement device and fluid sampling device such that the analyte in the reservoir is communicated to the analyte measurement device via the fluid sampling device and measured by the analyte measurement device while the analyte measurement device and fluid sampling device are engaged by the central housing.

Claim 44

Dependent Claim 102 words

A sensing system having a transcutaneous implant device comprising: an electroenzymatic sensor; a transcutaneous implant device, including: an access component to provide a stable dermal interface; a central housing disposed within the access component, the central housing having a first end for external access and a second end; a first septum disposed within the central housing; and a filtration membrane disposed at the second end of the central housing to allow analyte in bodily fluid to enter a reservoir formed by the filtration membrane, the first septum and the central housing, wherein the filtration membrane includes a first material to promote neovascularization.

Claim 45

Dependent Claim 102 words

A sensing system having a transcutaneous implant device comprising: an electroenzymatic sensor; a transcutaneous implant device, including: an access component to provide a stable dermal interface; a central housing disposed within the access component, the central housing having a first end for external access and a second end; a first septum disposed within the central housing; and a filtration membrane disposed at the second end of the central housing to allow analyte in bodily fluid to enter a reservoir formed by the filtration membrane, the first septum and the central housing, wherein the filtration membrane includes a first material to promote neovascularization.

Claim 46

Dependent Claim 42 words

The sensing system of claim 43 wherein the electroenzymatic sensor includes a chemical sensor disposed within the reservoir and first and second terminals disposed adjacent the first end of the central housing and coupled to the chemical sensor via respective electrical conductors.

Claim 47

Dependent Claim 23 words

The sensing system of claim 43 wherein the electroenzymatic sensor further includes a fluid withdrawal port to allow periodic withdrawal of the analyte.

Claim 48

Dependent Claim 12 words

The sensing system of claim 43 wherein the electroenzymatic sensor is removable.

Claim 49

Dependent Claim 35 words

The sensing system of claim 43 further comprising a display device coupled adjacent the first end of the central housing, the display device cooperating with the electroenzymatic sensor to display a measure of the analyte.

Claim 50

Dependent Claim 15 words

The sensing system of claim 47 wherein the display device is a wristwatch style device.

Claim 51

Dependent Claim 113 words

An implant to deliver fluid to, withdraw fluid from, or monitor a fluid of an animal body, the implant comprising: an access component to provide a stable dermal interface wherein the access, component includes a housing having a first end which is externally accessible, capable of being without puncturing the skin of the animal body and a second end; a septum, disposed within the housing, to provide a liquid tight seal; and a membrane disposed at, and coupled to the second end of the housing wherein the membrane includes a first material that promotes neovascularization when located within the animal body and wherein the membrane, the septum and the housing form a reservoir.

Claim 52

Dependent Claim 113 words

An implant to deliver fluid to, withdraw fluid from, or monitor a fluid of an animal body, the implant comprising: an access component to provide a stable dermal interface wherein the access, component includes a housing having a first end which is externally accessible, capable of being without puncturing the skin of the animal body and a second end; a septum, disposed within the housing, to provide a liquid tight seal; and a membrane disposed at, and coupled to the second end of the housing wherein the membrane includes a first material that promotes neovascularization when located within the animal body and wherein the membrane, the septum and the housing form a reservoir.

Claim 53

Dependent Claim 33 words

The implant of claim 49 wherein the first material is at least one of cellulose acetate, mixed esters of cellulose, polysulfone, polyester, polypropylene, cellulose nitrate, polycarbonate nylon, polyethylene, and vinyl acetate ethylene copolymers.

Claim 54

Dependent Claim 27 words

The implant of claim 49 wherein the membrane further includes a second material which allows fluid to diffuse therethrough and substantially prevents cells from entering the reservoir.

Claim 55

Dependent Claim 20 words

The implant of claim 51 wherein the second material is laminated onto the first material to form a two-layer membrane.

Claim 56

Dependent Claim 24 words

The implant of claim 51 wherein the second material is contained within a layer of the first material to form an embedded two-layer membrane.

Claim 57

Dependent Claim 20 words

The implant of claim 51 wherein the first material includes a pore size ranging from 0.05 μm to 40 μm.

Claim 58

Dependent Claim 20 words

The implant of claim 51 further including a safety stop to prevent a fluid sampling/delivery device from contacting the membrane.

Claim 59

Dependent Claim 112 words

An implant to deliver fluid to, withdraw fluid from, or monitor a fluid of an animal body, the implant comprising: an access component to provide a stable dermal interface wherein the access component includes a housing having a first end which is externally capable of accessible without puncturing the skin of the animal body and a second end; a septum, disposed within the housing, to provide a liquid tight seal; and a membrane disposed at, and coupled to the second end of the housing wherein the membrane includes a first material that retards avascularization when located within the animal body and wherein the membrane, the septum and the housing form a reservoir.

Claim 60

Dependent Claim 112 words

An implant to deliver fluid to, withdraw fluid from, or monitor a fluid of an animal body, the implant comprising: an access component to provide a stable dermal interface wherein the access component includes a housing having a first end which is externally capable of accessible without puncturing the skin of the animal body and a second end; a septum, disposed within the housing, to provide a liquid tight seal; and a membrane disposed at, and coupled to the second end of the housing wherein the membrane includes a first material that retards avascularization when located within the animal body and wherein the membrane, the septum and the housing form a reservoir.

Claim 61

Dependent Claim 20 words

The implant of claim 56 wherein the first material includes a pore size ranging from 0.05 μm to 40 μm.

Claim 62

Dependent Claim 27 words

The implant of claim 57 wherein the membrane further includes a second material which allows fluid to diffuse therethrough and substantially prevents cells from entering the reservoir.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2005-09-30	2006-04-01	2006-10-01	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2009-09-30	2010-04-01	2010-10-01	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2013-09-30	2014-04-01	2014-10-01	$7700.00	Window Closed / Lapsed

Apparatus for access to interstitial fluid, blood, or blood plasma components

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