Roche Diagnostics Operations, Inc.

Tissue Engineering Refraction Inc.

Roche Diabetes Care, Inc.

Amira Medical

Tissue Engineering Refractions, Inc.

Edward P Perez

Steven Nelson Roe

Charles C Raney

Paul Patel

Jeffrey N Roe

Ian Michael Munson

Chris Wiegel

David S Fisher

A Michael Jung

Rafael C Donnay

Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

Devices and methods for expression of bodily fluids from an incision

A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

Lancet device having capillary action

Bodily fluid is sampled by causing a lancet mounted in a housing to be displaced toward a skin surface. A vacuum mechanism disposed on the housing is utilized to create a suction in the area to be incised causing bodily fluid to pool. The vacuum mechanism may then be deactivated thereby releasing the vacuum force on the skin, or repeatedly activated and deactivated. After the vacuum device has been utilized, the lancet is advanced to form an incision. The vacuum device may be activated, activated and deactivated, or repeatedly activated and deactivated after forming the incision. The sample may be withdrawn from the incision through a capillary tube.

Method and apparatus for sampling bodily fluid

These methods, devices, and structures are useful in the field of ophthalmology; the devices and methods relate variously to separating or lifting corneal epithelium from the eye preferably in a substantially continuous layer, placing a lens or other suitable ocular or medical device beneath the epithelial membrane, and to the resulting structures formed by those procedures. The de-epilthelialization devices generally utilize a non-cutting separator or dissector that is configured to separate the epithelium at a naturally occurring cleavage surface in the eye between the epithelium and the corneal stroma (Bowman's membrane), specifically separating in the region of the lamina lucida. The separator or dissector may have a structure that rolls or vibrates (or both) at that cleavage surface or interface during the dissection step. The separated epithelium may be lifted or peeled from the surface of the eye to form an epithelial flap or a pocket. The epithelium may then be replaced on the cornea after a refractive procedure or after placement of an ocular lens (or other subepithelial device) on the eye. The subepithelial device may comprise a wide variety of synthetic, natural, or composite polymeric materials. The step of replacing epithelial tissue upon the subepithelial device or upon the anterior corneal surface promotes epithelial healing.

Methods for producing epithelial flaps on the cornea and for placement of ocular devices and lenses beneath an epithelial flap or membrane, epithelial delaminating devices, and structures of epithelium and ocular devices and lenses

An integrated bodily fluid sampling device includes a lancet, a test strip attached to the lancet, and a flexible sheet extending from the test strip. The lancet and the flexible sheet form a gap sized to draw bodily fluid onto the test strip via capillary action. Further, a sampling end portion of the flexible sheet is shaped to enhance capillary action of the sheet. In one form, a removable film covers the lancet and forms a seal with the flexible sheet such that the seal surrounds a lancet tip. In another form, an insulating layer covers a portion of the lancet to prevent electrical interference between the lancet and an electrical testing system on the test strip and ensure an accurate analysis of the bodily fluid.

Integrated lancing test strip with capillary transfer sheet

Systems and methods for the sampling of bodily fluid from an incision in the skin include test strips which are positioned adjacent to the skin and which include features to inhibit the passage of the bodily fluid between the skin and the underside of the test strip. One system utilizes a sealing member located on the bottom surface of the test strip and positioned to provide a fluid tight seal with the skin. A second system includes a recessed surface aligned with the inlet opening of the test strip to preclude contact of the bodily fluid directly with the bottom surface of the test strip. A third system involves the use of a hydrophobic surface on the underside of the test strip to inhibit wicking of the bodily fluid along the test strip. The present invention further encompasses the combination of the foregoing sampling systems with each other, and with incising, expressing and/or testing systems and methods, particularly in a single, integrated device.

Sampling devices and methods utilizing a horizontal capillary test strip

A sampling member defines a passageway including an inlet opening for reception of a bodily fluid therein, and a wicking member having a first portion coupled with the sampling member adjacent to the inlet opening. The wicking member further includes a second portion displaced from the first portion for initially contacting the bodily fluid. In use the sampling member is placed adjacent to an incision site with the second portion of the wicking member positioned to have the bodily fluid first contact the wicking member and thereby draw the fluid from the incision site to the inlet opening. In related embodiments there is provided a sampling system and method which further includes a lancing device to create the incision and optionally expression members to urge the bodily fluid from the incision, preferably in an integrated unit.

Wicking methods and structures for use in sampling bodily fluids

This relates to a lens made of donor corneal tissue suitable for use as a contact lens or an implanted lens, to a method of preparing that lens, and to a technique of placing the lens on the eye. The lens is made of donor corneal tissue that is acellularized by removing native epithelium and keratocytes. These cells optionally are replaced with human epithelium and keratocytes to form a lens that has a structural anatomy similar to human cornea. The ocular lens may be used to correct conditions such as astigmatism, myopia, aphakia, and presbyopia.

Method of lifting an epithelial layer and placing a corrective lens beneath it

A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a spring in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a testing device for measuring a body fluid. The testing device may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Methods and apparatus for expressing body fluid from an incision

This invention relates to a contact lens made of donor corneal tissue, to a method of preparing that lens, and to a technique of placing the lens on the eye. The lens is made of donor corneal tissue that is acellularized by removing native epithelium and keratocytes. These cells are replaced with human epithelium and keratocytes to form a lens that has a structural anatomy similar to human cornea. The ocular lens is used to correct conditions such as astigmatism, myopia, aphakia, and presbyopia.

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Redwood City, CA, United States of America

Edward P Perez