# US 9,039,638 B2 · Test unit for carrying out a one-time testing of a body fluid > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,039,638 B2 - Document ID: US9039638B2 - Status: Granted - Kind: B2 - Application number: 11/773,224 - Filed: 2007-07-03 - Published: 2008-04-24 - Granted: 2015-05-26 - Earliest claimed: 2005-01-19 - Assignees: Roche Diagnostics Operations, Inc. - Applicants: Theo Arnitz - Inventors: Theo Arnitz - Web page: https://patentgrep.com/patent/US9039638B2 ## CPC - A61B 5/1411: {by percutaneous method, e.g. by lancet} - A61B 5/150022: {for capillary blood or interstitial fluid} - A61B 5/150099: {by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes} - A61B 5/150236: {Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood} - A61B 5/150282: {for piercing elements, e.g. blade, lancet, canula, needle} - A61B 5/150335: {by radiation} - A61B 5/150358: {Strips for collecting blood, e.g. absorbent} - A61B 5/150404: {Specific design of proximal end} - A61B 5/150419: {comprising means for capillary action} - A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)} - A61B 5/150511: {Details of construction of shaft} - A61B 5/150572: {Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes} - A61B 5/150618: {Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element} - A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button} - A61B 5/15117: {comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap} - A61B 5/15142: {Devices intended for single use, i.e. disposable} - A61B 5/15186: {Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use} - A61B 5/1519: {comprising driving means, e.g. a spring, for propelling the piercing unit} - A61B 5/15194: {fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin} - A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood - A61B 2562/247: Hygienic covers, i.e. for covering the sensor or apparatus during use - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A test unit for carrying out blood analysis includes a lancing element that can be pricked into a body part which has a capillary channel for transporting the body fluid that leads from a lancing member to a target site. A pretensioned distal sterile cover and a liquid permeable proximal sterile cover are proposed for the lancing element that is advantageously formed as a deep-drawn component. ## Claims ### Claim 1 A test unit, comprising: a lancing element configured to prick a body part, wherein the lancing element has a capillary channel for transporting a body fluid that leads from the lancing element to a target site; and a sterile cover arranged in front of the lancing element, wherein the cover is pretensioned to burst when pierced to create a passage opening in the cover, wherein the cross-section of the passage opening is several times larger than the piercing cross-section of the lancing element, wherein the passage opening is configured to prevent wiping of blood onto the sterile cover during retraction of the lancing element, wherein the sterile cover is formed by an elastic pretensioned tear-membrane. ### Claim 2 (depends on 1) The test unit according to claim 1, further comprising: a detection element configured to detect an analyte in the body fluid to which body fluid can be applied via the capillary channel. ### Claim 3 (depends on 2) The test unit according to claim 2, further comprising a receiving part in which the lancing element is disposed. ### Claim 4 (depends on 3) The test unit according to claim 3, wherein the receiving part has a push guide in which the lancing element is guided. ### Claim 5 (depends on 3) The test unit according to claim 3, further comprising a return spring arranged between the receiving part and the lancing element, wherein the return spring is configured to be tensioned during a lancing advance movement of the lancing element. ### Claim 6 (depends on 3) The test unit according to claim 3, wherein the receiving part has a stop shoulder to hold the receiving part in a form-fitting manner in a housing. ### Claim 7 (depends on 2) The test unit according to claim 2, wherein the detection element has a measuring field extending transversely to the lancing element. ### Claim 8 (depends on 2) The test unit according to claim 2, wherein the detection element is coupled with the lancing element by a latching hook. ### Claim 9 (depends on 2) The test unit according to claim 2, further comprising a plunger arranged in the capillary channel of the lancing element. ### Claim 10 (depends on 1) The test unit according to claim 1, wherein the lancing element has a pointed lancing member, wherein the capillary channel is configured to transport the blood via capillary action from the pointed lancing member to a proximal central aperture, wherein the lancing element has a radially projecting front collar at the proximal central aperture. ### Claim 11 A test unit, comprising: a receiving part having a free outlet opening; a lancing element received in the receiving part, the lancing element including a capillary channel, the lancing element having a pointed lancing member, the capillary channel being configured to transport blood via capillary action from the pointed lancing member to a proximal central aperture, the lancing element having a radially projecting front collar at the proximal central aperture; a distal sterile cover spanning the free outlet opening in a sterile-tight manner to protect the lancing element from contaminants, wherein the distal sterile cover is an elastic pretensioned tear-membrane that is pretensioned to burst abruptly and create a large passage opening in the membrane for passage of the lancing element, wherein the large passage in the membrane has a cross-section that is several times larger than a piercing cross-section of the lancing element, wherein the passage opening is configured to prevent wiping of blood off onto the membrane during retraction of the lancing element; a proximal sterile cover lying flat against the front collar of the lancing element, the proximal sterile cover covering the proximal central aperture of the lancing element, the proximal sterile cover being made of fiber fleece that is permeable to the blood, wherein the fiber fleece is configured to prevent passage of germs; a detection element positioned on a rear side of the proximal sterile cover, wherein the rear side of the proximal cover faces away from the lancing element, the detection element having a measuring field with a reagent for analyzing the blood; and a return spring arranged between the lancing element and the receiving part, wherein the return spring presses the front collar of the lancing element against the proximal sterile cover, wherein the return spring via the front collar further presses the proximal sterile cover against the measuring field to ensure capillary coupling for transporting the blood.