Apparatus and method for efficient blood sampling with lancet

• US 6,210,420 B1
• Filed: 01/19/1999
• Issued: 04/03/2001
• Est. Priority Date: 01/19/1999
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Mauze, Ganapati R, Dias, J. Fleming
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Ngo, Lien
• Application Number:
  US09/233,298
• Time in Patent Office: 805 Days
• Field of Search: 606/182, 606/181, 606/183-185, 600/573, 600/538, 600/578, 600/576
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: 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
• CPC Class Codes: 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

Abstract

A technique for efficiently sampling blood from body tissue by reducing pressure on the body tissue. In the present technique a body tissue is placed under reduced pressure to improve perfusion of blood in the body tissue before lancing. An embodiment of this apparatus includes a lancet carried by a piston slidable in a housing, a mechanism for transmitting mechanical energy internally in the apparatus for creating the reduced pressure on the body tissue. The apparatus also includes a driver that drives the lancet for lancing. The apparatus has a head in the housing for contacting the body tissue in an air-tight manner against suction forces. In the head facing the body tissue is a channel in which the air pressure can be reduced.

Claims

1. An apparatus for sampling blood from body tissue, comprising:

(a) a lancet for lancing the body tissue to result in a wound for bleeding;

(b) a housing operatively connected to the lancet and shielding the lancet before lancing, the housing having an internal channel and a head for contacting the body tissue in an air-tight manner against suction forces, the housing having a piston which has sliding motion along the housing when implementing suction at the head in the reduction of air pressure at the body tissue prior to lancing the body tissue to create a wound; and

(c) a driver for driving the lancet toward the body tissue for lancing while the body tissue is under suction.

2. The apparatus according to claim 1 wherein the piston has a channel along its length, the housing has a rear portion remote from the lancet and wherein air passes through the channel of the piston from the head to about the rear portion as the air pressure at the head is being reduced, wherein the piston has a surface in slidable contact with the housing in an air-tight manner.

3. The apparatus according to claim 1 wherein the piston is slidably housed in the channel for air-tight sliding movement in the channel against the housing in a direction away from the head to reduce air pressure at the head.

4. The apparatus according to claim 1 wherein the head has a depression and a pore connected together, the depression being more towards the front of the head than the pore, both the depression and the pore being at the front portion of the channel.

5. The apparatus according to claim 4 wherein the head has a ridge encircling the depression for sealing against the body tissue.

6. The apparatus according to claim 5 wherein the lancet will extend to protrude forward through the pore in the head when driven for lancing, the protrusion of the lancet being not more forward than the ridge to reduce the risk of inadvertent injury to a user.

7. The apparatus according to claim 5 wherein the lancet protrudes forward through the pore into the depression when driven to lance, and wherein the head is adjustably secured in the housing to adjust the protrusion into the depression.

8. The apparatus according to claim 3 wherein the driver includes a spring which is compressed when the piston is moved to reduce air pressure in the channel, the spring can be decompressed thereafter to urge the lancet toward the body tissue.

9. The apparatus according to claim 8 wherein the housing further comprises a catch for operatively holding the piston to maintain the spring in a compressed state, wherein releasing the piston from the catch will permit the decompression of the spring to drive the lancet forward.

10. The apparatus according to claim 3 wherein the driver further includes a means for moving the piston backward to reduce air pressure in the channel before the piston is driven forward for lancing.

11. The apparatus according to claim 2 wherein the piston carries the lancet and has an open bore internally extending longitudinally from proximate to the head to proximate to the rear portion allowing air to pass through to a suction source at the rear portion to reduce pressure in the channel at the head, thereby sliding the piston forward by suction.

12. The apparatus according to claim 11 further comprising a resilient support for allowing the piston to be pulled forward by a reduction in air pressure at the head and retracting the piston when the reduction in air pressure is removed.

24. The apparatus according to claim 1, wherein the piston slides along the housing while reduces air pressure on the body tissue by one of expanding air space of air above the body tissue and allowing air to pass through the piston to a suction source.

13. A method for sampling blood from a body tissue, comprising the steps of:

(a) providing a lancing device which has a lancet for lancing and has a head with an opening for receiving blood from sampling and further having a housing with a channel in the lancing device extending longitudinally therein, the housing having a slidable piston therein, the piston carrying the lancet;

(b) applying the head with the opening against the body tissue and reducing air pressure in the channel at the head and on the body tissue to a pressure less than the ambient pressure while slidably moving the piston along the housing away from the head; and

(c) after step (b), puncturing the body tissue with the lancet.

14. The method according to claim 13 further comprising sliding the piston in the channel away from the head to generate a reduced pressure at the head when the head is applied against the body tissue, the piston carrying the lancet for lancing.

15. The method according to claim 13 further comprising applying a head having a ridge encircling a depression to seal the ridge against the body tissue against air leakage before reducing air pressure in the channel.

16. The method according to claim 15 further comprising extending the lancet to protrude forward through the opening into the depression for lancing and limiting the protrusion of the lancet to no more forward than the ridge to reduce the risk of inadvertent injury to a user.

17. The method according to claim 13 further comprising extending a lancet forward through the opening into the depression for lancing and adjusting the limit of extension of the lancet before extending the lancet.

18. The method according to claim 13 wherein the channel includes a head channel connected to a body channel and the method further comprises moving the piston backward in the body channel to reduce the air pressure in the head channel and compressing a spring at the same time, the spring can be later decompressed to urge the lancet toward the body tissue.

19. The method according to claim 13 further comprising moving the piston backward and retaining it against the driving force of a spring to result in reduced air pressure in the channel at the head, and thereafter releasing the piston to allow the piston to be driven forward by the spring for lancing.

20. A method for sampling blood from a body tissue, comprising the steps of:

(a) providing a lancing device which has a lancet for lancing and has a head with an opening for receiving blood from sampling and further having a housing with a channel in the lancing device extending longitudinally therein, the housing having a piston disposed in the channel;

(b) applying the head with the opening against the body tissue and reducing air pressure in the channel at the head and on the body tissue to a pressure less than the ambient pressure, wherein the step of reducing air pressure in the channel at the head and on the body tissue comprises the substep of sucking air through a passage extending longitudinally through the piston from the head to a suction source proximate to a portion of the lancing device remote from the head to effect a reduced pressure in the channel at the head, the piston being slidable in the lancet device and carrying the lancet such that the reduced pressure at the head causes the piston to slide towards the body tissue for lancing; and

(c) after step (b), puncturing the body tissue with the lancet.

21. A method for inserting a lancet through the body tissue of a patient, comprising the steps of:

(a) providing a lancing device having a housing and a lancet carried by a slidable piston therein, the housing having a head and a channel extending longitudinally in the housing and leading to an opening in the head, the head for the lancet to extend therein for lancing, the opening having a ridge encircling a depression for receiving blood;

(b) applying the housing with the ridge against the body tissue, such that the body tissue reaches into the depression;

(c) reducing the air pressure on the body tissue to a pressure less than the ambient pressure by one of mechanically drawing air and sliding the piston from the head to a rear portion of the housing through the channel, wherein the air pressure on the body tissue is being reduced while the piston is sliding along the housing;

(d) after the step (c) of reducing the air pressure on the body tissue, puncturing the body tissue with the lancet by extending the lancet in the channel forward in the opening to not pass the end of the ridge; and

(e) receiving blood into the depression from the body tissue.

22. An apparatus for sampling blood from body tissue, comprising:

(a) a lancet for lancing the body tissue to result in a wound for bleeding;

(b) a housing operatively connected to the lancet and shielding the lancet before and during lancing, the housing having an internal channel and a head for contacting the body tissue in an air-tight manner against suction forces, the housing having a piston which can be slid in the housing in a direction away from the head to implement suction at the head on the body tissue in the reduction of air pressure at the body tissue prior to lancing the body tissue to create a wound; and

(c) a driver for driving the piston to push the lancet toward the body tissue for lancing while the body tissue is under suction, the lancet not extending beyond the head during lancing.

23. An apparatus for sampling blood from body tissue, comprising:

(a) a lancet for lancing the body tissue to result in a wound for bleeding;

(b) a housing operatively connected to the lancet and shielding the lancet before lancing, the housing having an internal channel and a head for contacting the body tissue in an air-tight manner against suction forces, the housing having a piston which has sliding motion along the housing when implementing suction at the head in the reduction of air pressure at the body tissue prior to lancing the body tissue to create a wound, the piston being in rigid relation to the lancet and has a channel extending longitudinally from proximate to the head to proximate to the rear portion allowing air to pass from the head through the piston to a suction source at the rear portion to reduce pressure in the channel at the head, thereby sliding the piston towards the head by suction from the suction source; and

(c) a suction source for moving the lancet toward the body tissue for lancing while the body tissue is under suction.