HK1067027B - An endcap for a lancing device - Google Patents

Description

End cap for lancing device

Technical Field

The present invention relates generally to blood testing devices, and more particularly to an end cap for a blood testing device having a face with a pattern of ribs for massaging the skin to cause blood to flow from a puncture hole before or after the puncture hole is pierced with a needle on a replacement body part.

Background

It is often necessary to obtain a blood sample quickly and painlessly and to analyze the blood sample. One example of the need to obtain a blood sample painlessly is associated with a blood glucose testing system, in which case the user must use the system frequently to test the user's blood glucose level.

People with abnormal blood glucose concentration levels may be required to self-test their blood glucose concentration levels on a regular basis. Abnormal blood glucose levels may be caused by a variety of causes, including diseases such as diabetes. The purpose of detecting the blood glucose concentration level is to determine the blood glucose concentration level and then take corrective action based on whether the blood glucose level is too high or too low to bring the blood glucose level back into the normal range. Failure to take corrective action can have serious consequences. When the blood glucose level drops too low-a hypoglycemic state-the person may become nervous, trembling and confused. The person's judgment may be weakened and may eventually syncope. If blood glucose levels become too high-hyperglycemic state-a person may also become ill. Both states of hypoglycemia and hyperglycemia are potentially life-threatening emergencies.

One method of measuring a person's blood glucose level is to use a portable, hand-held blood glucose testing device. In order to check the blood glucose level with the test device, a drop of blood needs to be obtained from the fingertip using the lancing device. A typical lancing device includes a lancet for puncturing the skin of a finger. This testing process is often repeated several times a day. Because this process can be painful, the instrument is modified to obtain blood from alternate sites other than the fingertips, such as the arms, legs, and palms. Although obtaining blood samples from the replacement site reduces pain, the process is typically slow. Available instruments use vacuum or pressure to accelerate the blood draw from the puncture at the replacement site. These devices often cause hematomas at the site. Other devices use a pressure ring that blocks the blood supply at the puncture. These procedures are known to cut off blood flow through very thin capillaries that are typically found under the skin at these replacement sites.

Disclosure of Invention

The present invention is an end cap for a lancing device for lancing the skin to draw blood for testing. The end cap allows the lancing device to pierce a primary site, such as a fingertip, or an alternate site, such as an arm, painlessly and quickly. The end cap has a face with a pattern of pressure points or ribs. The pattern includes grooves or gaps between the pressure points or ribs.

An end cap is provided on the lancing device and the face of the end cap is pressed against the skin at the selected site. The skin is massaged with a pattern of ribs or pressure points by vibrating, rotating, sinking or pressing an end cap on the skin or a combination of more than one technique to encourage blood to flow under the channels to the puncture. The end cap may be molded of a transparent material to allow the user to view the puncture and the amount of blood drawn to the skin surface.

Drawings

Other objects and advantages of the present invention will become apparent upon reading the following detailed description in conjunction with the accompanying drawings in which:

FIG. 1 is an enlarged perspective view of a lancing apparatus with an endcap constructed in accordance with a first embodiment of the present invention;

FIG. 2 is an enlarged perspective view of a second embodiment of the present invention;

FIG. 3 is an enlarged perspective view of a third embodiment of the present invention;

FIG. 4 is an enlarged perspective view of a fourth embodiment of the present invention;

FIG. 5 is an enlarged perspective view of a fifth embodiment of the present invention;

FIG. 6 is an enlarged perspective view of a sixth embodiment of the present invention;

FIG. 7 is an enlarged perspective view of a seventh embodiment of the present invention;

FIG. 8 is an enlarged perspective view of an eighth embodiment of the present invention;

FIG. 9 is an enlarged perspective view of a ninth embodiment of the invention;

FIG. 10 is an enlarged perspective view of a tenth embodiment of the invention;

FIG. 11 is an enlarged perspective view of an eleventh embodiment of the invention;

figure 12 is a cross-sectional view of the end cap taken along line 12-12 of figure 1.

Description of The Preferred Embodiment

Many children and adults must draw blood several times a day in order to analyze the drawn blood samples. Blood was drawn using a lancing device. FIG. 1 illustrates one example of a known lancing device 10 with an endcap 12 constructed in accordance with the principles of the present invention. Such a known lancing device 10 is described in U.S. patent 5,954,738 and is incorporated herein by reference in its entirety. The lancing device 10 includes a main housing 14 and a movable housing 16 that is movable relative to the main housing 14. Internally, the lancing device 10 includes a needle for puncturing the skin and a drive mechanism for driving the needle outwardly of the end cap 12 and into the skin of a patient. The drive mechanism intervenes in the operating position by disengaging the movable housing 16 from the main housing 14. The drive mechanism is activated by pressing the button 18. In accordance with the present invention, lancing apparatus 10 is provided with a replacement site endcap 12. The lancing device 10 can be used to obtain blood samples from other parts of the patient's body other than the fingertips through the use of the end cap 12, the end cap 12 also allowing blood to be drawn from the fingertips if desired. Obtaining a blood sample from an alternate site such as an arm or leg reduces the pain experienced by the patient.

End cap 12 includes a base cap 20 releasably secured to lancing apparatus 10. The end cap 12 also includes a cap 22 having a central aperture 24, the central aperture 24 serving as a needle passage in the lancing device 10. The top cover has a concave surface (inclined surface) 26 (fig. 13) inclined toward the hole 24.

The face 26 of the cap 20 includes a pattern of 6 ribs or pressure points 28. The ribs 28 are of a height to achieve an action or massage as described hereinafter. Heights of 0.030 inches to 0.060 inches have been found to be effective. The pattern includes gaps or grooves 30 between adjacent ribs 28. The ribs 28 are also inclined parallel to the concave surface.

In use, lancing device 10 is placed with face 26 of cap 22 against the skin of a replacement site, such as an arm or leg. The pattern of ribs 28 provides pressurized spots on the skin around the puncture site, while the gaps or channels 30 between the ribs 28 define areas of no pressure on the skin. These areas of no pressure act as channels under the skin for blood to flow to the puncture hole formed in the skin by the needle of the lancing device 10.

After the needle has penetrated the skin and a puncture hole has been formed, lancing device 10 is held against the skin of the patient with face 26 of cap 22. The skin is then massaged using one of four techniques or a combination of more than one technique to induce blood flow to the puncture hole where the blood is taken and tested. These massage techniques may also be applied prior to puncturing the skin to provide for better blood flow. One massage technique is to apply gentle pressure to the skin while alternately rotating the end cap 12 clockwise and counterclockwise. The second massage technique is vibrating the cap 22. The third massage technique is to repeatedly apply and release pressure at the puncture site by the up-and-down movement of the cap 22. A fourth massage technique is to apply a continuous pressure at the puncture site for 5 to 20 seconds after the cap 22 is depressed to puncture the skin. In all of these techniques, the end cap 12 must be held rigidly in one position. Each of these massaging techniques causes blood to flow toward the puncture and may be performed before, after, or both before and after the puncture. These massage techniques may be performed independently or in combination. The ribs 28 also serve to grip the patient's skin during massaging to make the lancing device 10 more easily retained at the lancing site, thus reducing the chance of contaminating the blood sample.

The concave configuration of face 22 further facilitates the flow of blood (fig. 12). The face 22 has an angle of 5 to 6 degrees from the outer edge to the central aperture 24. Although face 22 may be flat, the concave configuration helps to promote blood flow to central bore 24. Preferably, the ribs or pressure points 28 extend parallel to and along the concave surface.

When massaging the puncture site, the user should observe the puncture site to determine the contact of face 26 with the skin and to determine when sufficient blood sample has been obtained. To enable these observations, the base cover 20 and the top cover 22 may be formed of a transparent material. Once there is sufficient blood sample at the puncture site, the lancing apparatus 10 can be removed from the site and the test instrument applied to the blood sample.

Various rib patterns are shown in fig. 2-11 and will be briefly described. The end cap, base cap and top cap in each of fig. 2-11 are the same as end cap 12, base cap 20 and top cap 22 in fig. 1. Therefore, these same reference numerals are used in FIGS. 2-11 to designate the end cap, base cap and top cap.

The rib pattern of fig. 2 includes two semicircular ribs 328 concentric with the central aperture 24. A gap or groove 330 is defined between adjacent ends of the semi-circular ribs 328.

The pattern shown in fig. 3 is three radial ribs 428 and three slits or grooves 430 defined between the ends of adjacent ribs 428. The rib 428 is concentric with the central bore 24. The rib pattern in fig. 4 is similar to that of fig. 3 but there are four radial ribs 528 concentric with the central aperture 24 and defining slots or grooves 530. Similarly, in fig. 5, a pattern of six radial ribs 628 and six slits or grooves 630 are shown, all concentric with the central bore 24.

The end cap 12 of fig. 6 differs from the end cap 12 of fig. 1-5 in that in fig. 6 is a pattern of six spherical ribs 728 and gaps or channels 730 defined between the spherical ribs 728.

The pattern in fig. 7 is similar to the pattern in fig. 1, except that the pattern in fig. 7 includes four radial ribs 828 and four slits or grooves 830.

FIG. 8 is an isolated isometric view of the endcap 12 of FIG. 1 detached from the lancing apparatus 10. The end cap 12 of fig. 9 is similar to the end cap of fig. 7 except that the four ribs 1028 in fig. 9 are S-shaped and define a gap or groove 1030 between adjacent ribs 1028. Similarly, the pattern of FIG. 10 includes six S-shaped ribs 1128 and six grooves 1130.

FIG. 11 shows another way of pattern of ribs. This pattern includes six T-shaped ribs 1128 and six grooves 1230.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that there is no intention to limit the invention to the specific embodiments disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Claims (10)

1. An end cap for a lancing device, the end cap comprising:

a main body;

a contact surface on said body, the contact surface having an inner portion and an outer portion;

an opening in a portion of the contact surface; and

a pattern of pressurized dots on the surface, wherein:

the pressure points include a pattern of ribs extending from a portion outside the contact face to a portion inside the contact face and grooves defined between adjacent ribs.

2. The end cap of claim 1, wherein: the body is formed of a transparent material.

3. The end cap of claim 1, wherein: the contact surface is concave.

4. The end cap of claim 1, wherein: the pressure points and the openings are concentric.

5. The end cap of claim 1, wherein: the pressure points extend radially from the opening.

6. An end cap for a lancing device, the end cap comprising:

a body comprising a face, an aperture in said face for passage of a needle, said face being concave, and a pattern of ribs on said face.

7. The end cap of claim 6, wherein: the rib pattern includes a plurality of ribs defining channels therebetween.

8. The end cap of claim 6, wherein: the body is formed of a transparent material.

9. The end cap of claim 6, wherein: the rib pattern includes a plurality of ribs concentric with the aperture.

10. The end cap of claim 6, wherein: the rib pattern includes a plurality of ribs extending radially from the aperture.