Apparatus and method for fetal scalp blood sampling

• US 6,423,011 B1
• Filed: 03/02/2000
• Issued: 07/23/2002
• Est. Priority Date: 03/02/2000
• Status: Expired due to Fees

• Current Assignee: Clinical Innovations LLC (Clinical Innovations)
• Original Assignee: Clinical Innovations Associates (Clinical Innovations)
• Inventors: Wallace, Wm. Dean, Arulkumaran, Sabaratnam
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/517,035
• Time in Patent Office: 873 Days
• Field of Search: 600/562, 600/564-567, 606/167, 606/170
• US Class Current: 600/576
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 method and apparatus for collecting blood from a fetal scalp. The apparatus includes an elongated housing containing a longitudinally spring-loaded, sharp-pointed, beveled blade disposed at the distal end thereof which can be advanced against the spring bias from the distal end against the fetal scalp. A groove located on an exterior side surface of the distal end of the housing is sized to receive a capillary tube which is resiliently retained on the housing with its distal end proximate a recessed region at the distal end of the housing. The groove may be oriented parallel to the housing, or at an angle thereto, to enhance visualization of blood pooling in the recessed region filling the capillary tube after an incision in the scalp is made using the blade. A light source may be included in or on the apparatus, or on the interior of an amnioscope with which the apparatus is employed. A method of using the apparatus is also disclosed.

Claims

1. A fetal blood collection apparatus, comprising:

an elongated housing having a proximal end, a distal end and a bore extending longitudinally therethrough;

a biasing mechanism configured to provide a proximal longitudinal bias to a member carried by the elongated housing;

a blade located at the distal end of the elongated housing within the bore thereof and extendable distally therefrom, the blade operably connected to the biasing mechanism through the member; and

a longitudinally extending groove in an exterior side surface of the elongated housing proximate a distal end thereof, the groove configured for receiving at least a portion of a capillary tube therein.

2. The apparatus of claim 1, further comprising a recessed region on the exterior side surface of the elongated housing proximate a distal end of the groove.

3. The apparatus of claim 2, wherein the groove is formed to a predetermined length so that a capillary tube of any length shorter than the length of the groove may be positioned in the groove with a distal end of the capillary tube disposed adjacent to the recessed region.

4. The apparatus of claim 2, further comprising a channel on the exterior side surface of the elongated housing disposed across, and oriented substantially transverse to, the groove at a location proximal of the recessed region.

5. The apparatus of claim 4, wherein said channel extends to a greater depth in the exterior side surface of the elongated housing than a depth of the groove.

6. The apparatus of claim 1, further comprising a capillary tube retention element located on the elongated housing within a longitudinal extent of the groove.

7. The apparatus of claim 6, wherein the capillary tube retention element comprises a resilient annular element.

8. The apparatus of claim 1, wherein said blade is configured with a cutting edge disposed in nonperpendicular relationship to the direction of the longitudinal bias.

9. The apparatus of claim 8, wherein the cutting edge comprises a beveled cutting edge.

10. The apparatus of claim 9, wherein the beveled cutting edge terminates distally at a sharp point.

11. The apparatus of claim 1, further comprising a stop element for limiting distal longitudinal exposure of the blade.

12. The apparatus of claim 1, wherein said biasing mechanism further comprises a spring and the member comprises a plunger including a head protruding proximally of the apparatus, and the apparatus further includes a releasable catch configured to cooperatively engage another element of the apparatus to maintain the plunger in a relatively distal position with the blade extending distally from the elongated housing against a bias of the spring.

13. The apparatus of claim 1, wherein the groove is oriented substantially parallel to a longitudinal axis of the distal end of the elongated housing.

14. The apparatus of claim 1, wherein the groove is oriented in nonparallel relationship to a longitudinal axis of the distal end of the elongated housing.

15. The apparatus of claim 1, further comprising a light source configured to illuminate an area proximate the distal end of the elongated housing.

16. The apparatus of claim 15, further including an electrical power source for the light source.

17. The apparatus of claim 15, wherein the light source is aimed toward the distal end of the elongated housing.

18. The apparatus of claim 15, wherein at least a portion of the elongated housing is formed of a material to provide a light guide from the light source to the distal end of the elongated housing.

19. The apparatus of claim 18, wherein an area of the exterior side surface of the elongated housing in a region underlying at least a portion of the groove is formed of the material.

20. The apparatus of claim 19, wherein substantially an entire distal portion of the elongated housing from the distal end thereof to a proximal end of the groove is formed of the material.

21. The apparatus of claim 15, wherein the light source is mountable to an amnioscope.

22. The apparatus of claim 1, wherein the blade is operably connected to the biasing mechanism member through at least one intermediate member extending into the bore of the elongated housing.

23. A method for collecting blood from a fetal scalp, comprising:

advancing an elongated element internally carrying a blade at a distal end thereof into a cervix to a location proximate a scalp surface of a fetus;

extending the blade against a spring bias from the distal end of the elongated element;

making an incision in the scalp surface to a limited depth with the extended blade;

retracting the blade within the elongated element using the spring bias;

collecting blood emanating from the incision on a region of an exterior surface of the elongated element;

drawing blood collected on the region of the exterior surface by capillary action into a distal end of a capillary tube secured to the exterior surface of the elongated element; and

withdrawing the elongated element from the cervix.

24. The method of claim 23, further comprising illuminating an area surrounding the distal end of the elongated element with a light source carried by the elongated element.

25. The method of claim 23, further comprising resiliently securing the capillary tube to the exterior surface of the elongated element prior to advancing the elongated element into the cervix.

26. The method of claim 23, further comprising securing the capillary tube to the exterior surface of the elongated element in nonparallel orientation to a longitudinal axis thereof prior to advancing the elongated element into the cervix.

27. The method of claim 23, further comprising securing the capillary tube at least partially within a groove on the exterior surface of the elongated element.

28. The method of claim 27, further comprising collecting the blood emanating from the incision in a recessed region on a distal end of the exterior surface proximate a distal end of the groove.

29. The method of claim 28, further comprising substantially constraining proximal movement of blood collected in the recessed region in the groove under the capillary tube during the drawing of the blood thereinto.

30. The method of claim 23, further comprising extending the blade from the distal end of the elongated element prior to making the incision and withdrawing the blade into the distal end of the elongated element prior to collecting the blood emanating from the incision.

31. The method of claim 23, further comprising initiating the incision by point contact of a sharp, distal tip of the blade and enlarging the incision laterally from the point contact.