Disposable needle assembly having sensors formed therein permitting the simultaneous drawing and administering of fluids and method of forming the same

• US 6,758,835 B2
• Filed: 05/01/2002
• Issued: 07/06/2004
• Est. Priority Date: 05/01/2002
• Status: Active Grant

• Current Assignee: MedTG LLC
• Original Assignee: MedTG LLC
• Inventors: Close, Benjamin W., Hall, Thomas A. III
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US10/137,186
• Publication Number:
  US 20030208154A1
• Time in Patent Office: 797 Days
• Field of Search: 604/93.01, 604/264, 604/272, 600/310, 600/322, 600/323, 600/324, 600/325, 600/326, 600/327, 600/328, 600/342, 600/372, 600/373, 600/381, 600/581, 600/583
• US Class Current: 604/272
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2202/0413 Blood
• CPC Class Codes: A61M 2230/00 Measuring parameters of the user
• CPC Class Codes: A61M 5/1582 Double lumen needles

Abstract

A micro-injection molded disposable needle assembly having more than one passageway formed therein to permit the simultaneous drawing and administering of fluids through separate passageways is disclosed. The micro-injection molded disposable assembly includes one or more sensors disposed therein for measuring and monitoring one or more desired body or surrounding environmental conditions. A method of forming the disposable needle from an elastomeric material using micro-injection molding is also disclosed.

Claims

1. A needle assembly for use in connection with treating a patient for administering fluids to the patient and drawing fluids from the patient, comprising:

an elongated needle shaft having a first end and a second end;

an insertion tip located at a first end of the elongated needle shaft to facilitate insertion of the needle assembly into a vessel of the patient;

at least one fluid drawing passageway formed in the elongated needle shaft for withdrawing fluid from the patient, wherein the at least one fluid drawing passageway extends from the second end of the elongated needle shaft to a fluid drawing opening in the elongated needle shaft, wherein fluid within the vessel is withdrawn through the at least one fluid drawing passageway;

at least one fluid supply passageway formed in the elongated needle shaft for supplying fluid to the patient, wherein the at least one fluid supply passageway extends from the second end of the elongated needle shaft to a fluid supply opening in the elongated needle shaft; and

at least one sensor assembly disposed within the elongated needle shaft, wherein the at least one sensor assembly senses at least one predetermined condition of the patient, wherein the at least one sensor assembly includes at least a first sensor operatively connected to the at least one fluid drawing passageway for performing a sensing operation on the fluid within the at least one fluid drawing passageway, wherein the at least a first sensor is located within the at least one fluid drawing passageway, and at least a second sensor for performing a sensing operation on the fluid within the vessel, wherein the at least a second sensor is located at least one of within the at least one fluid supply passageway or on the elongated needle shaft.

2. The needle assembly according to claim 1, wherein one of the fluid supply opening and the fluid drawing opening is located adjacent the insertion tip, wherein the other of the fluid supply opening and the fluid drawing opening is spaced from the insertion tip.

3. The needle assembly according to claim 1, wherein the elongated needle shaft is formed from an elastomeric material, wherein the elastomeric material has a durometer greater than the durometer of flesh.

4. The needle assembly according to claim 1, wherein each of the first sensor and the second sensor is one of a pressure sensor, an optical sensor, a temperature sensor, an acoustic sensor, an electrical sensor and a chemical sensor.

5. A needle assembly for use in connection with treating a patient for administering fluids to the patient and drawing fluids from the patient, comprising:

an elongated needle shaft having a first end and a second end;

an insertion tip located at a first end of the elongated needle shaft to facilitate insertion of the needle assembly into a vessel of the patient;

at least one fluid drawing passageway formed in the elongated needle shaft for withdrawing fluid from the patient, wherein the at least one fluid drawing passageway extends from the second end of the elongated needle shaft to a fluid drawing opening in the elongated needle shaft, wherein fluid within the vessel is withdrawn through the at least one fluid drawing passageway;

at least one fluid supply passageway formed in the elongated needle shaft for supplying fluid to the patient, wherein the at least one fluid supply passageway extends from the second end of the elongated needle shaft to a fluid supply opening in the elongated needle shaft;

at least one sensor assembly disposed within the elongated needle shaft, wherein the at least one sensor assembly senses at least one predetermined condition of the patient; and

a connector assembly connected to the second end of the elongated needle shaft, wherein the connector assembly includes at least one inlet port operatively connected to the at least one fluid supply passageway and at least one outlet port operatively connected to the at least one fluid drawing passageway.

6. The needle assembly according to claim 5, further comprising:

an attachment assembly for releasably securing the needle assembly to the patient, wherein the connector assembly is connected to the attachment assembly.

7. The needle assembly according to claim 5, wherein the at least one sensor assembly disposed within the elongated needle shaft comprises:

at least one sensor passageway formed in the elongated needle shaft; and

at least one sensor located within the sensor passageway.

8. The needle assembly according to claim 7, wherein the at least one sensor is operatively connected to the at least one fluid drawing passageway for performing a sensing operation on the fluid within the at least one fluid drawing passageway.

9. The needle assembly according to claim 8, wherein the at least one sensor is one of a pressure sensor, an optical sensor, a temperature sensor, an acoustic sensor, an electrical sensor and a chemical sensor.

10. The needle assembly according to claim 7, wherein the at least one sensor assembly performs a sensing operation on the fluid within the vessel.

11. The needle assembly according to claim 10, wherein the at least one sensor is one of a pressure sensor, an optical sensor, a temperature sensor, an acoustic sensor, an electrical sensor and a chemical sensor.

12. The needle assembly according to claim 7, wherein the at least one sensor assembly performs a sensing operation on the patient.

13. The needle assembly according to claim 12, wherein the at least one sensor is one of a pressure sensor, an optical sensor, a temperature sensor, an acoustic sensor, an electrical sensor and a chemical sensor.

14. The needle assembly according to claim 7, wherein the elongated shaft includes at least one recess formed therein, wherein at least a portion of the sensor disposed within the sensor passageway is exposed within the at least one recess formed therein.

15. A needle assembly for use in connection with treating a patient for administering fluids to the patient and drawing fluids from the patient, comprising:

an elongated needle shaft having a first end and a second end;

an insertion tip located at a first end of the elongated needle shaft to facilitate insertion of the needle assembly into a vessel of the patient;

at least one fluid drawing passageway formed in the elongated needle shaft for withdrawing fluid from the patient, wherein the at least one fluid drawing passageway extends from the second end of the elongated needle shaft to a fluid drawing opening in the elongated needle shaft, wherein fluid within the vessel is withdrawn through the at least one fluid drawing passageway;

at least one fluid supply passageway formed in the elongated needle shaft for supplying fluid to the patient, wherein the at least one fluid supply passageway extends from the second end of the elongated needle shaft to a fluid supply opening in the elongated needle shaft;

at least one sensor assembly disposed within the elongated needle shaft, wherein the at least one sensor assembly senses at least one predetermined condition of the patient; and

a molded core member removably located within one of the at least one fluid supply passageway and the at least one of the fluid drawing passageway, wherein the molded core member is located within the one passageway during a needle insertion operation.

18. The needle assembly according to claim 15, wherein each of the first sensor and the second sensor is one of a pressure sensor, an optical sensor, a temperature sensor, an acoustic sensor, an electrical sensor and a chemical sensor.

16. A disposable needle assembly for use in connection with treating a patient, wherein the disposable needle assembly is capable of simultaneously administering fluids to the patient and drawing fluids from the patient, comprising:

an elongated needle shaft having a first end and a second end;

an insertion tip formed in a first end of the elongated needle shaft to facilitate insertion of the needle assembly into a vessel of the patient;

a fluid drawing passageway formed in the elongated needle shaft for withdrawing

a first fluid from the patient, wherein the fluid drawing passageway extends from the second end of the elongated needle shaft to a fluid drawing opening in the elongated needle shaft, wherein first fluid within the vessel is withdrawn through the fluid drawing passageway;

a fluid supply passageway formed in the elongated needle shaft for supplying a second fluid to the patient, wherein the fluid supply passageway extends from the second end of the elongated needle shaft to a fluid supply opening in the elongated needle shaft, wherein the fluid drawing opening is spaced from the fluid supply opening to prevent mixing of the first fluid and the second fluid adjacent the fluid drawing opening; and

at least one sensor assembly formed within the elongated needle shaft, wherein the at least one sensor assembly senses at least one predetermined condition of the patient, wherein the at least one sensor assembly includes at least a first sensor operatively connected to the at least one fluid drawing passageway for performing a sensing operation on the fluid within the at least one fluid drawing passageway, wherein the at least a first sensor being located within the at least one fluid drawing passageway, and at least a second sensor for performing a sensing operation on the fluid within the vessel, wherein the at least a second sensor is located in at least one of within the at least one fluid supply passageway or on the elongated needle shaft.

17. The needle assembly according to claim 16, wherein the elongated needle shaft is formed from an elastomeric material, wherein the elastomeric material has a durometer greater than the durometer of flesh.

19. A disposable needle assembly for use in connection with treating a patient, wherein the disposable needle assembly is capable of simultaneously administering fluids to the patient and drawing fluids from the patient, comprising:

an elongated needle shaft having a first end and a second end;

an insertion tip formed in a first end of the elongated needle shaft to facilitate insertion of the needle assembly into a vessel of the patient;

a fluid drawing passageway formed in the elongated needle shaft for withdrawing a first fluid from the patient, wherein the fluid drawing passageway extends from the second end of the elongated needle shaft to a fluid drawing opening in the elongated needle shaft, wherein first fluid within the vessel is withdrawn through the fluid drawing passageway;

a fluid supply passageway formed in the elongated needle shaft for supplying a second fluid to the patient, wherein the fluid supply passageway extends from the second end of the elongated needle shaft to a fluid supply opening in the elongated needle shaft, wherein the fluid drawing opening is spaced from the fluid supply opening to prevent mixing of the first fluid and the second fluid adjacent the fluid drawing opening;

at least one sensor assembly formed within the elongated needle shaft, wherein the at least one sensor assembly senses at least one predetermined condition of the patient; and

a connector assembly connected to the second end of the elongated needle shaft, wherein the connector assembly includes at least one inlet port operatively connected to the at least one fluid supply passageway and at least one outlet port operatively connected to the at least one fluid drawing passageway; and

an attachment assembly for releasably securing the needle assembly to the patient, wherein the connector assembly is connected to the attachment assembly.

20. A disposable needle assembly for use in connection with treating a patient, wherein the disposable needle assembly is capable of simultaneously administering fluids to the patient and drawing fluids from the patient, comprising:

an elongated needle shaft having a first end and a second end;

an insertion tip formed in a first end of the elongated needle shaft to facilitate insertion of the needle assembly into a vessel of the patient;

a fluid drawing passageway formed in the elongated needle shaft for withdrawing a first fluid from the patient, wherein the fluid drawing passageway extends from the second end of the elongated needle shaft to a fluid drawing opening in the elongated needle shaft, wherein first fluid within the vessel is withdrawn through the fluid drawing passageway;

a fluid supply passageway formed in the elongated needle shaft for supplying a second fluid to the patient, wherein the fluid supply passageway extends from the second end of the elongated needle shaft to a fluid supply opening in the elongated needle shaft, wherein the fluid drawing opening is spaced from the fluid supply opening to prevent mixing of the first fluid and the second fluid adjacent the fluid drawing opening;

at least one sensor assembly formed within the elongated needle shaft, wherein the at least one sensor assembly senses at least one predetermined condition of the patient; and

a pair of sensor passageways formed in the elongated needle shaft, wherein the pair of sensor passageways are formed on opposite sides of at least one of the fluid drawing passageway and the fluid supply passageway; and

at least one a sensor located in each sensor passageway.

21. The disposable needle assembly according to claim 20, wherein the sensor is one of an optical sensor, a temperature sensor, an electrical sensor and a chemical sensor.

22. The needle assembly according to claim 20, wherein the elongated shaft includes at least one recess formed therein, wherein at least a portion of the sensor disposed within the sensor passageway is exposed within the at least one recess formed therein.

23. A disposable needle assembly for use in connection with treating a patient, wherein the disposable needle assembly is capable of simultaneously administering fluids to the patient and drawing fluids from the patient, comprising:

an elongated needle shaft having a first end and a second end;

an insertion tip formed in a first end of the elongated needle shaft to facilitate insertion of the needle assembly into a vessel of the patient;

a fluid drawing passageway formed in the elongated needle shaft for withdrawing a first fluid from the patient, wherein the fluid drawing passageway extends from the second end of the elongated needle shaft to a fluid drawing opening in the elongated needle shaft, wherein first fluid within the vessel is withdrawn through the fluid drawing passageway;

a fluid supply passageway formed in the elongated needle shaft for supplying a second fluid to the patient, wherein the fluid supply passageway extends from the second end of the elongated needle shaft to a fluid supply opening in the elongated needle shaft, wherein the fluid drawing opening is spaced from the fluid supply opening to prevent mixing of the first fluid and the second fluid adjacent the fluid drawing opening;

at least one sensor assembly formed within the elongated needle shaft, wherein the at least one sensor assembly senses at least one predetermined condition of the patient; and

a molded core member removably located within one of the at least one fluid supply passageway and the at least one of the fluid draw, wherein the molded core member is located within the one passageway during a needle insertion operation.