Placement aid for placing a catheter for diabetics

• US 10,426,924 B2
• Filed: 05/31/2016
• Issued: 10/01/2019
• Est. Priority Date: 11/28/2013
• Status: Active Grant

• Current Assignee: Medizinische Universitat Graz
• Original Assignee: Medizinische Universitat Graz
• Inventors: Fritz, Martin, Wuster, Christian, Regittnig, Werner
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US15/168,935
• Publication Number:
  US 20160345876A1
• Time in Patent Office: 1,218 Days
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/150503 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 5/150656 semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• 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 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2205/0272 Electro-active or magneto-active materials
• CPC Class Codes: A61M 2205/0283 Electro-active polymers [EAP]
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A placement aid for placing a catheter and a sensor wire into a body including a replacement device arranged in an interchangeable and replaceable manner having a main body, a placement needle, a catheter and a sensor wire. The placement needle is arranged within the catheter so that a tip of the placement needle protrudes from an end of the catheter along a puncturing direction and penetrates the skin when the catheter is inserted along the puncturing direction to generate a skin opening through which the catheter can be guided up to a subcutaneous final position. The sensor wire is arranged in the placement needle when the catheter is inserted along the puncturing direction and when the subcutaneous final position of the catheter is reached, the placement needle can be withdrawn from the catheter against the puncturing direction and the sensor wire remains in the catheter.

Claims

1. A placement aid for placing a catheter and a sensor wire into a body comprising:

a placement device;

a replacement device with a main body, a placement needle, a catheter and a sensor wire;

wherein the replacement device is arranged in the placement device in an interchangeable and replaceable manner,

wherein the placement needle is coupled to the main body,

wherein the placement needle and the catheter are arranged with regard to each other in such a way that the placement needle is arranged within the catheter, and that a tip of the placement needle protrudes from a proximal end of the catheter along a puncturing direction so that upon placement of the catheter along the puncturing direction, the tip of the placement needle penetrates a skin in order to produce a skin opening through which the catheter can be guided up to a subcutaneous end position, and

wherein the sensor wire is coupled to the placement needle in such a way that upon placement of the catheter along the puncturing direction, the sensor wire is arranged in the placement needle and that, upon reaching the subcutaneous end position of the catheter, the placement needle can be removed from the catheter against the puncturing direction and the sensor wire remains in the catheter; and

a holding-down rod which is arranged in the placement needle in a displaceable manner,

wherein the holding-down rod is designed to frictionally press the sensor wire against the placement needle, and

wherein the holding-down rod is further arranged at the main body in a movable manner along the puncturing direction such that, upon placement of the catheter along the puncturing direction, the placement needle, the sensor wire and the holding-down rod can jointly be advanced up to the subcutaneous end position of the catheter and such that, upon reaching the subcutaneous end position of the catheter, the holding-down rod can be withdrawn from the catheter against the puncturing direction.

2. The placement aid according to claim 1,

wherein the replacement device further comprises a piston and a needle holder, to which the placement needle is attached,

wherein the piston is arranged in the main body in a displaceable manner,

wherein the needle holder with the placement needle is arranged at the main body so as to be displaceable along the puncturing direction,

wherein the needle holder is coupled to the catheter in such a way that, upon placement of the catheter, the needle holder advances the catheter along the puncturing direction, and

wherein the piston is coupled to the needle holder in such a way that the needle holder can be advanced along the puncturing direction by means of the piston.

3. The placement aid according to claim 2, further comprising a first spring which is arranged between the main body and the needle holder in such a way that a first spring force of the first spring acts along the puncturing direction in order to advance the needle holder along the puncturing direction relative to the main body upon the placement of the catheter.

4. The placement aid according to claim 2, wherein the piston is designed to be introduced into and retracted from the main body in a telescopic manner.

5. The placement aid according to claim 2, wherein the piston is detachably coupled to the needle holder in such a way that, upon reaching the subcutaneous end position of the catheter, the needle holder can be decoupled from the piston and the needle holder can be moved relative to the piston against the puncturing direction.

6. The placement aid according to claim 2, further comprising a spring which is arranged between the placement device and the replacement device in such a way that a spring force of the spring acts along the puncturing direction in order to advance the needle holder along the puncturing direction upon placement of the catheter.

7. The placement aid according to claim 6, wherein the spring is set up in such a way that, when the needle holder is moved against the puncturing direction, the spring can be pre-tensioned.

8. The placement aid according to claim 6,

wherein the placement device comprises a locking element and a trigger element,

wherein the locking element locks the needle holder in an initial position, in which the spring is pre-tensioned, and

wherein the trigger element is coupled to the locking element in such a way that, when operating the trigger element, the locking element releases the needle holder and the needle holder can be advanced along the puncturing direction by means of the spring force.

9. The placement aid according to claim 8, further comprising an additional spring which is arranged between the placement device and the replacement device in such a way that a spring force of the additional spring acts against the puncturing direction in order to displace the trigger element and the locking element back into their respective initial position.

10. The placement aid according to claim 6,

wherein the piston is arranged in the placement device in a displaceable manner, and

wherein the piston is coupled to the spring and to the needle holder in such a way that the piston and the needle holder can be advanced along the puncturing direction by means of the spring force.

11. The placement aid according to claim 2, further comprising a return spring which is arranged between the placement device and the needle holder in such a way that return force of the return spring acts against the puncturing direction in order to advance the needle holder against the puncturing direction after placement of the catheter.

12. The placement aid according to claim 11, wherein the return spring is set up in such a way that when the needle holder moves along the puncturing direction, the return spring can be pre-tensioned.

13. The placement aid according to claim 1,

wherein a clamping element is arranged in a fastening section of the catheter, and

wherein the clamping element forms a force-fitting connection with the placement needle.

14. The placement aid according to claim 1, wherein the holding-down rod is further arranged at the main body in such a way that upon reaching the subcutaneous end position of the catheter, the holding-down rod can be withdrawn from the catheter after the placement needle has at least partially been pulled out of the catheter.

15. The placement aid according to claim 14,

wherein the holding-down rod comprises a plunger which is attached to the piston by mean of a force-fitting connection, and

wherein the plunger is further arranged in the piston in such a way that, at a predetermined position in the piston, the needle holder presses against the plunger against the puncturing direction in such a way that the force-fitting connection between the piston and the plunger can be overcome and the plunger with the holding-down rod can be moved by means of the needle holder against the puncturing direction relative to the piston.

16. The placement aid according to claim 1, further comprising a support element which can be attached to the skin,

wherein at least one of the main body and the placement device can be attached to the support element in a replaceable manner in such a way that the main body can be affixed with a predetermined puncture angle between the placement needle and the skin.

17. The placement aid according to claim 16, wherein the support element comprises a fastening element which is designed to fasten the catheter to the support element when the catheter is in the subcutaneous end position.

18. The placement aid according to claim 16, further comprising at least one of a sensor read-out unit, which can be attached in a replaceable manner to the support element in such a way that the sensor read-out unit is coupled to the sensor wire;

and

a pump unit for injecting a medication, wherein the pump unit can be attached at the support element in a replaceable manner in such a way that the pump unit is coupled to the catheter.

19. A method of placing a catheter in to a body with a placement aid according to claim 1, wherein the method comprises:

arranging the replacement device in the placement device;

applying the placement aid on a skin of the body;

placing the catheter by means of the placement aid; and

removing and replacing the replacement device from the placement device.