Delivery apparatus

• US 10,065,020 B2
• Filed: 07/03/2013
• Issued: 09/04/2018
• Est. Priority Date: 07/03/2012
• Status: Active Grant

• Current Assignee: University Hospitals of Leicester N H S Trust
• Original Assignee: University Hospitals of Leicester N H S Trust
• Inventors: Gaur, Atul
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Hoffman, Joanne
• Application Number:
  US14/410,407
• Publication Number:
  US 20150328434A1
• Time in Patent Office: 1,889 Days
• Field of Search: None
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 2005/3212 Blunting means for the sharp end of the needle
• CPC Class Codes: A61M 2025/0001 for pressure measurement
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0643 Devices having a blunt needle tip, e.g. due to an additional inner component
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

A delivery apparatus is provided for inserting catheters and/or cannulae into a patient'"'"'s blood vessel or body cavity either with or without the use of ultrasound imaging. The apparatus is used for the delivery of central venous catheters (CVCs) for creating a central line. The invention also relates to uses of the apparatus, and to methods for inserting catheters or cannulae (e.g. a CVC) into a patient.

Claims

1. A delivery apparatus for introducing a catheter or cannula into a subject'"'"'s vessel or body cavity, the apparatus comprising:

(i) a hub comprising a proximal end and a distal end,

(ii) a catheter or cannula attached to the distal end of the hub and comprising at least one channel extending therethrough and through which access to a subject'"'"'s vessel or body cavity is achieved,

(iii) a removable needle, comprising a distal end, extending through the catheter or cannula and the hub, the needle comprising a stellate concentric on the same axis of the needle, slideably disposed therein, and moveable between a first, retracted position in which its distal end does not extend beyond the distal end of the needle, and a second, extended position in which its distal end extends beyond the distal end of the needle;

(iv) biasing means, provided inside the hub, for biasing the stellate into the first, retracted position; and

(v) an actuator comprising a trigger which is disposed on the hub and arranged, in use, to be actuated by an operator to urge the stellate between the first and second positions, wherein the stellate is configured to move from the first, retracted position to the second, extended position when the trigger is depressed by the operator, and wherein the stellate does not move between the first, retracted position and the second, extended position automatically or when the trigger is released.

2. An apparatus according to claim 1, wherein the catheter is a central venous catheter (CVC).

3. An apparatus according to claim 1, wherein the apparatus is arranged, in use, to be introduced into the subject with real-time ultrasound guidance.

4. An apparatus according to claim 1, wherein the distal end of the stellate is substantially blunt-ended.

5. An apparatus according to claim 1, wherein the stellate comprises a channel extending therethrough.

6. An apparatus according to claim 5, wherein the channel is arranged in use to aspirate fluid from the subject.

7. An apparatus according to claim 5, wherein the channel is arranged in use to be connected to a pressure transducer in order to measure pressure inside the vessel near the needle tip during the insertion procedure.

8. An apparatus according to claim 1, wherein the biasing means comprises a spring.

9. An apparatus according to claim 1, wherein the needle extends through the center of the catheter or cannula, thereby forming a primary channel for direct access to a vessel or body cavity of the subject when the needle and stellate are subsequently removed.

10. An apparatus according to claim 9, wherein the primary channel is attached, in use, to a syringe or pressure transducer via a tube or both.

11. An apparatus according to claim 9, wherein the catheter or cannula comprises one or more additional channels extending therethrough, each of which allows direct access to the subject'"'"'s vessel or body cavity.

12. An apparatus according to claim 11, wherein the catheter or cannula comprises at least two channels extending therethrough.

13. An apparatus according to claim 11, wherein each of the channels comprises a one way valve to temporarily block or prevent spillage of fluid, or the aspiration of air.

14. An apparatus according to claim 1, further comprising:

(vi) an adapter comprising at least one channel extending therethrough, and arranged, in use, to be attached to the catheter or cannula following removal of the needle and stellate from the subject, such that the at least one channel in the adapter aligns with the at least one channel in the catheter or cannula to thereby create at least one continuous passageway through which access to the subject'"'"'s vessel or body cavity is achieved.

15. A method for obtaining a sample from a subject, or draining fluid from a subject, or administering medication or fluid to a subject, or monitoring a subject, or for carrying out a cardiovascular measurement on a subject, the method comprising use of the delivery apparatus according to claim 1.

16. A method for introducing a catheter or cannula into a vessel or body cavity of a subject, the method comprising:

attaching the delivery apparatus according to claim 1 to a subject, and introducing the catheter or cannula into the vessel or body cavity.

17. The method of claim 16, further comprising:

(i) causing the stellate of the apparatus of claim 1 to move to the first, retracted position;

(ii) advancing the distal end of the needle through skin;

(iii) confirming the placement of the needle tip using real-time ultrasound imaging;

(iv) causing the stellate to move to the second, extended position; and

(v) advancing the distal end of the needle further in the vessel or body cavity to thereby introduce the catheter or cannula in the vessel or body cavity.

18. The method of claim 17, further comprising after step (v):

(vi) advancing the catheter or cannula along the needle until the catheter or cannula has passed a distance beyond the distal end of the needle;

(vii) removing the needle and stellate; and

(viii) fastening the catheter or cannula to the patient.

19. An apparatus according to claim 14, wherein the adapter comprises a corresponding number of channels as is provided in the catheter or cannula, which, when aligned, each form a continuous passageway for providing direct access to the vessel or body cavity.