CATHETER

• US 20190321594A1
• Filed: 04/24/2019
• Published: 10/24/2019
• Est. Priority Date: 04/24/2018
• Status: Active Grant

• Current Assignee: Traceless Biopsy LLC
• Original Assignee: Traceless Biopsy LLC
• Inventors: GILLILAND, Charles, HEARD, Baylee Brooke, STRINGER, Ann Marie, HERNANDEZ, Asia Pauline, JOHNSTON, Elizabeth Kaleigh
• Granted Patent: US 11,938,280 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2039/0282 with implanted tubes connected to the port
• CPC Class Codes: A61M 2039/1083 having a plurality of female connectors, e.g. Luer connectors
• 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 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014

Abstract

A drainage catheter system comprising a catheter having an elongate body \configured for insertion into an organ or cavity of a patient and a hub configured for coupling with a longitudinal shearing device and the first end of the catheter and movable over the elongate body of the catheter. A locking stay suture extends through the elongate body of the catheter. The length of the elongate body of the catheter can be adjusted by sliding the hub coupled to the longitudinal shearing device along the longitudinal axis of the catheter, and then creating a longitudinal cut in the catheter through which the proximal end of the locking stay suture can be removed and secured, thereby enabling the excess catheter tubing to be removed by cutting and allowing the base to rest flush against the patient'"'"'s body.

Claims

1. A drainage catheter system comprising:

(a) a catheter having an elongate body extending a length along a longitudinal axis from a first end to a second end, the second end configured for insertion into an organ or cavity of a patient; and

(b) a hub configured for coupling with the first end of the catheter and movable over the elongate body of the catheter.

2. The catheter of claim 1, wherein the second end of the catheter comprises an end hole and a plurality of distal side holes.

3. The catheter of claim 2, wherein the end hole and plurality of distal side holes support a drainage flow rate of at least 2.1 mL/s.

4. The catheter of claim 2, wherein the catheter encloses a locking stay suture extending from a first end affixed at the end hole at the second end of the catheter, through one of the plurality of distal side holes, through the length of the elongate body to a second end extending through the first end of the catheter, and wherein the locking stay suture lacks a protective tube.

5. The catheter system of claim 4, further comprising a longitudinal shearing device configured to attach to the hub, wherein the longitudinal shearing device produces a cut along the longitudinal axis of the elongate body of the catheter when the hub has been moved down the longitudinal axis of the elongate body, and wherein the cut does not sever the locking stay suture.

6. The catheter system of claim 5, wherein the longitudinal shearing device is adapted to be removed from the hub after use.

7. The catheter system of claim 6, wherein the second end of the locking stay suture can be pulled through the cut in the longitudinal axis of the elongate body of the catheter and tightened by pulling and wherein tightening the locking stay suture pulls the end hole of the catheter into proximity with the distal side hole through which the locking stay suture extends, producing a curled structure in the organ or cavity.

8. The catheter system of claim 7, wherein the curled structure is configured to resist unwanted removal of the catheter from the organ or cavity.

9. The catheter system of claim 1, wherein the elongate body of the catheter is made from a flexible material.

10. The catheter system of claim 9, wherein the flexible material of the elongate body is placed by being guided over a sharp needle stylet that has been previously inserted into the organ or cavity.

11. The catheter system of claim 1, further comprising a metal stiffening cannula affixed to and extending partially into the first end of the catheter, wherein the metal stiffening cannula is configured to assist in catheter insertion and wherein the metal stiffening cannula can be removed following catheter insertion in the organ or cavity, leaving the catheter in place.

12. The catheter system of claim 1, wherein the hub further comprises a silicone ring configured to rest against an external body surface of the patient, and wherein the silicone ring fully surrounds a portion of the elongate body of the catheter, and optionally wherein the hub is further secured to the catheter by tightening a zip tie around the silicone ring.

13. The catheter system of claim 1, wherein the hub further comprises a luer lock adapter.

14. The catheter system of claim 7, wherein the hub further comprises a hinged locking arm configured to flip down over the locking stay suture following tightening and wherein flipping the hinged locking arm prevents the locking stay suture from loosening.

15. A method for inserting a catheter having an elongate body composed of a flexible material and having a proximal first end and a distal second end and surrounding a locking stay suture having a proximal end and a distal end in a patient, the method comprising the steps of:

(a) insertion of distal second end the elongate body over a previously-placed sharp needle stylet into the patient, optionally with the assistance of a metal stiffening cannula;

(b) removal of the sharp needle stylet and optional metal stiffening cannula from the patient; and

(c) placement of a hub and attached longitudinal shearing device over the proximal first end of the catheter.

16. The method of claim 15, further comprising the following steps:

(d) the hub and longitudinal shearing device are slid along the elongate body of the catheter to create a longitudinal cut extending from the proximal first end of the catheter a distance along the elongate body, wherein the hub reaches a final position against a body surface in the patient; and

(e) the longitudinal shearing device is removed from the hub.

17. The method of claim 16, wherein the proximal end of the locking stay suture is pulled through the longitudinal cut in the catheter, tightened by pulling to lock the catheter in place, and secured to prevent accidental catheter removal.

18. The method of claim 17, wherein the portion of the elongate body of the catheter comprising the first end of the catheter and extending proximally from the hub is cut to adjust the length of the catheter so that no portion of the catheter extends outside the body surface from the hub and wherein the curled structure can withstand greater than 2 pounds of pulling force on the elongate body of the catheter.

19. The method of claim 18, wherein a soft silicone cover is placed over the hub following removal of the shearing device.

20. A catheter assembly kit comprising a catheter comprising:

(a) a catheter having an elongate body and surrounding a locking stay suture;

(b) a hub comprising a silicone ring configured to surround the elongate body of the catheter, the hub comprising a means to secure the locking stay suture once the catheter has been placed in an organ or cavity of a patient and further comprising a luer lock connector; and

(c) a longitudinal shearing device configured to attach to the hub.