Vascular access device and guiding portion

• US 9,937,296 B2
• Filed: 07/26/2013
• Issued: 04/10/2018
• Est. Priority Date: 07/26/2012
• Status: Active Grant

• Current Assignee: Agency For Science Technology and Research
• Original Assignee: Agency For Science Technology and Research
• Inventors: Peh, Ruey Feng, Chew, Jing Ming, Loke, Wei Ling Fiona, Tay, Hsien Ts'ung
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US14/417,314
• Publication Number:
  US 20150190587A1
• Time in Patent Office: 1,719 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/06114 Packages or dispensers for needles or sutures packages for sharps A61B50/3001; for dental floss A61C15/043; packages for needles in general B65D85/24
• CPC Class Codes: A61B 17/132 Tourniquets sphygmomanometer A61B5/022
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/3962 palpable
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/80 Implements for cleaning or washing the skin of surgeons or patients
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• 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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3273 freely sliding on needle shaft without connection to syringe or needle
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/329 : characterised by features of the needle shaft
• CPC Class Codes: F04C 2270/0421 : Controlled or regulated

Abstract

According to various embodiments, a method and system to obtain access to a blood vessel underneath a skin layer that may preserve lifespan of the blood vessel and reduce executional skill variability may be provided. The method includes placing a guiding portion between the blood vessel and the skin layer; and configuring the guiding portion to receive and guide a needle to reach the same location of the blood vessel repeatedly and consistently; and forming a resultant scarred track between the blood vessel and the skin layer as the guiding portion is resorbed over time. The system includes a vascular access device configurable to first possess strength to penetrate through a tissue layer, subsequently possess flexibility to conform to the surrounding tissue beneath the tissue layer; and a guiding portion which may be resorbable, wherein the inlet includes a larger diameter compared to the outlet.

Claims

1. A method of obtaining access to a blood vessel underneath a skin layer, the method comprising:

providing a guiding portion and placing said guiding portion beneath the skin layer and above the blood vessel to receive and guide a needle to reach the blood vessel, the guiding portion comprising a channel portion comprising an inlet and an outlet;

accessing the blood vessel with a vascular access device comprising;

a needle having a tip portion; and

a rigid sheath axially translatable with respect to the tip portion arranged around and at least substantially along a longitudinal axis of the needle;

wherein the tip portion penetrates a tissue layer overlying the guiding portion, and the rigid sheath provides strength for said penetration as the tip portion extends out from the rigid sheath;

wherein the needle is received by the channel portion inlet, and conforms to the channel portion as the distance between the tip portion and the rigid sheath increases; and

wherein the outlet comprises a constriction which causes the needle to regain push force to penetrate the blood vessel.

2. The method according to claim 1,

wherein the vascular access device comprises an actuating portion coupled to a portion of the needle.

3. The method according to claim 2,

wherein the rigid sheath is slidable relative to the tip portion.

4. The method according to claim 2,

wherein the needle extends out from the rigid sheath as the rigid sheath retracts into the actuating portion.

5. The method according to claim 1,

wherein the rigid sheath comprises a sealing portion arranged adjacent to the tip portion so as to seal the needle within the rigid sheath.

6. The method according to claim 1,

wherein the needle further comprises a flexible portion, the flexible portion coupled to the tip portion.

7. The method according to claim 6,

wherein the flexible portion comprises a same material or a different material from the tip portion.

8. The method according to claim 1,

wherein the needle comprises a single material or a combination of materials with varying flexibility.

9. The method according to claim 1,

wherein the channel portion is biodegradable.

10. The method according to claim 1,

wherein the channel portion comprises a porous sidewall with a plurality of holes.

11. The method according to claim 1,

wherein the channel portion comprises at least one helical screw.

12. The method according to claim 1,

wherein the channel portion comprises a frusto-conical portion.

13. The method according to claim 1,

wherein the channel portion further comprises a tubular portion.

14. The method according to claim 1,

wherein the guiding portion further comprises an unidirectional valve positioned adjacent to the outlet of the channel portion.

15. The method according to claim 1,

wherein the guiding portion further comprises an anchor portion positioned adjacent to the outlet of the channel portion and to noninvasively anchor the channel portion over the blood vessel.

16. The method according to claim 15,

wherein the anchor portion comprises a dog-bone shaped portion.

17. The method according to claim 1,

wherein the channel portion is configured to be filled with an anti-bacteria or anti-microbial gel.

18. The method according to claim 1,

wherein the channel portion is positioned at an angle relative to a plane of the skin layer.

19. The method according to claim 1,

wherein the guiding portion is resorbed over time, thereby forming a scarred tissue track configured to serve as a guide for subsequent access of the vascular access device.

20. The method according to claim 1,

wherein the needle is configured to conform to an orientation of the blood vessel after penetration of the blood vessel.