Intravascular catheter assembly

Abstract

A peripheral intravascular catheter assembly comprising a tubular introducer needle and an adapter connected to the proximal end of the light guide. An introducer needle comprises a connection hub and a needle member. The needle member has a lumen, a distal end and a proximal end. The assembly may be further provided with a cannula tubing surrounding at least a portion of the needle member, with at least one light source and with an electronic module, configured to power the light source. The light guide has a distal end and a proximal end and extends along the lumen of the needle member. The adapter may be connected to the electronic module to the connection hub of the introducer needle so that light emitted by at least one light source is capable of entering the light guide, but blood flowing through the lumen of the needle member is prevented from contacting said light source.

1 . An intravascular assembly for catheterization ( 201 ) comprising:
 a. a needle member having a lumen, a distal end provided with a blood entry aperture, and a proximal end;   b. a light guide having a distal end and a proximal end and extending along at least a portion of the lumen of the needle member;   c. an adapter secured to the light guide, wherein the light guide is arranged to extend through the adapter; and   d. at least one light source,   wherein the adapter is provided with an interface for the at least one light source,   wherein the proximal end of the light guide is optically coupled to the at least one light source such that light emitted by the at least one light source enters the light guide and is emitted from the distal end of the needle member, and   wherein the light emitted from the distal end of the needle member has a total light intensity, and wherein at least 70% of the light emitted from the distal end of the needle member has a wavelength between 510 nm and 610 nm.   
     
     
         2 . is canceled. 
     
     
         3 . The assembly of  claim 1 , wherein the distal end of the light guide is arranged inside the lumen of the needle member, but spaced proximally apart from the blood entry aperture at the distal end of the needle member by a distance that is greater than 0.1 mm and smaller than 20 mm. 
     
     
         4 . The assembly of  claim 1 , further comprising a pushing mechanism that is configured to move the light guide, upon actuation of the pushing mechanism by a user, along the lumen of the needle member between a retracted position, in which the distal end of the light guide is positioned inside the distal end of the needle member, and a projecting position, in which the distal end of the light guide projects through the blood entry aperture of the needle member by a distance that is at least twice a minimal diameter of the lumen of the needle member. 
     
     
         5 . The assembly of  claim 1 , further comprising a cannula tubing surrounding at least a portion of the needle member. 
     
     
         6 . (canceled) 
     
     
         7 . The assembly of  claim 1 , wherein the at least one light source comprises at least two separate light sources that are configured to be operated independently. 
     
     
         8 - 10 . (canceled) 
     
     
         11 . The assembly of  claim 1 , further comprising at least one electronic module that is configured to power the at least one light source. 
     
     
         12 . The assembly of  claim 11 , wherein the at least one light source is arranged within the electronic module. 
     
     
         13 . The assembly of  claim 11 , wherein the adapter is provided with an interface for the electronic module. 
     
     
         14 . The assembly of  claim 11 , wherein the electronic module is fixed or mounted secured at the adapter. 
     
     
         15 . is canceled. 
     
     
         16 . The assembly of  claim 11 , wherein the adapter is connectable or connected to the electronic module so that the light emitted by the at least one light source is transmitted into the light guide. 
     
     
         17 . The assembly of  claim 11 , wherein the adapter comprises at least two adapter parts or that are connectable to each other, and wherein the first adapter part is connectable with the connection hub and the second adapter part is connectable with the electronic module. 
     
     
         18 - 22 . (canceled) 
     
     
         23 . The assembly of  claim 11 , wherein the adapter is configured as a two-unit member comprising an outer unit having a central aperture, and a central unit, which is positioned within the central aperture of the outer unit, wherein the central unit is configured to be movable within the aperture of the outer unit and is provided with a bore to receive the light guide, wherein the bore is sealed liquid-tightly against the light guide, wherein operation of the adapter is based on automatic movement of the central unit within the aperture of the outer unit upon mounting the introducer needle onto the electronic module or dismounting the introducer needle from the electronic module. 
     
     
         24 - 29 . (canceled) 
     
     
         30 . The assembly of  claim 1 , wherein the light guide is an optical fiber. 
     
     
         31 - 38 . (canceled) 
     
     
         39 . The assembly of  claim 14 , further comprising an ON/OFF switching mechanism, wherein the ON/OFF switching mechanism is configured to automatically activate the at least one light source upon mounting the electronic module with the adapter. 
     
     
         40 . The assembly of the  claim 39 , wherein the ON/OFF switching mechanism is configured to automatically deactivate the at least one light source upon dismounting the electronic module from the adapter. 
     
     
         41 - 44 . (canceled) 
     
     
         45 . The catheter assembly of  claim 1 , wherein at least 60% of light contributing to the total intensity emitted from the distal end of the introducer needle has a wavelength selected from one of the following ranges: between 510 nm and 572 nm, or 524 nm and 586 nm, or 546 nm and 608 nm. 
     
     
         46 - 48 . (canceled) 
     
     
         49 . A method for accessing a blood vessel of a subject, the method comprising:
 a. locating a blood vessel suitable to perform vascular access procedure;   b. activating at least one light source of the electronic module of an intravascular assembly, the intravascular assembly comprising:
 a needle member, wherein the needle member has a lumen, a distal end provided with a blood entry aperture, and a proximal end; 
 a light guide having a distal end and a proximal end and extending along at least a portion of the lumen of the needle member; 
 an adapter secured to the light guide, wherein the light guide is arranged to extend through the adapter; and 
 at least one light source, 
 wherein the adapter is provided with an interface for the at least one light source, 
 wherein the proximal end of the light guide is optically coupled to the at least one light source such that light emitted by the at least one light source enters the light guide and is emitted from the distal end of the needle member, and 
 wherein the light emitted from the distal end of the needle member has a total light intensity, and wherein at least 70% of the light emitted from the distal end of the needle member has a wavelength between 510 nm and 610 nm 
   c. puncturing the skin with the needle member;   d. localizing a blood vessel position intracutaneously by monitoring illumination at the distal end of the needle member;   e. detecting when the distal end of the needle member penetrates a wall of a blood vessel and enters a lumen of a blood vessel by observing a change in illumination at the distal end of the needle member; and   ensuring a correct position of the needle member inside the lumen of the blood vessel by monitoring illumination at the distal end of the needle member.   
     
     
         50 . The method of  claim 49 , wherein the observed change in illumination at the distal end of the needle member comprises at least one of: a disappearance of illumination; a fading of illumination; or a change in light color. 
     
     
         51 . The assembly of  claim 1 , wherein the light guide is fixed in a position in which the distal end of the light guide is spaced proximally from the blood entry aperture at the distal end of the needle member. 
     
     
         52 . The assembly of  claim 1 , wherein the light guide is fixed to the adapter. 
     
     
         53 . The assembly of  claim 1 , wherein the assembly comprises a butterfly needle, and wherein the butterfly needle comprises the needle member of the assembly.