Percutaneous catheter assembly

• US 6,488,662 B2
• Filed: 12/19/2000
• Issued: 12/03/2002
• Est. Priority Date: 12/19/2000
• Status: Expired due to Term

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Sirimanne, Laksen
• Primary Examiner(s): Freay, Charles G.
• Assistant Examiner(s): Liu, Han L.
• Application Number:
  US09/741,695
• Publication Number:
  US 20020077600A1
• Time in Patent Office: 714 Days
• Field of Search: 604/164.1, 604/164.01, 604/164.04, 604/164.06, 604/164.09, 604/167.01, 604/167.02, 604/167.03, 604/167.04, 604/523, 604/533, 604/535, 604/198
• US Class Current: 604/164.01
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

The present invention is a percutaneous catheter assembly intended for long-term blood flow of several days, said assembly comprising generally three components: a catheter housing having three sections, each of preferably differing diameter, with a set of perforations in a distal section, an end cap for closing off a proximal end of the catheter housing during insertion, and a dilator having an outer diameter substantially the same size as the inner diameter of the smallest section of the catheter housing, the dilator being configured to pass radiopaque contrast through a first and second set of openings in the dilator and the perforations in the catheter housing. The present invention further comprises a method of percutaneous blood perfusion in which the catheter assembly is used without the need for an introducer sheath.

Claims

1. A percutaneous catheter assembly comprising:

a catheter housing having a distal end and a proximal end and a lumen therethrough, said distal end configured to penetrate a blood vessel wall and pass axially through the blood vessel without trauma to the patient, said proximal end configured to connect to a standard sized blood pump, said catheter housing having a transition section between the distal end and the proximal end, said catheter housing further comprising a catheter housing side wall having at least one perforation therein in fluid communication with said lumen to permit the passage of a contrast fluid through said perforation;

a dilator having a distal end and a proximal end, said dilator configured to pass axially through the lumen of said catheter housing, said dilator having at least one opening in a side wall thereof proximate the distal end of the dilator for permitting passage of the contrast fluid therethrough, said proximal end of said dilator configured to receive said contrast fluid from an external source, said dilator configured with sufficient stiffness to withstand axial forces on said dilator during insertion of the dilator into the lumen of said catheter housing and during insertion of both said dilator and said catheter housing into the patient'"'"'s vascular system; and

an end cap having a central bore therethrough, said end cap configured to seal the proximal end of said catheter housing from fluid flow when said dilator is inserted within the lumen of said catheter housing while said cap is inserted within said proximal end of said catheter housing;

wherein the dilator further comprises at least one additional opening in said dilator side wall, said side wall openings being axially positioned relative to each other such that one opening is positioned more distal than the other opening so that, when the dilator is inserted within said catheter housing, the more distal opening is positioned so that at least a part thereof projects distally beyond the distal end of the catheter housing and wherein the other opening is positioned so as to be generally radially aligned with the perforation of said catheter housing side wall.

2. A percutaneous catheter assembly comprising:

a catheter housing having a distal end and a proximal end and a lumen therethrough, said distal end configured to penetrate a blood vessel wall and pass axially through the blood vessel without trauma to the patient, said proximal end configured to connect to a standard sized blood pump, said catheter housing having a transition section between the distal end and the proximal end, said catheter housing further comprising a catheter housing side wall having at least one perforation therein in fluid communication with said lumen to permit the passage of a contrast fluid through said perforation;

a dilator having a distal end and a proximal end, said dilator configured to pass axially through the lumen of said catheter housing, said dilator having at least one opening in a side wall thereof proximate the distal end of the dilator for permitting passage of the contrast fluid therethrough, said proximal end of said dilator configured to receive said contrast fluid from an external source, said dilator configured with sufficient stiffness to withstand axial forces on said dilator during insertion of the dilator into the lumen of said catheter housing and during insertion of both said dilator and said catheter housing into the patient'"'"'s vascular system; and

an end cap having a central bore therethrough, said end cap configured to seal the proximal end of said catheter housing from fluid flow when said dilator is inserted within the lumen of said catheter housing while said cap is inserted within said proximal end of said catheter housing;

wherein the catheter housing has a mid-section, a distal section, and a proximal section, the mid-section having a diameter greater than the diameter of the distal section but less than the diameter of the proximal section.

3. The catheter assembly of claim 2 further comprising a disk comprising a synthetic material having a suturing feature, said disk positioned at and surrounding a part of the proximal section of said catheter housing, said disk serving to provide a substrate upon which a treating physician may secure said catheter housing to the patient to minimized relative movement therebetween.

4. A percutaneous catheter assembly comprising:

a catheter housing having a distal end and a proximal end and a lumen therethrough, said distal end configured to penetrate a blood vessel wall and pass axially through the blood vessel without trauma to the patient, said proximal end configured to connect to a standard sized blood pump, said catheter housing having a transition section between the distal end and the proximal end, said catheter housing further comprising a catheter housing side wall having at least one perforation therein in fluid communication with said lumen to permit the passage of a contrast fluid through said perforation;

a dilator having a distal end and a proximal end, said dilator configured to pass axially through the lumen of said catheter housing, said dilator having at least one opening in a side wall thereof proximate the distal end of the dilator for permitting passage of the contrast fluid therethrough, said proximal end of said dilator configured to receive said contrast fluid from an external source, said dilator configured with sufficient stiffness to withstand axial forces on said dilator during insertion of the dilator into the lumen of said catheter housing and during insertion of both said dilator and said catheter housing into the patient'"'"'s vascular system; and

an end cap having a central bore therethrough, said end cap configured to seal the proximal end of said catheter housing from fluid flow when said dilator is inserted within the lumen of said catheter housing while said cap is inserted within said proximal end of said catheter housing;

wherein the dilator further comprises a lumen and struts axially positioned within the lumen of said dilator for stiffening the dilator, the distal end of said dilator having being tapered.

5. The assembly of claim 4 wherein the struts connect to a hub centrally positioned longitudinally in said dilator to permit the passage of a guide wire through said hub. lumen of said dilator for stiffening the dilator, the distal end of said dilator having being tapered.

6. A percutaneous catheter assembly comprising:

a catheter housing having a distal end and a proximal end and a lumen therethrough, said distal end configured to penetrate a blood vessel wall and pass axially through the blood vessel without trauma to the patient, said proximal end configured to connect to a standard sized blood pump, said catheter housing having a transition section between the distal end and the proximal end, said catheter housing further comprising a catheter housing side wall having at least one perforation therein in fluid communication with said lumen to permit the passage of a contrast fluid through said perforation;

a dilator having a distal end and a proximal end, said dilator configured to pass axially through the lumen of said catheter housing, said dilator having at least one opening in a side wall thereof proximate the distal end of the dilator for permitting passage of the contrast fluid therethrough, said proximal end of said dilator configured to receive said contrast fluid from an external source, said dilator configured with sufficient stiffness to withstand axial forces on said dilator during insertion of the dilator into the lumen of said catheter housing and during insertion of both said dilator and said catheter housing into the patient'"'"'s vascular system; and

an end cap having a central bore therethrough, said end cap configured to seal the proximal end of said catheter housing from fluid flow when said dilator is inserted within the lumen of said catheter housing while said cap is inserted within said proximal end of said catheter housing;

wherein the catheter housing further comprises a distal section, a helical coil positioned within the wall of at least the distal section of said catheter housing for stiffening the catheter housing.

7. A percutaneous catheter assembly comprising:

a catheter housing having a distal end and a proximal end and a lumen therethrough, said distal end configured to penetrate a blood vessel wall and pass axially through the blood vessel without trauma to the patient, said proximal end configured to connect to a standard sized blood pump, said catheter housing having a transition section between the distal end and the proximal end, said catheter housing further comprising a catheter housing side wall having at least one perforation therein in fluid communication with said lumen to permit the passage of a contrast fluid through said perforation;

a dilator having a distal end and a proximal end, said dilator configured to pass axially through the lumen of said catheter housing, said dilator having at least one opening in a side wall thereof proximate the distal end of the dilator for permitting passage of the contrast fluid therethrough, said proximal end of said dilator configured to receive said contrast fluid from an external source, said dilator configured with sufficient stiffness to withstand axial forces on said dilator during insertion of the dilator into the lumen of said catheter housing and during insertion of both said dilator and said catheter housing into the patient'"'"'s vascular system;

an end cap having a central bore therethrough, said end cap configured to seal the proximal end of said catheter housing from fluid flow when said dilator is inserted within the lumen of said catheter housing while said cap is inserted within said proximal end of said catheter housing; and

a disk comprising a synthetic material having a suturing feature, said disk positioned at and surrounding a part of the proximal section of said catheter housing, said disk serving to provide a substrate upon which a treating physician may secure said catheter housing to the patient to minimized relative movement therebetween.

8. A percutaneous catheter assembly for permitting fluid communication with a patient'"'"'s blood vessel, the assembly comprising:

a catheter housing having a distal end for penetrating the blood vessel and a proximal end for connection to a separate device, said catheter housing comprising a helical coil;

a dilator having a tapered distal end and a proximal end, said dilator configured to pass axially through a lumen of said catheter housing, said proximal end of said dilator configured to receive said contrast fluid from an external source, said dilator having axial struts to provide stiffness;

an end cap configured to seal the proximal end of said catheter housing from fluid flow when said dilator is inserted within the lumen of said catheter housing;

a first set of openings in a side wall of the dilator; and

a first set of openings in a side wall of the catheter housing for permitting passage of a contrast fluid through the dilator and the catheter housing into the blood vessel.

9. The assembly of claim 8 wherein the dilator further comprises a second set of openings being distally positioned relative to said first set of dilator openings, said second set of openings being positioned so that at least a part of at least one of such openings in said first set projects distally beyond the distal end of the catheter housing when the dilator is fully inserted within said housing.

10. The assembly of claim 8 wherein the catheter housing further comprises a radiopaque marker.

11. The assembly of claim 8 wherein the helical coil is positioned within the wall of at least the distal section of said catheter housing for stiffening the catheter housing.

12. A method of percutaneous cannulation of a patient'"'"'s vascular system with a catheter assembly without the need for an introducer sheath or a separate guiding catheter, said method comprising the steps of:

penetrating a blood vessel site with a standard cannulation procedure;

inserting a guide wire into the blood vessel;

placing an end cap within a proximal section of a catheter housing;

placing a dilator through said end cap and within the catheter housing so that a distal tip of the dilator extends beyond a distal tip of the catheter housing, said dilator having means for controlling the flow of contrast therethrough, said catheter assembly comprising the catheter housing, the end cap and the dilator;

placing the catheter assembly over the guide wire and into the blood vessel; and

retracting the dilator from the catheter housing and removing the end cap, leaving the catheter housing in place for permitting blood flow therethrough.

13. The method of claim 12 further comprising the steps of:

prior to retraction of the dilator, injecting radiopaque contrast through the dilator and out through a distal end of the dilator to permit detection of the distal end as the catheter assembly is advanced through the patient'"'"'s vascular system; and

,

following retraction of the dilator and end cap, attaching a delivery line to a proximal end of the catheter housing for aspiration or infusion.

14. The method of claim 13 wherein the dilator comprises a first set of openings in the side wall thereof, proximate the distal end of the dilator.

15. The method of claim 14 wherein the dilator comprises a second set of openings in the side wall thereof, proximate the said first set of openings.

16. A method of percutaneous cannulation of a patient'"'"'s vascular system without the need for an introducer sheath or a separate guiding catheter, said method comprising the steps of:

placing an end cap within a proximal section of a catheter housing;

placing a dilator through the end cap and within the catheter housing so that a distal tip of the dilator extends beyond a distal tip of the catheter housing;

placing the catheter assembly over a guide wire within a blood vessel of the patient;

injecting radiopaque contrast through the dilator as the dilator and catheter housing are advanced through the patient'"'"'s blood vessel; and

retracting the dilator from the catheter housing, removing the cap from the catheter housing, and attaching a delivery line to a proximal end of the catheter housing for aspiration or infusion.

17. A method of percutaneous cannulation of a patient'"'"'s vascular system without the need for an introducer sheath or a separate guiding catheter, said method comprising the steps of:

placing an end cap within a proximal section of a catheter housing;

placing a dilator through the end cap and within the catheter housing so that a distal tip of the dilator extends beyond a distal tip of the catheter housing;

placing the catheter assembly over a guide wire within a blood vessel of patient; and

injecting radiopaque contrast through the dilator as the dilator and catheter housing are advanced through the patient'"'"'s blood vessel;

wherein the dilator comprises a first and second set of openings in the side wall thereof, said first set being positioned proximate the distal tip of said dilator, so that the contrast flows both through the first and second set of openings during the injecting step.