Percutaneous catheter assembly

• US 6,905,481 B2
• Filed: 12/02/2002
• Issued: 06/14/2005
• 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): Tyler, Cheryl
• Assistant Examiner(s): Sayoc, Emmanuel
• Application Number:
  US10/308,235
• Publication Number:
  US 20030144628A1
• Time in Patent Office: 925 Days
• Field of Search: 604/523, 604/533, 604/534, 604/535, 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, 604/174, 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 at least one perforation in a wall thereof 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; and

a sleeve comprising a synthetic material having a generally textile characteristic, said sleeve positioned at and surrounding a part of the proximal section of said catheter housing, said sleeve serving to provide a substrate upon which a treating physician may secure said catheter housing to the patient to minimize relative movement therebetween, wherein the catheter housing has a mid-section having a diameter greater than the diameter of the distal section but less than the diameter of the proximal section.

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 at least one perforation in a wall thereof 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 sleeve comprising a synthetic material having a generally textile characteristic, said sleeve positioned at and surrounding a part of said proximal end of said catheter housing, said sleeve serving to provide a substrate upon which a treating physician may secure said catheter housing to the patient to minimize relative movement therebetween.

3. The assembly of claim 2 further comprising at least one additional perforation positioned within the side wall of said catheter housing.

4. The assembly of claim 2, wherein said catheter housing further comprises a radiopaque marker.

5. The assembly of claim 2, wherein the dilator further comprises a hemostasis valve at the proximal end of said dilator, said hemostasis valve configured to control the passage of contrast fluid through the dilator.

6. The assembly of claim 5 further comprising a tube in fluid communication with said hemostasis valve to permit the introduction of fluid contrast from an external source into said dilator.

7. The catheter assembly of claim 2 wherein the catheter housing is configured with sufficient stiffness to withstand axial forces on said catheter housing during insertion of the catheter housing into a patient'"'"'s vascular system.

8. A percutaneous catheter assembly comprising:

a catheter housing having a distal end, a proximal end, a lumen therethrough, and 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, said proximal end configured to connect to a standard sized blood pump;

a dilator having a distal end, a proximal end, a first opening in a side wall thereof proximate the distal end of the dilator for permitting passage of the contrast fluid therethrough and a second 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;

an end cap; and

a sleeve comprising a synthetic material having a generally textile characteristic, said sleeve positioned at and surrounding a portion of the proximal section of said catheter housing, whereby a treating physician may secure said sleeve to the patient to minimize relative movement therebetween.

9. The percutaneous catheter of claim 8, wherein the catheter housing further comprises a proximal section, a transition section, and a distal section.

10. The percutaneous catheter of claim 9, wherein the transition section comprises a diameter greater than a diameter of the distal section.

11. The percutaneous catheter of claim 9, wherein the transition section comprises a diameter greater than a diameter of the distal section, but less than a diameter of the proximal section.

12. The percutaneous catheter of claim 8, further comprising a disk comprising synthetic material located at the proximal section of the catheter housing, said disk comprising a suturing feature whereby a treating physician may secure said catheter housing to the patient to minimize relative movement therebetween.

13. A percutaneos catheter assembly comprising:

a catheter housing having a distal end, a proximal end, a lumen therethrough, and 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, said proximal end configured to connect to a standard sized blood pump;

a dilator having a distal end, a proximal end, a first opening in a side wall thereof proximate the distal end of the dilator for permitting passage of the contrast fluid therethrough and a second 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; and

an end cap;

wherein the dilator further comprises a plurality of struts axially positioned within the lumen of said dilator, the distal end of said dilator being tapered.

14. The percutaneous catheter of claim 13, wherein the dilator further comprises a hub to which the plurality of struts connect, said hub being centrally positioned within said dilator to permit the passage of a guidewire therethrough.

15. 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;

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 dilator openings in a side wall of the dilator and a second set of dilator openings being distally positioned relative to said first set of dilator openings; 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;

wherein said second set of dilator openings are positioned so that at least a part of at least one of such openings projects distally beyond the distal end of the catheter housing when the dilator is fully inserted within said housing; and

wherein the dilator further comprises a hub to which the struts connect, said hub being centrally positioned within said dilator to permit the passage of a guidewire therethrough.

16. The catheter of claim 15, wherein said catheter housing further comprises a helical coil.

17. A percutaneous catheter assembly comprising:

a catheter housing having a distal end, a proximal end, a lumen therethrough, and 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, said proximal end configured to connect to a standard sized blood pump;

a dilator having a distal end, a proximal end, an opening in a side wall thereof proximate the distal end of the dilator for permitting passage of the contrast fluid therethrough, and a plurality of struts axially positioned within a lumen of said dilator, wherein the opening is positioned so as to be generally aligned with the perforation of said catheter housing side wall; and

an end cap;

wherein the dilator further comprises a hub to which the plurality of struts connect, said hub being centrally positioned within said dilator to permit the passage of a guidewire therethrough.

18. A dilator comprising:

an elongate body defining a side wall extending between a proximal end and a distal end, a first opening formed in the side wall proximate the distal end, and a second opening in said side wall, said second opening being positioned proximal of said first opening, at least one of said first and said second openings for permitting passage of contrast fluid therethrough;

wherein when the dilator is inserted within a catheter housing, the first opening is located so that at least a portion thereof is distal of a distal end of the catheter housing and the second opening is located so that at least a portion thereof is proximal of the distal end of the catheter housing;

wherein the distal end of said dilator is tapered; and

wherein the dilator further comprises a hub to which a plurality of struts connect, said hub being centrally positioned within said dilator to permit the passage of a guidewire therethrough.

19. The dilator of claim 18, wherein when the dilator is inserted within the catheter housing, the second side wall opening is generally radially aligned with a perforation of the catheter.