Cannula and method of manufacture and use

• US 6,533,770 B1
• Filed: 01/21/1998
• Issued: 03/18/2003
• Est. Priority Date: 01/21/1998
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Lepulu, Keke J., Fan, Sylvia W.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/010,296
• Time in Patent Office: 1,882 Days
• Field of Search: 604/264, 604/273, 604/523, 604/524, 604/525, 604/526, 604/527, 604/6, 604/16, 138/123, 138/124, 138/125, 138/127, 138/129, 138/132, 138/133, 138/134, 138/138, 138/144
• US Class Current: 604/524
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid

Abstract

A cannula having reinforced sections and nonreinforced sections, the nonreinforced sections having openings communicating with the lumen of the cannula. The nonreinforced sections are plain tubing and the reinforced sections are formed by winding a coated elongate member in a helical manner around a mandrel. The coated elongate member preferably has a square cross-sectional shape so that adjacent portions of the coated elongate member engage one another when the coated elongate member is wound around the mandrel. The coated elongate member is then heated so that the coating on adjacent portions of the coated elongate member fuse together to form an integral structure. Another layer of material may be provided on the radially inner or outer wall of the coated elongate member. The resulting tubular body is reinforced by the elongate member which is encased in the fused coating. The tubular body is cut into sections which are fused to the plain tubing sections to form the cannula. The reinforced sections and the plain tubing sections are alternately disposed along all or a portion of the length of the cannula. The openings are formed in the plain tubing sections for withdrawing or delivering fluid into or out of the lumen of the cannula.

Claims

1. A cannula for delivering fluid to or withdrawing fluid from a patient, the cannula comprising:

a tubular body having a proximal end, a distal end, and at least one lumen;

wherein the tubular body has at least two reinforced sections having an elongate reinforcing member, the tubular body having at least two unreinforced sections which are substantially free of any reinforcing member and include at least one opening through which fluid passes.

2. The cannula of claim 1, wherein the reinforcing member is encased in a material separate from the material forming the reinforcing member.

3. The cannula of claim 2, wherein the reinforcing member is stainless steel wire and the material comprises a polymer.

4. The cannula of claim 3, wherein the reinforcing member is configured in a helical path.

5. The cannula of claim 1, wherein the section which is substantially free of the reinforcing member comprises plain tubing sections that are completely free of any reinforcing member.

6. The cannula of claim 5, wherein the plain tubing sections comprise polyurethane.

7. The cannula of claim 1, wherein the section which is substantially free of the reinforcing member has a plurality of openings therein.

8. The cannula of claim 7, wherein the openings are disposed circumferentially about said section.

9. The cannula of claim 1, wherein the cannula is configured for use in a patient'"'"'s femoral vein or artery and the tubular body has a length within a range of from about 50 to about 75 cm.

10. The cannula of claim 9, wherein the reinforced section has an inner diameter within a range of from about 16 French to about 29 French and an outer diameter within a range of from about 19 French to about 32 French.

11. The cannula of claim 10, wherein the reinforced section has an inner diameter within a range of from about 18 French to about 22 French and an outer diameter within a range of from about 21 French to about 25 French.

12. The cannula of claim 11, wherein the section which is substantially free of the reinforcing member has an inner and outer diameter which are substantially the same as the inner and outer diameter of the reinforced section.

13. A method of delivering fluid to a patient'"'"'s body, the method comprising the steps of:

providing a cannula comprising a tubular body including a proximal portion, a distal portion, a central portion disposed between the proximal and distal portions, and a lumen;

wherein at least the distal portion and one of the central and proximal portions of the tubular body comprises a plurality of sections reinforced by an elongate reinforcing member encased in a material, the reinforced sections being separated by an unreinforced section which is substantially free of any reinforcing member and includes at least one opening extending into the lumen of the tubular body;

placing at least the distal portion of the cannula into a patient'"'"'s vascular system; and

delivering fluid to the patient'"'"'s vascular system by passing the fluid through the opening in the distal portion of the tubular body and the lumen, wherein the fluid is delivered to the patient'"'"'s vascular system through openings in the distal portion and through openings in at least one of the proximal and central portions of the tubular body and into the lumen.

14. The method of claim 13, further comprising the step of connecting the cannula to a cardiopulmonary bypass system and delivering oxygenated blood to the patient'"'"'s vascular system.