Stent treatment apparatus and method

• US 6,709,449 B2
• Filed: 01/12/2001
• Issued: 03/23/2004
• Est. Priority Date: 01/12/2001
• Status: Expired due to Fees

• Current Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Schwartz, Robert S., Camrud, Allan R., Bayes-Genis, Atoni
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US09/759,906
• Publication Number:
  US 20020138126A1
• Time in Patent Office: 1,166 Days
• Field of Search: 151/040.3, 623/1.11, 137/12
• US Class Current: 623/1.11
• CPC Class Codes: A61B 2090/701 for flexible tubular instruments, e.g. endoscopes
• CPC Class Codes: A61B 90/70 Cleaning devices specially adapted for surgical instruments
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: Y10T 137/0379 By fluid pressure

Abstract

Manual stent manipulation before implantation results in foreign body contamination and increased neointimal hyperplasia. Rinsing commercially available sterile stents with high pressure immediately before implantation eliminates residual surface stent contaminants and reduces inflammation elicited by stent struts. Ex-vivo stent expansion and surface analysis revealed that rinsed stents had fewer surface contaminants than untouched or handled stents. In a porcine stent restenosis model, rinsed stents elicited less inflammation and less neointimal hyperplasia at one month than handled and untouched stents. Pressure-rinsing of coronary stents immediately before implantation reduces inflammation and neointimal hyperplasia.

Claims

1. A stent treatment apparatus configured for use outside of a patient, comprising:

stent washing means for pressure washing a stent preloaded on a balloon catheter;

fluid inflow means for providing a washing fluid to the stent washing means;

fluid outflow means for removing the washing fluid from the stent washing means to a location outside of the patient; and

receiving means for receiving a catheter within the stent washing apparatus.

2. The stent treatment apparatus of claim 1, wherein the stent washing means comprise a stent washing chamber.

3. The stent treatment apparatus of claim 2, wherein the fluid inflow means is in fluid communication with a first end of the stent washing chamber.

4. The stent treatment apparatus of claim 2, wherein the fluid outflow means is in fluid communication with a second end of the stent washing chamber.

5. The stent treatment apparatus of claim 1, wherein the washing fluid is provided from a pressurized source comprising a syringe or an indeflator.

6. The stent treatment apparatus of claim 1, wherein the wash fluid comprises a mixture of heparin and water.

7. The stent treatment apparatus of claim 1, wherein the fluid inflow means and the fluid outflow means are reversible between a closed position that does not permit fluid flow and an open position that does permit fluid flow.

8. The stent treatment apparatus of claim 1, further comprising pressure means for inflating inflate the balloon.