Prosthesis deployment device with translucent distal end

• US 8,226,702 B2
• Filed: 05/18/2009
• Issued: 07/24/2012
• Est. Priority Date: 05/14/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Sisombath, Kakao, Raeder-Devens, Jennifer E, Shelso, Susan I, Hemerick, James F, Schneider, Eric M, Getty, Heather L, Borgmann, Doreen M, Helgerson, Jeffrey A
• Primary Examiner(s): Houston, Elizabeth
• Application Number:
  US12/467,491
• Publication Number:
  US 20090228092A1
• Time in Patent Office: 1,163 Days
• Field of Search: 623/1.11, 623/1.12, 623/903, 606/108, 606/119, 606/194, 606/200, 606/198, 128/899
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/5221 for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
• CPC Class Codes: B29C 66/712 the composition of one of the parts to be joined being different from the composition of the other part
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/322 comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A prosthesis delivery and deployment device includes an elongate and flexible outer catheter. The outer catheter has a tubular wall of layered construction, including a translucent inner liner running the complete catheter length, and three outer layers including a translucent distal layer, an opaque medial layer and an opaque proximal outer layer. The outer layers are adjacent one another and are bonded to the liner. A braid composed of helically wound metal filaments is disposed between the liner and the proximal and medial outer layers, and includes a distal portion between the liner and a proximal portion of the distal outer layer. The liner and distal outer layer provide a translucent distal region of the catheter that is adapted to constrain a radially self-expanding prosthesis in a radially reduced, axially elongated state. Because the stent constraining region is translucent, an endoscope can be used to visually monitor the stent when so constrained. Radiopaque markers can be mounted to the outer catheter and to an inner catheter used to deploy the prosthesis, to afford a combined visual and fluoroscopic monitoring for enhanced accuracy in positioning the prosthesis, both before and during its deployment.

Claims

1. A medical device delivery system for a self expanding stent comprising:

an outer sheath comprising an elongated tubular body, a proximal end, a distal end, a sheath length extending from the proximal end to the distal end, a distal section, an inner polymeric layer, an outer polymeric layer, and a metallic braid having a distal end and a braid length,

an entire length of the inner polymeric layer being transmissive of wavelengths in the visible spectrum,

the outer polymeric layer in the distal section being transmissive of wavelengths in the visible spectrum, and

the metallic braid being positioned between the inner polymeric layer and the outer polymeric layer, the braid length being less than the sheath length so that the braid extends from the proximal end of the outer sheath to a portion of the distal section of the outer sheath the distal end of the braid being proximal to the distal end of the outer sheath;

an inner shaft located coaxially within the outer sheath, the shaft having a distal end and a proximal end; and

a self-expanding stent releasably retained entirely within the distal section of the outer sheath, the distal end of the stent being distal to the distal end of the metallic braid;

wherein the outer polymeric layer comprises a first polymeric material and the inner polymeric layer comprises a second polymeric material,

the first polymeric material being different from the second polymeric material,

the first polymeric material having relatively high flexibility as compared to the second polymeric material, and

the inner polymeric layer having a low-friction surface proximal to the self-expanding stent.

2. The medical device delivery system of claim 1, wherein the sheath includes a radiopaque marker disposed between the outer polymeric layer and the inner polymeric layer.

3. The medical device delivery system of claim 1, wherein the first polymeric material comprises a clear polymeric material.

4. The medical device delivery system of claim 3, wherein the clear polymeric material is either a nylon polymer or a polyether block amide.

5. The medical device delivery system of claim 1, wherein the second polymeric material comprises polytetrafluoroethylene (PTFE).

6. The medical device delivery system of claim 1, wherein the low-friction surface of the inner polymeric layer is coated with silicone.

7. The medical device delivery system of claim 1, the inner shaft being longitudinally moveable relative to the outer sheath, the distal end of the inner shaft being proximal to the stent.

8. The medical device delivery system of claim 1, the inner shaft comprising a sleeve on a distal outer surface portion of the inner shaft, the sleeve having a sleeve length equal to a length of the distal portion of the outer sheath, the sleeve made of a polymer, the stent frictionally retained by the sleeve.