Prosthesis deployment device with translucent distal end

• US 9,545,299 B2
• Filed: 09/16/2013
• Issued: 01/17/2017
• Est. Priority Date: 05/14/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Raeder-Devens, Jennifer E., Shelso, Susan I., Hemerick, James F., Schneider, Eric, Getty, Heather, Borgmann, Doreen, Sisombath, Kakao, Helgerson, Jeffrey A.
• Primary Examiner(s): Tucker, Philip
• Assistant Examiner(s): Slawski, Brian R
• Application Number:
  US14/027,792
• Publication Number:
  US 20140013572A1
• Time in Patent Office: 1,219 Days
• Field of Search: 156/60, 156/64, 156/70, 156/148, 156/149, 156/157, 156/158, 156/242, 156/244.11, 156/244.13, 156/296, 156/303.1, 156/304.1, 156/304.2, 156/304.3, 156/293, 156/294, 156/278, 623/1.1, 623/1.11, 623/1.12, 623/1.23, 623/903, 606/108, 606/194, 606/198
• US Class Current: 1/1
• 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 translucent layers, opaque layers, and a braid composed of helically wound metal filaments. The outer catheter has a translucent distal 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 method of forming a catheter with a longitudinal length, the method comprising:

bonding a distal outer tube, the distal outer tube being either translucent or transparent, to a distal region of an inner tube having a longitudinal length equal to the longitudinal length of the catheter, the inner tube also comprising a proximal region, and a medial region extending between and connecting the distal and proximal regions,

wherein the distal region of the inner tube is either translucent or transparent;

bonding a medial outer tube to the medial region of the inner tube, the medial outer tube being opaque;

bonding a proximal outer tube to the inner tube, the proximal outer tube being opaque; and

interposing a support structure between the inner tube and the proximal, medial, and distal outer tubes and bonding the support structure thereto, wherein the support structure extends from a proximal end of the inner tube to a position that is proximal to a distal end of the inner tube and distal to a distal end of the medial outer tube, the support structure positioned such that a stent disposed in the distal region of the catheter extends distal of the support structure.

2. The method of claim 1, wherein the inner tube comprises PTFE and the distal, medial, and proximal outer tubes comprise polyether block amide.

3. The method of claim 2, wherein the medial and proximal outer tubes further comprise a dye.

4. The method of claim 2, wherein the polyether block amide of the distal and medial outer tubes has a lower Shore D durometer than the polyether block amide of the proximal outer tube.

5. The method of claim 4, wherein the Shore D durometer of the distal and medial outer tubes is 63±

15 and the Shore D durometer of the proximal outer tube is 72±

15.

6. The method of claim 1, wherein the support structure comprises metal filaments.

7. The method of claim 6, wherein the metal filaments are in the form of a braid.

8. The method of claim 1, further comprising coating an inner surface of the inner tube with silicone.

9. The method of claim 1, further comprising coupling a manifold to a proximal end of the catheter.

10. A method for forming a prosthesis delivery system comprising:

positioning an inner catheter having a handle at a proximal end, the inner catheter comprising a wall defining a lumen and comprising a first inner catheter polymer, in a lumen defined by a wall of an outer catheter comprising;

an inner tube having a longitudinal length equal to the longitudinal length of the outer catheter, the inner tube comprising a distal region, a proximal region, and a medial region extending between and connecting the distal and proximal regions, the distal region of the inner tube being either translucent or transparent;

a distal outer tube bonded to the distal region of the inner tube, the distal outer tube being either translucent or transparent;

a medial outer tube bonded to the medial region of the inner tube, the medial outer tube being opaque; and

a proximal outer tube bonded to the proximal region of the inner tube, the proximal outer tube being opaque;

interposing a support structure between the inner tube and the proximal, medial, and distal outer tubes and bonding the support structure thereto;

wherein the inner catheter is movable axially relative to the outer catheter; and

disposing a radially self-expanding prosthesis in a compressed state on a prosthesis deployment region, wherein the prosthesis deployment region is defined by a distal region of the inner catheter and by a distal region of the outer catheter, the distal region of the outer catheter formed by the distal region of the inner tube and the distal outer tube;

wherein the support structure extends from a proximal end of the inner tube to a position that is proximal to a distal end of the inner tube and distal to a distal end of the medial outer tube, the support structure positioned such that the radially self-expanding prosthesis disposed in the distal region of the outer catheter extends distal of the support structure.

11. The method of claim 10, wherein the inner tube comprises PTFE and the distal, medial, and proximal outer tubes comprise polyether block amide.

12. The method of claim 11, wherein the medial and proximal outer tubes further comprise a dye.

13. The method of claim 11, wherein the polyether block amide of the distal and medial outer tubes has a lower Shore D durometer than the polyether block amide of the proximal outer tube.

14. The method of claim 13, wherein the Shore D durometer of the distal and medial outer tubes is 63±

15 and the Shore D durometer of the proximal outer tube is 72±

15.

15. The method of claim 10, wherein the support structure comprises metal filaments.

16. The method of claim 15, wherein the metal filaments are in the form of a braid.

17. The method of claim 10, further comprising coating an inner surface of the inner tube with silicone.

18. A method for forming a prosthesis delivery system comprising:

providing an outer catheter with a manifold at a proximal end, the outer catheter comprising a multi-layer wall defining a lumen, the multi-layer wall comprising;

an inner tube with a distal region, a proximal region, and a medial region extending between and connecting the distal and proximal regions;

a distal outer tube bonded to the distal region of the inner tube, wherein the distal outer tube and the distal region of the inner tube are either translucent or transparent;

a medial outer tube bonded to the distal outer tube and the medial region of the inner tube;

a proximal outer tube bonded to the medial outer tube and the proximal region of the inner tube, wherein the proximal outer tube is opaque; and

a support structure interposed between the inner tube and a proximal portion of the distal outer tube;

providing an inner catheter with a handle at a proximal end, the inner catheter comprising a wall defining a lumen, the wall comprising a first inner catheter polymer;

positioning the inner catheter in the lumen of the outer catheter, the inner catheter movable axially relative to the outer catheter; and

disposing a radially self-expanding prosthesis in a compressed state on a prosthesis deployment region, wherein the prosthesis deployment region is defined by a distal region of the inner catheter and by a distal region of the outer catheter, the distal region of the outer catheter formed by the distal region of the inner tube and the distal outer tube;

wherein the radially self-expanding prosthesis disposed on the prosthesis deployment region extends distal of the support structure.