Catheter for reduced reflux in targeted tissue delivery of a therapeutic agent

• US 8,147,480 B2
• Filed: 06/07/2008
• Issued: 04/03/2012
• Est. Priority Date: 09/28/2007
• Status: Active Grant

• Current Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Hoofnagle, John R., Kapur, Terri, Keeley, Daniel, Greg, Schorn
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US12/157,070
• Publication Number:
  US 20090088730A1
• Time in Patent Office: 1,396 Days
• Field of Search: 604/523, 604/524, 604/29, 604/500
• US Class Current: 604/523
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A therapeutic agent delivery system that includes a catheter having a proximal end and an opposite distal end. The catheter has a body with a lumen defined therein. The body of the catheter includes a non-bulbous region having a substantially uniform outer diameter and a bulbous region made from an elastically deformable material. While in a first state the bulbous region has a maximum outer diameter greater than the substantially uniform outer diameter of the non-bulbous region; and while in a second state the maximum outer diameter of the bulbous region is reduced relative to that while in the first state.

Claims

1. A therapeutic agent delivery system comprising:

a catheter having a proximal end and an opposite distal end, the catheter having a body with a lumen defined therein;

the body including a non-bulbous region having a substantially uniform outer diameter and a radially closed bulbous region, the bulbous region being made from an elastically deformable material;

while in a first state the bulbous region having a maximum outer diameter greater than the substantially uniform outer diameter of the non-bulbous region; and

while in a second state the maximum outer diameter of the bulbous region being reduced relative to that while in the first state;

wherein the bulbous region of the body of the catheter is adapted to transition between the first and second states prior to introduction of a therapeutic agent via the lumen, wherein the first state in a non-stressed state and the second state is a stressed state, wherein the maximum outer diameter of the bulbous region while in the second state is substantially equal to the substantially uniform outer diameter of the non-bulbous region.

2. The system in accordance with claim 1, wherein the bulbous region is disposed proximate the distal end of the catheter.

3. The system in accordance with claim 1, wherein the body of the catheter further comprises:

a proximal section disposed closest to the proximal end of the catheter; and

a distal section disposed closest to the distal end of the catheter, the lumen extending through both the proximal and distal sections;

the bulbous and non-bulbous regions being defined in the proximal section.

4. The system in accordance with claim 3, wherein the proximal section is formed of an elastically deformable material;

and the distal section is formed of a substantially rigid material.

5. The system in accordance with claim 3, further comprising a stylet configured to be received in the lumen starting from the proximal end of the catheter and extending into at least a portion of the distal section.

6. The system in accordance with claim 5, wherein a distal end of the stylet extends into the at least the portion of the distal section that overlaps with the proximal section.

7. The system in accordance with claim 5, further comprising a connector for releasably securing the stylet inserted in the catheter while the bulbous region is in the first state.

8. The system in accordance with claim 1, further comprising a stylet configured to be received in the lumen starting from the proximal end of the catheter and extending at least through the bulbous region.

9. The system in accordance with claim 8, further comprising a connector for releasably securing the stylet inserted in the catheter while the bulbous region is in the first state.

10. The system in accordance with claim 3, further comprising:

a stylet that includes an outer body member axially displaceable relative to an inner body member;

the inner body member having a hub, a first section of substantially uniform outer diameter, a shoulder, and an arm smaller in diameter relative to that of the first section; and

a deployment member disposed between the outer body member and the arm of the inner body member; and

the lumen is configured to permit passage of the inner and outer body members of the stylet therein starting from the proximal end of the catheter, the shoulder contacts the proximal end of the distal section with the arm extending into at least a portion of the lumen disposed in the distal section.

17. The system in accordance with claim 1, wherein the bulbous region while in the first state creates a barrier that substantially prevents reflux exterior of the catheter.

19. The system in accordance with claim 5, wherein the stylet is removable from the catheter.

11. A method for using a therapeutic agent delivery system, the delivery system includes a catheter having a proximal end and an opposite distal end;

the catheter having a body with a lumen defined therein, the body including a non-bulbous region having a substantially uniform outer diameter and a radially closed bulbous region, the bulbous region being made from an elastically deformable material, comprising the steps of;

inserting a stylet into the lumen starting at the proximal end of the catheter and extending through at least the bulbous region;

implanting the assembled stylet and catheter in a patient at a targeted site while the bulbous region is in a first state in which the maximum outer diameter of the bulbous region is substantially equal to the substantially uniform outer diameter of the non-bulbous region; and

removing the assembled stylet from the catheter while the bulbous region of the catheter is maintained in a second state in which the maximum outer diameter of the bulbous region is greater than in the first state so as to reduce back flow;

wherein the first state is a non-stressed state and the second state is a stressed state.

12. The method in accordance with claim 11, wherein prior to the removing step, further comprising the step of applying a radial force to the catheter so that the bulbous region is in a stressed state in which its maximum outer diameter is enlarged relative to that while in a non-stressed state.

13. The method in accordance with claim 11, wherein the body of the catheter comprises:

a proximal section disposed closest to the proximal end of the catheter; and

a distal section disposed closest to the distal end of the catheter, the lumen extending through both the proximal and distal sections;

the bulbous and non-bulbous regions being defined in the proximal section.

14. The method in accordance with claim 13, wherein the proximal section is formed of an elastically deformable material;

and the distal section is formed of a substantially rigid material.

15. The method in accordance with claim 13, wherein the stylet includes an outer body member axially displaceable relative to an inner body member;

the inner body member having a hub, a first section of substantially uniform outer diameter, a shoulder, and an arm smaller in diameter relative to that of the first section; and

the lumen of the catheter has located therein a deployment member disposed between the outer body member and the arm of the inner body member; and

the lumen is configured to permit passage of the inner and outer body members of the stylet therein starting from the proximal end of the catheter, the shoulder contacts the proximal end of the distal section with the arm extending into at least a portion of the lumen disposed in the distal section.

16. The method in accordance with claim 11, further comprising the step of dispensing a therapeutic agent while the bulbous region is in the second state applying outward radial pressure against surrounding tissue circumferentially about the catheter creating a barrier that substantially prevents reflux of the therapeutic agent exterior of the catheter.

18. The method in accordance with claim 11, wherein the bulbous region of the body of the catheter is adapted to transition between the first and second states prior to introduction of a therapeutic agent via the lumen.