Drug Introduction and Placement System

• US 20120083765A1
• Filed: 10/05/2010
• Published: 04/05/2012
• Est. Priority Date: 10/05/2010
• Status: Active Grant

• Current Assignee: Alcon Research Limited (Nestle SA)
• Original Assignee: Alcon Research Limited (Nestle SA)
• Inventors: LaBelle, Mark D.
• Granted Patent: US 8,864,703 B2
• Time in Patent Office: Days
• US Class Current: 604/521
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

A drug introduction sleeve is disclosed that includes a selectively expandable body portion. The body portion is defined by a first open end and a second open end. A hollow interior is formed within the body portion. The body portion is selectively expandable from a first unexpanded configuration to a second expanded configuration whereby the volume of the hollow interior is increased when the body portion is expanded to the second expanded configuration, sufficient to temporarily retain a drug bolus.

Claims

1. A drug introduction sleeve, comprising:

a body portion defined by a first open end and a second open end and having a hollow interior therein; and

wherein the body portion is selectively expandable from a first unexpanded configuration to a second expanded configuration whereby the volume of the hollow interior is increased when the body portion is expanded to the second expanded configuration, sufficient to temporarily retain a drug bolus therewithin.

2. The drug introduction sleeve of claim 1, further comprising at least one perforation segment extending from the first open end toward second open end, wherein the perforation segment is defined by a plurality of perforations, the perforations permitting the sleeve to stretch along the perforation segment upon application of a predetermined amount of force.

3. The drug introduction sleeve of claim 2, further comprising a plurality of perforation segments, wherein the perforation segments are spaced equi-distance from one another.

4. The drug introduction sleeve of claim 2, wherein the sleeve is constructed of a biocompatible material.

5. The drug introduction sleeve of claim 1, wherein the sleeve is constructed of a material that dissolves after a predetermined time period.

6. The drug introduction sleeve of claim 1 wherein the first open end is defined by a first diameter and wherein the second open end is defined by a second diameter, wherein the second diameter is larger than the first diameter.

7. A drug introduction system, comprising:

a selectively expandable sleeve having a body portion defined by a first open end and a second open end, wherein the body portion defines a hollow interior therein;

the body portion configured to be selectively expandable from a first unexpanded configuration to a second expanded configuration whereby the volume of the hollow interior is increased when the body portion is expanded to the second expanded configuration; and

a drug introduction tool comprising a needle housing and a needle shaft, wherein the needle shaft is mounted to the needle housing such that the needle shaft is selectively moveable with respect to the needle housing;

wherein the needle shaft further includes a distal piercing tip having an opening therein, whereby the opening is in communication with a drug supply such that introduction of a drug causes the body portion of the sleeve to expand from the first unexpanded configuration to the second expanded configuration, sufficient to temporarily retain a drug therewithin.

8. The drug introduction system of claim 7, wherein the body portion further comprises at least one perforation segment defined by a plurality of perforations, whereby the perforations permit the body portion to stretch along the perforation segment such that introduction of the drug into the body portion expands the body portion from the first un-expanded configuration to the second expanded configuration.

9. The drug introduction system of claim 8, further comprising a plurality of perforation segments, wherein the perforation segments are spaced equi-distance from one another.

10. The drug introduction system of claim 7, wherein the first open end of the sleeve is mounted around a portion of the needle shaft and the second open end of the sleeve is mounted around a portion of the needle housing.

11. The drug introduction sleeve of claim 9, wherein the second open end of the sleeve is fixedly secured to the needle housing.

12. The drug introduction sleeve of claim 7, wherein the sleeve is constructed of a material that dissolves after a predetermined time period.

13. The drug introduction sleeve of claim 7 wherein the first open end is defined by a first diameter and wherein the second open end is defined by a second diameter, wherein the second diameter is larger than the first diameter.

14. The drug introduction sleeve of claim 7, wherein the drug is a phase transition drug that coagulates into a drug bolus within the sleeve after dispensing from the opening of the needle shaft.

15. A method of introducing a drug into a patient, comprising:

providing a drug introduction tool comprised of a needle shaft mounted for sliding engagement within a needle housing, the needle shaft having a distal piercing tip and an opening that is in fluid communication with a drug supply;

mounting a selectively expandable sleeve in a first unexpanded configuration on the drug introduction tool, whereby the sleeve comprises a first open end and a second open end, wherein the first open end is mounted on the needle shaft so as to be spaced away from the distal piercing tip in a proximal direction and the second open end is mounted to a portion of the needle housing;

creating an incision by inserting the distal piercing tip a predetermined depth into a patient such that at least a portion of sleeve is disposed in the patient;

retracting needle shaft such that the opening of needle shaft is retracted away from the first open end of the sleeve and positioned within an interior of the sleeve;

injecting a predetermined volume of drug through the needle shaft and out of the opening thereof such that the drug is directed into the sleeve and encapsulated therein such that a drug bolus is formed within the sleeve, the injection of the drug expanding the sleeve into the second expanded configuration;

positioning the drug bolus within the patient; and

removing the drug introduction tool from the patient.

16. The method of claim 15, further comprising removing the sleeve from the patient prior to positioning the drug bolus within the patient.

17. The method of claim 16, wherein the second open end of the sleeve is fixedly secured to the needle housing and retraction of the needle housing applies a force to stretch and then release the sleeve from the drug bolus and permit the sleeve to exit the incision.

18. The method of claim 15, wherein the drug coagulates around the distal piercing end and the needle shaft is selectively moved within the patient to selectively position the drug bolus.

19. The method of claim 18, wherein the distal piercing end is selectively removed from the drug bolus after the drug bolus is positioned.

20. The method of claim 19, wherein the needle shaft is vibrated to dislodge the drug bolus from the distal piercing end.

21. The method of claim 15, wherein the sleeve is constructed of a material that dissolves within the patient within a predetermined time period such that the sleeve remains encapsulating the drug bolus for a predetermined time, after the drug introduction tool is removed from the patient.