Method and system for drug delivery

• US 20060129128A1
• Filed: 11/15/2005
• Published: 06/15/2006
• Est. Priority Date: 11/15/2004
• Status: Abandoned Application

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Sampson, Russel M.
• Application Number:
  US11/280,979
• Publication Number:
  US 20060129128A1
• Time in Patent Office: Days
• US Class Current: 604/515
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A medical device and procedure for delivering a drug into a uterus are described. In one implementation, the medical device includes a first elongate member, a second elongate member and a stopper device. The first elongate member is configured for transcervical insertion into the uterus and includes a lumen extending therethrough. The second elongate member is positioned within said lumen and also includes a lumen therethrough. The second elongate member is positionable in a retracted or an extended position. A distal end of the second elongate member is configured to extend beyond a distal end of the first elongate member and penetrate uterine tissue when in the extended position. A proximal end of the second elongate member is configured to receive a drug for delivery through the lumen of the second elongate member. The stopper device controls movement of the second elongate member within the first elongate member.

Claims

1. A medical device for drug delivery, comprising:

a first elongate member configured for transcervical insertion into a uterine cavity, the first elongate member including a proximal end, a distal end and a lumen extending therethrough;

a second elongate member positioned within the lumen of the first elongate member and including a proximal end, a distal end and lumen therethrough, where;

the second elongate member is positionable in a retracted or an extended position relative to the first elongate member;

the distal end is configured to extend beyond the distal end of the first elongate member and penetrate uterine tissue when in the extended position;

the proximal end is configured to receive a drug for delivery through the lumen of the second elongate member; and

a stopper device configured to control movement of the second elongate member within the first elongate member thereby defining the retracted and extended positions of the second elongate member.

2. The medical device of claim 1, wherein the stopper device includes a groove formed in the proximal end of the first elongate member and a retainer clip connected to the proximal end of the second elongate member, where the retainer clip is configured to engage the groove when the second elongate member is in the extended position.

3. The medical device of claim 1, wherein the stopper device includes a first finger grip included at the proximal end of the first elongate member and a second finger grip included at the proximal end of the second elongate member, where the second finger grip is configured to contact the first finger grip when the second elongate member is in the extended position.

4. The medical device of claim 1, where the first elongate member further includes:

a second lumen extending therethrough, the second lumen including light fibers;

a third lumen extending therethrough, the third lumen including a micro-endoscope;

a light post coupler coupled to the light fibers and configured to couple to a light source; and

a camera adapter coupled to the micro-endoscope and configured to couple to a camera.

5. The medical device of claim 1, further comprising:

a first connector coupled to the proximal end of the second elongate member and configured to couple to a drug source; and

a second connector coupled to the proximal end of the second elongate member and configured to couple to a distension medium source.

6. The medical device of claim 1, wherein the drug is a local anesthetic.

7. A system for drug delivery, comprising:

a hysteroscope including a working channel; and

a medical device configured to position within the working channel of the hysteroscope, the medical device including;

a first elongate member configured for transcervical insertion into a uterine cavity, the first elongate member including a proximal end, a distal end and a lumen extending therethrough;

a second elongate member positioned within the lumen of the first elongate member and including a proximal end, a distal end and lumen therethrough, where;

the second elongate member is positionable in a retracted or an extended position relative to the first elongate member;

the distal end is configured to extend beyond the distal end of the first elongate member and pierce uterine tissue when in the extended position;

the proximal end is configured to receive a drug for delivery through the lumen of the second elongate member; and

a stopper device configured to control movement of the second elongate member within the first elongate member thereby defining the retracted and extended positions of the second elongate member.

8. The system of claim 7, further comprising:

a drug source coupled to the proximal end of the second elongate member.

9. The system of claim 8, further comprising:

a distension medium source coupled to the proximal end of the second elongate member.

10. The system of claim 7, wherein the stopper device includes a groove formed in the proximal end of the first elongate member and a retainer clip connected to the proximal end of the second elongate member, where the retainer clip is configured to engage the groove when the second elongate member is in the extended position.

11. The system of claim 7, wherein the stopper device includes a first finger grip included at the proximal end of the first elongate member and a second finger grip included at the proximal end of the second elongate member, where the second finger grip is configured to contact the first finger grip when the second elongate member is in the extended position.

12. The system of claim 7, wherein the first elongate member further includes:

a second lumen extending therethrough, the second lumen including light fibers;

a third lumen extending therethrough, the third lumen including a micro-endoscope;

a light post coupler coupled to the light fibers and configured to couple to a light source; and

a camera adapter coupled to the micro-endoscope and configured to couple to a camera.

13. The system of claim 7, the medical device further comprising:

a first connector coupled to the proximal end of the second elongate member and configured to couple to a drug source; and

a second connector coupled to the proximal end of the second elongate member and configured to couple to a distension medium source.

14. The system of claim 7, wherein the drug is a local anesthetic.

15. A method of delivering a drug to a uterus, the method comprising:

transcervically positioning a delivery device within a uterine cavity until a distal end of the delivery device is near or contacting the fundus, where the delivery device includes a second elongate member included in a lumen of a first elongate member and a stopper device configured to define a retracted position and an extended position of the second elongate member relative to the first elongate member;

translating the second elongate member within the lumen of the first elongate member toward the distal end of the delivery device and from a retracted position to an extended position;

penetrating tissue at or near the fundus with a distal tip of the second elongate member, the second elongate member including a lumen filled with a drug; and

purging at least some of the drug from the lumen of the second elongate member into the tissue at approximately the fundus.

16. The method of claim 15, further comprising:

translating the second elongate member within the lumen of the first elongate member toward a proximal end of the delivery device and from the extended position to the retracted position; and

withdrawing the delivery device from the uterine cavity.

17. The method of claim 15, further comprising:

coupling the second elongate member to a distension medium source; and

delivering the distension medium to the uterine cavity through the lumen and distal tip of the second elongate member.

18. The method of claim 15, wherein translating the second elongate member from a retracted position to an extended position includes engaging a retainer clip included a proximal end of the second elongate member with a locator included in a proximal end of the first elongate member.

19. The method of claim 15, wherein translating the second elongate member from a retracted position to an extended position includes advancing a second finger grip included at a proximal end of the second elongate member toward and into contact with a first finger grip included at a proximal end of the first elongate member.

20. The method of claim 15, wherein transcervically positioning a delivery device within a uterine cavity includes:

transcervically positioning a hysteroscope within a uterine cavity, where the delivery device is included in a working channel of the hysteroscope.

21. The method of claim 15, wherein the drug is a local anesthetic.

22. A medical device for local anesthesia delivery, comprising:

a first elongate member configured for transcervical insertion into a uterine cavity, the first elongate member including a proximal end, a distal end and a lumen extending therethrough;

a second elongate member positioned within the lumen of the first elongate member and including a proximal end, a distal end and lumen therethrough, where;

the second elongate member is positionable in a retracted or an extended position relative to the first elongate member;

the distal end is configured to extend beyond the distal end of the first elongate member and penetrate uterine tissue when in the extended position;

the proximal end is configured to receive a local anesthesia for delivery through the lumen of the second elongate member; and

a stopper device configured to control movement of the second elongate member within the first elongate member thereby defining the retracted and extended positions of the second elongate member.

23. The medical device of claim 22, wherein the stopper device includes a groove formed in the proximal end of the first elongate member and a retainer clip connected to the proximal end of the second elongate member, where the retainer clip is configured to engage the groove when the second elongate member is in the extended position.

24. The medical device of claim 22, wherein the stopper device includes a first finger grip included at the proximal end of the first elongate member and a second finger grip included at the proximal end of the second elongate member, where the second finger grip is configured to contact the first finger grip when the second elongate member is in the extended position.

25. The medical device of claim 22, where the first elongate member further includes:

a second lumen extending therethrough, the second lumen including light fibers;

a third lumen extending therethrough, the third lumen including a micro-endoscope;

a light post coupler coupled to the light fibers and configured to couple to a light source; and

a camera adapter coupled to the micro-endoscope and configured to couple to a camera.

26. The medical device of claim 22, further comprising:

a first connector coupled to the proximal end of the second elongate member and configured to couple to a local anesthesia source; and

a second connector coupled to the proximal end of the second elongate member and configured to couple to a distension medium source.