Targeting therapeutic agents

• US 9,061,121 B2
• Filed: 08/03/2010
• Issued: 06/23/2015
• Est. Priority Date: 08/03/2009
• Status: Active Grant

• Current Assignee: Emory University
• Original Assignee: Emory University
• Inventors: Galloway, Niall, Galloway, James, McHugh, Patrick, Collins, Brian
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US13/388,695
• Publication Number:
  US 20120130282A1
• Time in Patent Office: 1,785 Days
• Field of Search: 600/29, 600/104, 600/135, 600/587, 604/116, 604/500, 604/515, 604/517
• US Class Current: 1/1
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• 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 17/4241 Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3411 with a plurality of holes, e.g. holes in matrix arrangement
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2202/06 Solids
• CPC Class Codes: A61M 2210/1089 Urethra
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

Provided are devices, systems, and methods for targeted administration of therapeutic agents to a subject. For example, provided are devices, systems, and methods for targeting the administration of peri-urethral bulking agents.

Claims

1. A device for targeting administration of a therapeutic agent to a subject, comprising:

a sleeve having a proximal end and a distal end and defining a lumen that is open at the proximal end and the distal end;

a frame for insertion into an organ lumen, wherein the frame is adapted to shape a concavity into an outer wall of the organ and a portion of the frame is disposed about the distal end of the sleeve; and

a guide apparatus positioned on the sleeve and adapted to guide an administration device external to the sleeve and the organ lumen and proximate to the shaped concavity,

wherein the guide apparatus includes a guiding member that is slidable along the sleeve.

2. The device of claim 1, wherein the frame comprises a proximal portion and a distal portion and at least two rib members extend between the proximal and distal portions.

3. The device of claim 2, wherein each rib member has a length between the proximal and distal portions of the frame and wherein at least two of the rib members are spaced from each other along at least a portion of the length between the proximal and distal portions.

4. The device of claim 3, wherein a void is defined between the portion of the rib members that are spaced apart from each other.

5. The device of claim 4, wherein the concavity shaped into an outer wall of the organ is formed between the portion of the rib members that are spaced apart from each other.

6. The device of claim 5, wherein the concavity is shaped in the void.

7. The device of claim 2, wherein the proximal portion has a cone shape.

8. The device of claim 1, wherein an optical device is positionable and slidable within the sleeve lumen.

9. The device of claim 1, further comprising at least two rib members that extend distally from the distal end of the sleeve in a direction a long axis of the sleeve.

10. The device of claim 9, wherein at least two of the rib members are spaced from each other along at least a portion of their length between the proximal and distal portions.

11. The device of claim 10, wherein a void is defined between the portion of the rib members that are spaced apart from each other.

12. The device of claim 11, wherein the concavity shaped into an outer wall of the organ is formed between the portion of the rib members that are spaced apart from each other.

13. The device of claim 12, wherein the concavity is shaped in the void.

14. The device of claim 9, further comprising a distal point portion,

wherein at least two of the rib members terminate at the distal point portion proximal to a tip of the distal point portion.

15. The device of claim 1, wherein the frame is sized to fit into the urethra of the subject.

16. The device of claim 15, wherein the concavity is shaped in the outer wall of the urethra.

17. The device of claim 16, wherein the therapeutic agent is administered proximate to the shaped concavity in the urethra.

18. The device of claim 17, wherein the therapeutic agent is a peri-uretheral bulking agent.

19. The device of claim 1, wherein the frame has a first retracted configuration and a second extended configuration, the first retracted configuration adapted to be inserted into the organ lumen and the second extended configuration adapted to shape a concavity into an outer wall of the organ.

20. The device of claim 19, further comprising an actuator for urging the frame from the first retracted configuration to the second extended configuration.

21. The device of claim 19, wherein the frame is adapted to shape a plurality of concavities into an outer wall of the organ.

22. The device of claim 19, wherein the frame comprises a plurality of arms each having a distal tip portion and a proximal base portion.

23. The device of claim 22, wherein an elastic ring is positioned around a periphery of the arms such that the ring provides a biasing force that urges the arms together towards the retracted configuration of the frame.

24. The device of claim 22, wherein the base portion of each arm is pivotably fixed about the distal end of the sleeve.

25. The device of claim 24, wherein:

the sleeve has a central longitudinal axis, and

the base portion of each arm is pivotably fixed about the distal end of the sleeve.

26. The device of claim 25, wherein:

the frame has a first retracted configuration and a second extended configuration;

the first retracted configuration includes the tip portion of each of the plurality of arms converging about the central longitudinal axis; and

the second extended configuration includes the tip portion of each of the plurality of arms extending away from the central longitudinal axis.

27. The device of claim 1, wherein an optical device is positionable and slidable within the sleeve lumen.

28. The device of claim 27, wherein sliding the optical device is configured to actuate expansion of the frame from the first refracted configuration to its the second extended configuration when the optical device is slid through the distal end of the sleeve.

29. The device of claim 28, wherein the optical device is a lens.

30. The device of claim 29, wherein the lens is adapted for coupling to an imaging device to allow visualization inside the organ lumen.

31. The device of claim 1, wherein the guide apparatus comprises a guiding portion integral with or fixed to an outer wall of the sleeve, the guiding portion having a hole spaced from the outer wall of the sleeve and adapted for the passage there through of the administration device.

32. The device of claim 31, wherein the guiding member is slidable along the outer wall of the sleeve and positioned about the sleeve distal to the guiding portion.

33. The device of claim 32, wherein the guiding member comprises a hole spaced from the outer wall of the sleeve and adapted for the passage there through of the administration device.

34. The device of claim 33, wherein the administration device is a needle of a syringe.

35. The device of claim 33, wherein the guiding member is adapted to be fixed in a desired location about the sleeve.

36. The device of claim 1, further comprising a measuring device for measuring urethral length.

37. The device of claim 1, wherein:

the guiding member includes one or more guide projections adapted for passage there through of the administration device.

38. The device of claim 1, wherein the frame includes a proximal portion and a distal portion, the proximal portion of the frame is fixed about the distal end of the sleeve.

39. A system for targeting administration of a therapeutic agent to a subject, comprising:

a sleeve having a proximal end and a distal end and defining a lumen that is open at the proximal end and the distal end, the sleeve having a central longitudinal axis;

an expandable frame sized for insertion into an organ lumen, the frame including a plurality of arms, each arm having a distal tip portion and a proximal base portion, the base portion of each arm being pivotably fixed about the distal end of the sleeve, the frame having a first retracted configuration and a second extended configuration, the first retracted configuration adapted to be inserted into the organ lumen and the second extended configuration adapted to shape a concavity into an outer wall of the organ, the first retracted configuration including the tip portion of each of the plurality of arms converging about the central longitudinal axis and the second extended configuration including the tip portion of each of the plurality of arms extending away from the central longitudinal axis;

a guide apparatus positioned on the sleeve and adapted to guide an administration device external to the organ lumen and proximate to the shaped concavity; and

an actuator configured to urge the expandable frame from the first retracted configuration to the second extended configuration.

40. The system of claim 39, wherein the expandable frame is adapted to shape a plurality of concavities into an outer wall of the organ.

41. The system of claim 39, wherein the actuator is an optical device that is positionable and slidable within the sleeve lumen.

42. The system of claim 41, wherein the optical device is configured to actuate expansion of the frame from the first refracted configuration to the second extended configuration when the optical device is slid through the distal end of the sleeve.

43. The system of claim 42, wherein the optical device is a lens.

44. The system of claim 43, wherein the lens is adapted for coupling to a imaging device to allow visualization inside the organ lumen.

45. The system of claim 39, wherein the guide apparatus comprises a guiding portion integral with or fixed to an outer wall of the sleeve, the guiding portion having a hole spaced from the outer wall of the sleeve and adapted for the passage there through of the administration device.

46. The system of claim 45, wherein the guide apparatus further comprises a guiding member slidable along the outer wall of the sleeve and positioned about the sleeve distal to the guiding portion.

47. The system of claim 46, wherein the guiding member comprises a hole spaced from the outer wall of the sleeve and adapted for the passage there through of the administration device.

48. The system of claim 47, wherein the administration device comprises a needle of a syringe.

49. The system of claim 48, wherein the administration device further comprises a syringe barrel configured to be filled with the therapeutic agent to be administered to the subject.

50. The system of claim 49, wherein the therapeutic agent is a peri-urethral bulking agent.

51. The system of claim 47, wherein the guiding member is adapted to be fixed in a desired location about the sleeve.

52. The system of claim 39, further comprising a measuring device for measuring urethral length.

53. The system of claim 39, wherein the guide apparatus further comprises a guiding member and a guiding portion disposed about the sleeve, the guiding portion being located proximal to the guiding member with respect to the distal end of the sleeve.

54. The system of claim 53, wherein each of the guiding member and the guiding portion includes one or more guide projections adapted for passage there through of the administration device.

55. A system for targeting administration of a therapeutic agent to a subject, comprising:

a sleeve having a proximal end and a distal end and defining a lumen that is open at the proximal end and the distal end;

a frame for insertion into an organ lumen, the frame being adapted to shape a concavity into an outer wall of the organ, the frame including a plurality of arms, each arm having a distal tip portion and a proximal base portion, the base portion of each arm being spaced about and pivotably fixed about the distal end of the sleeve, and extending from the distal end of the sleeve to a point distal to the distal end of the sleeve; and

a guide apparatus positioned on the sleeve and adapted to guide an administration device external to the organ lumen and proximate to the shaped concavity.

56. The system of claim 55, wherein:

the sleeve has a central longitudinal axis;

the frame has a first retracted configuration and a second extended configuration;

the first retracted configuration includes the tip portion of each of the plurality of arms converging about the central longitudinal axis; and

the second extended configuration includes the tip portion of each of the plurality of arms extending away from the central longitudinal axis.

57. The system of claim 55, wherein:

the guide apparatus further comprises a guiding member and a guiding portion disposed about the sleeve, the guiding portion being located proximal to the guiding member with respect to the distal end of the sleeve.

58. The system of claim 57, wherein each of the guiding member and the guiding portion includes one or more guide projections adapted for passage there through of the administration device.