Methods for application of intraluminal photopolymerized gels

• US 5,665,063 A
• Filed: 06/24/1994
• Issued: 09/09/1997
• Est. Priority Date: 06/24/1994
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Melanson, David, Khosravi, Farhad, Herman, Stephen J., Dumont, Michael, Roth, Laurence A.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/265,448
• Time in Patent Office: 1,173 Days
• Field of Search: 604/19, 604/20, 604/21, 604/265, 604/96, 604/101, 604/49, 604/52, 604/53, 606/191-195
• US Class Current: 604/509
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Devices for providing polymeric layers on the interior surface of body lumens and spaces are disclosed. The devices can include proximal and distal occlusion elements to define the treatment space and an optical emitter to provide light for a photopolymerization procedure. The devices may include a molding member for providing a thick polymeric gel. Alternatively, devices without a molding member may be used to carry out an interfacial polymerization procedure.

Claims

1. A method for providing a polymeric coating on a surface of a body lumen which comprises the steps of:

a) providing a device which comprises;

i) an elongated shaft including at least one occlusion element for occluding the body lumen and an injection lumen for injecting a fluent prepolymer material into a space defined at least at one end by the occlusion element; and

ii) an optical emitter positioned in the space defined at least at one end by the occlusion element;

b) positioning said at least one occlusion element at a desired location in the body lumen;

c) positioning the optical emitter at a treatment site;

d) actuating said at least one occlusion element to define a treatment space;

e) injecting a fluent prepolymer into the treatment space;

f) directing light through the optical emitter into the prepolymer to photopolymerize at least a portion of the prepolymer;

g) deactuating said at least one occlusion element; and

,

h) withdrawing the device from the body lumen, thereby leaving a layer of polymeric material on at least a surface of the body lumen.

2. The method of claim 1 wherein at least one occlusion element comprises an inflatable balloon.

3. The method of claim 1 wherein the treatment space is flushed with at least one fluid prior to injecting the fluent prepolymer into the treatment space.

4. The method of claim 1 wherein the device further includes a molding member positioned in the treatment space, and the method further includes the step of using the molding member to form the fluent prepolymer solution into an annular or partially annular layer on the body lumen.

5. The method of claim 4 wherein the molding member comprises an inflatable balloon.

6. The method of claim 1 wherein at least one occlusion element comprises a valve-occlusion balloon.

7. A method for providing a polymeric coating on a surface of a body lumen which comprises the steps of:

a) providing a device which comprises;

I) an elongated shaft including at least one occlusion element for occluding the body lumen and an injection lumen for injecting a fluent prepolymer material into a space defined at least at one end by the occlusion element; and

ii) an optical emitter positioned in the space defined at least at one end by the occlusion element;

b) positioning said at least one occlusion element at a desired location in the body lumen;

c) positioning the optical emitter at a treatment site;

d) actuating said at least one occlusion element to define a treatment space and flushing the treatment space with a photoinitiator;

e) then injecting a fluent prepolymer into the treatment space;

f) directing light through the optical emitter into the prepolymer to photopolymerize at least a portion of prepolymer;

g) deactuating said at least one occlusion element; and

,

h) withdrawing the device from the body lumen, thereby leaving a layer of polymeric material on at least a surface of the body lumen.

8. The method of claim 7, further comprising removing from the treatment space one of either photoinitiator that is not adsorbed by the body lumen surface or prepolymer that is not polymerized by the light prior to deactuating the at least one occlusion element.

9. The method of claim 7, wherein at least one occlusion element comprises an inflatable balloon.

10. The method of claim 7, wherein the device further includes a molding member positioned in the treatment space, and the method further includes the step of using the molding member to form the fluent prepolymer solution into an annular or partially annular layer on the body lumen.

11. A method for providing a polymeric coating on a surface of a body lumen which comprises the steps of:

a) providing a device which comprises;

i) proximal and distal radially expandable occlusion elements, each being independently actuable and axially movable relative to the other and an injection lumen for injecting a fluent prepolymer material into a space defined between the proximal and distal occlusion elements; and

ii) an optical emitter positioned at least partially between the proximal and distal occlusion elements, the emitter being axially movable relative to at least one of the occlusion elements;

b) positioning the proximal and distal occlusion elements at a desired location in the body lumen;

c) positioning the optical emitter at a treatment site;

d) actuating at least one of the proximal and distal occlusion elements to define a treatment space;

e) injecting a fluent prepolymer into the treatment space;

f) directing light through the optical emitter into the prepolymer to photopolymerize at least a portion of the prepolymer;

g) deactuating said at least one occlusion element; and

,

h) withdrawing the device from the body lumen, thereby leaving a layer of polymeric material on at least a surface of the body lumen.

12. The method of claim 11 wherein at least one of the occlusion elements comprises an inflatable balloon.

13. The method of claim 11 wherein the treatment space is flushed with at least one fluid prior to injecting the fluent prepolymer into the treatment space.

14. The method of claim 11 wherein at least one occlusion element comprises a valve-occlusion balloon.

15. The method of claim 11 wherein the device further includes a molding member positioned in the treatment space, and the method further includes the step of using the molding member to form the fluent prepolymer solution into an annular layer on the body lumen.

16. The method of claim 15 wherein the molding member comprises an inflatable balloon.

17. A method for providing a polymeric coating on a surface of a body lumen which comprises the steps of:

a) providing a device which comprises;

I) proximal and distal radially expandable occlusion elements, each being independently actuable and axially movable relative to the other and an injection lumen for injecting a fluent prepolymer material into a space defined between the proximal and distal occlusion elements; and

ii) an optical emitter positioned at least partially between the proximal and distal occlusion elements, the emitter being axially movable relative to at least one of the occlusion elements;

b) positioning the proximal and distal occlusion elements at a desired location in the body lumen;

c) positioning the optical emitter at a treatment site;

d) actuating at least one of the proximal and distal occlusion elements to define a treatment space and flushing the treatment space with a photoinitiator;

e) then injecting a fluent prepolymer into the treatment space;

f) directing light through the optical emitter into the prepolymer to photopolymerize at least a portion of the prepolymer;

g) deactuating said at least one occlusion element; and

,

h) withdrawing the device from the body lumen, thereby leaving a layer of polymeric material on at least a surface of the body lumen.

18. The method of claim 17, further comprising removing from the treatment space one of either photoinitiator that is not absorbed by the body lumen surface or prepolymer that is not polymerized by the light prior to deactuating the at least one occlusion element.

19. The method fo claim 17, wherein at least one of the occlusion elements comprises an inflatable balloon.

20. The method of claim 17, wherein the device further includes a molding member positioned in the treatment space, and the method further includes the step of using the molding member to form the fluent prepolymer solution into an annular layer on the body lumen.

21. The method of claim 20, wherein the molding member comprises an inflatable balloon.

22. A method for providing a polymeric coating on a surface of a body lumen which comprises the steps of;

a) providing a device which comprises;

i) an elongate tubular sheath having a proximal occlusion element near its distal end;

ii) an elongate shaft, axially movable relative to the tubular sheath having a distal occlusion element near its distal end; and

iii) an optical emitter positioned at least in part between the proximal and distal occlusion elements, the emitter axially movable relative to at least the proximal occlusion element;

b) advancing the elongate member such that the distal occlusion element is positioned at a desired location;

c) advancing the tubular sheath relative to the elongate member such that the distal end of the tubular sheath is positioned proximal to the distal end of the elongate member;

d) positioning the optical emitter at a treatment site;

e) actuating at least one of the proximal and distal occlusion elements to define a treatment space;

f) injecting a fluent prepolymer into the treatment space;

g) directing light through the optical emitter into the prepolymer to photopolymerize at least a portion of the prepolymer; and

h) deactuating said at least one occlusion element; and

,

i) withdrawing the device from the body lumen, thereby leaving a layer of polymeric material on at least a surface of the body lumen.

23. The method of claim 22 wherein at least one of the occlusion elements comprises an inflatable balloon.

24. The method of claim 22 wherein the treatment space is flushed with at least one fluid prior to injecting the fluent prepolymer into the treatment space.

25. The method of claim 22 wherein the relative distance between the proximal occlusion element and the distal occlusion element is adjustable.

26. The method of claim 22 wherein at least one occlusion element comprises a valve-occlusion balloon.

27. The method of claim 22, wherein said elongate shaft is coaxial with said sheath for at least a portion of its length.

28. The method of claim 22 wherein the device further includes a molding member positioned at least in part in the treatment space, and the method further includes the step of using the molding member to form the fluent prepolymer solution into an annular layer on the body lumen.

29. The method of claim 28 wherein the molding member comprises an inflatable balloon.

30. A method for providing a polymeric coating on a surface of a body lumen which comprises the steps of:

a) providing a device which comprises;

I) an elongate tubular sheath having a proxtmal occlusion element near its distal end;

ii) an elongate shaft, axially movable relative to the tubular sheath having a distal occlusion element near its distal end; and

iii) an optical emitter positioned at least in part between the proximal and distal occlusion elements, the emitter axially movable relative to at least the proximal occlusion element;

b) advancing the elongate member such that the distal occlusion element is positioned at a desired location;

c) advancing the tubular sheath relative to the elongate member such that the distal end of the tubular sheath is positioned proximal to the distal end of the elongate member;

d) positioning the optical emitter at a treatment site;

c) advancing the tubular sheath relative to the elongate member such that the distal end of the tubular sheath is positioned proximal to the distal end of the elongate member;

d) positioning the optical emitter at a treatment site;

e) actuating at least one of the proximal and distal occlusion elements to define a treatment space and flushing the treatment space with a photoinitiator;

f) then injecting a fluent prepolymer into the treatment space;

g) directing light through the optical emitter into the prepolymer to photopolymerize at least a portion of the prepolymer;

h) deactuating said at least one occlusion element; and

,

I) withdrawing the device from the body lumen, thereby leaving a layer of polymeric material on at least a surface of the body lumen.

31. The method of claim 30, further comprising removing from the treatment space one of either photoinitiator that is not adsorbed by the body lumen surface or prepolymer that is not polymerized by the light prior to deactuating the at least one occlusion element.

32. The method of claim 30, wherein at least one of the occlusion elements comprises an inflatable balloon.

33. The method of claim 30, wherein the relative distance between the proximal occlusion element and the distal occlusion element is adjustable.

34. The method of claim 30, wherein the device further includes a molding member positioned at least in part in the treatment space, and the method further includes the step of using the molding member to form the fluent prepolymer solution into an annular layer on the body lumen.

35. The method of claim 34, wherein the molding member comprises an inflatable balloon.

36. A method for providing a polymeric coating on a surface of a body lumen which comprises the steps of:

a) providing a device which comprises;

i) an elongated shaft including at least one injection lumen for injecting a flushing liquid, a photoinitiator, and a fluent prepolymer material into the body lumen; and

ii) an optical emitter positioned adjacent to the surface to be coated;

b) guiding the device through a body lumen to position the optical emitter adjacent to the surface to be coated;

c) optionally injecting a flushing liquid into the lumen at the surface to be coated;

d) injecting a photoinitiator to stain the surface to be coated;

e) injecting a fluent prepolymer to contact surfaces stained with the photoinitiator;

f) directing light through the optical emitter into the prepolymer to photopolymerize at least a portion of the prepolymer and render it non-fluent; and

g) withdrawing the device from the body lumen, thereby leaving a layer of polymeric material on at least a surface of the body lumen.

37. A method as in claim 36 which further includes the step of injecting a flushing liquid into the lumen at the surface to be coated subsequent to the step of injecting the photoinitiator.