Treatment catheters with thermally insulated regions

• US 6,758,857 B2
• Filed: 11/13/2001
• Issued: 07/06/2004
• Est. Priority Date: 11/13/2000
• Status: Expired due to Fees

• Current Assignee: Wit Ip Corporation
• Original Assignee: ACMI Corp. (Olympus Corporation)
• Inventors: Cioanta, Iulian, Klein, Richard Barry, Lazarovitz, Jacob
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Rodriguez, Cris
• Application Number:
  US10/011,700
• Publication Number:
  US 20020082556A1
• Time in Patent Office: 966 Days
• Field of Search: 604/113, 604/114, 604/43, 604/96.01, 604/27, 604/48, 604/919, 604/6.13, 604/544, 604/101.01, 604/101.03, 604/101.05, 604/102.01, 604/102.02, 604/523, 604/264, 606/27, 606/28, 606/192-194, 607/104-106, 607/113, 607/116, 607/154, 607/156, 607/96, 607/99, 607/143
• US Class Current: 607/105
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2210/166 Prostate
• 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

Abstract

Flexible treatment catheters are configured to be inserted into a body lumen or cavity to deliver heated fluid through at least one fluid lumen therein to thermally treat or ablate a targeted site in a biological subject. The flexible treatment catheters can include improved thermally insulated regions comprising a mixture formed of liquid elastomeric (such as a polyurethane) mixture (which transitions to a solid state) and miniaturized hollow plastic bodies positioned between the outer wall of the treatment catheter and the fluid lumen. The thermally insulated region is configured such that, measured ex vivo, the treatment catheter can present a maximum temperature of below about 45° C. on the external surface of the outer wall of the treatment catheter when the treatment catheter circulates fluid having an inlet temperature of above or between about 60°-62° C. Alternatively or additionally, the treatment catheter can include an elongated insert positioned in a catheter fluid lumen to inhibit the closure of the lumen after exposure to fluids in the treatment catheter at temperatures sufficient to thermal ablate targeted tissue over a thermal ablation treatment period. The treatment catheter can include a urinary drainage lumen with an elongated insert frictionally engaged therewith, the drainage lumen and insert are configured to provide a fluid volume throughput through the drainage lumen of greater than about 20-25 ml/min during and after (for about 12-72 hours after) a thermal ablation session.

Claims

1. A treatment catheter configured for insertion into a body cavity or lumen of a biological subject, said treatment catheter comprising:

a flexible elongated tubular body having an outer wall with an external surface and at least one fluid lumen axially extending therein, wherein said tubular body comprises a region having increased thermal insulation relative to another region thereof, said increased thermal insulation region configured to encase said at least one fluid lumen therein, said at least one fluid lumen extending a length along said tubular body, wherein said increased thermal insulation region comprises a liquid elastomeric material which is introduced into said catheter such that it is captured between said outer wall and said at least one fluid lumen and then solidified therein prior to use.

2. A treatment catheter according to claim 1, wherein said increased thermal insulation region is defined by said outer wall, a plurality of void spaces interposed between said outer wall and the inner wall of said at least one fluid lumen, and wherein said liquid elastomeric material is introduced into selected ones of said void spaces.

3. A treatment catheter according to claim 2, wherein at least one of said void spaces has a perimeter with a polygonal shape.

4. A treatment catheter according to claim 3, wherein at least one of said void space perimeters has a substantially triangulated shape.

5. A treatment catheter according to claim 2, wherein at least one of said void spaces has a perimeter with a substantially circular shape.

6. A treatment catheter according to claim 2, wherein at least one of said void spaces has a perimeter with a substantially oval shape.

7. A treatment catheter according to claim 1, wherein said liquid elastomeric material comprises hollow microspheres.

8. A treatment catheter according to claim 7, wherein said insulating material comprises at least 10% volume of hollow microspheres.

9. A treatment catheter according to claim 7, wherein said hollow microspheres are hollow plastic microspheres, and wherein said liquid elastomeric material comprises at least one of nylon, polyurethane, polyethylene, silicone.

10. A treatment catheter according to claim 1, wherein said liquid elastomeric material comprises polyurethane.

11. A treatment catheter according to claim 1, further comprising an inflatable treatment balloon positioned about a peripheral distal portion of said elongated tubular body such that said treatment balloon is expandable to a configuration which extends radially outward a distance from said outer wall external surface of said tubular body, wherein said at least one fluid lumen is a plurality of lumens all axially extending within said tubular body such that said plurality of lumens are encased by said outer wall and, for at least a portion of the length of a more proximal portion of said tubular body relative to said treatment balloon, said plurality of fluid lumens are encased by outer wall and said increased thermal insulation region, wherein said plurality of lumens include a circulating fluid inlet lumen, a circulating fluid outlet lumen, and a drainage and fluid delivery lumen, and wherein said fluid inlet and outlet lumens are in fluid communication with said treatment balloon and are configured, in operation, to cause said treatment balloon to expand.

12. A treatment catheter according to claim 11, wherein, in position in a subject, said treatment catheter is configured to circulate a liquid heated external of said tubular body through said inlet lumen to said treatment balloon and out through said outlet lumen, the liquid heated to a temperature sufficient to thermally treat or ablate tissue at a desired biological target site proximate said treatment balloon, and wherein, in operation, said outer surface of said outer wall in said increased thermal insulation region has a temperature which is at or below about 45°

C.

13. A treatment catheter according to claim 12, wherein the temperature of the heated circulating liquid as it enters said inlet lumen of said tubular body is at or greater than about 60°

C., and wherein, measured ex vivo, said external surface of said outer wall about said increased thermal insulation region exhibits a maximum average temperature of about 42-45°

C. after a thermal treatment period of at least 30 minutes.

14. A treatment catheter according to claim 13, wherein said drainage and delivery lumen is centrally disposed within said tubular body, and wherein said inlet and outlet lumens are positioned on opposing sides thereof.

15. A treatment catheter according to claim 12, wherein said treatment catheter is sized and configured for insertion into the urethra of a male subject, the urethra generally including, in serial order from the external most portion to the internal portion, the penile meatus, the penile urethra, the bulbous urethra, the sphincter, the membranous urethra, the prostatic urethra, the bladder neck and the bladder, wherein said tubular body is sufficiently conformable to yield to the contours of the subject'"'"'s body as it is inserted therein, yet sufficiently rigid to maintain said drainage and delivery lumen in an open condition sufficient to discharge urine at a flow rate of at least about 20 ml/min when said catheter is in position in the urethra and exposed to prostatic tissue which is exhibiting distress during or subsequent to undergoing a thermal ablation therapy.

16. A treatment catheter according to claim 15, further comprising a anchoring balloon positioned on a distal portion of said tubular body such that it is more distal than said treatment balloon, said anchoring balloon configured and sized such that, when inflated and in position in the biological subject, said anchoring balloon resides against the bladder neck of the subject to position said treatment balloon in the prostate relative to the bladder of the subject, wherein said treatment catheter includes a port on said distal portion thereof in fluid communication with said drainage and delivery lumen to allow urine to drain therethrough.

17. A treatment catheter according to claim 1, wherein said at least one fluid lumen comprises at least one drainage and fluid delivery lumen, and wherein said tubular body is sufficiently conformable to yield to the contours of the subject'"'"'s body as it is inserted therein, yet sufficiently rigid to maintain said drainage and delivery lumen in an open condition which is sized at about at least 50-75% of the size of the lumen outside the body before the treatment, when in position in the body and exposed to tissue which is exhibiting distress during or subsequent to a treatment.

18. A treatment catheter according to claim 1, wherein said at least one fluid lumen comprises three lumens, a circulating inlet channel, a circulating outlet channel, and at least one drainage lumen, wherein in cross-section, said three lumens define three substantially equal pie shaped areas extending radially outward from a common center, and wherein said tubular body is sufficiently conformable to yield to the contours of the subject'"'"'s body as it is inserted therein.

19. A treatment catheter according to claim 1, wherein said at least one fluid lumen comprises four lumens, a circulating inlet channel, a circulating outlet channel, and two drainage lumens, wherein in cross-section, said four lumens each occupy a quadrant of a common circle, and wherein said tubular body is sufficiently conformable to yield to the contours of the subject'"'"'s body as it is inserted therein.

20. A treatment catheter according to claim 1, wherein said at least one fluid lumen includes at least one drainage and fluid delivery lumen with a flexibly configured elastomeric wall, and said catheter further comprises an elongated insert disposed in said drainage and delivery lumen to provide increased structural rigidity to said lumen wall inhibit the collapse of said drainage and delivery lumen when positioned in the subject and exposed to the body'"'"'s reaction to a therapeutic treatment.

21. A treatment catheter according to claim 1, wherein said treatment balloon comprises a thin wall expandable elastomeric balloon comprising a surface coating comprising ceramic microspheres positioned thereon to enhance the thermal transmissivity of said treatment balloon.