Treatment catheters with thermally insulated regions
First Claim
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 a thin 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 plurality of segments defining spaces having associated perimeter shapes radially extending between said at least one fluid lumen and said outer wall, wherein at least one of said plurality of segment spaces has a perimeter shape with at least one edge portion which is arranged so that said perimeter shape radially tapers into said edge portion as it approaches at least one of said at least one fluid lumen and said outer wall such that said at least one said edge portion is oriented to reside proximate to one of said outer wall and said at least one fluid lumen to define a contact point thereat.
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Accused Products
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.
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Citations
76 Claims
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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 a thin 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 plurality of segments defining spaces having associated perimeter shapes radially extending between said at least one fluid lumen and said outer wall, wherein at least one of said plurality of segment spaces has a perimeter shape with at least one edge portion which is arranged so that said perimeter shape radially tapers into said edge portion as it approaches at least one of said at least one fluid lumen and said outer wall such that said at least one said edge portion is oriented to reside proximate to one of said outer wall and said at least one fluid lumen to define a contact point thereat. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 26, 27, 28, 29, 30, 31, 32)
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25. 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 a thin outer wall with an external surface and at least one fluid lumen axially extending therein, and a plurality of segments having associated perimeter shapes radially extending between said at least one fluid lumen and said outer wall, said fluid lumen axially extending a length along said tubular body, wherein at least one of said plurality of segments has a perimeter shape with at least one edge portion which is arranged so that said perimeter shape radially tapers into said edge portion as it approaches at least one of said at least one fluid lumen and said outer wall such that said at least one said edge portion is oriented to point toward and reside proximate to one of said outer wall and said at least one fluid lumen to define a contact point thereat.
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33. 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. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53)
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54. A catheter configured for insertion into a body cavity or lumen of a biological subject, said treatment catheter comprising:
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a flexible elongated tubular body having a thin outer wall with an external surface;
at least one fluid lumen axially extending within said tubular body such that said at least one lumen is encased by said outer wall; and
an elongated insert sized and configured to be received into said at least one fluid lumen to inhibit the closure of said fluid lumen to allow fluid throughput volumes of at least about 20 ml/min, when in position in the subject, and wherein said elongated insert has increased rigidity compared to said at least one fluid lumen. - View Dependent Claims (55, 56, 57, 58, 59, 60, 61, 62, 63)
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64. A method of thermally treating a subject, comprising the steps of:
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inserting a flexible treatment catheter in the natural lumen or body cavity of a subject;
circulating liquid, heated external of the subject, in the treatment catheter such that it travels, captured in the treatment catheter, to a localized treatment region and exposes targeted tissue to a temperature of above about 45°
C. for a predetermined thermal ablation treatment period;
insulating non-targeted tissue below the targeted region such that the non-targeted tissue is exposed to a maximum temperature of about 42-45°
C. from contact with the external surface of the treatment catheter during said circulating step;
draining body fluids through the treatment catheter during said circulating step, wherein said treatment catheter is configured in a manner which allows a drainage volume of above about 20 ml/min after said circulating step and before said removing step; and
removing the treatment catheter after an initial healing period of about 12-72 hours. - View Dependent Claims (65, 66, 67, 68, 69)
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70. A method of inhibiting the closure of a flexible thin walled lumen in a catheter configured for insertion into a lumen or cavity of a biological subject, comprising the steps of:
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providing a flexible elongated catheter such that it is sized for insertion into a natural body lumen or cavity of a biological subject and such that it can bend to follow the contour of the body lumen or cavity, the flexible catheter comprising at least one fluid channel therein; and
positioning an elongated insert into the at least one fluid channel such that it axially extends along a length thereof, the elongated insert configured to maintain an open fluid channel during and after the flexible catheter delivers a thermal therapy to a desired target site in the biological subject. - View Dependent Claims (71, 72)
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73. A method for providing increased thermal insulation in a treatment catheter having at least one fluid lumen therein, the treatment catheter having an outer wall which encases the at least one fluid lumen therein, the treatment catheter being configured to deliver a thermal or thermal ablation treatment to a target site in a natural lumen or body cavity of a biological subject, the method comprising the steps of:
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introducing a quantity of liquid insulation mixture into a desired region of the treatment catheter such that it is held intermediate the at least one fluid lumen and the outer surface of the treatment catheter; and
allowing the liquid mixture to harden to a non-liquid state to define a thermally insulated region in the catheter. - View Dependent Claims (74, 75, 76)
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Specification