|Publication number||US20020077680 A1|
|Application number||US 10/012,929|
|Publication date||Jun 20, 2002|
|Filing date||Dec 10, 2001|
|Priority date||Dec 15, 2000|
|Also published as||US6602243, US20020082587, US20030114835, WO2002047742A2, WO2002047742A3|
|Publication number||012929, 10012929, US 2002/0077680 A1, US 2002/077680 A1, US 20020077680 A1, US 20020077680A1, US 2002077680 A1, US 2002077680A1, US-A1-20020077680, US-A1-2002077680, US2002/0077680A1, US2002/077680A1, US20020077680 A1, US20020077680A1, US2002077680 A1, US2002077680A1|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (3), Referenced by (34), Classifications (13), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
 Priority of application Ser. No. 60/256,083 filed on Dec. 15, 2000 in the United States of America with the USPTO is claimed under 35 U.S.C. § 119(e).
 This invention relates to Foley Catheters, and particularly Foley Catheters having temperature sensors.
 The disclosures of U.S. Pat. No. 6,019,783, issued Feb. 1, 2000, U.S. Pat. No. 6,126,684, issued Oct. 3,2000, and U.S. Pat. No. 6,146,411, issued Nov. 14, 2000, are incorporated herein by reference.
 Foley catheters typically include a soft, thin rubber tube with a balloon on one end. The catheter is threaded through the urinary duct (urethra) and into the bladder to drain urine from the bladder. A Foley catheter is typically used when normal urination is disrupted by an infection, a swollen prostate gland, bladder stones, or, sometimes, an injury. In very sick people, a catheter may be used to keep track of urine production.
 A typical Foley catheter has drainage lumen, and an inflation lumen for inflating and deflating the balloon. The balloon is normally deflated until properly positioned in a patient's bladder. Once the catheter is properly positioned, the inflation lumen delivers fluid to inflate the balloon. The inflated balloon holds the catheter in place.
 There are risks associated with the use of a Foley catheter. For example, the bladder or urethra could be injured when the Foley catheter is inserted. Infection is also possible. Patients may find the process of insertion of a Foley catheter unpleasant and sometimes painful.
 The bladder is an accepted situs for core body temperature measurements. Accordingly, some Foley catheters include a temperature sensor included on the end of the catheter. A wire connects the sensor, via the catheter, to externally located monitoring devices.
 One drawback to Foley catheters with a temperature sensor is that the sensor may fail. When the sensor fails, the failed catheter may have to be replaced. This not only compounds patient discomfort, but also increases the risk of injury and infection for the patient.
 What is desired is a way to measure a patient's core body temperature while minimizing patient discomfort and risk of injury. What is also desired is a way of assuring redundancy and accuracy in core body temperature measurements.
 The adapter of the present invention attaches to the drainage lumen of a standard Foley catheters, including Foley catheters having integrated temperature sensors. The adapter is generally “Y” shaped, having a drainage lumen in communication with the catheter drainage lumen, and a temperature sensor lumen with a temperature sensor.
 The adapter has a threaded fitting fixed on the adapter temperature sensor lumen for sealing the temperature sensor lumen and for anchoring the temperature sensor. The adapter has a threaded cap and a seal. The seal seats in the adapter and the threads of the cap join with the threads of the fitting to actuate the seal.
 The temperature sensor includes a sensor element disposed distally on the temperature sensor, and a wire. The wire extends from the sensor element through the fitting.
 The cap compresses the seal against the fitting when the cap attaches to the adapter. Accordingly, the fitting prevents leakage and anchors the temperature sensor wire with respect to the adapter.
FIG. 1 is a perspective view of a Foley catheter and the adapter in accordance with the present invention.
FIG. 2 is a perspective view of a Foley catheter inserted into a patient and the adapter in accordance with the present invention.
FIG. 3 is a cross-sectional view of the catheter body as seen along the line 3-3 in FIG. 2.
FIG. 4 is an exploded cross-sectional view of the cap and fitting in accordance with the present invention.
FIG. 5 is a cross-sectional view of the cap operatively engaged with the fitting as seen along the line 4-4 of FIG. 2.
FIG. 1 shows a Foley catheter generally designated with the reference numeral 10. The catheter 10 includes a catheter body 12 with a proximal end 14 and a distal end 16. The catheter 10 also includes a balloon 18, an inflation lumen 20, a drainage lumen 22, and an adapter 24.
 The balloon 18 is deflated for insertion into a patient. The balloon 18 is disposed near the distal end 16. The inflation lumen 20 extends within the catheter body 12 from the proximal end 14 to the balloon 18, in fluid communication with the balloon 18, for inflating and deflating the balloon 18.
 The catheter drainage lumen 22 extends from the proximal end 14 to the distal end 16. The distal end 16 includes an opening 26 in fluid communication with the drainage lumen 22 to facilitate drainage of urine from the bladder of a patient.
 The adapter 24 has a drainage lumen 30, a temperature sensor lumen 32 and a connector 25. The connector 25 attaches to the proximal end 14 of the catheter body 12. The connector 25 establishes fluid communication between the adapter drainage lumen 30 and the catheter drainage lumen 22. Preferably the connector 25 is tapered and includes ribs 27 for insertion and press-fit into the proximal end 14 of the catheter body 12.
 The adapter temperature sensor lumen 32 includes a fitting 34 and a cap 36. The temperature sensor 38 has a wire 40 and a distally located sensor element 33 (FIG. 2). The fitting 34 is fixed on the temperature sensor lumen 32 of the adapter 24. Preferably the fitting 34 bonds to the temperature sensor lumen 32. The fitting 34 receives the cap 36. The cap 36 and a portion of the fitting 34 are threaded to enable the cap 36 to rotate onto the fitting 34. The cap 36 is rotatable to adjustably torque the cap 36 onto the fitting 34.
 The temperature sensor wire 40 normally slides through the cap 36, the fitting 34, the connector 25, and the catheter drainage lumen 22. The temperature sensor 38 includes a distally mounted temperature sensor element 33 (FIG. 2) that seats in the distal end 16 of the catheter body 12. Rotating the cap 36 with respect to the fitting 34 selectively anchors the wire 40 with respect to the adapter 24 to prevent movement of the sensor element 33.
 FIG.2 shows the Foley catheter 10 inserted into the bladder 42 of a patient. The Foley catheter 10 includes an integrated temperature sensor 46 with an integrated sensor element 35 disposed at the distal end 16 of the catheter body 12.
 During normal operation of the Foley catheter 10, the catheter 10 is introduced into the bladder 42 of a patient. The balloon 18 inflates to hold the catheter 10 in the bladder 42. Urine drains from the bladder 42 through the opening 26 and via the catheter drainage lumen 22. The integrated sensor 46 with the sensor element 35 senses the patient's bladder temperature.
 The adapter 24 attaches to the proximal end 14 of the catheter body 12. An operator manually advances the temperature sensor wire 40 to slide the temperature sensor wire 40 and sensor element 33 via the drainage lumen, towards the distal end 16 of the catheter body 12. Preferably, the temperature sensor wire 40 slides the temperature sensor element 33 fully to the distal end 16 of the catheter body 12.
 According to one method of using the invention, the integrated temperature sensor 46 fails. This failure is detected. The Foley catheter 10 remains in the bladder 42. The adapter 24 of the present invention then attaches to the proximal end 14 of the catheter and the sensor 38 with the sensor element 33 advances through the drainage lumen of the Foley catheter 10 to position the sensor element 33 in the distal end 16 of the catheter body 12.
 The sensor element 35 and the sensor element 33 are collocated for redundancy and improved accuracy. The sensor elements 33 and 35 provide a primary and secondary measure, respectively, of core body temperature. The secondary measure of temperature is used in conjunction with primary temperature measurements for improved temperature sensing accuracy and reliability.
 Collocated temperature sensor elements 33 and 35 are also useful for communicating with discrete monitoring and data compilation devices requiring temperature input, such as a discrete patient data recorder and a medical device, for examples.
 It can be appreciated that sensor collocation may not be required in some systems. For example, when a patient normothermia is desired, and an intravascular temperature regulator is used on the patient, it may be desirable to have multiple temperature sensors in various parts of the body (including the bladder) to optimally determine the patient core body temperature and communicate that body temperature to the intravascular temperature regulator.
 According to one aspect of the invention, the temperature adapter 24 and Foley catheter 10 are used in conjunction with vascular heat exchange catheter such as disclosed in copending U.S. patent application Ser. No. 09/220,897, the disclosure of which is incorporated herein by reference. It can be appreciated that core body temperature measurements are important to facilitate proper functioning of any system that regulates the core body temperature of a patient. Accordingly, redundant bladder temperature measurements with collocated sensor elements 33 and 35, is desirable to minimize any risk or inconvenience associated with temperature monitoring failure.
 Foley catheters can be used to drain urine for several weeks. An integrated temperature sensor 46, may fail during this period. The method, thus, enables an introduced Foley catheter having a failed integrated temperature sensor 46 to be used continuously for draining urine notwithstanding failure of the integrated temperature sensor 46. The steps of maintaining the catheter 10 in the bladder 42 and attaching the adapter 24 to the proximal end 14 and advancing the adapter temperature sensor 38 provides a secondary measure of temperature without requiring the unpleasant steps of removal and replacement of the Foley catheter 10.
FIG. 3 shows the catheter body 12 having three lumens, the inflation lumen 20, the drainage lumen 22, and an integrated temperature sensor lumen 48. The temperature sensor lumen 48 houses the wire 46 of the integrated temperature sensor 46. The wire 40 of the adapter temperature sensor 38 is positioned freely in the drainage lumen 22.
FIG. 4 shows the cap 36, the fitting 34 and a seal 56. The cap 36 has internal threads 50 and the fitting 34 has external threads 52. The cap 36 has an axis and includes an axially disposed post 54. The seal 56 seats within the fitting 34. The post 54 defines a portion of a channel 58. The channel 58 extends axially through the cap 36, the fitting 34 and the seal 56. The temperature sensor wire 40 normally slides through the channel 58 when the cap 36 and the fitting 34 loosely engage, or disengage.
 According to an aspect of the invention, the seal 56 is generally cylindrical in shape and circumscribes the wire 40. The wire 40 is lubricated to facilitate sliding when the cap 36 loosely fits on the fitting 34.
 The fitting 34 defines an annular flange 62 so that when the cap 36 threads on to the fitting 34, the post 54 of the cap 36 presses the seal 56 against the annular flange 62. Rotation of the cap 36 with respect to the fitting 34 deforms the seal 56, which grips the wire 40 and thereby selectively anchors the wire 40 with respect to the cap 36 and the fitting 34.
FIG. 5 shows the cap 36 engaging the fitting 34. The cap 36 rotates to compress the seal 56 against the flange 62. The seal 56 circumscribes the wire 40 so that compressing the seal 56 anchors the wire 40.
 In Use
 An anticipated use for the invention described herein is in conjunction with a patient temperature regulation system having a heat exchange catheter. A system having a heat exchange catheter is described generally in U.S. Pat. No. 6,019,783, the disclosure of which is incorporated herein by reference. A feedback loop between the temperature sensor of the Foley catheter and the patient temperature regulation system is established.
 A typical patient temperature regulation system includes an venous catheter having a heating and/or cooling element. The catheter inserts into a patient's central venous system to warm and/or cool the blood. The warmed/cooled blood circulates within the patient to effect the patient core body temperature. In accordance with the present invention, the core body temperature is measured using a Foley catheter and adaptor as described herein.
 A heat exchange catheter is described in U.S. Pat. Nos. 6,146,411 and 6,126,684, the disclosures of which are incorporated herein by reference. One heat exchange catheter includes lumens for circulating heat exchange fluid within the catheter. This creates a closed system heat exchanger so that circulation of heat exchange fluid within the catheter cools/warms the blood of the patient. A system employing the heat exchange catheter has a temperature measurement device and a control unit. The control unit regulates the rate of flow of the heat exchange fluid as well as the temperature of the fluid. A feedback loop established between the Foley catheter-based temperature sensor elements of the present invention is used to regulate the heat exchange fluid temperature of the closed system, and the rate of heat exchange fluid flow.
 While the present invention is anticipated to be used in conjunction with a patient temperature regulation system, it can be appreciated that it can be used in any of a number of systems. For example, the present invention can be used in virtually any surgical procedure requiring a measurement of a patient's core body temperature.
 It can also be appreciated that the seal 56 may take many forms, including that of an o-ring. Notwithstanding the form of the seal 56, the relative movement of the cap with respect to the seal 56 deforms the seal 56 to anchor the wire 40. It can be appreciated that the seal 56 need not simply seat in the fitting 34, the seal may also be formed as part of the fitting 34, or the cap 36. The fitting 34 maybe discrete, or integrated with the temperature sensor lumen 32 of the adapter 24. Accordingly, the present invention should be limited only by the claims as set forth below.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4413633 *||Jun 1, 1981||Nov 8, 1983||Yanda Roman L||Method and apparatus for monitoring body conditions|
|US5344435 *||Nov 5, 1990||Sep 6, 1994||Bsd Medical Corporation||Urethral inserted applicator prostate hyperthermia|
|US5352215 *||Aug 26, 1992||Oct 4, 1994||Scimed Life Systems, Inc.||Y-adapter with a sideport radius|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US6533804||Jan 11, 2001||Mar 18, 2003||Innercool Therapies, Inc.||Inflatable catheter for selective organ heating and cooling and method of using the same|
|US6540771||Jan 8, 2001||Apr 1, 2003||Innercool Therapies, Inc.||Inflatable catheter for selective organ heating and cooling and method of using the same|
|US6585752||Nov 7, 2001||Jul 1, 2003||Innercool Therapies, Inc.||Fever regulation method and apparatus|
|US6595967||Sep 16, 2002||Jul 22, 2003||Innercool Therapies, Inc.||Collapsible guidewire lumen|
|US6602243 *||Mar 21, 2001||Aug 5, 2003||Alsius Corporation||Foley catheter having redundant temperature sensors and method|
|US6602276||Mar 1, 2001||Aug 5, 2003||Innercool Therapies, Inc.||Method and device for performing cooling- or cryo-therapies for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation|
|US6648908||Mar 11, 2002||Nov 18, 2003||Innercool Therapies, Inc.||Inflatable catheter for selective organ heating and cooling and method of using the same|
|US6676689||Mar 11, 2002||Jan 13, 2004||Innercool Therapies, Inc.||Inflatable catheter for selective organ heating and cooling and method of using the same|
|US6676690||Jun 20, 2001||Jan 13, 2004||Innercool Therapies, Inc.||Inflatable heat transfer apparatus|
|US6685732||Aug 17, 2001||Feb 3, 2004||Innercool Therapies, Inc.||Method and device for performing cooling- or cryo-therapies for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation employing microporous balloon|
|US6695873||Mar 11, 2002||Feb 24, 2004||Innercool Therapies, Inc.||Inflatable catheter for selective organ heating and cooling and method of using the same|
|US6974463||Aug 14, 2002||Dec 13, 2005||Innercool Therapies, Inc.||System and method for patient temperature control employing temperature projection algorithm|
|US7458984||Jan 28, 2004||Dec 2, 2008||Innercool Therapies, Inc.||System and method for inducing hypothermia with active patient temperature control employing catheter-mounted temperature sensor and temperature projection algorithm|
|US7651518||Nov 14, 2003||Jan 26, 2010||Innercool Therapies, Inc.||Inflatable catheter for selective organ heating and cooling and method of using the same|
|US7766949||Aug 16, 2006||Aug 3, 2010||Innercool Therapies, Inc.||Fever regulation method and apparatus|
|US7822485||Sep 25, 2006||Oct 26, 2010||Zoll Circulation, Inc.||Method and apparatus for spinal cooling|
|US7857781||May 16, 2005||Dec 28, 2010||Zoll Circulation, Inc.||Indwelling heat exchange catheter and method of using same|
|US7867266||Nov 13, 2006||Jan 11, 2011||Zoll Circulation, Inc.||Temperature management system with assist mode for use with heart-lung machine|
|US7892269||Apr 4, 2006||Feb 22, 2011||Zoll Circulation, Inc.||External heat exchange pad for patient|
|US7892270||Nov 21, 2006||Feb 22, 2011||Zoll Circulation Inc.||Temperature management system and method for burn patients|
|US7914564||Dec 12, 2005||Mar 29, 2011||Innercool Therapies, Inc.||System and method for patient temperature control employing temperature projection algorithm|
|US7951182||Jul 14, 2005||May 31, 2011||Zoll Circulation, Inc.||System and method for leak detection in external cooling pad|
|US7951183||May 13, 2008||May 31, 2011||Innercool Therapies, Inc.||Medical procedure|
|US8597183||Dec 21, 2009||Dec 3, 2013||Pneumoflex Systems, Llc||Involuntary contraction induced pressure as a medical diagnostic tool using involuntary reflex cough test|
|US8597184||Sep 9, 2010||Dec 3, 2013||Pneumoflex Systems, Llc||Techniques for evaluating urinary stress incontinence and use of involuntary reflex cough as a medical diagnostic tool|
|US8602987||Dec 21, 2009||Dec 10, 2013||Pneumoflex Systems, Llc||Techniques for evaluating stress urinary incontinence (SUI) using involuntary reflex cough test|
|US8840550||Oct 22, 2013||Sep 23, 2014||Pneumoflex Systems, Llc||Involuntary contraction induced pressure as a medical diagnostic tool using involuntary reflex cough test|
|US8845533||Oct 22, 2013||Sep 30, 2014||Pneumoflex Systems, Llc||Techniques for evaluating urinary stress incontinence and use of involuntary reflex cough as a medical diagnostic tool|
|US8845534||Oct 23, 2013||Sep 30, 2014||Pneumoflex Systems, Llc||Techniques for evaluating stress urinary incontinence (SUI) using involuntary reflex cough test|
|US9011328||Sep 9, 2010||Apr 21, 2015||Pneumoflex Systems, Llc||Oral-esophageal-gastric device with esophageal cuff to reduce gastric reflux and/or emesis|
|US9028406||Sep 9, 2010||May 12, 2015||Pneumoflex Systems, Llc||Oral-esophageal-gastric device to diagnose reflux and/or emesis|
|US20040102826 *||Nov 17, 2003||May 27, 2004||Innercool Therapies, Inc.||Method and apparatus for regulating patient temperature by irrigating the bladder with a fluid|
|US20040267339 *||Jan 28, 2004||Dec 30, 2004||Innercool Therapies, Inc.||System and method for inducing hypothermia with active patient temperature control employing catheter-mounted temperature sensor and temperature projection algorithm|
|WO2009116000A2 *||Mar 18, 2009||Sep 24, 2009||Nova Biomedical Corporation||Intravascular sensor and insertion set combination|
|U.S. Classification||607/105, 604/317, 600/549|
|International Classification||A61B5/01, A61B17/00, A61B17/22|
|Cooperative Classification||A61B17/00, A61B2017/00084, A61B2017/00115, A61B2017/00119, A61B2017/22068, A61B2017/00292|
|Dec 10, 2001||AS||Assignment|
Owner name: ALSIUS CORPORATION, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:NODA, WAYNE A.;REEL/FRAME:012383/0921
Effective date: 20011205