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United States Patent m

Fletcher et al.

...

US005190539A

[ii] Patent Number: 5,190,539 [45] Date of Patent: Mar. 2,1993

[54] MICRO-HEAT-PIPE CATHETER

[75] Inventors: Leroy S. Fletcher; George P.

Peterson, both of College Station,
Tex.

[73] Assignee: Texas A & M University System,
College Station, Tex.

[21] Appl. No.: 550,519

[22] Filed: Jul. 10,1990

[51] Int. CI.' A61B 17/36

[52] U.S. Q 606/25; 606/28

[58] Field of Search 606/21-25,

606/27, 28; 128/401

[56] References Cited

U.S. PATENT DOCUMENTS

3,929,136 12/1975 Kreeb et al 606/25

4,140,130 2/1979 Storm, III .

4,206,759 6/1980 Shaw 606/28

4,476,867 10/1984 Parks .

4,479,798 10/1984 Parks .

4,662,383 5/1987 Sogawa et al. .

4,667,658 5/1987 Guibert .

4,676,258 6/1987 Inokuchi et al. .

4,719,919 1/1988 Marchosky et al. .

4,791,930 12/1988 Suzuki et al. .

4,819,642 4/1989 Andersen et al. .

4,825,880 5/1989 Stauffer et al. .

4,869,247 9/1989 Howard, III et al. .

4,900,303 2/1990 Lemelson .

OTHER PUBLICATIONS

Lele, Local Tumor Hyperthermia in the 1990's Reprinted from: Consensus of Hyperthermia for the 1990's, H. I. Bicker, Ed., Plenum Pub. Corp. "Encyclopedia of Medical Devices and Instrumenta

tion", J. G. Webster (Ed) John Wiley & Sons, N.Y. Bol. 3:1583 et seq. (1988).

Lele, Ultrasound Hyperthermia, reprinted from "Encyclopedia of Medical Devices and Instrumentation", J. G. Webster (Ed.), John Wiley & Sons, N.Y. vol. 3:1599-1612 (1988).

Waterman et al., Mechanisms of Heat Removal During Local Hyperthermia.

Roizin-Towle, A Concept of Thermal Dose is Urgently Needed For the Clinical Application of Hyperthermia (Letter).

Bicher et al., Local Superficial and Deep Hyperthermia—Factors Affecting Tumor Response and Patient Survival (Meeting Abstract).

Steger et al., Study of Local Interstitial Hyperthermia

Induced by Low Power ND:YAG Laser.

Furse et al., Three Dimensional Electromagnetic

Power Deposition in Tumors Using Interstitial Antenna

Arrays.

Surgery Cryoprobe.

Primary Examiner—Lee S. Cohen

Attorney, Agent, or Firm—Arnold, White & Durkee

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other intracavitary methods or interstitial techniques,

MICRO-HEAT-PIPE CATHETER such as placing heating elements directly into the tumor. The use of interstitial techniques permits the

SUMMARY OF THE INVENTION achievement of therapeutic temperature levels without

Millions of people are afflicted with some form of 5 appreciable heating of normal tissues, regardless of the cancer every year, and new techniques for cancer treat- tumor geometry. The use of a number of heating element are continually being developed. The use of local ments permits the regulation of the heat rate to the hyperthermia, or elevating the temperature of a cancer- appropriate level. Interstitial hyperthermia devices inous part of the body to a slightly higher temperature has elude sets of implanted electrodes connected to a radio received increased attention over the past few years. 10 frequency generator, combinations of implanted and Localized heating of a cancerous tumor (including the external electrodes, and implanted microwave antennas, edges of the tumor) to therapeutic temperatures of 42.5° Implanted or injected thennoseeds are also considered C. (108.5° F.) to 43.0° C. (109.4° F.) for periods of 20 to an invasive heating technique. 30 minutes will in most cases destroy the rapidly grow- Each of these invasive techniques has drawbacks, ing cancer cells and lead to the arrest of tumor growth. 15 The use of implanted electrodes, while simple, involves

Total body temperatures above 41.8° C. (107.2° F.) placing an array of needles into the tumor and connect

are detrimental to the functions of the central nervous ing them to an RF generator. The temperature field for

system, heart, liver, and kidney, and may even cause such electrodes is very difficult to control, and the

histologically obvious damage to tissue cells, whereas volume that can be heated effectively is rather small,

tumorcidal effects are generally not observed below 20 requiring many implants. Such an arrangement may

42.5° C. (108.5* F.). At brain temperatures of over 41.8° resuit m non-uniform heating with excessive tempera

C. (107.2* F.), the mechanism for regulation of body tures. Further, the use of high frequencies and high

temperature can be incapacitated and there is danger of voltage may interfere with the electronic thermometers

'malignant' or 'runaway' hyperthermia. Further, tern- md could be harmful to the patient.

peratures of up to 45* C. (113.0° F.) may cause soft 25 x lanted electrodes require connections t0 an exter

Ossue necroses and fistulas as well as skin burns. There- na, r sonnje- A j number of connection wires,

fore accurate temperature control is critical to success- of feed lin major blems. These

ful hyperthermia. As a consequence, there is a sigmfi- b,ems mdude ^ 0ver-heating of feed lines, as well

cant need for development of a simple hyperthermia temperature inhomoeeneity

device which will generate a precisely controllable heat 30 £ ... ^ from

rate that is confined to the tumor region in order to ., v .. . . . . . ~ ,j — .

minimize the risk of damage to the surrounding normal n"%*PI*«> magnetic induction field Each acts as a

tissue and the overall body functions. sma" heatm8 urat' transfernng heat to the tumor by

Local hyperthermia must elevate the temperature of conduction. Implanting microwave antennas is probaa cancerous tumor to a therapeutic level while maintain- 35 «y the most popular invasive heating technique and has ing the temperature of the surrounding tissue at normal been used ln manv treatments Generally, an array of levels. Numerous heating methods for tumor treatment sfds or an1tennas are Ranted m the tumor and left m have been proposed over the past few decades, and Place for the duration of the treatment, several methods are currently in practice. These heating Thermoseeds are generally small cylinders and retechniques may be classified from a clinical point of 40 °«mre careful placement m the tumor because the onenview as non-invasive and invasive. mioa respect to the induced magnetic field dic

Non-invasive hyperthermia techniques involve the tates the degree of tumor heating. As a consequence,

use of electromagnetic or ultrasound energy focused on each cylinder must be implanted individually. As with

the region to be heated by means of external systems. °th.er invasive methods, the use of thermoseeds has

This energy heats the body tissues to the desired tern- 45 limited temperature control. Further, areas with poor

peratures. While it is possible to focus this energy, the blo°d flow may overheat while regions with high blood

resulting effect is regional heating rather than local flow may not attain therapeutic temperatures,

heating, and the blood flow carries much of the heat Small ferromagnetic microspheres may be injected

away. This approach often exhibits large fluctuations in into the tumor or into the blood supply. The appropri

heating due to variations in blood flow and tissue ther- 50 ate region is then subjected to a high intensity, low

mal conductivity. frequency magnetic field. The microspheres absorb

Both electromagnetic and ultrasound energy must be energy from the magnetic field and heat the cancerous

carefully focused, and the wavelength of the beam must tissue by conduction heating. This technique, however,

be small compared to the tumor dimensions. As a conse- has not been used on humans.

quence, microwave heating is not useful for deep tu- 55 AH non-invasive and invasive techniques require a mors, but may be used on diseased areas only a few complete knowledge of the temperature distribution in centimeters into the body. Thus, microwave energy is the diseased region. As a consequence, these techniques restricted to superficial tumors or diseased areas not require the insertion of a large number of invasive temrequiring deep penetration. Ultrasound also exhibits a perature probes or an improvement in the thermal modfrequency-dependent penetration depth. Bones are very 60 eling of the region between temperature probes, strong absorbers of ultrasound beams while air cavities An ideal heating technique must account for the are almost perfect reflectors. Further, reflections occur three-dimensional character of a tumor and its surat dissimilar tissue interfaces, causing additional prob- roundings. Microwave antennas and implanted needle lems. Coupling between the applicator and skin also electrodes lack this ability. However, a technique emposes a problem in some cases. 65 ploying a micro-heat-pipe can account for this charac

Invasive heating techniques include the perfusion of teristic.

the extremities with extracorporally heated blood, the Micro-heat-pipe technology is well known to those in

irrigation of the urinary bladder with heated saline, and the field, and small heat-pipes and miniature heat-pipes

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