CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 12/902636, filed Oct. 12, 2010, which is a continuation of U.S. patent application Ser. No. 10/436,500, filed on May 13, 2003, now U.S. Pat. No. 7,837,720, which is a continuation-in-part of U.S. patent application Ser. No. 09/954,194, filed Sep. 18, 2001, now U.S. Pat. No. 6,958,075, and a continuation-in-part of U.S. patent application Ser. No. 10/247,747, filed Sep. 20, 2002, now U.S. Pat. No. 6,788,977, which is a continuation-in-part of U.S. patent application Ser. No. 09/597,234, filed Jun. 20, 2000, now U.S. Pat. No. 6,477,426. The entirety of each of the above referenced patent applications is hereby incorporated by reference.
- Top of Page
OF THE INVENTION
1. Field of the Invention
The present invention generally relates to an apparatus and method for administering focused energy to a body using either a single energy applicator or multiple microwave applicators and compression of the body with a balloon filled with fluid, in order to treat visible tumors and microscopic malignant and benign cells in tissue with thermotherapy. In particular, the present invention relates to a transurethral catheter for thermal and warming therapy with compression of prostate tissue adjacent a urethra where the compression balloon is coated with a drug to create a drug-infused biological stent.
2. Description of the Prior Art
In order to treat the prostate with thermotherapy, it is necessary to heat a significant portion of the prostate gland while sparing healthy tissues in the prostate as well as the surrounding tissues including the urethral and rectal walls of a patient. The prostate gland encircles the urethra immediately below the bladder. The prostate, which is the most frequently diseased of all internal organs, is the site of a common affliction among older men, benign prostatic hyperplasia (BPH), acute prostatitis, as well as a more serious affliction, cancer. BPH is a nonmalignant, bilateral nodular tumorous expansion of prostate tissue occurring mainly in the transition zone of the prostate. Left untreated, BPH causes obstruction of the urethra that usually results in increased urinary frequency, urgency, incontinence, nocturia and slow or interrupted urinary stream.
Recent treatment of BPH includes transurethral microwave thermotherapy in which microwave energy is employed to elevate the temperature of tissue surrounding the prostatic urethra above about 45° C., thereby thermally damaging the tumorous prostate tissue. U.S. Pat. Nos. 5,330,518 and 5,843,144 describe methods of ablating prostate tumorous tissue by transurethral thermotherapy, the subject matter of which is incorporated by reference. However, improvements still need to be made in this type of therapy to further maintain or enhance the patency of the urethra after the thermotherapy treatment. In particular, urine flow is not always improved despite ablation of the tumorous tissue causing constriction of the urethra because edema produced by the transurethral thermo-therapy treatment blocks the urethra passage resulting in patients treated by the above methods to be fitted with catheters for several days or weeks after the thermotherapy treatment.
U.S. Pat. Nos. 5,007,437, 5,496,271 and 6,123,083 disclose transurethral catheters with a cooling balloon in addition to the anchoring or Foley balloon and are incorporated by reference herein. However, these patents circulate fluid, which acts as a coolant for removing heat preferentially from the non-prostatic tissue adjacent thereto, through the cooling balloons. The '083 patent further discloses the use of a thermotherapy catheter system taught by U.S. Pat. No. 5,413,588 that employs chilled water between about 12° C.-15° C. as the coolant. Chilled water significantly cools the urethra adjacent the cooling balloon. Likewise, the '271 patent describes a coolant as the fluid to keep the urethral wall temperatures cool. This chilling of the urethra does not aid in maintaining an opening within the heated urethra after the cooling balloon is removed, and reduces the therapeutic effect in the tissue immediately adjacent the urethral wall.
Another known alternative to thermal surgery, as described in U.S. Pat. No. 5,499,994, is to insert a dilation balloon in the urethra and to expand the dilation balloon to compress the obstructed urethra. However, the expansion of the dilation balloon occurs over 24 hours and the patient still is not cured of the diseased prostate. Further, the expansion can cause adverse effects (e.g., tearing of the urethral walls). U.S. Pat. No. 6,102,929 describes a post-operative procedure where the prostate tissue is expanded after the surgical procedure to enlarge the urethra to enable a patient to void comfortably. This expansion requires insertion of another device and requires the device to remain in the patient for a day or more.
In view of the fact that post-treatment catheters or other devices are still considered necessary by the medical community, further improvements are needed in thermotherapy to avoid the obstruction caused by edema and to maintain and enhance the opening of the urethra.
- Top of Page
OF THE INVENTION
The present invention is directed to an apparatus and a method for thermally treating tissue adjacent a bodily conduit, such as a urethra, while preventing obstructions of the bodily conduit due to edema and delivering a drug or medicine to a targeted region. To achieve this object, the instant invention employs a catheter with an energy-emitting source and a compression balloon surrounding the energy-emitting source which is inflated by fluid that compresses, preps, and allows better energy coupling to the bodily conduit walls adjacent the compression balloon. The fluid inflating the compression balloon is maintained under pressure after the compression balloon is inflated to the desired diameter and, in a preferred embodiment, is not circulated so that heat is not carried away from the bodily conduit walls thereby improving the formation of the biological stent and sustaining the formation of the biological stent, especially in the area and tissue immediately adjacent to the compression balloon.
The compression balloon is coated with a drug or medicine or gene modifier, designed to aid in cancer treatment, cure infectious diseases, relieve pain, and/or to cause a stronger biological stent thus limiting the potential for restenosis. In conjunction with drug or medicine therapy, or alone, gene modifiers may coat the compression balloon for gene therapy. The heat from microwave, radio frequency, ultrasound or a like energy-emitting source, and/or light from any light emitting source, such as a laser, that is generated immediately adjacent to the coated compression balloon allow the gene modifier, drug or medicine to be effectively released, absorbed, and/or activated into the target area. The compression balloon may be coated with any of the standard cytotoxic drugs so that may be released adjacent to the target area being treated for cancer, for example. If benign conditions surrounding a bodily conduit are being treated, antibiotics or other drugs that combat one of the infectious diseases or a benign condition, such as prostititus, may coat the compression balloon. Depending upon the treatment, a general pain relief medication may be coated on the outside of the compression balloon, alone or in combination with another drug or gene modifier for a specific disease that is readily accessible via a bodily conduit.
While the instant invention will be described with respect to a preferred embodiment where the bodily conduit is the urethra and prostatic tissue is to be treated by thermotherapy, the combination of compression, an energy source such as, microwaves, radio frequency, ultrasound, heated fluid or laser, and gene or drug therapy can be used to achieve the above goal in other bodily conduits or intracavity sites including, but not limited to, cardiovascular, esophageal, nasal pharynx, and rectal cavities or organs accessible by body conduits such as lung, liver, ovaries, and etc. That is, it is a goal of the instant invention to open up bodily conduits so that the normal function of that conduit is not hampered and to treat both diseased and/or benign sites, as well as the relief of pain, by delivering applicable gene modifiers, drugs or medication to the targeted area. The power to the energy-emitting source for heat or light, and diameters and shaping of the compression balloon and catheter will vary depending upon the tissue or bodily conduit or organ to be treated and the coated material on the compression balloon.
Unlike known techniques that circulate fluid to remove heat from the urethral walls, the instant invention employs, in a preferred embodiment, low energy to heat tissue adjacent the bodily conduit walls and compression so that tissue further from the bodily conduit walls is easier to heat using a lower energy while still maintaining the temperature of the urethra above 30° C. and avoiding overheating of the urethra. The Applicant believes that the urethral wall or targeted area should not be cooled by a circulating fluid as a biological stent or molded opening would not be formed effectively with cooled circulation fluid (i.e., fluid circulated into a patient in the range of 25° C.-30° C. or lower). The lack of a circulating fluid is advantageous in that a lower energy may be used to therapeutically heat the prostate or other treatment site, as the heat is not drawn away from the treatment site when the fluid does not circulate or remains in the inflated compression balloon. Additionally, the lack of the circulating fluid does not detract from the heating and/activating or releasing of the gene modifier, drug and/or medicine disposed in the coated material on the compression balloon. While no circulation of the water is the preferred embodiment, a circulation of non-cooled fluid may also be used.
According to the exemplary invention, a select volume of collagen-containing tissue surrounding the urethra or an area immediately adjacent thereto is heated to a temperature of greater than 43° C. for a time sufficient to substantially destroy or modify the select volume of tissue. Prior to energizing the energy-emitting source, a preshaped coated compression balloon is filled with fluid to expand the urethral walls compressing the prostate thereby reducing blood flow in the prostate surrounding the urethral walls and as a result, the energy-absorptive heating is more efficient in the region of constricted blood supply. The compression will also enlarge the surface area of the walls of the bodily conduit so that more drug is delivered efficiently per tissue area. In addition, compression of the area via the compression balloon could also lessen the distance from the surface of the balloon to the total targeted tissue thereby increasing the treatment zone if desired. The compression, together with the lack of a circulating fluid, theoretically enables a lower amount of energy than previously thought possible to heat the prostatic tissue or other tissues to therapeutic temperatures while causing the proteins of the urethral walls to become denatured or unraveled in the presence of the heat emitted from the energy-emitting source. That is, energy-emitting source 110 may be energized to a low power in the range of 0 watts to approximately 20 watts. Alternatively, the energy-emitting source alone may radiate heated fluid, such as water to provide the needed heat, or may be another energy source used in conjunction with heated fluid. As a result, it is envisioned that this preferred embodiment, in combination with a coated balloon, may provide a more permanent stent or a more effective treatment than thought possible with a lower treatment or release temperature, such as greater than or equal to 38° C.
The fluid, which expands the compression balloon and remains inside the inflated balloon, does not detract from the denaturing process which forms the biological stent, as the fluid does not carry away heat from the urethral walls. In one aspect of this invention, the non-circulating fluid together with the material of the inflated balloon provides the ability to form a more lasting and efficient biological stent to the urethral wall or closed vesicle as the result of the heat, compression and the coated material. This invention addresses a new, improved and more effective method of thermotherapy by uniquely coating the compression balloon with a drug, gene therapy compound or other medicament, compressing the coated balloon with circulating or non-circulating fluid and activating the drug, gene therapy compound or other medicament of the coated material via either heat or light energy sources.
A second aspect of this invention is directed towards a targeted direct therapeutic delivery system with drug therapy and/or gene therapy compounds to treat the affected area. The non-circulating fluid is in direct contact with the antenna or other energy-emitting source that emits the lower energy so that it provides a better coupling of the emitted lower energy to produce heat in the compressed prostatic tissues or other tissues. This is referred to as direct coupling technology as the non-circulating fluid conducts the energy emitted from the antenna or other source to the compressed prostatic tissues. Certain applications of the low energy-emitting apparatus according to the invention are envisioned where the inflation fluid would not be in direct contact with the antenna or other source and still would provide the necessary heat or light to therapeutically treat the diseased tissue. As a result of the fluid in the compression balloon coupling the low emitted energy to the prostate and urethra, air pockets in the balloon are minimized and thus, “hot spots”, which occur as a result of the air pockets, are less of a problem thereby resulting in better patient tolerance to the heat treatment and better uniform heating to the entire prostate.
The heating of the proteins of the urethral walls to more than 43° C. causes the proteins to become denatured or unraveled. The denaturing allows the urethral walls to conform to the expanded shape of the urethra created by the compression balloon and reduces the elasticity of the urethral walls so that a stent reinforcement period following the heating naturally solidifies the expanded shape resulting in a biological stent. That is, the expanded bodily conduit walls do not return to their previous shape after the compression balloon is deflated and removed thereby achieving a natural opening in the bodily conduit. The addition of a cytotoxic drug, for example, will aid to the ability in synergy with the heat or light to cause the biological stent, and/or cause activation and/or delivery of the desired drug or compound to also treat the affected tissue.
During the applications phase, a physical pulsing via compression and decompression of the compression balloon may be perform at various specified periods throughout the treatment to allow the rush of blood in and out of the compressed tissue. This physical or mechanical manipulation of the coated compression balloon also may be used in situations calling for a drug and/or a gene therapy compound so that the pulsing activates/releases the compound material applied to a patient via an intravenous or injection method so that the compound, which is dependent on heat or light for activation or release, is delivered to the targeted tissue. This mechanical compression and decompression can also aid in the mechanical fixation of the drugs and or gene therapy compounds to the targeted protein and/or DNA tissue. It is noted that this mechanical method fixation may cause the binding of the drugs and/or gene therapy compound disposed in the coated balloon to the protein and/or DNA. The resultant binding of the drug or gene therapy compound to the targeted protein and/or DNA is a major new innovation to ensure that the desired compound is effectively fixated or delivered to the targeted tissue.
According to a preferred embodiment of the invention, a stent reinforcement period of approximately up to 10 minutes or less follows the heating step. The stent reinforcement period maintains the pressure of the compression balloon after power to the energy-emitting source has been turned off so that a solidified expanded urethra is achieved minutes after thermotherapy and a catheter or other device is not necessary. The compression balloon during this reinforcement period also fixates the released drugs and/or gene therapy compounds within compressed tissue as a result of reduced blood flow.
Due to the fact that fluid is not circulated inside the balloon, the compression balloon may be made from either a compliant material, such as silicone material, or a non-compliant material, such as PET and still be easy to expand or be inflated by the fluid. In a preferred embodiment, the compression balloon is generally cylindrical with a sloped area on both sides of the compression balloon and is symmetrical along the length of the diameter according to a preferred embodiment. The position of the energy-emitting source in the preferred embodiment may be fixed. However, the compression balloon may be of any shape to create a desired mold or stent within a bodily conduit or urethra and may be asymmetrical along the length of the catheter. The use of a non-compliant material, such as PET, enables unique fixed expansion shapes to be formed when the balloon is inflated.
The compression balloon needs to maintain a pressure of about 5-25 psi against the urethral wall or other targeted tissue area along the length of the catheter with the preferred level of pressure being about 10-25 psi. Depending upon the size and shape of the compression balloon, the volume of fluid necessary to inflate or expand the balloon to its desired shape varies so that the appropriate amount of pressure is achieved in the inflated compression balloon. The compression balloon may have a variable diameter along the length of the catheter and may be formed from a single balloon or multiple balloons.
The material of the compression balloon touching the urethral wall is very thin in contrast to the thickness of a traditional low temperature catheter, which is generally 5 times the thickness of the compression balloon material or up to 1 cm. A preferred thickness of the material of the inflated compression balloon touching the urethral wall could be less than approximately 2 mm, and as a result of the compression, the transition zone between the fluid coupling and the prostatic tissue is minimized. In addition, the temperature of the fluid used to inflate the compression balloon is predetermined depending upon the application and varies over a range from about 0° C. to 50° C. This represents the starting temperature of the non-circulating fluid used to compress the balloon to the desired size and hardness. The fluid could be low lose or high lose depending on if the energy is to be either absorbed by the fluid or transparent through the fluid. The fluid may be heated to diffuse the energy uniformly in the bodily conduit or organ, or if a transparent fluid is employed, the heat generated by the energy-emitting source would heat the coated balloon directly and/or adjacent tissue. Again, the starting temperature of the fluid for inflating the compression balloon is dependent on the specific release and/or activation properties of the drugs and/or compounds disposed in the coated material. The beginning temperature of this fluid (before heating by the energy-emitting source) is envisioned to be from about 0° C. to 50° C.
According to the invention, a standard Foley bladder location balloon is disposed at the end of the catheter and a distal end of the compression balloon is mounted close to the neck of the Foley bladder balloon so that the distal end of the compression balloon is no greater than 2 cm away from the neck in the applications heating the prostate. For other sites, other forms of physical structures or imaging techniques are envisioned to provide direct placement to the delivery site. However, for example, in a preferred embodiment heating the prostate, the distal end of the compression balloon would be mounted within 1 cm of the bladder neck.
The energy-emitting source, such as a microwave antenna, may be mounted within the compression balloon fixedly or movably. If the energy-emitting source is movable, the maximum heating field may be moved forward or backward relative to the compression balloon. That is, the position of the energy-emitting portion can vary to optimize the heating of tissue for a particular therapy. The preferred location and movement, if any, of the energy-emitting source would depend on the size and shape of the compression balloon and the type of coated material or adjacent tissue to be treated. For example, a movable energy-emitting source (e.g., microwave antenna) could be used with compression balloons having a longer length. Alternatively, the energy-emitting source may be removable from one compression balloon and used with another compression balloon of differing length and diameter. This would provide a versatile apparatus, where the antenna can be used a multiple of times with different compression balloons. This feature together with less equipment needed to produce the thermocompression apparatus according to the invention makes the catheter apparatus easier and less expensive to manufacture.
BRIEF DESCRIPTION OF THE DRAWINGS
- Top of Page
These and other features and advantages of the invention will be further understood from the following detailed description of the preferred embodiment with reference to the accompanying drawings in which:
FIG. 1 is a vertical sectional view of a male pelvic region showing urinary organs affected by benign prostatic hyperplasia and an inserted catheter according to the invention with inflated compression and Foley balloons;
FIG. 2 is an enlarged portion of FIG. 1;
FIG. 3 is a plan view of the urethral catheter of the present invention;
FIG. 3a is a cross-sectional view of the urethral catheter of FIG. 3 taken along line a-a;