JP2003510159A - Ultrasound therapy method and ultrasound therapy device for reducing prostate in particular - Google Patents

Abstract

(57) [Summary] An ultrasonic treatment apparatus has an ultrasonic probe (6) provided with an ultrasonic tip (7). The ultrasonic probe (6) is slidably incorporated in a flexible joint sheath (70). The flexible joining sheath (70) is then slidably incorporated into the rigid sheath (80). The rigid sheath (80) is connected to and performs the same movement as the retractable housing (90). The retractable housing (90) includes a suction joint or luer (13), which is designed to mate with a flexible tube connected to a vacuum source. A suction joint or lure (13) is connected inside the flexible joint sheath (70).

Description

Detailed Description of the Invention

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a treatment method and a treatment device. In particular, the invention relates to methods and devices for shrinking the prostate by irradiating the prostate tissue with ultrasonic energy.

Prior Art As shown in FIG. 7, the prostate P is a fibrous muscular gland beneath the male bladder B. A normal prostate P is about the size of a walnut. The prostate P contains the prostate tissue inside and is surrounded by the prostate sac C. The prostate sac C instead surrounds the urethra U. The prostate P is surrounded by the prostatic sac C and surrounds the urethra U of the penis E at the site of the bladder B. The urethral lumen L is located at the site of the glans G.

Generally, when a person is in his or her 40s, the prostate P begins to enlarge, causing a condition called benign prostatic hypertrophy (BPH). In BPH, benign nodules develop in the prostate tissue. Due to the growth of these nodules, the prostate P is pressed against the tubular urethral wall W that drains urine from the bladder B and passes through the center of the prostate P. Therefore, the urethra U is restricted because the walls W of the urethra approach each other. FIG. 7 shows a normal prostate P without BPH. FIG. 8 shows a prostate P that has become BPH. As can be seen in FIG. 8, the prostate tissue P in the prostate sac C of a patient with BPH partially occludes the urethra U and also pushes it on the prostate sac C while pushing the wall W of the urethra U inward. Is spreading. In patients without BPH, the prostate P is smaller and the wall W of the urethra U does not obstruct the flow through the urethra U.

This growth of prostate tissue can interfere with the flow of urine through the urethra U. Thus, men begin to feel urinary problems such as frequent urination, urinary urination, residual bladder B urine, and burning or pain during urination. Delayed treatment can have serious consequences, including complete obstruction (body waste or acute retention of urine), loss of bladder function, and in extreme cases renal failure. The symptoms of BPH can be debilitating and can significantly alter a patient's quality of life. Currently, BPH usually involves the surgical removal of prostate tissue, or the compression and obstruction of the urethra U, the urethral wall W.
Is treated by surgically reducing or destroying. However, these surgical solutions are time consuming and costly procedures with significant post-procedure complications.

There are many known techniques for BPH treatment. The first technique is transurethral resection of the prostate (“TURP”). TURP is the most common technique used in BPH therapy today. With TURP, the urethra and prostate tissue are surgically removed. TURP entails not only the surgical technique and many other problems associated with the complete removal of the prostate, but also the potential for significant side effects such as incontinence, impotence, sepsis and bladder rupture.

The second technique for BPH treatment is transurethral needle ablation (“TUNA”). TUN
In A, a series of needles are inserted transurethrally into the prostate. After that, these needles are used so that the temperature inside the prostate reaches 90 to 100 ° C.
(In degrees Celsius), acts to generate high frequency (RF) energy in the prostate. This high frequency (RF) energy causes thermal destruction or necrosis of the prostate tissue within the prostate capsule. TUNA also has some drawbacks. TUNA uses heat destruction or necrosis and thus causes edema or swelling. Therefore, post-procedural catheterization is usually required to allow urination until the edema subsides. Moreover, thermal destruction of tissue is an inefficient technique for treating hypertrophic tissue as it contracts rather than is removed.

The third technique of BPH treatment uses microwaves and is sometimes referred to as TRGUS. In this technique, a urethral probe is aimed at the site of the prostate and then irradiated with electromagnetic energy to thermally destroy or necrotize the prostate tissue. In microwave technology, such as TUNA, it is desirable to raise the temperature to 90 ° C. to 100 ° C. in order to necrotize or shrink the treated tissue. Since the microwave energy is not targeted, it can destroy surrounding tissues and have side effects. Furthermore, this technique, like TUNA, does not remove tissue as it relies on thermal destruction or necrosis. The microwave thermal energy also acts to thermally destroy the tissue behind the urethra rather than the prostate tissue itself. This results in loss of elasticity of the urethra and may be associated with long-term complications such as incontinence and possible retrograde ejaculation.

The fourth technique for BPH treatment is high intensity focused ultrasound (“HIFU”). HI
In the FU, ultrasonic energy is focused on the site of the prostate and the temperature of the prostate tissue is
The temperature is raised from 0 ° C to 100 ° C to cause thermal destruction or necrosis of the prostate tissue. TUNA
And like TARGUUS, HIFU is a thermal technique that causes edema and swelling (which may require catheterization), and may be unlocalized, so that it is not prostatic tissue. May be damaged.

The fifth technique of BPH treatment may include many techniques of tissue destruction, including inserting a probe with a thermal energy source into the urethra. The probe can have a coiled electrical loop or laser at one end, passing through the urethra U to the prostate P area at the sphincter site of the bladder B. Then, the probe end is activated to heat the temperature of the adjacent tissue from 80 ° C to 100 ° C. The probe enters laterally from the urethra. The probe end heats and causes thermal destruction or necrosis of the urethral tissue portion of the urethral wall at the site of urethral obstruction. As a result of the use of this technique, there are numerous complications for BPH treatment. Incontinence may occur because the probe end may pass along the urethral wall W tissue, removing the urethral wall W tissue and also removing the sphincter. Irradiation of thermal energy to the sphincter area of the bladder may damage that sphincter,
This may result in incontinence or retrograde ejaculation. Furthermore, thermal destruction of tissue causes temporary edema and swelling of the urethra, necessitating catheterization and causing discomfort to the patient.

One experimental technique for the treatment of BPH is by Krawitt et al., “Ultrasonic Aspiration of the Prostat.
e, Bladder Tumors and Stones) ", Urology 30: 6 (1
987), pp. 578-580. BP described in this paper
The technique of H treatment involves inserting an ultrasound probe, usually designed for orthopedics, inside through the urethra. When the probe is inserted, the ultrasound tip operates so that the ultrasound energy destroys the obstructed urethral wall tissue that extends to the urethra immediately in front of the probe tip. This technique had at least two drawbacks. First, the probe used was not intended to be used for the urethra,
This probe needs to be pushed inward during treatment. In contrast, preferred techniques in other procedures pull the probe outward during the procedure. Therefore, the surgeon had no opportunity to observe the tip of the probe and could not know where along the urethra the tip was located. Therefore, the probe is likely to extend too far back, thereby damaging the sphincter of the bladder, resulting in permanent incontinence and retrograde ejaculation. This is because the tip of the ultrasonic probe used in Clawit et al. Is large and stiff, and furthermore, only the tissue immediately before the tip, that is, the urethral wall W tissue, can be treated during insertion. . However, the technique of Clawit et al. Had the advantage of not causing thermal destruction or necrosis of the tissue. This technique also had the advantage of reducing edema. Another drawback of the Cravit et al. Technology is that
Like other surgical therapies, it is the destruction of urethral wall tissue, which results in long-term side effects for the patient. However, a significant drawback with each technique that uses a urethral probe is that it can only destroy tissue immediately before or in the immediate vicinity of the tip, thus destroying both urethral and prostatic tissue when treating BPH. That's what it means.

One of the drawbacks of all the prior art mentioned above is that the equipment required to perform the procedure is generally expensive.

US Pat. No. 4,867,141 discloses a therapeutic device that utilizes therapeutic ultrasonic energy, especially for breaking up calculi formed in the body. An endoscopic conduit is used to insert a portion of the instrument into the body cavity, where an ultrasonic transmission member transmits ultrasonic vibrations to a stone contacting the distal end of the device. Used. Perfusate is supplied to the calculus site as the calculus is disrupted by mechanical ultrasonic vibrations. This perfusate is aspirated and removed from the stone site. As a result of aspiration, perfusate and debris of crushed stones are extracted from the body cavity. The device in that patent includes
An ultrasonic transmission member that is coaxial with the center axis of the probe is installed,
Therefore, it is effective in treating conditions such as calculi. In these conditions, the abnormality or condition to be removed is in line with the body vessel through which the endoscope passes. The device of that patent is used on unhydrated calcified tissue and uses direct mechanical vibration of the calcified tissue to effect fracture and destruction of the tissue.

US Pat. No. 5,176,677 discloses endoscopic ultrasonic rotary electrocautery suction. The background portion of this patent contains a discussion of several medical literature relating to prostatectomy, and in particular, the technique of Clawit et al. It is possible to remove the gland. However, the device shown in this patent is disclosed as useful for arthroscopic surgery. The device shown in this patent includes not only a mechanism for aspirating the peripheral region of the tip, but also a function for supplying the irrigation liquid to the tip of the ultrasonic probe. The aspiration and irrigation features of that invention require a separate path coaxial with the ultrasonically actuated tip,
Each is connected to a source of pressurized liquid for irrigation or to a vacuum source for aspiration.
The device of that invention also includes other features near the tip, such as a coated hood and a telescopic viewing instrument to remove obstacles. Irrigation, aspiration, coated hoods and telescopic viewing instruments all increase the cross-sectional profile of those devices. The instrument is designed to be on-axis, immediately in front of the ultrasound probe, and thus to treat only the site axially aligned with the lumen or incision into which the probe is inserted.

Various other patents describe devices that use ultrasonic energy to fragment or deform body tissue. U.S. Pat. Nos. 5,112,300, 5,180,
363, 4,989,583, 4,931,047, 4,922
No. 902 and No. 3,805,787 each show an ultrasonic treatment device used for the treatment of various medical conditions. In each of these patents, several mechanisms are shown to provide irrigation and / or suction at the site where ultrasound treatment is performed. However, in each of these patents, the mechanism for irrigation or aspiration is configured to increase the overall cross-sectional profile of the device. Furthermore, in each of those patents, the irrigation and suction ports are at a fixed distance from each other and no variation is possible.

“Ultrasound treatment” used in the prior art, and especially in orthopedics, is a technique in which ultrasonic energy substantially “blasts” a body, either a liquid or a solid. In ultrasonic treatment, ultrasonic energy generated by ultrasonic vibrations affects water molecules found in body tissues. Ultrasonic energy takes the form of acoustic vibrations at very high frequencies and fairly strong. These powerful, high frequency acoustic vibrations result in strong chemical and physical reactions within the water molecules in body tissues. These reactions within the water molecule ultimately lead to what is called "cavitation", which is believed to be the cold (non-thermal) boiling of water in body tissues. In this state, the rapid formation and collapse of numerous fine bubbles in water occurs.

The result of cavitation in water is the "breakdown" of the liquid. The rapid vibrations in water that result from the application of ultrasonic waves to water, and the resulting cavitation, can cause fatigue in water molecules that break the bonds between them.
The result is that water changes from a liquid form to a gas form, for example steam,
This change occurs without imparting heat energy to the water. As a result, "cold boiling" of water
Happens.

When vapor bubbles are created in a cold liquid, such as when ultrasonic energy is applied to water, the vapor condenses as it is surrounded by the cold liquid. This creates a void or cavity. The surrounding water molecules ooze to fill the cavity. When the water molecules reach the center of the cavity, they collide with each other with great force. This process is called cavitation. Cavitation is a known phenomenon that results in an outwardly running impact from a collapsed bubble. Cavity shock waves are known to wear or destroy materials and wear metal at the ends of outboard motor propellers.

Ultrasonic treatment or ultrasonic waves are extremely high intensities, high frequencies (usually above the hearing of humans,
Application of sound at 20 kHz, ie 20,000 cycles per second and above), causing a change in the material. Ultrasound is used in many different applications to transform a variety of different materials. Ultrasound accelerates both physical and chemical reactions within a material exposed to ultrasonic energy, these reactions being accomplished, among many others, by the action of cavitation, among many others. There are more important effects inherent in bubble collapse. As used herein, the term "bubble" means a space within a liquid containing gas or vapor. However, voids or cavities still exist in the space until the inward rupture occurs after the gas or vapor has condensed. Thus, the term "bubble" as used herein also means a void or cavity.

One description of how cavitation is used in medical applications is provided by Professor Lawrence Crum of the Institute of Applied Physics, University of Washington, Seattle, website: <http: // pluto. apl. washingt
on. edu / harlett2 / artgwww / acoustic / med
ical / medical. html> can be found. "When the pressure surrounding a bubble falls below the vapor pressure of a liquid, the bubble grows explosively and grows explosively," said Crum, who writes about lithotripsy, which uses ultrasonic energy to crush kidney stones. Collapses violently when pressure returns, and if this collapse occurs near a boundary, such as a target kidney stone, a high-velocity liquid jet is formed that impacts the boundary with great force. The violent process is believed to play an important role in calculus destruction and related tissue damage. "

In addition to jet erosion or ablation of surfaces, cavitation causes a number of other effects. Important of these in a purely physical sense are the powerful cavitation bubbles generated by the inward rupture of cavitation bubbles against kidney stones (lithotripsy), gallstones, tumors, and other internal invasions. It is the action of the impact surface. Some of this effect can be achieved by direct impact of the vibrating ultrasonic tool tip, but no (or minimal) cavitation is required.

SUMMARY OF THE INVENTION The present invention is directed to methods and devices for tissue treatment using ultrasonic energy. The present invention has particular application in reducing prostate tissue in patients suffering from BPH. This device of the present invention is designed to have a small cross-sectional profile, thus the present invention allows the device to be used in a minimally invasive manner. Thus, the present invention provides both minimal post-operative complications and minimal damage to non-treatment sites, both in conventional surgical facilities for BPH, and in outpatient treatment. It has the advantage that it can be used for. Therefore, BPH
There is a significant advantage over the prior art in the treatment of BPH and the present invention provides an improved method of BPH treatment. However, although the present invention is designed for the treatment of BPH, it is advantageous because it has a small cross-sectional profile and is a technique that minimizes invasiveness and is useful for treating any condition that reduces postoperative complications. It is valid. The present invention is therefore not limited to the treatment of BPH. For example, the present invention can be used not only for the removal of fibroids, which is common in gynecology, but also for the removal of polyps.

One particularly advantageous aspect of the invention is the use of inserting the probe into the prostate by inserting the probe into the urethra, penetrating the wall of the urethra and advancing the probe tip inside the prostate sac. Is to adapt to. Since the large size is difficult to insert into the urethra and is significantly uncomfortable, the probe of the present invention has a minimal cross section and is especially designed for use in prostate reduction. This will minimize post-operative complications and patient discomfort. One way the present invention allows the profile of the cross section of the probe to be minimized is by allowing suction through grooves or channels on the outer surface of the probe. This method provides a suction path without the need for any additional tubular suction sheath that would be inserted into the urethra. Instead, the aspiration probe sheath can be placed entirely outside the prostate, i.e., within the lumen of the glans. This allows for sufficient suction without the need for a sheath to create a separate suction channel that would be inserted into the urethra. Thus, it is possible to vary the aspiration lumen or opening in terms of distance to the probe tip and either irrigation port. Therefore, the aspiration lumen or opening can be adjustably located at the location where the aspiration tube strikes the urethral wall at the probe insertion point. As a result, suction features other than the suction channel on the probe can be placed entirely outside the prostate, reducing the total area affected by the device and reducing tissue damage and edema. Another advantage of using a suction channel is that it is easier to contact the substance to be aspirated, easier to keep clean than the internal passage for aspiration, and less occlusive than the internal suction passage. That is.

The present invention also enables treatment of the prostate via an episiotomy. The perineum is the area between the male scrotum and rectum, which is very close to the prostate. As a result, it is possible to make a small surgical incision in the perineum to approach the prostate with minimal tissue damage. By using the minimally invasive ultrasound probe of the present invention, the perineal incision can be made particularly small while still providing better access to the prostate. Thus, the perineal technique of the present invention is capable of minimizing surgical complications and has the added benefit of allowing significant access to prostate tissue for treatment.

In the device of the present invention, the irrigation passageway is preferably located in the center of the probe. The end of the irrigation passage can be located at the tip of the probe or beside the probe tip. When the end of the irrigation passage is next to the probe tip, thereby exiting the side of the probe, the effective area of ultrasonic energy is increased.

An important advantage of the technique of the present invention is that it physically destroys or removes the enlarged prostate tissue by the function of cavitation, which is a non-thermal aspect. Cavitation removal of tissue also provides the ability to use a small diameter probe to remove large amounts of tissue without creating large holes in the urethra. Because of the use of cavitation as a function to destroy tissue in conjunction with the use of irrigation and aspiration, the methods and devices of the present invention allow tissue to be destroyed or removed within a temperature range of ± 7 ° C from normal human body temperature. It is possible to Thus, in addition to loss of elasticity, complications associated with using thermal destruction or necrosis of tissue such as swelling or edema are avoided. The present invention non-thermally destroys or removes prostate tissue during treatment,
It is particularly beneficial as it reduces the symptoms of BPH. Thus, the present invention offers numerous advantages over the prior art. All of the prior art relies on either surgical removal of prostate tissue and urethra, or thermal destruction or necrosis of prostate tissue that does not remove the tissue. The present invention is the only method of removing tissue without destroying the urethra.

The method and apparatus can each be advantageously used in three different technologies. One technique in which the present invention may be utilized is transurethral use in the outpatient setting. Prior to treatment, the physician will administer to the patient a local anesthesia and / or oral sedative such as lidocaine jelly. After administration of local anesthesia or oral sedative, the device of the invention is inserted transurethrally, i.e., through the patient's urethra until the tip of the ultrasound probe penetrates the prostate sac and contacts the enlarged prostate tissue. It is possible to Thereafter, ultrasonic vibrations are activated at or along the tip of the probe to generate ultrasonic energy. As a result, the enlarged portion of the tissue is destroyed by cavitation and suctioned. Other techniques of the invention that may be utilized are used in standard hospital operating rooms where the patient is anesthetized in the operating room. After the patient is anesthetized, a percutaneous perineal incision is made (skin incision between the scrotum and the rectum), the ultrasound probe of the present invention is inserted through the incision, and the prostate sac is surgically operated. And is inserted into the prostate. After that, ultrasonic vibration is activated,
The tip of the ultrasonic probe irradiates the prostate tissue with ultrasonic energy. Thereby, the cavitation destroys the prostate tissue. A preferred technique of the invention that will be used is to probe the probe of the invention with an ultrasonic tip on enlarged prostate tissue that is advanced through the urethral lumen of the glans and through the urethra, where the urethral wall closes or obstructs the urethra. It is used transurethrally by inserting it until it comes close. After that, ultrasonic vibration is activated so that the tip of the ultrasonic probe passes through the urethral wall tissue and is inserted into the greatly enlarged prostate tissue. Then move the probe through the prostate tissue, destroy, shrink,
Cavitation-affected tissue is removed by aspiration while moving the tip of the probe to various locations in the prostate tissue. In each of the techniques for using the present invention, the small cross-sectional profile of the present invention reduces or eliminates damage to any adjacent tissue outside of the treated hypertrophic prostate tissue, surgically, Greatly reduces procedural and postoperative complications.

Since the profile of the cross section of the probe has been significantly reduced, it is possible to make the probe of the invention flexible and flexible. The probe can have a sufficiently small cross-sectional profile that the material of the probe bends over a wide range of joint angles.
The probe may be housed in a joined catheter or sheath, which may be bendable or made to be joined. Therefore, the present invention enables the probe to be operated or treated on a body part that is not coaxial with the channel or lumen through which the probe is inserted.
The present invention can be applied. As such, the probe of the present invention has much more surgical applications and can be used to treat a wider variety of tissues than prior art devices and methods. In the joints described above, the probe of the present invention is flexible and, in conjunction with the lateral cavitation mode of operation, allows for the "windshield wiper" action of the probe. Thereby, it is possible to treat arcuate tissue and significantly increase the effective area of treatment through the incision.

The probes of the present invention are particularly useful in therapeutic techniques where the treatment site is imaged by ultrasound imaging, especially with color ultrasound methods. The oscillatory action of the probe can produce a clear, crisp, bright image on the ultrasound from the echo. Thus, the surgeon or physician will be able to place the probe (as opposed to the surrounding tissue)
It is easily visible and distinguishable as a probe, increasing ease of use and therapeutic efficacy. The ultrasound transducer probe is preferably inserted into the patient's rectum for the treatment of BPH. Alternatively, the transducer may be placed on the surface of the skin.

The probe of the present invention can also be designed to have pinching and excision functions. This feature is useful for surgically treating a suspended or flaccid treatment site in a patient's body cavity or hollow organ. This probe embodiment is particularly beneficial for gynecological treatments. A sheath or catheter surrounding the probe includes lateral openings. In this opening, a suspended or relaxed treatment site can be captured and excised by the reciprocating probe tip.

The small size of the probe of the present invention makes it particularly suitable for use in flexible fiber optic viewing devices. This device consists of an optical fiber that is inserted with an ultrasonic probe, either attached to or removed from the probe.
It preferably includes a cable. This optical cable is connected to the fiber optic viewing eyepiece, but not to the handle of the ultrasonic mechanism or other device. In this way, the operation of the observation system is reduced to a minimum. The fiber optic cable preferably comprises a central optical observation cable surrounded by optical fibers that emit light. The fiber optic cable may be placed inside the flexible sheath of the device, on the flexible sheath, or on the rigid sheath of the device.

The method of the present invention uses ultrasonic energy in cavitation and transverse modes that do not have a thermal effect on it, so the effect is local and affects tissues other than the particular prostate lobe tissue being treated. Don't give. This method reduces or eliminates tissue damage, inflammation and swelling in the patient because it reduces the cross-sectional profile to prevent damage to surrounding tissue during insertion, treatment and removal. Therefore, the method of the present invention is
It is particularly advantageous because, due to its minimal size and lack of thermal action, the need for post-operative patient catheterization or stenting can be reduced or eliminated.
However, if a patient is unable to urinate after the procedure due to temporary swelling or inflammation of the urethra, a short term catheter or stent may be inserted into the patient's urethra.

The method of the invention presents an advantage over conventional treatment regimens for benign prostatic hyperplasia (BPH) in that it immediately shrinks the prostate at the time of treatment while leaving the urethra intact. Prior art treatments 1) necrotize or otherwise destroy the urethral wall tissue at the affected site, and / or 2) heat destroy the prostate tissue by necrosis without reducing the tissue mass, Prior art treatments do not result in a practical reduction of prostate tissue, as this either simply kills the tissue and, after a period of time, the tissue shrinks due to the death of the tissue. From the patient's perspective, the present invention provides immediate weight loss of the prostate so that restriction / compression in the urethra is relieved almost immediately, allowing the patient to urinate without restriction almost immediately without catheterization. Owing to the reduced size requirements of the device, smaller diameter devices do not dilate the urethra and cause less damage, so induced edema is also reduced. The present invention offers the advantage of being a minimally invasive procedure. And it will preferably be an outpatient procedure. Thus, the tissue reduction method of the present invention is a minimally invasive, ambulatory treatment that immediately relieves the symptoms of BPH. Other currently used outpatient treatments for BPH do not actually remove the tissue and, due to collateral damage due to size and heat, reduce the volume of each necrotic tissue in the affected area, thereby It takes a few weeks for the symptoms to disappear. Thus, the present invention is superior to currently used techniques in that the method of the present invention provides immediate relief of symptoms in patients with BPH. The present invention also provides a faster method of treatment than the prior art.

The present invention also provides benefits to the treating physician. The present invention provides that the components of the apparatus and methods of the present invention only apply ultrasonic energy to the surgical site and that the effect of ultrasonic energy on the tissue is based on the tissue plane and their hydration level. It is safer for the doctor as it retains the tactile sensation to the surgeon. Similarly, due to the tissue distinction, the device of the present invention directs cavitation only within the prostate and prostate tissue. Thus, the device of the present invention protects the prostatic sac, bladder sphincter and bladder neck. This reduces the risk of unintentional thermal damage to surrounding structures. Each of these non-prostate tissue sites has a different hydration level compared to prostate tissue and is therefore not considered to be affected to the same degree by ultrasonic energy. Furthermore, in the device of the present invention, the region where cavitation is effective is a region of about 1 to 2 mm around the periphery of the ultrasonic probe, and there is no further energy spread or influence on the tissue. Therefore, the present invention can considerably increase the degree of diseased part control as compared with the conventional technique. In other treatment methods where the control of tissue damage of the present invention does not exist, the urethra and other structures may be damaged and destroyed by the appearance of heat diffusion or other energy directed at the prostate tissue, It causes serious patient distress and unexpected complications such as urinary incontinence, impotence and retrograde ejaculation. The present invention significantly reduces these post-operative complications, as opposed to the prior art, because it destroys little or no compliance of the urethral or prostatic sac wall tissue (except for penetration by small probe diameters <1 mm). It is possible.

In the application of ultrasonic energy directed to the controlled destruction and removal of tissue within a cavity, the ultrasound probe is specifically used in such a way as to puncture and / or create a cavity in the organ cavity. If the tip of the probe is inserted substantially below the surface of the tissue, there is a need for some mechanism to remove tissue and particulates from this site caused by ultrasonic puncture or tissue removal. Conventional methods of removing substances and exudates are done using a suction mechanism that provides suction through a suction path that is part of the probe. These conventional methods use irrigation of a liquid that is infused at the site where the procedure is to be performed, in connection with suction to remove tissue from the surgical site. However, as mentioned above, providing both perfusion and suction to the surgical site in the prior art causes the probe to have a relatively large cross-sectional profile. Therefore, the therapeutic device is significantly larger than the ultrasound probe required to perform the procedure. These prior art devices use a coaxial tube in which the irrigation fluid is normally supplied through the central core of the probe and the aspiration is supplied to the outer coaxial tube and the lumen.

The prior art devices also maintain the strict orientation of the aspiration and irrigation mechanisms so that the irrigation and aspiration inner and outer lumens are in a fixed position relative to each other.
Generally, it will remain in close proximity to the site of treatment. Thus, the irrigation lumen does not extend beyond the aspirating lumen (ie, there is no migration of the lumen with respect to each other).
Aspiration is also designed to pick up any liquid and / or tissue remnants within the limited distance between the two lumens. The present invention uses aspiration or irrigation channels or channels on the outside of the probe through the control portion of the probe. Irrigation appears in the central portion of the side of the probe. This allows the distance between the irrigation lumen and the suction lumen to be changed. This reduces the cross-sectional profile of the device inserted into the patient's body. The reduced cross-sectional area allows for easy insertion through the urethra. In the present invention, the axially movable suction catheter or sheath moves along the entire length of the probe. Thereby, changing the position of the suction lumen relative to the probe tip and the irrigation lumen or lumens. This allows the aspiration lumen and associated aspiration structure to be placed outside the patient's body, except for the probe channels or channels.

Similarly, as the probe creates voids in tissue, it forms a pocket with a unique entry point. In order to aspirate substances through the flow path created by the probe and the opening maintained by the probe, it is possible to apply suction to this inlet point on the outside that is affected by the ultrasonic energy.

In the application of ultrasonic energy of the present invention, the diameter of the probe is substantially smaller than the diameter of conventional ultrasonic probes. Therefore, the diameter of the probe is ideally designed for a minimally invasive procedure. The probes of the invention are therefore designed to be used on body parts such as the urethra. The smaller probe is less invasive and therefore less painful. The smaller size results in the size of the device being inserted into the urethra, expanding the tissue receiving the device, and thus the need for additional devices such as catheters used to maintain the lumen of the organ opening. It is possible to remove tissue without possibly inducing additional tissue response, usually in the form of inflammation and swelling. The present invention thus relates to the application of small diameter probes, which can be inserted into small diameter body vessels and then utilize cavitation to remove tissue. To increase the treatment area that is effective for the small probes of the present invention, the irrigation lumen can be laterally oriented with respect to the axis of the probe, ie the side of the probe body can be open. Thus, the largest area of the probe tip is used to provide energy for ultrasound treatment and cavitation.

The probe used with the present invention is shaped to facilitate insertion through the urethra. As such, these probes are not sharp, as they pose no risk of tissue damage during insertion. The probe includes a tapered point adapted to insert the probe into tissue via the application of ultrasonic energy. There, the velocity is amplified by the transition from the larger mass to the smaller mass. The tapered shape of the probe is generally conical, spherical or hemispherical, but the tissue cracks or fissures created by ultrasonic perforation at the tip of the probe are formed initially in a manner that is free of cuts or sharp edges. The rift does not extend beyond the piercing point rift, which is particularly useful for surgical applications. Similarly, ultrasonic energy is focused toward the distal end of the probe, decreasing in amplitude and frequency as the distance from the tip increases, so that the tapered shape of the probe penetrates through tissue. Minimize the overall size of the dots. The probe has a relatively constant diameter so that the tissue will fit snugly around it.

One Tissue with Tissue Tightly Tucks Around the Probe One problem is that the tight fit tissue causes the irrigant to be trapped and stored within the organ or tissue with the added hydrostatic load. This hydrostatic load causes potential undesirable consequences through the insertion of fluid into the tissue space. This is because this liquid serves as a medium for tearing and expanding the tissue. The dissection leads to unwanted rupture of the vascular system as well as connective tissue, nerves and the like. Similarly, swelling of tissues and organs that is conventional or beyond normal size may have a deleterious effect on their normal and normal function and may interfere with their function for a period well beyond the treatment time. Become.

In order to counteract the deleterious effects associated with fluid ingress, the need for secondary pores without increasing the diameter of the initial tissue cut, without the need for delicate pressure monitoring. Instead, some mechanism is needed to allow the removal of cavitation-induced liquids and particulates from the cavities.

The present invention solves the problem of liquid ingress and retention by applying grooves or channels on the surface of the ultrasonic probe. The ultrasonic probe may be curved such that the surface of the probe forms a continuous bend and the groove or channel is dug into the surface of the probe, thereby reducing the contour of the groove or channel. . Where the groove or flow path begins near the proximal end of the probe and increases in depth and width as the groove or flow path extends toward the distal end of the probe, the groove or flow path is a liquid in a rapid manner. It also has the effect of sucking out hollow tissue. In the present invention, preferably two, three, four or more vertical grooves or channels extend from the tip of the probe toward the end. The use of a single or two grooves or channels starting from the proximal end of the probe and spirally (as well as the screw spiraling) across the diameter of the probe has the same effect as in the present invention. It may be used to obtain.

The purpose of these grooves or channels and their unique shape is to provide a path for liquids and particulates to escape the voids. Grooves or channels also allow flushing of substances and fluids deep within the tissue. The groove or channel is also for the continuous exchange of liquid below the tissue surface to maintain normal physiological conditions. This is done in particular by supplying irrigation fluid to the cavitation site, creating a continuous cavitation fluid medium. This ensures the extracellular water content via liquid exchange so that the ultrasonic energy causes any unwanted or undesired thermal heating when the cell matrix is destroyed and the intracellular fluid is removed. Nor.

Grooves or channels offer advantages over prior art suction geometries in several respects.
First, the use of grooves or channels eliminates the need for an additional sheath surrounding the probe to create a suction path. As a result, it is possible to reduce the profile of the cross section of the device. Thereby reducing residual tissue damage and edema. Further, the groove or channel allows the suction sheath to be placed outside of a conduit or lumen to a treatment site, such as the urethra.

Furthermore, because the grooves or channels are located outside the probe, they are less likely to occlude or clog. Furthermore, the grooves or channels are much easier to clean than the internal suction path.

Accordingly, the present invention includes a number of advantageous features that make it particularly useful for minimally invasive procedures. First, ultrasound through a small diameter probe that allows passage through a duct or opening, such as the urethra, and also allows tissue removal through the action of cavitation on the tissue, Energy can be applied. Thus, the present invention is capable of creating a cavity and shrinking the prostate. Second, the present invention is
It has the ability to create small through holes in and through the body canal, such as the urethra, or in the body, such as the perineum, between the scrotum and anus. The invention then allows the probe to be directed to the tissue to be treated, such as the hypertrophied tissue of the prostate. Third, the present invention allows the action of cavitation and the surgeon to create a large cavity such that the cavity is larger than the size of the probe by moving the ultrasound tip across the treatment site. Fourth, the device of the present invention may be designed with a soft, flexible or bendable member on the inside and a rigid member on the outside. This therefore allows the device of the invention to be inserted into the body, such as the urethra and the prostate, without causing excessive twisting and bending of the anatomy. This flexibility allows the probe to bend or articulate so that it can reach sites that are not axially aligned with the lumen or conduit into which it is inserted. Fifth, the present invention allows this ability to remove tissue at the site of treatment. Sixth, the present invention allows this ability to irrigate the site of cavitation through the ultrasound probe both when the probe is rigid and when the probe is flexible and flexible. Seventh, the present invention uses energy at a frequency in the range of 20 kHz to 80 kHz so as to specifically energize hydrated (water-containing) tissue. Allows the use of applied ultrasonic energy. Therefore, little or no energy is provided to the high collagen connective tissue. This selectivity in the application of energy thus preserves the tissues of the bladder neck and these tissues, which are important for retaining normal fluids such as the internal sphincter. Thus, this selectivity prevents post-operative complications such as retrograde ejaculation, incontinence, etc. which are typical of urological applications. Eighth, the invention allows the use of probes that bend, flex, or articulate. This limits the amount of force exerted on the probe when advancing the probe in the anterior direction, and thus limits any force exerted on the prostatic capsule. In this way, the force applied to the probe is mitigated via bending. That is, less pressure is applied to the tip of the probe. This reduces the likelihood of accidental tissue penetration by the probe via pure physical forces. Such unfavorable results could occur with a straight probe on the prostate sac and applying similar forces.

One important feature of the present invention is that it is athermal in its effect on tissue. It is important to use treatments that do not use heat or heat energy and the invention produces very low heat. Also, the range of motion of heat is limited to the area directly related to the sound waves that are ablating tissue. The present invention treats treatment sites within ± 7 ° C. of normothermia through the use of ultrasonic energy, along with irrigation and aspiration. This is because it is possible to reduce the size of the prostate without necrosis and collateral heat damage to the surrounding tissue (e.g. the lack of heat diffusion into healthy tissue is important, e.g. It is particularly advantageous in the treatment of BPH (as well as other applications such as). Furthermore, this temperature range is directly applicable to prostate tissue rather than complication-causing urethral tissue due to the nature of the probe of the present invention. In addition, concomitant irrigation in the form of extracellular fluid keeps residual tissue within a narrow range of normal physiological body temperature throughout the treatment of the invention. In the present invention, without generating heat,
Remarkably, residual tissue shows little or no inflammatory response, as treatments can be made to remove tissue immediately. This results in little edema (swelling) in the surrounding tissue. Due to the minimal swelling, patients can be discharged without the use and assistance of either catheters or postoperative stents. Alternatively, if such treatments are needed, those treatments will be of minimal duration. Furthermore,
Prior art methods for the treatment of BPH symptoms, except for the traditional TURP treatment, which is extremely invasive and requires a nightly hospital stay, heat destroys the enlarged prostate tissue at temperatures above 45 ° C. It exposes non-prostate tissue to lethal temperatures. This results in the destruction of the prostate and non-prostate tissue, and the treatments that rely on necrosis are
Although it takes 4 to 8 weeks for the tissue to degenerate, the amount of tissue to be removed remains unchanged. These drawbacks do not exist in the present invention.

The present invention applies to the use of autologous and / or other tissue adhesives that are injected into the cuts or cavities created by the procedure following shrinkage of the prostate. This allows
The tissue cut or cavity is closed and adhesively sealed. Because the incision in the tissue is closed, the result of the procedure is faster urethral decompression and less postoperative complications.

Another advantageous feature of the present invention is that the ultrasonic probe can bend after insertion into a body canal such as the urethra. Unlike prior art devices that allow a rigid ultrasonic probe to only contact tissue or physical abnormalities that are in the straight line of the body vessel or incision into which the probe is inserted, this feature allows the ultrasonic tip to It allows the tissue located on the off-axis vessel wall to be contacted and allowed to become hollow. Thus, in the present invention, the ultrasound probe can be inserted into a relatively small diameter lumen or conduit. The ultrasound probe is then bent at an angle (which may be relatively sharp) to penetrate tissue on the side of the lumen or conduit.

The ultrasonic tip of the present invention uses cavitation as a mode of tissue removal,
It does not need to be sharp as the tissue penetration is by cavitation and not by the physical shape of the probe. Therefore, the tip is smooth, insertion is less obstructive, and residual tissue damage is less likely to occur.

The ultrasonic energy applied to a particular treatment site is a function of amplitude and frequency. Generally, the travel speed or amplitude of energy provided by the device of the present invention is in the range of 150 microns to 250 microns and the frequency is in the range of 20 kHz to 80 kHz.

Embodiment of the Invention FIG. 1 shows one embodiment of the handle 5 used in the present invention. Handle 5
Is comprised of an irrigation joint or lure 2, a grip portion 3, and a probe mount 4. The irrigation joint or lure 2 is designed to connect to a flexible tubing, which is then connected to a source of pressurized irrigation fluid such as water. The grip portion 3 is molded so that it can be grasped by an operator of a device such as a surgeon, and is used for activating and deactivating various functions of the device such as suction, irrigation, and power supply. Or it may include more triggers or buttons.

FIGS. 2 and 3 show one embodiment of the ultrasonic treatment apparatus 1 of the present invention including the handle 5 shown in FIG. The ultrasonic treatment apparatus 1 includes an ultrasonic probe 6 having an ultrasonic probe tip 7. The ultrasonic probe 6 is axially disposed within the suction sheath or catheter 70 such that the probe tip 7 can move axially inward and outward relative to the distal end of the suction sheath or catheter 70. It is movably attached. Both the ultrasound probe 6 and the suction sheath or catheter 70 are attached to a suction shroud 9 including a suction shroud housing 8. Within the suction shroud housing 8 is the suction end 10 of the suction sheath or catheter 70, which transfers suction or negative pressure to the interior of the suction sheath or catheter 70. Its suction end surrounds the ultrasonic transmission element 11 and is sealed to it, extends towards the ultrasonic probe 6 and becomes the proximal end of the ultrasonic probe 6. The suction end 10 is connected to a suction joint or lure 13. The suction fitting or lure 13 is set for connection with a flexible tube, which tube is in turn connected to a vacuum source. The suction sheath is slidable relative to the handle 5 and the probe 6, allowing the distance between the ultrasonic tip 7 and the distal end of the suction sheath or catheter 70 to be varied. The operating mechanism 12 can extend from the suction shroud 9 towards the handle 5 and is surrounded by suitable covers 14 and 15.

FIG. 4 shows one embodiment of the ultrasonic probe 16 and the ultrasonic probe tip portion 17 of the present invention. The body of the ultrasonic probe 16 in the embodiment of FIG. 4 preferably tapers slightly from the distal end to the proximal end. The ultrasonic tip 17 is in the shape of a spherical protrusion from the end of the ultrasonic probe 16. Ultrasonic tip 1
This shape of 7 eliminates sharp edges and surfaces at the tip that result in tissue damage during insertion, treatment, or removal. The ultrasonic tip 17 has one or more irrigation ports 18 on its distal surface. All irrigation ports 18 are connected to an internal irrigation passageway, which is preferably centrally located in the ultrasonic tip 17 and ultrasonic probe 16. Although not shown in FIG. 4, the ultrasonic probe 16 can have one or more grooves or channels extending along its entire length, as described in detail below.

FIG. 5 shows a second embodiment of the suction sheath or catheter of the ultrasonic probe of the present invention. The embodiment of FIG. 5 is particularly useful for treating pathological conditions where the treatment site is suspended or relaxed, and the embodiment of FIG. 5 is particularly useful for gynecological treatment.
In the embodiment of FIG. 5, the tip 75 of the suction sheath or catheter 70 is a spherical end. The suction sheath or catheter 70 has a gutter or opening 19 on one side. An ultrasonic probe 23 having an ultrasonic tip 21 including a bevel 20 (sloping surface) is mounted for axial sliding within a suction sheath or catheter 70. At least one suction channel 23 is created in the space between the ultrasound probe 22 and the inner wall of the suction sheath or catheter 70. Thus, when suction is applied to the suction joint or lure 13, negative pressure or suction is created in the suction passage 23 to suck up the crushed or hollowed tissue and any residual or irrigation fluid.

At the proximal end of the tip 75 is a catching surface or anti-backlash 76. This capture surface or anti-return feature 76 serves as a counter surface for the ultrasonic tip 21, thereby allowing a suspended or flaccid treatment portion to be captured during treatment. In operation, the suction sheath or catheter 70 is guided to the procedural portion until the suspended or relaxed treatment portion fits into the gutter or opening 19. During this stage, the ultrasonic probe 23 is in the retracted position as shown in FIG. The ultrasonic probe 23 is then advanced axially outward until the suspended or relaxed treatment site is sandwiched between the ultrasonic tip 21 and the capture surface or anti-return device 76. . Then, the ultrasonic vibration generator is activated to transmit the ultrasonic energy to the ultrasonic tip 21. Thus, the captured treatment portion is treated using ultrasonic energy and the resulting cavitation.

11 and 13 show radial cross-sections of an ultrasonic probe 6 according to one embodiment of the present invention, which probe 6 is particularly useful for urethral treatment of BPH.
The probe 6 includes a central passage 62 connected to the irrigation joint or lure 2. The central passage terminates in two side lumens 61 located on the sides of the probe 6. The central passage 62 is used to deliver irrigation fluid to the area surrounding the ultrasonic tip 7 and thereby regulate the temperature of the treatment area. The irrigation solution together with the cavitation of the ultrasonic tip 7 allows the treatment site to be controlled at a temperature of normal body temperature ± 7 ° C. Furthermore, since the lumen 61 does not pass through the ultrasonic tip 7, the ultrasonic tip 7
The therapeutic effect area of is increased.

As shown in FIGS. 11 and 13, the outer surface of the ultrasonic probe 6 has one or more grooves or channels 60. Although these grooves or flow paths are linear in FIG. 13, they may be spiral along the entire length of the ultrasonic probe 6. The groove or channel 60 is used to aspirate liquid or tissue fragments from the treatment site as a result of negative pressure or suction applied at the proximal end of the groove or channel 60. As a result, liquids or tissue fragments travel down the channels or channels 60 and away from the treatment site,
This ensures that the liquid or fragments do not interfere with sonication or cavitation of other tissues.

FIG. 14 illustrates a technique by which the ultrasound probe 6 of FIGS. 11 and 13 can be used to urethrally reduce prostate tissue. The ultrasonic probe 6 is inserted into the urethra U by inserting it through the lumen L of the urethra U in the glans G region. The ultrasound probe 6 projects the urethral wall W adjacent to the prostate P protruding into the urethra U and obstructing the urethra U.
Push through the urethra U until it touches. The suction sheath or catheter 70 is then slid along the long axis of the ultrasonic probe 6 until its distal end contacts the lumen L of the urethra U located in the glans G and seals. . The central passage 62 is then replenished with irrigation fluid, and negative pressure or suction is applied to the suction path 72 located between the outer surface of the ultrasound probe 6 and the inner surface of the suction sheath or catheter 70. Next, the ultrasonic vibration source is activated, which transmits ultrasonic energy to the ultrasonic probe 6 and consequently the ultrasonic tip 7 irradiates the ultrasonic vibration energy. The ultrasonic tip 7 is pressed against the urethral wall W, thereby making a small incision or hole through the urethral wall W by the action of cavitation. The ultrasonic tip 7 is pushed through the hole in the urethral wall W until it enters the interior of the prostate P. The urethral wall W tends to expand around the ultrasound probe 6, which ensures that the pores are of a minimum size. The position of the ultrasonic tip 7 shown in FIG.
After having made a hole through the urethral wall and entered the prostate. The doctor then manipulates the ultrasound tip 7 to various locations within the prostate P, thereby moving the ultrasound tip 7 to different locations within the prostate P,
The prostate tissue adjacent to the vicinity of the ultrasonic tip 7 is contracted. As the tissue shrinks, the suction or negative pressure in the suction path 72 creates suction or negative pressure at the site of the groove or channel 60. This allows liquid and fragmented, depleted tissue to flow from the treatment site through the channel or channel 60 into the suction path 72 and through the suction joint or luer 13 to the collection or disposal site. Suck out. Similarly, as the tissue shrinks, irrigation fluid is delivered to the central passageway 62 via the irrigation fitting or luer 2 and exits the lumen 61. This regulates the temperature at the treatment site and provides a medium for delivering the fragments through the channels or channels 60.

Once a sufficiently large hollowed lesion is created, the physician moves the ultrasound probe 6 to the next site to be reduced and repeats the process. In the preferred method of treatment of the present invention, depending on the size of the prostate P, two or more cavitation treatments are performed on the prostate lobes on each side, thereby reducing the size of the prostate P and eliminating urethral obstruction. It is expected. Since the ultrasonic energy causes very localized cavitation damage in a small area around the ultrasonic tip 7, very different water content of other urethral tissues, such as the urethral wall W adjacent to the treated prostate lobe. The content and compressibility prevent the prostate sac C, bladder B neck and sphincter from suffering any persistent injury. This eliminates the persistent obstructions associated with less localized treatment methods. When the ultrasound probe 6 is withdrawn through a hole in the urethral wall W, the urethral wall W will expand to occlude or substantially occlude the hole.

9 and 10 show the perineal treatment method of the present invention. FIG. 9 shows a sectional view of the lower part of a male patient. The perineum N is the site between the scrotum (which houses the testicle T) and the rectum R in men. The perineum N is a shortcut for approaching the prostate P. In the perineal method of the present invention, the patient is placed in a supine position on the operating table and a local or general anesthetic is administered.
A small incision I is made in the perineum N as shown in FIG. Thereafter, the ultrasonic probe 6 is inserted into the perineal incision and the ultrasonic tip 7 is activated. The ultrasonic energy at the ultrasonic tip 7 is used to pierce through the prostate capsule C, and then the ultrasonic tip 7 is inserted and moved within the prostate P. This causes the prostate tissue in the prostate P immediately adjacent to the ultrasonic tip 7 to shrink. With the distal end of the suction sheath or catheter 70 placed against the perineum at the site of the incision I, suction and irrigation are applied in the same manner as discussed above for urethral treatment. After each prostate lobe has been treated in this way, the ultrasound probe 6 is withdrawn and the incision I is closed using known surgical techniques.

FIGS. 6 and 12 show the features of the ultrasonic treatment apparatus according to another embodiment of the present invention, and FIG. 15 shows the method used in the urethral prostate reduction treatment. There is. As shown in FIG. 6, the ultrasonic therapy device has an ultrasonic probe 6 with an ultrasonic tip 7. The ultrasonic probe 6 is slidably incorporated in a flexible joint sheath 70. The flexible coaptation sheath 70 then provides the rigid sheath 8
It is slidably installed in 0. Rigid sheath 80 is retractable housing 90
It is connected to the same movement as this. Retractable housing 90 is retractable trigger 94
And is rotated about the handle 5 as a fulcrum. The retractable housing 90 includes a suction fitting or lure 13, which is designed to mate with a flexible tube that is connected to a vacuum source. As will be discussed in more detail below, the suction fitting or luer 13 is connected to the inside of the flexible cohesive sheath 70.

The joining trigger 91 is housed in the retractable housing 90. Bonding trigger 91 is connected to bonding wire 71, which is described in more detail below. The trigger 92 can also be housed on the retractable housing 90. The cover 93 covers parts between the retractable housing 90 and the handle 5.

FIG. 12 shows details of the proximal end of the ultrasound device of FIG. The ultrasonic probe 6 has one or more grooves or channels 60, which are used to perform suction to the peripheral area of the ultrasonic tip 7. One or more irrigation lumens 61 are capable of supplying irrigation fluid to the area surrounding the ultrasonic tip 7. The ultrasound probe 6 is somewhat flexible so that it can be bent and joined due to its small cross-sectional profile and the material from which it is constructed. The ultrasonic probe 6 is fitted into a joining sheath 70 made of a relatively flexible and elastic material for axial movement. The space 72 between the ultrasonic probe 6 and the joining sheath 70 forms a suction path together with the groove or flow channel 60. The joining sheath 70 may include one or more embedded joining wires 71 at one or more locations around the circumference of the joining shaft 70, the distal end of which is attached to the joining sheath 70. . The proximal end of the joining wire 71 is attached to the joining trigger 91. The splicing sheath 70 is housed in a rigid sheath 80 for axial movement. The rigid sheath 80 is made of a relatively rigid material.

When the rigid sheath 80 slides backwards away from the distal end of the splicing sheath 70 and the splicing wire 71 is pulled axially inward by the splice trigger 91, the splicing sheath will bend or splay. Will bend to A or move like a joint. Therefore, the ultrasonic probe 6 and the ultrasonic tip 7 will bend in the joining direction A or move like a joint. In this way, the ultrasonic waves can be used to reach a site that is not axially aligned with the lumen or conduit into which the ultrasonic probe 6 is inserted.

FIG. 15 illustrates the technique by which the embodiments shown in FIGS. 6 and 12 are used to shrink prostate tissue. In the initial stage, the rigid sheath 80, the junction sheath 70, and the ultrasound probe 6 are all in a fully extended position, with their distal ends generally adjacent each other. Next, the rigid sheath 80 and the joining sheath 70
, And the ultrasound probe 6 are all advanced through the urethra U of the patient until the ultrasound tip 7 enters the site of the urethral wall W adjacent to the enlarged prostate lobe of the prostate P. next,
The retractable trigger 94 is moved to withdraw the rigid sheath 80 from the urethra U to a position outside the lumen L of the urethra U (as shown in FIG. 15). The distal end of the splicing sheath 70 is then bent and adjusted in direction A by actuating the splice trigger 91 so that the splice trigger 91 pulls the proximal end of the splice wire 71 axially inward. This bending or articulating movement of the joining sheath 70 subsequently serves to bend or articulate the distal end of the ultrasound probe 6. Then, the ultrasonic probe 6
It is advanced axially and outwardly (as shown in FIG. 15) so that it can ultrasonically puncture the prostate P through the urethral wall W, whereupon the prostate is ultrasonically advanced. It can be used to reduce.

In the preferred embodiment of the present invention, the maximum oscillatory motion is not limited to the tip of the probe as is the case with prior art ultrasonic devices. Rather, the probe of the present invention is designed to provide a number of so-called antinodes (ie, points along the probe where maximum vibration occurs) spaced along the axial length of the probe in addition to the tip of the probe. . This design is optimal for the method of the invention, as tissue removal is not limited to the tissue site that contacts the probe tip. Rather, as the probe is swept through the tissue, preferably by the windshield method as described above, the tissue is removed in all areas proximate the numerous antinodes along the length of the probe. In this way, the device of the present invention allows the removal of tissue to be most effectively performed consistent with the method of the present invention, thus reducing the actual treatment time compared to prior art methods. Significantly reduced.

Furthermore, the vibration mode of the ultrasonic probe in the device of the present invention is different from the conventional vibration axial mode of the prior art. The probe in the device of the present invention oscillates transversely to the axis, rather than only oscillating axially. Because of this transverse mode of vibration, the probe of the present invention removes tissue not only at the point where the probe actually contacts the tissue, but usually in an area 1.0 to 1.5 mm around the probe's radius. Therefore, the transverse mode vibration of the probe used in the present invention also contributes to the efficiency of the method of the present invention by extending the effective area around the probe where tissue is removed.

In general, the vibration frequency applied to the probe should be increased in order to increase the number of antinodes that occur along the axial length of the probe. The frequency, however, is not critical, and running the oscillator at 20 kHz is generally sufficient to give an effective number of antinodes along the axial length of the probe. In addition, as will be appreciated by those in the art, it is possible to adjust the dimensions of the probe, including diameter, length, and location of attachment to the ultrasonic energy source, in order to place the antinodes at the desired spacing. is there. Serial number 60 / 178,901, which is the applicant's co-pending patent application, further describes the design parameters of an ultrasonic probe operating in transverse mode, which is incorporated herein by reference. .

16 and 17 show another ultrasonic tip used in the present invention. The tip 100 is generally cylindrical with a distal end 101 and a proximal end 102. Near the distal end of the tip is a recessed portion 103 having a distal end 104 and a proximal end 105. The recessed portion 103 is closed at a distal end 104 having a flat surface 106. The flat surface is positioned at an angle of 90 ° with respect to the long shaft of the ultrasonic tip. The proximal end 102 of the tip is adapted to be coupled to a source of ultrasonic vibration (not shown). The probe is made of any suitable titanium alloy. When ultrasonic waves are applied, the vibrations are transmitted to the flat surface. The entire area of the flat surface then acts as the cutting surface. The operator of the ultrasound probe can then use an ablation probe that resembles a standard electrocautery but has no thermal effect.

Thus, the unique design and concept of an ultrasonic therapy device and its use has been shown and described. While this description is directed to particular embodiments, those of skill in the art will of course be able to contemplate changes and / or variations to the particular embodiments shown and described herein. Any such modifications or variations that fall within the scope of this description are intended to be included as part of this invention. The descriptions herein are intended to be merely illustrative, not limiting. The scope of the invention described herein is limited only by the claims.

[Brief description of drawings]

[Figure 1]   FIG. 1 is a side elevational view of a handle of the ultrasonic treatment apparatus of the present invention.

[Fig. 2]   FIG. 2 is a perspective view of the first embodiment of the ultrasonic therapeutic apparatus of the present invention.

[Figure 3]   FIG. 3 is a side elevational view of the embodiment of FIG.

[Figure 4]   FIG. 4 is a perspective view of one embodiment of the ultrasonic tip of the present invention.

[Figure 5]   FIG. 5 is a perspective view of a second embodiment of the ultrasonic tip portion of the present invention.

[Figure 6]   FIG. 6 is a side elevational view of the second embodiment of the ultrasonic treatment apparatus of the present invention.

[Figure 7]   FIG. 7 is a cross-sectional view of the urinary tract of a patient not suffering from BPH.

[Figure 8]   FIG. 8 is a cross-sectional view of the urinary tract of a patient suffering from BPH.

[Figure 9]   FIG. 9 is a cross-sectional view of the lower torso of a patient showing the first stage of the surgical procedure of the present invention.

FIG. 10 is a cross-sectional view of the lower torso of a patient showing a second stage of the surgical procedure of the present invention.

FIG. 11 is a radial cross-sectional view of an ultrasonic probe according to an embodiment of the present invention.

FIG. 12 is a partial perspective view of one embodiment of the ultrasonic treatment apparatus of the present invention.

FIG. 13 is an axial cross-sectional view of one embodiment of the ultrasonic therapeutic probe of the present invention.

FIG. 14 is a cross-sectional view of the urethra of a patient undergoing BPH treatment using one embodiment of the present invention.

FIG. 15 is a cross-sectional view of a urethra of a patient undergoing BPH treatment with another embodiment of the present invention.

FIG. 16   FIG. 16 is a plan view of a right-angled ultrasonic tip.

FIG. 17   FIG. 17 is a perspective view of the ultrasonic tip at a right angle.

─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) A61B 1/307 1/31 (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES) , FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE) , SN, TD, TG), AP (GH, GM, KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CR, CU, CZ, DE. DK, DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK , LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZW (72) Inventor Hair, Blood A. 01824 Chelmsford Warsun Street A-230 (72) Inventor Fisher, David M. Massachusetts, United States. United States Massachusetts 02451 Waltham Candlewood Drive 126 (72) Inventor Levin, Andy United States Massachusetts 02159 Newton Center Daniel Drive 16 (72) Inventor Mead, John United States Massachusetts 01756 Mandan Millville Street 85 F-term (reference) 4C060 GG19 GG38 JJ11 JJ12 JJ13 JJ15 JJ17 JJ23 JJ25 4C061 AA15 CC04 HH56 4C301 EE12 EE19 FF07 FF21 FF25 KK02 KK22

Claims (62)

[Claims] 1. A method for treating benign prostatic hypertrophy in a human male, comprising the steps of inserting a flexible ultrasonic probe into the long-axis urethra, the distal end and the proximal end, and introducing the flexible ultrasonic probe into a site adjacent to the enlarged prostate lobe. Stretching the ultrasonic probe, supplying ultrasonic vibrations to the proximal end of the ultrasonic probe so that the ultrasonic vibrations generate multiple nodes and antinodes along the entire length of the ultrasonic probe. Step of, and ultrasonically perforating through the urethral wall tissue using the ultrasonic probe, inserting the ultrasonic probe inside the prostate of a human male, of the enlarged prostate lobe Shrinking the enlarged prostate lobe tissue by causing cavitation in the prostate tissue. 2. The method of claim 1, wherein the step of reducing the tissue is performed by deflecting the ultrasound probe toward the prostate while leaving the urethra substantially intact. . 3. The treatment method according to claim 1, further comprising the step of removing tissue during treatment. 4. The treatment method according to claim 1, wherein the ultrasonic probe directly contacts the enlarged prostate lobe. 5. The treatment method according to claim 1, further comprising the step of applying suction to remove tissue destroyed by the cavitation during treatment. 6. The treatment method according to claim 1, further comprising the step of monitoring the position of the ultrasonic probe using ultrasonic waves. 7. The ultrasonic wave used to monitor the position of the ultrasonic probe is provided by one ultrasonic probe inserted into the rectum of the human male. How to treat. 8. The therapeutic method according to claim 1, wherein the treatment of tissue destruction is performed without the action of heat. 9. The treatment method according to claim 1, further comprising the step of removing prostate tissue without destroying the urethra. 10. The treatment method according to claim 1, further comprising the step of monitoring the temperature of the ultrasonic probe. 11. The method further comprises: monitoring the frequency and amplitude of the ultrasonic vibration and automatically ending the delivery of the ultrasonic vibration once the set frequency and amplitude values become excessive. The treatment method according to claim 1. 12. The method comprises monitoring the amount of tissue removed by monitoring the motion caused by echoes in the probe, and monitoring the void created by the probe. The described method of treatment. 13. The frequency of the ultrasonic vibration is 20 kHz to 80 kHz.
The treatment method according to claim 1, which is in the range of z. 14. The amplitude of the ultrasonic vibration is from 150 microns to 250.
2. The method of treatment according to claim 1, characterized in that it is in the micron range. 15. The ultrasonic probe vibrates in a direction transverse to a long axis of the ultrasonic probe, and the distal end of the ultrasonic probe is substantially immobile along the long axis of the probe. The treatment method according to claim 1, wherein 16. The treatment method according to claim 1, wherein the flexible probe is capable of bending and deflecting during operation without affecting its ability to cause cavitation. 17. An ultrasonic treatment apparatus, comprising: an ultrasonic probe having an ultrasonic tip portion; and a suction sheath surrounding the ultrasonic probe, wherein the suction sheath has a suction port formed at a distal end thereof. However, the ultrasonic treatment device is characterized in that it is movable in the axial direction relative to the ultrasonic probe. 18. The ultrasonic probe has at least one flow path on an outer surface of the ultrasonic probe, and extends from a proximal end of the ultrasonic probe to a position adjacent to an ultrasonic tip of the ultrasonic probe. The ultrasonic therapy device according to claim 17, further comprising at least one flow path. 19. The ultrasonic therapeutic apparatus according to claim 18, wherein the suction port communicates with at least one of the flow paths. 20. The ultrasonic therapeutic apparatus according to claim 18, wherein the ultrasonic probe includes a plurality of flow paths. 21. The ultrasonic therapy apparatus according to claim 18, wherein at least one of the flow paths spirally winds an outer peripheral surface of the ultrasonic probe. 22. The ultrasonic treatment apparatus according to claim 17, wherein the ultrasonic probe includes an irrigation passage. 23. The ultrasonic therapeutic apparatus according to claim 22, wherein the irrigation passage is located at the center of the ultrasonic probe. 24. The ultrasonic treatment apparatus according to claim 22, wherein the irrigation passage includes at least one lumen on one side surface of the ultrasonic probe. 25. The ultrasonic treatment apparatus according to claim 17, further comprising a flexible optical fiber observation device attached to the suction sheath. 26. The ultrasonic wave according to claim 17, wherein the suction sheath is made of a flexible and elastic material, and the suction sheath has a bonding wire for controllable joint-like movement. Treatment device. 27. When the suction sheath is controllably articulated,
27. The ultrasonic therapy device according to claim 26, wherein the probe is deflected. 28. The ultrasonic therapeutic apparatus according to claim 17, wherein the suction port is a side groove located on one side surface of the suction sheath. 29. A method of treating a human male prostate, comprising inserting a medical device through the human male perineum, and advancing at least a portion of the medical device into the human male prostate. Treating the prostate of the human male with the medical device, and treating the prostate of the human male with ultrasound. 30. Inserting at least a portion of the medical device through the prostate sac of the prostate of the human male.
The described method of treatment. 31. The method of claim 30, wherein the prostate of the human male is treated to reduce prostate tissue. 32. The treatment method according to claim 30, further comprising ultrasonically perforating the prostate sac before inserting at least a part of the treatment device through the prostate sac. 33. The treatment method according to claim 29, further comprising the step of withdrawing the treatment device through the perineum of the human male. 34. In a method for treating benign prostatic hypertrophy in a human male, providing an ultrasonic probe; inserting the ultrasonic probe inside an enlarged prostate lobe of the human male; By causing cavitation in the lobe prostate tissue,
Shrinking the tissue of the enlarged prostate lobe. 35. Inserting the ultrasound probe into the human male urethra, and using the ultrasound tip to insert the hypertrophy before inserting the tip of the ultrasound probe into the prostate lobe. 35. The method of claim 34, further comprising: ultrasonically perforating through the urethral wall tissue adjacent the prostate lobe. 36. The treatment method according to claim 34, further comprising the step of sucking the tissue destroyed by cavitation. 37. Inserting the ultrasound probe through the human male perineum, and inserting the ultrasound probe through the prostate sac using the ultrasound probe prior to inserting the ultrasound tip into the prostate lobe. The method according to claim 34, further comprising: ultrasonically perforating. 38. Inserting the ultrasound probe into the human male across the urethra, using the ultrasound tip prior to inserting the ultrasound tip into the interior of the prostate lobe. 35. The method of claim 34, further comprising ultrasonically perforating the prostate membrane. 39. The frequency of the ultrasonic probe is 20 kHz to 80 kHz.
35. The method of treatment according to claim 34, characterized in that it is in the range of kHz. 40. The amplitude of energy delivered to the ultrasonic probe is in the range of 150 microns to 250 microns.
The described method of treatment. 41. The treatment method according to claim 34, wherein the ultrasonic probe vibrates in a direction transverse to a long axis of the probe. 42. A method for treating benign prostatic hypertrophy in a human male, comprising the step of inserting a medical device into the enlarged prostate lobe of the human male, shrinking the tissue of the enlarged prostate lobe, and reducing the temperature of the reduced tissue. Maintaining the normal body temperature within ± 7 ° C., wherein the tissue is hemostatically removed. 43. The treatment method according to claim 42, wherein the reduction of the tissue is performed using ultrasonic waves. 44. The treatment method according to claim 43, wherein the ultrasonic waves reduce the tissue by cavitation. 45. Inserting the medical device into the human male urethra, and inserting the medical device through the urethral wall tissue adjacent the enlarged prostate lobe prior to inserting the medical device inside the prostate lobe. 45. The method of claim 44, further comprising the step of inserting. 46. Inserting the medical device through the perineum of the human male; inserting the medical device through a prostatic capsule prior to inserting the medical device inside the prostate lobe; 43. The treatment method according to claim 42, comprising: 47. Inserting the medical device into the human male across the urethra; inserting the medical device through the prostatic capsule prior to inserting the medical device inside the prostate lobe; 43. The treatment method according to claim 42, comprising: 48. The method of treatment of claim 42, further comprising the steps of withdrawing the medical device and filling the cavity created by the device with an adhesive to fill the cavity. 49. An ultrasonic treatment apparatus, comprising an ultrasonic probe having an ultrasonic tip, wherein the ultrasonic probe has at least one flow channel on an outer surface of the ultrasonic probe, The ultrasonic treatment device, wherein one flow path extends from the proximal end of the ultrasonic probe to a position adjacent to the ultrasonic tip. 50. The ultrasonic therapeutic apparatus according to claim 49, wherein the ultrasonic probe includes a plurality of flow paths. 51. The ultrasonic therapeutic apparatus according to claim 49, wherein at least one of the flow paths spirally winds an outer peripheral surface of the ultrasonic probe. 52. A suction sheath surrounding the ultrasonic probe, wherein the suction sheath has a suction port formed at a distal end, and the suction port communicates with at least one flow path. 50. The ultrasonic therapy device according to claim 49. 53. The ultrasonic therapeutic apparatus according to claim 52, wherein the suction sheath is axially movable with respect to the ultrasonic probe. 54. The suction sheath is formed of a flexible and elastic material,
53. The ultrasonic therapy device of Claim 52, including a bond wire for controllable joint-like movement. 55. The ultrasonic treatment apparatus according to claim 54, wherein the suction sheath can be used to bend the ultrasonic probe. 56. The ultrasonic treatment apparatus according to claim 51, wherein the ultrasonic probe has an irrigation passage. 57. The ultrasonic therapeutic apparatus according to claim 56, wherein the irrigation passage is located at the center of the ultrasonic probe. 58. The ultrasonic treatment apparatus according to claim 56, wherein the irrigation passage includes at least one lumen on one side surface of the ultrasonic probe. 59. The ultrasonic treatment apparatus according to claim 49, further comprising a flexible optical fiber observation device attached to the probe. 60. The ultrasonic treatment apparatus according to claim 49, wherein the suction port is a side groove located on one side surface of the suction sheath. 61. An ultrasonic probe,   Having an elongated shaft with a long axis having a recess,   The recess is bounded by a flat surface at one end.   Ultrasonic probe characterized by. 62. The ultrasonic probe of claim 50, wherein the flat surface is approximately 90 ° with respect to the long axis of the elongate shaft.