Medical probe (with stylets) device

Information

  • Patent Grant
  • 5895370
  • Patent Number
    5,895,370
  • Date Filed
    Tuesday, January 7, 1997
    27 years ago
  • Date Issued
    Tuesday, April 20, 1999
    25 years ago
Abstract
A medical probe device of this invention comprising a catheter having a control end and a probe end. The probe end includes a stylet guide housing having at least one stylet port and stylet guide means for directing a flexible stylet outward through at least one stylet port and through intervening tissue to targeted tissues. A stylet is positioned in at least one of said stylet guide means, the stylet comprising a non-conductive sleeve having a RF electrode lumen and an optional a fluid supply lumen and a temperature sensor lumen therein. At least one portion of an opposed surface of the electrode lumen and the electrode can be spaced apart to define a liquid supply passageway for delivery of medicament liquid. The RF electrode enclosed within the non-conductive sleeve has a distal length optionally having at least one current focusing groove means thereon and a distal tip shaped to focus current crowding on its terminal end, whereby Rf current passing therefrom into surrounding tissue forms a lesion extending outward from the groove and tip. The focusing groove means can be a plurality of annular focusing grooves or a spiral focusing groove thereon.
Description

FIELD OF THE INVENTION
This invention is directed to a unique device and method for penetrating body tissues for medical purposes such as tissue ablation and fluid substance delivery, for example. The device penetrates tissue to the precise target selected in order to deliver energy to the tissue and/or deliver substances. It limits this treatment to the precise preselected site, thereby minimizing trauma to normal surrounding tissue and achieving a greater medical benefit. This device is a catheter-like device for positioning a treatment assembly in the area or organ selected for medical treatment with one or more stylets in the catheter, mounted for extension from a stylet port in the side of the catheter through surrounding tissue to the tissue targeted for medical intervention.
BACKGROUND OF THE INVENTION
Treatment of cellular tissues usually requires direct contact of target tissue with a medical instrument, usually by surgical procedures exposing both the target and intervening tissue to substantial trauma. Often, precise placement of a treatment probe is difficult because of the location of targeted tissues in the body or the proximity of the target tissue to easily damaged, critical body organs, nerves, or other components.
Benign prostatic hypertrophy or hyperplasia (BPH), for example, is one of the most common medical problems experienced by men over 50 years old. Urinary tract obstruction due to prostatic hyperplasia has been recognized since the earliest days of medicine. Hyperplastic enlargement of the prostate gland often leads to compression of the urethra, resulting in obstruction of the urinary tract and the subsequent development of symptoms including frequent urination, decrease in urinary flow, nocturia, pain, discomfort, and dribbling. The association of BPH with aging has been shown to exceed 50% in men over 50 years of age and increases in incidence to over 75% in men over 80 years of age. Symptoms of urinary obstruction occur most frequently between the ages of 65 and 70 when approximately 65% of men in this age group have prostatic enlargement.
Currently there is no proven effective nonsurgical method of treatment of BPH. In addition, the surgical procedures available are not totally satisfactory. Currently patients suffering from the obstructive symptoms of this disease are provided with few options: continue to cope with the symptoms (i.e., conservative management), submit to drug therapy at early stages, or submit to surgical intervention. More than 430,000 patients per year undergo surgery for removal of prostatic tissue in the United States. These represent less than five percent of men exhibiting clinical significant symptoms.
Those suffering from BPH are often elderly men, many with additional health problems which increase the risk of surgical procedures. Surgical procedures for the removal of prostatic tissue are associated with a number of hazards including anesthesia related morbidity, hemorrhage, coagulopathies, pulmonary emboli and electrolyte imbalances. These procedures performed currently can also lead to cardiac complications, bladder perforation, incontinence, infection, urethral or bladder neck stricture, retention of prostatic chips, retrograde ejaculation, and infertility. Due to the extensive invasive nature of the current treatment options for obstructive uropathy, the majority of patients delay definitive treatment of their condition. This circumstance can lead to serious damage to structures secondary to the obstructive lesion in the prostate (bladder hypertrophy, hydronephrosis, dilation of the kidney pelves, chronic infection, dilation of ureters, etc.) which is not without significant consequences. In addition, a significant number of patients with symptoms sufficiently severe to warrant surgical intervention are therefore poor operative risks and are poor candidates for prostatectomy. In addition, younger men suffering from BPH who do not desire to risk complications such as infertility are often forced to avoid surgical intervention. Thus the need, importance and value of improved surgical and non-surgical methods for treating BPH is unquestionable.
High-frequency currents are used in electrocautery procedures for cutting human tissue especially when a bloodless incision is desired or when the operating site is not accessible with a normal scalpel but presents an access for a thin instrument through natural body openings such as the esophagus, intestines or urethra. Examples include the removal of prostatic adenomas, bladder tumors or intestinal polyps. In such cases, the high-frequency current is fed by a surgical probe into the tissue to be cut. The resulting dissipated heat causes boiling and vaporization of the cell fluid at this point, whereupon the cell walls rupture and the tissue is separated.
Destruction of cellular tissues in situ has been used in the treatment of many diseases and medical conditions alone or as an adjunct to surgical removal procedures. It is often less traumatic than surgical procedures and may be the only alternative where other procedures are unsafe. Ablative treatment devices have the advantage of using an electromagnetic energy which is rapidly dissipated and reduced to a non-destructive level by conduction and convection forces of circulating fluids and other natural body processes.
Microwave, radiofrequency, acoustical (ultrasound) and light energy (laser) devices, and tissue destructive substances have been used to destroy malignant, benign and other types of cells and tissues from a wide variety of anatomic sites and organs. Tissues treated include isolated carcinoma masses and, more specifically, organs such as the prostate, glandular and stromal nodules characteristic of benign prostate hyperplasia. These devices typically include a catheter or cannula which is used to carry a radiofrequency electrode or microwave antenna through a duct to the zone of treatment and apply energy diffusely through the duct wall into the surrounding tissue in all directions. Severe trauma is often sustained by the duct wall during this cellular destruction process, and some devices combine cooling systems with microwave antennas to reduce trauma to the ductal wall. For treating the prostate with these devices, for example, heat energy is delivered through the walls of the urethra into the surrounding prostate cells in an effort to ablate the tissue causing the constriction of the urethra. Light energy, typically from a laser, is delivered to prostate tissue target sites by "burning through" the wall of the urethra. Healthy cells of the duct wall and healthy tissue between the nodules and duct wall are also indiscriminately destroyed in the process and can cause unnecessary loss of some prostate function. Furthermore, the added cooling function of some microwave devices complicates the apparatus and requires that the device be sufficiently large to accommodate this cooling system.
Application of liquids to specific tissues for medical purposes is limited by the ability to obtain delivery without traumatizing intervening tissue and to effect a delivery limited to the specific target tissue. Localized chemotherapy, drug infusions, collagen injections, or injections of agents which are then activated by light, heat or chemicals would be greatly facilitated by a device which could conveniently and precisely place a fluid (liquid or gas) supply catheter opening at the specific target tissue.
OBJECTS AND SUMMARY OF THE INVENTION
It is an object of this invention to provide a device and method for penetrating tissue, through intervening tissues to the precise target tissue selected for a medical action such as tissue ablation and/or substance delivery, limiting this activity to the precise preselected site, thereby minimizing the trauma and achieving a greater medical benefit.
It is another object of this invention is to provide a device and method for tissue ablation of body tissues which delivers the therapeutic energy directly into targeted tissues while minimizing effects on its surrounding tissue.
It is a still further object of this invention is to provide a device and method for introducing fluid treatment agents such as flowable liquids and gases, with greater precision and ease to a specific location in the body.
Another object of this invention is to provide a thermal destruction device which gives the operator more information about the temperature and other conditions created in both the tissue targeted for treatment and the surrounding tissue. In addition, it will provide more control over the physical placement of the stylet and over the parameters of the tissue ablation process.
In summary, the medical probe device of this invention comprises a catheter having a control end and a probe end. The probe end includes a stylet guide housing having at least one stylet port and stylet guide means for directing a flexible stylet outward through at least one stylet port and through intervening tissue to targeted tissues. A stylet is positioned in at least one of said stylet guide means, the stylet comprising a non-conductive sleeve having at least two and preferably three lumina therein. An RF electrode lumen terminates at a distal port in the distal end of the non-conductive sleeve, and a radiofrequency electrode is positioned in the RF electrode lumen for longitudinal movement therein through the distal port. Preferably, at least one portion of an opposed surface of the electrode lumen and the electrode are spaced apart to define a liquid supply passageway for delivery of medicament liquid. A second optional fluid passage lumen terminates at a distal port in the distal end of the non-conductive sleeve and comprises means passing fluid therethrough.
A temperature sensor third lumen terminates in a sealed closure adjacent the distal end of the non-conductive sleeve. At least one and preferably a plurality of temperature sensing devices such as thermocouples are positioned in the third lumen, the leads extending through the lumen. One preferred embodiment has two temperature sensing devices positioned in the third lumen, one temperature sensing device being positioned within about 1 mm of the distal end of the non-conductive sleeve, and the second temperature sensing device being positioned at least 3 mm and preferably from 3 to 6 mm from the distal end of the non-conductive sleeve.
In summary, another embodiment of this invention comprises a catheter having a control end and a probe end, the probe end including a stylet guide housing having at a stylet port and stylet guide means for directing a flexible stylet outward through the stylet port and through intervening tissue to targeted tissues. A stylet is positioned in at least one of said stylet guide means, the stylet comprising an electrical conductor enclosed within a non-conductive sleeve. The electrode has a distal length having at least one current focusing groove means thereon and a distal tip shaped to focus current on its terminal end, whereby RF current passing therefrom into surrounding tissue forms a lesion extending outward from the groove and tip. In one preferred embodiment, the distal length has a plurality of annular focusing grooves or a spiral focusing groove thereon.
Preferably at least a part of the electrode is enclosed within a support tube having sufficient strength to maintain electrode linearity when the electrode is directed outward through the stylet port.





BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an isometric view of an RF ablation catheter embodiment of this invention with an fiber optic viewing accessory.
FIG. 2 is a cross-sectional view of a catheter of FIG. 1 showing details of the stylet guide housing.
FIG. 3 is a side view of the stylet and lumen assembly of this invention.
FIG. 4 is a cross-sectional side view of the of the junction of the stylet and control tube assembly taken along the central axis of the tubing.
FIG. 5 is a cross-sectional view of the junction of the stylet and control tube assembly taken along the line 5--5 of FIG. 4.
FIG. 6 is a cross-sectional view of a trilumen stylet of this invention taken along the line 6--6 in FIG. 3.
FIG. 7 is a cross-sectional side view of the trilumen stylet tip shown in FIG. 3 taken along line 7--7 of FIG. 6.
FIG. 8 is a plane view of the annular groove embodiment of the current density focusing electrode of this invention.
FIG. 9 is a plane view of the spiral groove embodiment of the current density focusing electrode of this invention. position and the sleeve partially retracted therefrom.
FIG. 10 is an exploded view of the RF ablation catheter shown in FIG. 1.
FIG. 11 is an isometric view of the adjuster block and tension tube assembly of the RF ablation catheter shown in FIG. 10.
FIG. 12 is a detailed view "A" of the tension tube connections shown in FIG. 11.
FIG. 13 is an exploded view of the-sleeve and electrode slide block assembly of the embodiment shown in FIG. 10.





DETAILED DESCRIPTION OF THE INVENTION
The device of this invention provides a precise controlled positioning of a treatment stylet in a tissue targeted for treatment, destruction or sampling from a catheter positioned in the vicinity of the target tissue.
The term "stylet" as used hereinafter is defined to include both solid and hollow probes which are adapted to be passed from a catheter port through normal tissue to targeted tissues. The stylet is shaped to facilitate easy passage through tissue. It can be a solid wire, thin rod, or other solid shape or it can be a thin hollow tube or other shape having a longitudinal lumen for introducing fluids to or removing materials from a site. The stylet can also be a thin hollow tube or other hollow shape, the hollow lumen thereof containing a reinforcing or functional rod or tube such as a laser fiber optic. The stylet preferably has a sharpened end to reduce resistance trauma when it is pushed through tissue to a target site.
The stylet can be designed to provide a variety of medically desired treatments of a selected tissue. As a radiofrequency electrode or microwave antenna, it can be used to ablate or destroy targeted tissues. As a hollow tube, it can be used to deliver a treatment fluid such as a liquid to targeted tissues. The liquid can be a simple solution or a suspension of solids, for example, colloidal particles, in a liquid. Since the stylet is very thin, it can be directed from the catheter through intervening normal tissue with a minimum of trauma to the normal tissue.
The device and method of this invention provide a more precise, controlled medical treatment which is suitable for destroying cells of medically targeted tissues throughout the body, both within and external to body organs. The device and method are particularly useful for treating benign prostate hyperplasia (BPH), and the device and its use are hereinafter described with respect to BPH, for purposes of simplifying the description thereof. It will be readily apparent to a person skilled in the art that the device and method can be used to destroy body tissues in any body cavities or tissue locations that are accessible by percutaneous or endoscopic catheters, and is not limited to the prostate. Application of the device and method in all of these organs and tissues are intended to be included within the scope of this invention.
BPH is a condition which arises from the replication and growth of cells in the prostate and the decrease of cell death rate, forming glandular and stromal nodules which expand the prostate and constrict the opening of the prostatic urethra. Glandular nodules are primarily concentrated within the transition zone, and stromal nodules within the periurethral region. Traditional treatments of this condition have included surgical removal of the entire prostate gland, digital removal of the adenoma, as well as transurethral resection of the urethral canal and prostate to remove tissue and widen the passageway. One significant and serious complication associated with these procedures is istrogenic sterility. More recently, laser treatment has been employed to remove tissue, limiting bleeding and loss of body fluids. Balloons have also been expanded within the urethra to enlarge its diameter, with and without heat, but have been found to have significant limitations.
Microwave therapy has been utilized with some success by positioning a microwave antenna within the prostatic urethra and generating heat in the tissue surrounding the urethra with an electromagnetic field. Coolants are sometimes applied within the catheter shaft to reduce the temperature of the urethral wall. This necessitates complicated mechanisms to provide both cooling of the immediately adjacent tissues while generating heat in the more distant prostatic tissue. This technique is similar to microwave hyperthermia. Similarly, radiofrequency tissue ablation with electrodes positioned within the urethra exposes the urethral wall to destructive temperatures. To avoid this, low temperature settings required to protect the urethra must be so low that the treatment time required to produce any useful effect is unduly extended, e.g. up to three hours of energy application.
One embodiment of the device of this invention uses the urethra to access the prostate and positions RF electrode stylets directly into the tissues to be destroyed. The portion of the stylet conductor extending from the urethra to targeted tissues is enclosed within a longitudinally adjustable sleeve shield which prevents exposure of the tissue adjacent to the sleeve to the RF current. The sleeve movement is also used to control the amount of energy per unit surface area which is delivered by controlling the amount of electrode exposed. Thus the ablative destruction is confined to the tissues targeted for destruction, namely those causing the constriction. Other aspects of the invention will become apparent from the drawings and accompanying descriptions of the device and method of this invention. It will be readily apparent to a person skilled in the art that this procedure can be used in many areas of the body for percutaneous approaches and approaches through body orifices.
FIG. 1 is an isometric view of an RF ablation catheter embodiment of this invention with a fiber optic viewing accessory. The flexible catheter 2, attached to handle 4, has a terminal stylet guide 6 with two stylets 8. The handle has stylet electrode tabs 10 and 11 and sleeve tabs 12 and 13 as will be described in greater detail hereinafter. The handle 4 is also connected to a optical viewing assembly 14 and RF power connector 16, transponder connector 18 and thermocouple connectors 20. The portions of the catheter 2 leading from the handle 4 to the stylet guide tip 6 can optionally has a graduated stiffness. For example, the catheter can be designed to be more stiff near the handle and more flexible near the tip, or any other stiffness profiles. The catheter can be constructed of an inner slotted stainless steel tube with outer flexible sleeve such as is described in U.S. Pat. No. 5,322,064, the entire contents of which are incorporated herein by reference. It can also be made of coiled or braided wire to which an outer sleeve is bonded.
The fiber optic viewing assembly in this embodiment includes a lens focusing assembly 22, a lens viewing assembly support connector 24 assembly attached to a male quick disconnect connector 26 by flexible tubing 28.
FIG. 2 is a cross-sectional view of a catheter of FIG. 1 showing details of the stylet guide housing. The stylet guide housing 6 has a curved passageway 28 through which the stylet 8 is extended into the tissue to be treated. Further details of these components are described in copending applications Ser. No. 08/012,370 filed Feb. 2, 1993, now U.S. Pat. No. 5,370,675 and application Ser. No. 08/063,364 filed May 13, 1993 now U.S. Pat. No. 5,435,805.
FIG. 3 is a side view of the stylet and lumen assembly of this invention. The key components of the stylet of this embodiment are an insulating sleeve 30 and an electrode 32 extending therethrough. The electrode 32 has a sharpened tip, in this embodiment a broadened spear tip. The proximal end of the electrode and sleeve are connected by respective sleeve connector 334 and electrode connector 338 to handle sleeve and electrode slides described in greater detail hereinafter with respect to FIGS. 10 and 13. An electrode support tube 36 extends from the electrode connector 338 to the area 38 of the sleeve connector 334 to transmit compressive pressure without collapsing the electrode 32. An insulating sleeve support tube 40 made of shrink tubing extends from the sleeve connector 334 to the beginning or proximal end 42 of the outer tubing 44. Tubing 44 joins the support tubing to the control tube 46. The control tube 46 supporting both the electrode and insulating sleeve extends to the junction 48 (see FIG. 4) of the electrode lumen passageway 50 and the electrode 32. In this manner, support is provided over the length of the stylet extending from the handle to the trilumen tip, preventing collapse or loss of linearity of the highly flexible electrode when it is pushed through the stylet guide housing.
FIG. 4 is a side elevational view in section of the junction of the stylet and control tube assembly along the central axis of the tubing, and FIG. 5 is a cross-sectional view of the junction of the stylet and control tube assembly taken along the line 5--5 of FIG. 4. At the junction 48, the electrode 32 extends through the upper electrode lumen wall 62 and enters the electrode lumen 50. The outer tubing 52 encloses and supports both the distal ends of the control tubing 46 and a trilumen sleeve tube 54.
Referring to FIG. 5, the space 56 between the control tube 46 and the trilumen sleeve tube 54 can be filled with adhesive to secure them together. The trilumen sleeve tube 54 includes the electrode lumen 50, a temperature sensor lumen 58 and a fluid supply lumen 60 for supply of optional fluids such as antibiotics or anesthetics to the area of treatment.
FIG. 6 is a cross-sectional view of a trilumen stylet-of this invention taken along the line 6--6 in FIG. 3. The trilumen sleeve 30 is an insulating sleeve for the electrode 32 and includes the additional temperature sensor lumen 58 and liquid supply lumen 60. The inner surface of the electrode lumen 50 can be spaced from the outer surface of the electrode by a distance "h" which can be, for example, from about 1 to 3 mm to define an additional liquid supply conduit with an approximate annular cross-section.
FIG. 7 is a cross-sectional side view of the trilumen stylet tip shown in FIG. 6 taken along the line 7--7. The terminal end of the temperature sensor lumen 58 is sealed to protect the electrical components. Thermocouple 64 is placed at the distal end of the sleeve 30 to monitor the temperature of the tissue surrounding the electrode 32 and is preferably less than about 1 mm from the exposed electrode. Thermocouple 66 is placed at least about 3 mm and preferably from about 3 to 6 mm from the tip of sleeve 30 to monitor the temperature of the duct wall (such as the urethra) through which the stylet is extended. This is provided to ensure the duct wall temperature does not reach destructive levels when the RF treatment of tissue surrounding the extended electrode is underway.
FIG. 8 is a plane view of the annular groove embodiment of the current density focusing electrode of this invention. In this embodiment, the electrode is ground to a single current focusing sharp tip 68 without secondary corner or other sharp edges which could also focus or crowd current. Additional current focusing can be provided along the electrode surface by the annular grooves 70 and 72. The temperature of the tissue surrounding the electrode initially increases in initial zones 74, 76 and 78. The elevated temperature zone then extends to two intermediate zones 80 and 82, as the zones from the grooves merge. Thereafter all of the elevated temperature zones merge to form the single oval zone lesion 84. Use of these current focusing grooves 70 and 72 produces a more symmetrical lesion.
FIG. 9 is a plane view of the spiral groove embodiment of the current density focusing electrode of this invention. In this embodiment, the electrode is also ground to a single current focusing sharp tip 86 without secondary sharp corners or edges which could also focus or crowd current. Additional current focusing can be provided along the electrode surface by at least one spiral or helical groove 88. The temperature of the tissue surrounding the electrode initially increases in the initial tip zone 90 and spiral zone 92. The elevated temperature zone then extends to two intermediate zones 94 and 96, as the spiral zone 92 merges to form a single zone 96. Thereafter all of the elevated temperature zones merge to form the single oval zone lesion 98. Use of the spiral focusing groove 88 provides a more symmetrical lesion.
FIG. 10 is an exploded view of the RF ablation catheter assembly shown in FIG. 1. The upper handle plate 276 has two central slots 278 and 280 through which the electrode control slides 10 and 11 are attached to respective left electrode slide block 282 and right electrode slide block 284. Sleeve control slides 12 and 13 are attached through outer slots 286 and 288 to respective left sleeve slide block 290 and right sleeve slide block 292. Fiber optic receptor housing 30 is mounted on the proximal surface of the upper handle plate 276. The electrical receptor 294 is received in respective cavities 296 and 298 in the upper handle plate 276 and lower handle plate 300 attached thereto. The lower handle plate 300 has a central cavity 302 which accommodates the electrode and sleeve slide blocks and associated elements.
Microswitch activator blocks 304 (only left sleeve block shown) are connected to the sleeve slide blocks 290 and 292. They are positioned to actuate the microswitches 306 when the respective sleeve block (and sleeve attached thereto) have been advanced. The microswitches 306 hold the respective RF power circuits open until the respective sleeves are advanced to a position beyond the urethra wall and into the prostate to prevent direct exposure of the urethra to the energized RF electrodes. Extension of the sleeve 5 mm beyond the guide is usually sufficient to protect the urethra.
The tension-torque tube assembly 308 is mounted in the distal end of the housing in the receptor 310.
FIG. 11 is an isometric view of the adjuster block and tension tube assembly 308 of the RF ablation catheter shown in FIG. 10. The torque tube 312 extends from the torque coupler 314 through the twist control knob 316 to the stylet guide 6. Bending flexure of the torque tube 312 during use lengthens the path from the handle to the guide tip 6. To prevent a resulting retraction of the stylet sleeve and electrode components when the torque tube 312 is flexed, a tension tube 318 having a fixed length and diameter smaller than the inner diameter of the torque tube 312 is provided. The distal end of the tension tube 318 is securely attached to the stylet guide 6, and the proximal end 320 is secured to the adjuster block 322, for example by an adhesive. The axial position of the adjuster block 322 can be adjusted to ensure the stylets are initially positioned just inside the outlet ports in the stylet 8 guide 6. Torque coupler 314 is mounted on the coupler block 324. Twist control knob stop pin 326 extends into a grove (not shown) and limits rotation of the control knob 316.
FIG. 12 is a detailed view "A" of the distal end tension tube connections of the tension tube shown in FIG. 11. The tension tube 318 is securely connected to the proximal end 328 of the stylet guide 6, for example by a length of shrink tubing 330.
FIG. 13 is an exploded view of the sleeve and electrode slide block assembly of the embodiment shown in FIG. 10. The right sleeve slide block 292 has a projection 332 which extends inward under the right electrode slide block 284. Right sleeve connector 334 is mounted to the inner end of the projection 332, secured to the end of the proximal end of the sleeve 336. Right electrode connector 338 is attached to an inner surface of the electrode slide block 284 and is secured to the proximal end of electrode 340. The right sleeve and electrode slide blocks 292 and 284 are slidingly attached to the right friction adjustment rail 342 by screws (not shown) through slots 344 and 345, the screws being adjustable to provide sufficient friction between the blocks and the rail 342 to provide secure control over the stylet movement. The left sleeve slide block 290 and left electrode slide block 282 are mirror replicas of the right blocks and are similarly mounted on the left friction rail 348. The left sleeve and electrodes are not shown.
Although preferred embodiments of the subject invention have been described in some detail, it is understood that obvious variations can be made without departing from the spirit and the scope of the invention as defined by the appended claims.
Claims
  • 1. A medical probe device for medical treatment of tissue of a prostate through a urethra defined by a urethral wall comprising a guide housing having proximal and distal extremities and a passageway extending from the proximal extremity to the distal extremity, the guide housing having a length so that when the distal extremity of the guide housing is in the vicinity of the prostate the proximal extremity of the guide housing is outside the urethra, a stylet slidably mounted in the passageway of the guide housing, the stylet having proximal and distal extremities, handle means coupled to the proximal extremity of the guide housing for introducing the distal extremity of the guide housing into the urethra so that the distal extremity of the guide housing is in the vicinity of the prostate, the handle means including means for advancing the stylet from the passageway to cause the distal extremity of the stylet to penetrate the urethral wall and to extend into the tissue of the prostate, the stylet having a lumen extending from the proximal extremity to the distal extremity for delivering a liquid into the tissue of the prostate, means coupled to the guide housing for supplying a liquid to the lumen of the stylet and means for supplying radio frequency energy to the stylet for delivery through the distal extremity of the stylet to cause the temperature of the tissue of the prostate adjacent the distal extremity of the stylet to be raised so as to destroy cells in the tissue of the prostate.
  • 2. A medical probe device for medical treatment of tissue of a prostate through a urethra defined by a urethral wall comprising a guide housing having proximal and distal extremities and having a passageway extending therethrough, a stylet carried by the guide housing slidably mounted in said passageway, said stylet including an insulating sleeve having a lumen extending therethrough and a flexible radio frequency conductive electrode with a sharp tip disposed within the lumen of the insulating sleeve and movable relative to the insulating sleeve, said lumen having a size so that with the insulating sleeve disposed therein there remains an annular space extending longitudinally of the lumen, means carried by the distal extremity of the guide housing and in communication with the lumen for directing the radio frequency electrode and the insulating sleeve sidewise of the guide housing, handle means mounted on the proximal extremity of the guide housing for introducing the distal extremity of the stylet through urethra so that the distal extremity of the guide housing is in the vicinity of the prostate, means mounted on the proximal extremity of the guide housing for advancing the stylet and to cause the radio frequency electrode to cause the sharp tip of the radio frequency electrode to penetrate the urethral wall and to extend into the tissue of the prostate with the insulating sleeve extending through the urethral wall, means connected to the handle means for causing relative movement between the insulating sleeve and the radio frequency electrode of the stylet to expose a predetermined length of radio frequency electrode in the tissue of the prostate with the insulating sleeve extending through the urethral wall, means for supplying radio frequency energy to the radio frequency electrode to cause the temperature of the tissue of the prostate adjacent the predetermined length of radio frequency electrode to be raised to cause destruction of cells in the tissue of the prostate and means coupled to the insulating sleeve for supplying a medicament liquid to the annular space for delivery alongside the electrode into engagement with the tissue of the prostate.
  • 3. A medical probe device as in claim 1 wherein the stylet is a flexible radio frequency electrode with a tip and a layer of insulating material coaxially mounted on at least a portion of the radio frequency electrode.
  • 4. A medical probe device as in claim 3 wherein the layer of insulating material is movable relative to the radio frequency electrode, the handle means including means for causing relative movement between the layer of insulating material and the radio frequency electrode.
  • 5. A medical probe device as in claim 3 wherein the lumen constitutes an annular space surrounding the radio frequency electrode.
  • 6. A medical probe device as in claim 3 wherein the lumen extends longitudinally through the layer of insulating material to an opening at the distal extremity of the stylet.
  • 7. A medical probe device as in claim 3 wherein the lumen extends longitudinally through the radio frequency electrode.
  • 8. A medical probe device as in claim 3 together with temperature sensing means carried by the layer of insulating material.
  • 9. A medical probe device as in claim 1 together with means carried by the distal extremity of the guide housing and in communication with the passageway for directing the stylet sidewise of the guide housing.
  • 10. A medical probe device as in claim 1 wherein the stylet is a needle electrode.
RELATIONSHIP TO COPENDING APPLICATION

This application is a continuation of U.S. patent application Ser. No. 08/470,621 filed Jun. 6, 1995, now U.S. Pat. No. 5,591,125, which is a continuation of U.S. patent application Ser. No. 08/061,647 filed May 13, 1993, now U.S. Pat. No. 5,421,819, which is a continuation-in-part of U.S. patent application Ser. No. 07/929,638 filed Aug. 12, 1992, now abandoned, and U.S. patent application Ser. No. 08/012,370 filed Feb. 2, 1993, now U.S. Pat. No. 5,370,675. A related copending application U.S. patent application Ser. No. 08/062,364 filed May 13, 1993, now U.S. Pat. No. 5,435,805. The entire contents of all of the above applications are hereby incorporated by reference.

US Referenced Citations (192)
Number Name Date Kind
RE32066 Leveen Jan 1986
1879249 Hansaker Sep 1932
1950788 Ewerhardt et al. Mar 1934
1968997 Drucker Aug 1934
2008526 Wappler et al. Jul 1935
2022065 Wappler Nov 1935
2038393 Wappler Apr 1936
2047535 Wappler Jul 1936
2118631 Wappler May 1938
2619724 Manthey et al. Dec 1952
2710000 Cromer et al. Jun 1955
3230957 Seifert Jan 1966
3339542 Howell Sep 1967
3556079 Omizo et al. Jan 1971
3590808 Muller Jul 1971
3595239 Petersen Jul 1971
3598108 Jamshidi et al. Aug 1971
3682162 Colyer et al. Aug 1972
3828780 Morrison et al. Aug 1974
3835842 Iglesias Sep 1974
3840016 Lindemann Oct 1974
3850175 Iglesias Nov 1974
3858577 Bass et al. Jan 1975
3884237 O'Malley et al. May 1975
3924628 Droegemueller et al. Dec 1975
3939840 Storz Feb 1976
3942530 Northeved Mar 1976
3948270 Hasson Apr 1976
3977079 Rebold Aug 1976
3991770 Leveen Nov 1976
4011872 Komiya Mar 1977
4016886 Doss et al. Apr 1977
4119102 Leveen Oct 1978
4121592 Whalley Oct 1978
4136566 Christensen Jan 1979
4137920 Bonnet et al. Feb 1979
4154246 Leveen May 1979
4204549 Paglione May 1980
4224929 Furihata Sep 1980
4228809 Paglione Oct 1980
4237898 Whalley Dec 1980
4267828 Matsuo May 1981
4295467 Mann et al. Oct 1981
4307720 Weber Dec 1981
4311145 Esty Jan 1982
4311154 Sterzer et al. Jan 1982
4312364 Convert et al. Jan 1982
4336809 Clark Jun 1982
4375220 Matvias Mar 1983
4397314 Vaguine Aug 1983
4402311 Hattori Sep 1983
4405314 Cope Sep 1983
4411266 Cosman Oct 1983
4448198 Turner May 1984
4452236 Utsugi Jun 1984
4470407 Hussein Sep 1984
4474174 Petruzzi Oct 1984
4494539 Zenitani et al. Jan 1985
4524770 Orandi Jun 1985
4552554 Gould et al. Nov 1985
4562838 Walker Jan 1986
4565200 Cosman Jan 1986
4568329 Mahurkar Feb 1986
4580551 Siegmund et al. Apr 1986
4594074 Andersen et al. Jun 1986
4601296 Yerushalmi Jul 1986
4612940 Kasvich et al. Sep 1986
4658836 Turner Apr 1987
4660560 Klein Apr 1987
4669475 Turner Jun 1987
4672962 Hershenson Jun 1987
4676258 Inokuchi et al. Jun 1987
4681122 Winters et al. Jul 1987
4682596 Bales et al. Jul 1987
4697595 Breyer et al. Oct 1987
4700716 Kasevich et al. Oct 1987
4706681 Breyer et al. Nov 1987
4709698 Johnston et al. Dec 1987
4719914 Johnson Jan 1988
4753223 Bremer Jun 1988
4765331 Petruzzi et al. Aug 1988
4769005 Ginsburg et al. Sep 1988
4774949 Fogarty Oct 1988
4776086 Kasevich et al. Oct 1988
4781186 Simpson et al. Nov 1988
4784638 Ghajar et al. Nov 1988
4785829 Convert et al. Nov 1988
4798215 Turner Jan 1989
4800899 Elliott Jan 1989
4805616 Pao Feb 1989
4813429 Herzlia et al. Mar 1989
4817601 Roth et al. Apr 1989
4818954 Flachenecker et al. Apr 1989
4822333 Lavarnne Apr 1989
4823791 D'Amelio et al. Apr 1989
4823812 Eshel et al. Apr 1989
4860744 Johnson et al. Aug 1989
4865047 Chou et al. Sep 1989
4872458 Kanehira et al. Oct 1989
4887615 Taylor Dec 1989
4893623 Rosenbluth Jan 1990
4896671 Cunningham et al. Jan 1990
4898577 Badger Feb 1990
4905667 Foerster et al. Mar 1990
4906230 Maloney et al. Mar 1990
4907589 Cosman Mar 1990
4911148 Sosnowski et al. Mar 1990
4911173 Terwilliger Mar 1990
4919129 Weber et al. Apr 1990
4920978 Colvin May 1990
4932958 Reddy et al. Jun 1990
4936281 Stasz Jun 1990
4940064 Desai Jul 1990
4943290 Rexioth et al. Jul 1990
4946449 Davis Aug 1990
4949706 Thon Aug 1990
4950267 Ishihara et al. Aug 1990
4955377 Lennox et al. Sep 1990
4961435 Kitagawa et al. Oct 1990
4966597 Cosman Oct 1990
4967765 Turner et al. Nov 1990
4982724 Saito et al. Jan 1991
4998932 Rosen Mar 1991
4998933 Eggers et al. Mar 1991
5002558 Klein et al. Mar 1991
5003991 Takayama et al. Apr 1991
5007437 Sterzer Apr 1991
5007908 Rydell Apr 1991
5010886 Passafaro et al. Apr 1991
5026959 Ito et al. Jun 1991
5029588 Yock et al. Jul 1991
5030227 Rosenbluth et al. Jul 1991
5035695 Weber et al. Jul 1991
5035696 Rydell Jul 1991
5045056 Behl Sep 1991
5045072 Castillo Sep 1991
5055109 Gould et al. Oct 1991
5057105 Malone et al. Oct 1991
5057106 Kasevich et al. Oct 1991
5057107 Parins Oct 1991
5059851 Corl et al. Oct 1991
5060660 Gambale et al. Oct 1991
5071418 Rosenbaum Dec 1991
5080660 Buelna Jan 1992
5083565 Parins Jan 1992
5084044 Quint Jan 1992
5100423 Fearnot Mar 1992
5108415 Pinchuk et al. Apr 1992
5109859 Jenkins May 1992
5116615 Gokeen et al. May 1992
5120316 Morales et al. Jun 1992
5122137 Lennox Jun 1992
5135525 Biscoping et al. Aug 1992
5150717 Rosen et al. Sep 1992
5170789 Lindegren Dec 1992
5178620 Eggers et al. Jan 1993
5179962 Dutcher et al. Jan 1993
5190539 Fletcher et al. Mar 1993
5195965 Shantha Mar 1993
5195968 Lundquist et al. Mar 1993
5197963 Parins Mar 1993
5201732 Parins et al. Apr 1993
5207672 Roth May 1993
5220927 Astrahan et al. Jun 1993
5222953 Dowlatshahi Jun 1993
5228441 Lundguist Jul 1993
5234004 Hasroet et al. Aug 1993
5235964 Abenaim Aug 1993
5249585 Turner et al. Oct 1993
5254088 Lundquist et al. Oct 1993
5257451 Edwards et al. Nov 1993
5273535 Edwards et al. Dec 1993
5275162 Edwards et al. Jan 1994
5281213 Milder et al. Jan 1994
5281217 Edwards et al. Jan 1994
5281218 Imran Jan 1994
5287845 Faul et al. Feb 1994
5290286 Parins Mar 1994
5293368 Nardella Mar 1994
5293869 Edwards et al. Mar 1994
5299559 Bruce et al. Apr 1994
5300068 Rosar et al. Apr 1994
5300069 Hunsberger et al. Apr 1994
5300070 Gentelia et al. Apr 1994
5300099 Rudie Apr 1994
5301687 Wong et al. Apr 1994
5304134 Kraus et al. Apr 1994
5304214 Deford Apr 1994
5309910 Edwards et al. May 1994
5313943 Houser et al. May 1994
5421819 Edwins et al. Jun 1995
5591125 Edwards et al. Jan 1997
Foreign Referenced Citations (42)
Number Date Country
1085892 Aug 1992 AUX
0495443 EPX
0370890 EPX
521264A2 EPX
0453071 EPX
3218314 DEX
3838840 DEX
3844131 DEX
2848484 DEX
2941060 Apr 1980 DEX
3247793 Jul 1983 DEX
2121675 May 1990 JPX
1284979 Aug 1972 GBX
9407412 WOX
9407413 WOX
9304727 WOX
9407441 WOX
9407446 WOX
9407549 WOX
9407411 WOX
9207622 WOX
9007303 WOX
9221278 WOX
9221285 WOX
9308755 WOX
9308756 WOX
9308757 WOX
9320767 WOX
9320768 WOX
9320886 WOX
9320893 WOX
9403759 WOX
9404222 WOX
9405226 WOX
9406377 WOX
9407410 WOX
WO911213 Aug 1991 WOX
9116859 Nov 1991 WOX
WO9210142 Jun 1992 WOX
9210142 Jun 1992 WOX
9315664 Aug 1993 WOX
WO9325136 Dec 1993 WOX
Non-Patent Literature Citations (25)
Entry
Urology, 5th Ed., Storz, Jan. 1992.
Blute, Michael L. et al., Mayo Clinic Proceedings, 67:417-421 (1992).
Bruskewitz, Reginald, Mayo Clinic Proceedings, 67:493-495 (1992).
Chang, Raymond J. et al., American Heart Journal, 125: 1276-1283 (May, 1993).
Standard Urology Product Catalog, Circon ACMI: Stanford (1992).
Cosman, Eric R. et al., Sterostatic and Functional Neurosurgery, pp. 2490-2499 (Date Unknown).
Diasonics, Brochure DIA 2000 171 CRF May 1988.
U.I. Dept. of Health and Human Services, MMWR, 41:401-404 vol. 41, No. 23, (Jun. 12, 1992).
Perinchery, Narayan, "Neoplasms of the Prostate Gland." pp. 378-409. (Date Unknown).
Scala, Stephen M. et al., Cowen: Industrial Strategies (1991).
U.S. Ser. No. 832,115--presently Abandoned.
Greenwald Surgical Company, Inc., "Orandi Resectoscope Injection Needle for Injection of Local Anesthetics", ( Undated) Sheet No. P000121.
E.F. Nation, M.D., "Evolution of Knife-Punch Resectoscope," (Apr. 1976) Urology, vol. VII, No. 4, pp. 417-427.
R. Gutierrez, "Transurethral Treatment of Bladder Neck Obstructions: Endoscopic Prostatic Resection," (Apr. 1933) History of Urology, vol. II, Chapter V, pp. 137-186.
C.W. Ogden, Heat and the Prostate from Electrolysis to Microwaves: Lessons form an Historical Perspective, (Undated) Abstract, 2 sheets, p. 366.
Graversen, et al., "Transurethral incisions of the prostate under local anaesthesia in high-risk patients: a pilot study," (1987) Abstract, HealthGate Home Page, p. P000115.
Miller, et al., "Integrated cystoscope: first rigid multipurpose operating cystoscope for local anesthetic endoscopy," (1989) Abstract, HealthGate Home Page, p. P000116.
Orandi, "Urological endoscopic surgery under local anesthesia: a cost-reducing idea," (1984) Abstract, HealthGate Home Page, p. P000117.
Orandi, "Transurethral resection versus transurethral incision of the prostate," (1990) Abstract, HealthGate Home Page, p. P000118.
H. LeVeen, "Method for treating benign and malignant tumors utilizing radio frequency," (Nov. 16, 1976) Abstract, USPTO.Gov, U.S. Patent No. 3,991,770, pp. P000119-P000120.
R. Auhll, "The Use of the Resectoscope in Gynecology," (Oct. 1990) Biomedical Business International, pp.91-99.
L. Geddes, "A Short History of the Electrical Stimulation of Excitable Tissue Including Electrotherapeutic Applications," (1984) A Supplement to The Physiologist, vol. 27, No. 1, pp. P000066-P000071.
W. Moseley, M.D., "The History of Treatment of BPH Including Current Treatment Alternatives," (Undated) pp. P000187-P000190.
D. Paulson, M.D., "Diseases of the Prostate," (1989) Clinical Symposia, vol. 41, No. 2., pp. P000191-P000195.
T. Kirwin, "The Treatment of Prostatic Hypertrophy by a New `Shrinkage` Method," (Aug. 1934) J. Urology, pp. 481-494.
Continuations (2)
Number Date Country
Parent 470621 Jun 1995
Parent 061647 May 1993
Continuation in Parts (1)
Number Date Country
Parent 929638 Aug 1992