WO1997028840A1

WO1997028840A1 - Prostatic tissue expander

Info

Publication number: WO1997028840A1
Application number: PCT/US1996/002500
Authority: WO
Inventors: Christopher J. Conway; Terance M. Fogarty
Original assignee: Mentor Urology, Inc.
Priority date: 1996-02-12
Filing date: 1996-02-12
Publication date: 1997-08-14
Also published as: AU5173296A; EP0883417A1; CA2246434A1; JP2001500023A

Abstract

A prostatic tissue expander and method for treating benign prostatic hypertrophy comprising a flexible catheter having a distensible tissue expansion balloon, an inflatable Foley balloon at the distal end, a urine lumen, balloon inflation lumens and valves at the ends of the balloon inflation lumens for maintaining balloon inflation.

Description

PROSTATIC TISSUE EXPANDER

Background of the Invention

This invention relates to medical tissue expansion, and more particularly it pertains to a prostatic tissue expander balloon catheter for expanding the prostatic urethra over a period of time. Inflation balloon pressure is maintained by valves in the inflation lumens. The tissue expander catheter is used to expand the prostatic urethra for the treatment of BPH (Benign Prostatic Hypertrophy).

By far the most common prostate problem is enlargement of the gland, or BPH. Common in men over 50, it is simply excess growth in the innermost part of the prostate. The urethra that empties the bladder runs through the middle of the prostate. The more the prostate enlarges, the more the flow of urine is constricted, causing a variety of uncomfortable symptoms when one tries to urinate. The surgical solution to prostate enlargement has become the most common surgery confronting adult males today. It is known as Transurethral Resection of the Prostate (TURP). The Transurethral Resection procedure is carried out through a narrow tube-like instrument called a resectoscope, which is inserted into the urinary canal via the penis. Working through the resectoscope, the urologist carves out a portion of the prostate to enlarge the urinary passageway.

A recent alternative to TURP prostate surgery is the use of a small balloon, temporarily inserted into the urinary canal, precisely positioned where the urethra passes through the prostate, then inflated (for just minutes usually) to enlarge the urinary passageway where it is constricted by the enlarged prostate. During the 1980's, this concept in a different procedure won wide acceptance among cardiologists, who use a tiny balloon catheter to enlarge clogged blood vessels through a procedure called "angioplasty" . In the case of the prostate, the procedure is known as "transcystoscopic urethroplasty" . It is the urethra (not an artery) that is blocked, and it is the flow of urine (not blood) that is obstructed. The Optilume Prostate Balloon Dilator manufactured by American

Medical Systems is a dilator of the foregoing type for use in transcystoscopic urethroplasty. It has a non-distensible, single size, dilation balloon (diameter: 30mm [90Fr], length: 80mm) located near the tip of a catheter shaft. A transparent locating balloon is mounted proximal to the dilation balloon. The balloons are enclosed in a PTFE sheath for placement in the urethra. This type of dilator is more fully described in U.S. patents 4,932,956 and 4,932,958 to Ready.

The sheath enclosed catheter of the dilator is inserted into the urethra. The balloons are moved out of the sheath and into working position with the locating balloon in the bulbous urethra, resting against the external sphincter. Positioning is accomplished by palpation, fluoroscopy or by placing a rod lens along side of the PTFE sheath and looking through the transparent locating balloon to confirm diat the dilation balloon is in the proper location. The dilation balloon is inflated up to 60 PSI for 10 to 15 minutes, after which both balloons are deflated. The catheter is then drawn back into the sheath and removed.

In order to improve the removal characteristics, and thereby increase patient comfort, the dilator utilizes a PET balloon design which has a layer of silicone over the PET balloon with a coating of lubricant between the layers. The smooth finish and the elastic properties of the silicone permit easier removal of the deflated balloon.

Another known device is the Dowd catheter manufactured by Mic ovasive, Inc., which also has a non-distensible dilation balloon measuring 30mm in diameter and 85mm in length. A palpation nodule is mounted proximal of the balloon near the proximal end of the shaft. A knob is affixed to the shaft to provide a means of maintaining the position of the balloon during inflation. In use, the Dowd catheter is manually inserted without benefit of introducers or otiier sheaths. Throughout the entire procedure, the physician has a finger in the rectum against the nodule to judge positioning of the catheter. The balloon is inflated up to 60 PSI for the duration of the 10 to 15 minute procedure. During this time d e urologist must maintain traction of the shaft to prevent the balloon from migrating into the bladder. The balloon is removed following deflation by twisting and pulling.

Another known device is the Uroplasty TCU design manufactured by Advanced Surgical Intervention. It features a Foley Balloon at its distal lip and a non-distensible dilation balloon mounted just proximal to the Foley balloon. The dilation balloon has a diameter of 25mm (75Fr), and is available in lengths from 15mm to 55mm. -3- A special "calibration" catheter with distance graduations on its shaft is inserted through a disposable introducer sheath which contains a rod lens for viewing the graduation adjacent to the sphincter. The calibration catheter is removed and a dilation catheter having the proper length balloon is installed. The Foley balloon on the dilation catheter is inflated in the bladder and exact placement is confirmed through the lens. The dilation balloon is inflated at up to 45 PSI for 10 to 15 minutes. Migration is not possible because the catheter is anchored by having one balloon on each side of the bladder neck. Upon deflation, the balloon is removed by withdrawing it through the introducer sheath thereby preventing further trauma to the urethra. Rosenbluth, U.S. Patent Nos. 5,007,898 and 5,030,227, and Klein U.S. Patent Nos. 4,660,560 and 5,002,558 describe such devices and are incorporated herein by reference in their entirety.

Balloon dilation of the prostatic urethra may produce a commissurotomy or tearing, which is considered by some to enhance the results. Bleeding frequently accompanies the procedure. A catheter may be placed immediately following the dilation to allow the patient to void comfortably. Unfortunately, it has been found that the beneficial results from treatment as mentioned above are fairly short lived for the balloon dilation procedure.

As noted above, transcystoscopic urethroplasty (TCU) or transurethral balloon dilation of the prostate (TUDP) can and in many cases does rupture the urethra (commissurotomy). Even so, the progressive development of this technique has tended toward the use of larger and larger diameter dilation balloons. See the paper entitled "Dilation of the Prostatic Urethra with 35mm Balloon" by McLaughlin et al., which appeared in the BRITISH JOURNAL OF UROLOGY (1991), 67, 177- 181.

A procedure known as tissue expansion is also known in the medical art. In tissue expansion procedures, a temporary device for expanding or stretching skin and tissue is placed within the body and is expanded over an extended period of time and left in place until the tissue or skin stabilizes to an enlarged and permanent size. This procedure is used to treat burn victims and for breast reconstruction. Sec U.S. Patents 4,643,733 and 4,217,889 for example. No one to date has thought to apply the concept of tissue expansion to the TCU or TUDP procedure, utilizing a -4- distensible balloon, as a substitute for the presently practiced procedure utilizing short time balloon dilation with a non-distensible balloon.

Summary of the Invention In summary, this invention provides means, including a distensible balloon, for applying tissue expansion to the alleviation of obstructive prostatism. The invention may be expressed in terms of both an apparatus and a method. Tissue Expansion as used in this invention relates to relatively long term gradual expansion, preferably applied in gradual steps over a period of time, to stabilize tissue growth. On the other hand dilation as used in the prior art relates to short term somewhat drastic expansion and is readily distinguished from this invention.

This invention offers several advantages over the prior art including the following:

Dilation balloon devices traumatically and temporarily dilate the prostatic urethra with mixed results reported over the short term (up to 18 months). Long term results are unavailable but expectations are low. On the otiier hand, the tissue expansion approach of the present invention, occurring over an extended period, which allows physiological compensation and tissue generation, should yield good long term results. Tissue expansion is less traumatic and inherently requires less volumetric displacement than dilation.

The expansion and expansion rate of the prostatic urethra in accordance with the tissue expansion approach of this invention is based on patient comfort and tolerance. A commissurotomy can be avoided and instead tissue expansion will occur. When full expansion is achieved the tissue expander may be left in place for a few days to stabilize the tissue expansion.

There has been noted in other devices, some tendency for a dilation balloon to migrate into the bladder. In some cases, damage to the sphincter or bladder neck has been reported leading to incontinence and retrograde ejaculation. The tissue expansion technique minimizes the potential for such problems.

The procedure is an out-patient one versus a hospital procedure. A choice of multiple balloon sizes will accommodate individual anatomy . The use of a sheath or introducer is not required.

Distensible balloons as suggested for use in this invention increase in size in proportion to the inflation pressure and shrink or constrict approximately to their original shape upon deflation; non-distensible balloons as used in the prior art are of fixed surface area (the envelope does not readily shrink on deflation) and can cause trauma upon removal.

Significant features of this invention are as follows. Tissue expansion is minimal and may take place at a gradual rate. In the previous applications of balloon dilation catheters for the treatment of BPH, the balloon was inflated for only a short time. The longest period of dilation suggested is described in the Klein patent 5,002,558, abstract and line 30 of Column 6, as a period of "one hour or more" . The present invention teaches that inflation extending over much longer periods, perhaps days or even weeks, should be used to accomplish tissue expansion. This gradual expansion, which is accomplished by adding small amounts of the expanding solution to the balloon over a period of time, minimizes discomfort. When the procedure is completed, the prostatic urethra has been enlarged, with relief of the symptoms of BPH without significant trauma.

Brief Description of the Figures Various objects of the present invention and many of its attendant advantages will be more readily appreciated by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the Figures thereof and wherein: Figure 1 illustrates a perspective view of a prostatic tissue expander according to the present invention;

Figure 2 illustrates a longitudinal cross-sectional view of a major portion of the proximal end of the tissue expander catheter of Figure 1 taken along line 2-2 thereof; Figures 2a and 2b are longitudinal cross-sectional views of the valves

24 and 28 taken along lines 2a-2a and 2b-2b, respectively in Figure 2; Figure 2c is a cross-sectional view of the 2b valve taken along line 2c-2c in Figure 2b; Figure 3 illustrates a cross-sectional view of the catheter shaft taken along line 3-3 of Figure 1 ;

Figure 4 illustrates the inflation of the balloons of the tissue expander shown in Figure 1; Figure 5 illustrates a longitudinal sectional view of the distal Lip of the catheter taken along line 5-5 of Figure 1 and includes a palpated nodule 62 on the catheter shaft;

Figure 6 is a cross-sectional view along line 6-6 of Figure 5; Figure 7 is a cross-sectional view along line 7-7 of Figure 5; Figure 8 illustrates the urethral placement of the distal tip, and the balloons of the tissue expander of the invention with respect to the bladder and the prostate gland;

Figure 9 shows an embodiment of a pump to be used with the catheter device of the invention; Figure 9a is an enlarged view of a portion of the pump; Figure 10 shows a modified structure for the pump of Figure 9; and,

Figure 11 shows a syringe with pressure indicator for use with the pump of Figure 9. ,

Detailed Description of the Preferred Embodiments The preferred prostatic tissue expander of this invention as illustrated in Figure 1 includes two inflatable balloons: A first positioning balloon, preferably a Foley balloon, located at the distal tip and a second balloon, a distensible tissue expansion balloon, located proximal of the first balloon. Preferably, the tissue expansion balloon will be available in a range of lengths and sizes for each patient. Being distensible, the diameter of the tissue expansion balloon increases as internal pressure is raised by inflation. The catheter shaft upon which the balloons are mounted is of a flexible material and may be reinforced in the region of the tissue expansion balloon to prevent occlusion of the catheter lumens, if required. The catheter shaft of this embodiment is equipped with two lumens to connect the balloons to pressure retaining valves located at the proximal end of the device. A center lumen is also provided having a proximal connector to attach to a urine collection device, such as a leg bag. -7-

Insertion of the device into the urethra is similar to the procedure used with a standard Foley catheter: The shaft is lubricated and manually inserted until the distal tip is in the bladder. The positioning balloon is inflated and mild traction is appli d while the tissue expansion balloon is partially inflated. With both balloons inflated, the device is anchored in place. Since no part of the second balloon is in the bladder, there is no tendency of the device to migrate into the bladder. Inflation of the second balloon may be increased gradually over a period of days or weeks to effect tissue expansion. After the expansion reaches a desired level, the balloon may be left in place while the prostate adjusts to the increased size of the urethra and establishes tissue stability. Upon completion of the treatment, the balloons are deflated and returned to their original diameter, approximately that of the device shaft. The device is then withdrawn from the urethra.

Referring now to Figure 1 in detail, there is shown a perspective view of a prostatic tissue expander, generally indicated at 10, including a plastic, lumenεd catheter shaft 12, a distal end generally indicated at 14 having a Foley balloon 16, a distensible tissue expander balloon 18, and a urine port 20. The proximal end of the prostatic tissue expander 10, generally indicated at 21 , includes a Foley balloon inflation port generally indicated at 22 and an associated inflation control valve 24, a distensible tissue expander balloon inflation port generally indicated at 26, an associated inflation control valve 28, and a connector generally indicated at 30 for coupling the device to a urine collection bag (not shown). An inflation syringe generally indicated at 32 may be used to inflate the Foley balloon 16 as shown and the distensible tissue expander balloon 18 by connection to the proper inflation port 22 as shown or 26 by means of, for example, Luer fittings. Such fittings are well known in the art.

Valves 24 and 28 may in the most basic form of this invention be simple manual "off" "on" valves for selectively inflating and deflating the balloons. Optional valving arrangements may be used if desired and preferred valves are described fully hereinbelow. Catheter shaft 12 is formed of a material which is flexible enough to follow the bends in the urethra on insertion of device 10. The material should be rigid enough, however, to allow device 10 to pass over any obstructions within the urethra. Catheter shaft 12 may be composed of or covered by a biocompatible material to avoid irritation and complication in the urethra. Such catheters and covering materials are well known in the art. Suitable biocompatible materials which may be made into lumencd tubing of suitable flexibility and rigidity lor shall 12 arc, for example, silicone, latex, polyvinylchloride and polyurethane, silicone presently being most preferred.

Balloon 16, the positioning balloon, is formed of a biocompatible material such as silicone or C-Flex, a styrene ethylene butylene styrene modified block copolymer, and is preferably of the Foley type.

Balloon 18, the distensible tissue expanding balloon, is also formed of biocompatible low modulus elastomer material such as latex, silicone or C-Flex, being of the distensible type its diameter can be varied on inflation over a range of diameters. Distensible balloon construction is known in the art and need not be described here in detail. In some instances, balloons of controlled distensibility may be desired and in such instances a high modulus elastomer such as polyurethane may be used or reinforcement may be incoφorated into a balloon of low modulus elastomer in accordance with known techniques.

Reference is now made to Figure 2 which shows a cross-sectional view of the major portion of the proximal end generally indicated at 21 of the tissue expander 10 taken along line 2-2 of Figure 1 in which all numerals correspond to those elements previously described. Proximal end 21 includes a branched body 34 having a central urine drainage lumen 36 flanked by lumens 38 and 40, all of which extend longitudinally through the catheter shaft 12 of Figure 1. Urine drainage lumen 36 is a requisite feature of the device since the device is in place over a period of time extending from days to weeks and provision must be made for urination during that extended time. Lumen 38 terminates proximally in a funnel¬ like end portion 39 and interconnects the positioning balloon 16 inflation port 22 and inflation control valve 24 (see Figures 1 and 2) to positioning balloon 16 through a balloon port 44 (seen in Figures 4 and 5). Lumen 40 connects the distensible tissue expander balloon inflation port 26 and inflation control valve 28 (see Figures 1 and 2) to the distensible tissue expander balloon 18 through a balloon port 48 (seen in Figures 4 and 5). Lumens 38 and 40 likewise may terminate in funnel-like branched end portions 39 and 41 respectively. -9-

Valvcs 24 and 28 are shown in a preferred construction in Figures 2b and 2a, respectively and in 2c. Valve 24 is shown with a standard tapered Leur fitting by means of which the syringe pump of Figure 1 is attached to port 22, as is known in the art. Because the attachment is of relatively short duration, this arrangement is considered to be satisfactory although not critical. On the other hand, valve 28 includes a hub fitting 29, another standard Leur fitting known in the art, because a pump ( as will be described further hereinbelow) is attached to port 26 for long term association with the device. In other respects, the two valves 24 and 28 are essentially identical and include the same elements, all of which are preferably formed of any suitable thermoplastic. Many specific materials will be readily apparent to those familiar with the medical device art, including materials other than thermoplastics.

Both valves include valve bodies 31, a retainer 33 which holds the valve body in place as shown in the respective branch of body 34. Valve bodies 31 respectively define the inflation ports 22 or 26 and contain a flexible multi-fingered valve actuator retainer 35 and valve actuator rod 43. Actuator rod 43 seats against seat 45 to normally close the valve and is held in place normally by actuator retainer 35 as shown. When a syringe or other device is inserted into the respective port 22 or 26 and pushes against actuator rod 43 it is moved against the bias provided by the actuator retainer 35 to move away from seat 45 thus opening the valve.

Figure 3 illustrates in cross-sectional view the lumened catheter shaft 12 taken along line 3-3 of Figure 1 where all numerals correspond to those elements previously described. Illustrated in particular are the inflation lumens 38 and 40 flanking the central urine drainage lumen 36. The inflated distensible tissue expander balloon 18 and the positioning balloon 16 at the distal end 14 of the prostatic tissue expander 10 is illustrated in Figure 4 where all numerals correspond to those elements previously described.

Reference to Figures 5, 6 and 7 provides an illustrated sectional views of the distal tip portion 14 of tissue expander 10. In Figure 5 the cross-section is taken longitudinally and parallel to line 5-5 of Figure 1 in which the positioning balloon 16 and the distensible tissue expander balloon 18 are slightly expanded and in which all numerals correspond to those elements previously described. In Figure 6 the cross-section is taken along line 6-6 in Figure 5 of the partially inflated - 10- distcnsiblc tissue expander balloon 18 of Figure 5 in which all numerals correspond to those elements previously described. In Figure 7 the cross-section is taken along line 7-7 of the partially inflated Foley balloon 16 of Figure 5 where all numerals correspond to those elements previously described. Illustrated in particular is a reinforcement tube 50 located in the urine lumen 36.

In these Figures 5-7 the positioning balloon 16 (preferably the Foley type) and distensible tissue expander balloon 18 arc shown bonded to or otherwise suitably secured around and about the lumened catheter shaft 12 in communication with their respective balloon ports 44 and 48. Inflation lumen 38 is ported to the interior 42 of the positioning balloon 16 by port 44. Inflation lumen 40 is ported to the interior 46 of the distensible tissue expander balloon 18 by port 48. Optional reinforcement tubes 50 and 52, having interior lumen passageways 50a and 52a respectively, are located and suitably secured in the urine lumen 36 within the Foley balloon 16 and the distensible tissue expander balloon 18, respectively. These may be of a higher modulus elastomer, a thermoplastic or metal. Pressure by fluid flow through the lumens is exerted against the inner walls of balloons 16 and 18 to expand the balloons. Pressure is also exerted inwardly upon the exterior of lumened catheter shaft 12. Reinforcement tubes 50 and 52 prevent closing of the urine path by pressure exerted upon the exterior of the lumened catheter shaft 12 and extend proximally from urine port 20 along urine lumen 36. Thus, a continuous urine passageway, including the urine lumen 36 and interior lumen passageways 50a and 52a is maintained during any state of balloon inflation. Other arrangements for achieving this end will be apparent to those familiar with the catheter art.

Also, a locating nodule 62 as earlier referred to may be included on catheter shaft 12 as shown in Figure 5 and as is known in the art.

As can be seen from the preceding description, one basic embodiment of the invention comprises the following elements:

A. Tip with drainage cyelet(s) - 14 and 20;

B. Positioning balloon - 16; C. Expander balloon - 18;

D. Triple lumen catheter shaft - 12;

E. Urine drainage funnel - 37;

F. Inflation valve, positioning balloon - 24; and, -11-

G. Inflation valve, expander balloon - 28.

The following dimensional information will aid in understanding the construction of a tissue expander device.

A. Tip with drainage eyelet(s) - 14 and 20: The tip or distal end 14 and catheter tube or shaft is preferably between about 12-30 French, and preferably about 14-18 French. The end of the tip is preferably radiused. The length of the tip, from the end of the tip to the positioning balloon is preferably about 30-40 mm. Drainage eyelets (orifices) 20 are preferably round, circular or oval in shape and should preferably not exceed the width of the drainage lumen. Eyelet size should preferably not be less than 2.5 times greater than, the cross-sectional area of the drainage lumen. Reference: British Standard (BS) 1965 Part 1 (incorporated herein in its entirety by reference). B. Positioning balloon - 16:

The positioning balloon is preferably located about 30-40 mm from the end of the tip 14 and should not cover the drainage eyelets 20 when inflated. The balloon is preferably distensible and has a preferred shape which is a relatively symmetrical doughnut shape when inflated. The balloon has a preferred nominal inflation volume of about 5-30 ml. The balloon may be fabricated from latex, silicone, C-Flex or other distensible elastomer, preferably silicone and may include double layers as seen in Figures 5, 6 and 7. Uninflatcd, the balloon may be up to about 4 sizes French greater than the labeled shaft size, but preferably no greater than 1 French. The length of the uninflated balloon should be 1-2 cm, preferably about 1.5 cm. Reference: BS 1965 Part 1 and ASTM F 623 (incoφorated herein in their entirety by reference). C. Expander balloon - 18; The expander balloon 18 should preferably be located about one-half centimeter or less from the positioning balloon 16. The shape of the expander balloon 18 is preferably cylindrical with the ends configured to enable expansion close to the external sphincter and the bladder neck. See U.S. Patent 5,007,898 which is incorporated herein by reference for general guidance in this respect. The expander balloon is distensible or preferably exhibits controlled distensibility, unlike the prior art dilating devices which are non-distensible. The expander balloon 18 may be produced in various inflated lengths from about 15-75 mm. Inflated diameters of expander balloons with limited distensibility may range from about 10-30 mm (30-90 French). The expander balloon may be fabricated from elastomers such as C- flex, silicone, latex or other low modulus elastomers and may be comprised of double layers as seen in Figures 5, 6 and 7. Balloons with limited distensibility may be fabricated from higher modulus polyurethane or lower modulus elastomers in combination with reinforcing materials. Reinforcements of this type and limited distensibility arc taught in U.S. Patents 4,651 ,721 , 4,718,410 and 4,881,530, all of which are incoφoratcd herein by reference. For example, extensible polyurethane spandex filament may be wrapped with a non-extensible polyester filament and knitted into a reinforcing element which is embedded in a low modulus elastomer. Longitudinal pleated elements of non-distensible materials may also be used in combination with elastomeric membranes for expander balloons with controlled extensibility. Triple lumen catheter - 12:

The triple lumen catheter 12 will preferably have a round or oval shape and range in size from about 12-30 French, preferably about 16 French. A major lumen 36 is provided for urine drainage and is preferably sized to yield a minimum flow rate of about 100 ml. per minute when tested per BS 1965 Part 1 or ASTM F-623. Two minor lumens 38 and 40 are provided for inflating the positioning and expander balloons. Preferably the cross-sectional area of the minor lumens is about .50-1.0 square mm., to afford a reasonably rapid balloon inflation rate.

A nodule 62 (Figure 5) may be located on the shaft 8 mm or thereabouts proximal from the expander balloon. In this respect, -13- reference is made to "Balloon Dilation of the Catheter", Joseph B. Dowd and John Smith, Urolo^ic Clinics of North America. Volume 17, No. 3, August 1990 which is incoφorated herein by reference. This nodule 62 may be used by the physician to assure that the expander balloon is not positioned in the external sphincter, i.e. , the nodule may be palpated with the index finger through the rectum. To prevent occlusion of major lumen 36 at the balloons, reinforcement may be incoφoratcd in the wall of the shaft. For example, a sleeve having higher modulus than the catheter shaft walls may be used to support the lumen and resist external forces on the shaft. This has already been referred to in connection with Figure 5. The catheter shaft or tube 12 may be fabricated from latex, silicone, C-Flex, polyurethane, or other suitable elastomer. The preferred material is silicone. E. Urine drainage funnel - 37:

The proximal end of the catheter shaft 12 terminates at the urine drainage funnel end portion 37 and the branched funnels 39 and 41 connected to the minor catheter lumens 38 and 40. The urine drainage funnel 37 is preferably the central funnel end portion because it connects to the major lumen 36. The funnel length is about 25-60 mm long and is preferably cylindrical, conical or a combination thereof. An appropriate connector joins the drainage funnel to a urine collection device (not shown). The material used for the funnel is preferably the same as the catheter shaft. F. and G. Inflation funnels 39 and 41 and valves 24 and 28 for positioning and expander balloons 16 and 18: The branched funnels 39 and 41 , preferably cylindrical, ¹ are used to connect the minor lumens 38 and 40 to the inflation valves 24 and 28. Thermoplastic medical inflation check valves 24 and 28 are secured to the branched funnels. The check valves have elastomeric seals and may have stainless steel springs. The valves preferably have a 6% female Luer taper per ANSI/HIMA MD 70.1 and BS3930 (incoφorated herein by reference), and are operated with a medical syringe 32 or other pump having a 6% Luer taper (valve 28 including a hub as earlier described). A thermoplastic retainer sleeve may be fitted over the exterior surface of the funnel end portions to retain the valves. Valves and retainers of this type arc available from Bcspak Pic, of Norfolk, England. The branched funnels are preferably fabricated with the same materials as the catheter shaft. The overall length of the tissue expander device is preferably about

380 mm (reference BS 1965 part 1).

The tissue expander device may include a hydrophilic surface which is bonded to the catheter shaft and balloons. Considerable prior art exists on composition and attachment of hydrogels and hydrophilic surface treatments to hydrophobic elastomers. This will already be known to those familiar with the medical device art.

Because indwelling catheters present a path for infection, a prophylactic antibiotic may be incoφorated in the hydrophilic surface. Alternatively the antibiotic may be applied by the physician who would soak the expander in an antibiotic solution before placing it in the patient.

Following are examples of hydrogel surfaces and antibiotics which may be impregnated into them. Hydrogel materials may be bonded to the surfaces of the balloons and shaft for greater patient comfort and reduced tissue irritation. The hydrogel may be impregnated and packaged with antibiotic agents. Alternately the physician may soak the hydrogel coated device in antibiotic prior to insertion.

-15-

The following are examples of hydrophilic (Hydrogel) materials:

PHcma (Poly 2-IIydiOxycthylmcthacrylatc)

PVΛ (Poly Vinyl Alcohol)

PEO (Poly Ethylene Oxide)

NVP (N, Vinyl -2- Pyrrolidone)

Cellulose Ethers

Examples of Hydrophilic Copolymers are:

NVP and Polyurethane

NVP and PHema

Examples of Hydrophilic/Hydrophobic Copolymers are:

NVP and MMA (Methyl Methacrylate)

PHema and EMA (Ethyl Methacrylate)

PHema and Hexanediol Mono Methacrylate

Copolymerization of hydrogels affords the opportunity to tailor the properties such as water content, processing characteristics, and physical properties in die unhydrated state. The time release characteristics for the release of antibiotics may also be tailored with copolymerization of the hydrogel surface component. The following are examples of antibiotics which have obtained acceptance in the treatment of urinary tract infections, which may be incorporated into a hydrophilic surface:

Nitrofurantoins Quinolones Cephalasporins. Combinations of more than one antibiotic may prove beneficial in controlling organisms that may develop resistance to extended exposure to a single antibiotic.

The expander will preferably be supplied sterile in a quadruple barrier package (not shown). A first microbial barrier package inside a second microbial barrier package would be placed in a shelf box which has a protective plastic shrink wrap. Sterilization may be accomplished using gas sterilant such as ethylene oxide, radiation such as electron beam or gamma, steam autoclave or dry heat. TISSUE EXPANSION PROCEDURE

Sizing of the appropriate distensible balloon to be used in the procedure is done first. This may be accomplished as in the prior art by use of a calibration catheter which measures the distance between the bladder neck and the external sphincter within the prostatic urethra. The physicians may then select the tissue expander catheter of the invention whose distensible balloon length is closest to the measurement taken. A variety of sizes will be available for this selection.

Commercially, the expander balloon will be made available in different lengths to conform to the length of the prostatic urethra. Measuring the distance from the bladder neck to the bottom of the prostate gland has been previously described by Klein in U.S. Patent 4,660,560 and Klein et al, in U.S. Patent 5,002,558, both of which are incoφorated herein by reference. The device of the present invention would preferably be accompanied by such a catheter to measure prostate length with a cystoscope as part of the commercial package. However, since it is well known it need not be described herein in detail.

The selected tissue expander catheter is inserted into the urethra with the aid of lubricating jelly pr the like making sure that the positioning balloon and catheter tip have passed through the bladder neck and the expander balloon is positioned within the prostatic urethra. Figure 8 illustrates the placement of the tissue expander 10 including the distal tip 14 and associated components, including the positioning balloon 16 and the distensible tissue expander balloon 18 with respect to the bladder 54 and the prostate 56 through the urethra 59 of a male. Before insertion into the urethra, the balloons are in a completely deflated state and are collapsed against the tube 12. The inflation of both the positioning balloon 16 and at least the partial inflation of the distensible tissue expander balloon 18 anchors the distal tip 14 of the expander device to the bladder neck 58 at a point between the positioning balloon 16 and the distensible tissue expander balloon 18. The positioning balloon 16 remains entirely within the bladder 54 and the distensible tissue expander balloon 18 remains entirely within the prostatic urethra 60 within prostate 56. The distensible tissue expander balloon 18 is then slowly inflated as desired over a period of time to gradually increase the prostatic urethra to a desired size. Once the desired size is reached, the tissue expander may remain in place for a period of time to stabilize growth. -17-

Afterwards, the balloons are deflated by opening valves 24 and 28 and the expander device 10 is then withdrawn from the bladder and the urethra.

Generally speaking, it is anticipated that a maintenance pressure ol^" about 2-5 psi will be adequate within the distensible balloon and a fluid inflation volume adequate to size the balloon within about 8-10 mm in diameter initially with gradual step-wise expansion to about 15-30 mm in diameter will be effective with the procedure of this invention. The procedure may extend over a period of days or even weeks. It is anticipated that about 3 weeks will be effective. During this time it will be necessary for the patient to wear a leg bag or the like which may be connected to port 30 for collection of urine.

FURTHER EMBODIMENTS

Up to this point the invention has been described with reference to a more basic embodiment thereof. In that embodiment, the physician installs the tissue expander and sees that patient periodically, perhaps once a day for example, to adjust the pressure and size of the distensible balloon as desired and otherwise inspect the device for proppr positioning and the like.

In this basic embodiment the physician would inflate the expander balloon 18 and adjust intraluminal pressure using a syringe with pressure gauge to introduce sterile fluid through the check valve 28 attached to the proximal end of the expander. The patient would return to the physician periodically during the prostate tissue expansion period for expander fluid adjustments.

However, a pump may be included with the device during the procedure and connected long term to the distensible balloon port 26. The pump may include a pressure regulator arrangement (as shown in Figure 9) or the like for the physician to adjust the pressure or it may be preset to regulate a predetermined pressure within the balloon (as shown in Figure 10). Such versions are now described hereinbelow.

Patient Pump With Optional Features (Figure 9) The first mentioned further embodiment offers a patient pump 80 with optional features which is similar to the basic embodiment except that pump 80 includes a means (shown in Figure 9) for the physician to adjust the pressure at which the regulating pump valve 88 opens. The physician uses a Lucr adapter to conncct a syringe 150 (see Figure 11) and pressure gauge 160 to the pump. An optional adjusting tool 100 is inserted through an optional access port 102 and engaged with an optional pressure adjusting set screw 104. The surgeon uses the syringe to create back pressure on ihe pump lulling 90 and valve 88. The gauge attached to the syringe will indicate the pressure at which the regulating valve 88 is set. Excess fluid will vent from the pump bulb along the optional fluid path 106 between the access port 102 in the pump bulb 82 and the adjustment tool 100.

The following optional components (all shown in Figure 9), distinguish the pump as modified for this embodiment. Threaded bushing - 108

The chamber housing valve 88 also contains the internally threaded bushing 108. The bushing may be metal or thermoplastic and is bonded to the chamber. The bushing thread must be large enough to accommodate the spring. For a .125" spring diameter, a #8-32 UNF thread is used. The bushing length is adequate to house the set screw and to allow for advance or withdrawal of the screw to achieve the anticipated pressure range. For example with a 0-10 psi range the bushing would be approximately .38" in length. Adjustment Set Screw - 104 The socket head adjustment screw 104 is fabricated from metal or thermoplastic and has a thread compatible with the bushing 108. The set screw is advanced or withdrawn to lengthen or shorten the chamber length available for the compression spring 88c. Varying the chamber length varies the preload of spring 88c and changes the pressure setting of regulating valve 88. Adjustment screw 104 has through hole 110 in it so fluid may pass through the screw during adjustment. A thermoplastic insert (not shown) may be set in a recess located in the threads to prevent rotation below the torque that is available with the adjustment tool 100. Pressure Adjustment Tool - 100

A metal or thermoplastic adjustment tool 100 in the form of a hex shaft with a finger grip is provided. The adjustment tool engages adjustment screw 104 so that it can be rotated for pressure adjustment. -19- The end of the tool shaft which engages the set screw contains a fluid passage 106 which terminates at a cross hole 106a on the tool shaft. The purpose of this fluid channel 106 is to allow fluid lo escape the valve during adjustment without having lo remove the tool. Access Port - 102

The pump bulb contains access port 102, through which the adjustment tool 100 is passed to engage set screw 104. This may be a simple aperture and plug or a duckbill-type valve that is configured to resist opening with negative pump bulb pressures. A leaf-type valve of the type used in inflatable mammaries, Ref. U.S. Patent 4,782,826 incorporated herein by reference may also be used. The pump and syringe both have a male Lucr Lock fitting as can be seen in Figure 11, respectively.

A Female Lucr adapter 162 (sec Figure 11) is provided to connect the syringe 150 and gauge 160 to the pump in order to adjust the pressure of regulating valve 88.

The adapter may be metal or thermoplastic. The fitting is fabricated with 6% female Lucr tapers on both ends to engage the syringe and pump Luer. Luer hubs are optional. The Preset Patient Pump (Figure 10)

In a preset pump embodiment (Figure 10) the physician inflates the expander balloon and adjusts the pressure using the method described hereinabove for the more basic embodiment. The syringe and gauge arc then removed and the inflation check valve 28 closes. With this embodiment, a patient pump 120 with reservoir and preset pressure regulating valve is provided. Such a pump is shown in Figure 10.

The physician fills the pump and reservoir with sterile fluid and connects the pump to the inflation check valve for the expander balloon. A male Luer Lock fitting affixed to the pump engages the female Luer hub on the check valve. The physician squeezes the pump bulb and the expander intraluminal pressure is established by the pump regulating valve. The patient is instructed to periodically squeeze the pump to maintain the intraluminal pressure on the expander balloon. The preset regulation feature of the pump prevents over pressurizing. The preset patient pump is shown in Figure 10, generally indicated at 120 and consists of an elastomeric pump bulb 82, that may double as a reservoir, which is joined to a valve segment 84 containing two valves 86 and 88. A single tube 90 emanates from the valve segment and terminates al a male Lucr Lock fitting 92 (not shown but similar to Figure 9). The pump includes a pressure regulation feature which is set at the factory. Pump Bulb - 82:

The pump bulb 82 is preferably a molded elastomer such as latex, silicone, polyurethane, EPDM or C-Flex, preferably silicone. The fluid volume may vary but is anticipated to be on the order of about

10-20 milliliters. Valve - 86:

Valve 86 is located in the fluid path between the pump bulb 82 and the tubing 90. The valve consists of an elastomeric valve seat 86a, check ball 86b and compression spring 86c. The ball preferably is about .125" in diameter and the spring is about .125" outside diameter with a length of approximately .31 " . The ball 86b and spring 86c may be fabricated from AISI 304 if sterile water is used, or a cobalt, nickel, molybdenum and chrome alloy if a saline solution is used. Both metals are commercially available from several sources domestically. Valve 86 is oriented as a spring-loaded check valve, so that when the pump bulb 82 is squeezed, fluid will flow from the pump bulb through valve 86 and into the tubing 90. Pump valve 86 prevents fluid flow in the reverse direction from tubing 90 to the pump bulb 82.

Valve - 88:

Valve 88 uses the same type of ball and spring as valve 86, and has a similar valve seat 88a, ball 88b and spring 88c. This valve is oriented so that it functions as a preset pressure regulating valve. This valve is also located in a fluid path between the pump bulb 82 and tubing 90.

When the pump bulb is squeezed, the regulating valve 88 remains closed and fluid is prevented from flowing from the pump bulb to the tubing. When the pump bulb is released, pressure in the tubing 90 and expander balloon 18 in excess of the pressure setting of the regulating valve, is vented from the tubing 90 through valve 88 to the pump bulb 82.

The valve segment housing 84 valves 86 and 88 arc fabricated from an elastomer, preferably silicone. As is known in the valve art, the springs may be selected to provide predetermined or preset regulation based on their strength. Pump Tubing - 90:

The pump tubing 90 connects the pump valve segment 84 to the male Luer Lock fitting 92, and provides a flexible fluid conduit so that the pump may be remote from the proximal end of the expander device 10. The tubing is elastomer, preferably silicone. The tubing preferably has a bore of about .031 to .062 inch, with a wall thickness equal to or greater than about 50% of the bore. The tubing may be molded integral with the valve segment 84 or extruded and subsequently bonded to it.

Luer Lock -,92: (Sec Figure 9 for similar arrangement) A male Luer Lock 92 having a 6% taper is affixed to the end of the tubing 90 with a compression collar 94. The Luer fitting and collar are fabricated from either metal or thermoplastic, and arc available from several domestic sources. The male Luer Lock is sized per ANSI/HIMA MD 70.1 (incoφorated herein by reference) to engage a female Luer taper and hub on the expander inflation check valve 28. MEASURING PROCEDURE An anesthetic sterile lubricating jelly is inserted into the urethra a few minutes prior to measuring. A cystoscope sheath with a minimum bore of 11 French is inserted into the ureϋira up to the external sphincter. The measuring catheter is passed through the cystoscope bridge sidearm and working channel of the cystoscope sheath and into the bladder. The positioning balloon is then inflated with sterile fluid, to its recommended volume, using a syringe engaged to the check valve. The syringe is then removed which closes the check valve and maintains fluid in the positioning balloon. A gentle traction is applied to the measuring catheter to draw the positioning balloon against the bladder neck. The cystoscope is then used to measure the distance to the external sphincter. When measurement is completed, the positioning balloon is deflated using a syringe engaged to the check valve. The measuring catheter is withdrawn form the cystoscope and the cystoscope is withdrawn form the urethra. PROSTATE EXPANSION PROCEDURE WITH PATIENT PUMP

After the prostatic urethra is measured to determine the distance from the bladder neck to the external sphincter, an expander 10 of appropriate size is selected. An anesthetic lubricating jelly is inserted into the urethra. The expander is coated with jelly and inserted through the urethra and into the bladder. A syringe filled with sterile fluid is connected to the inflation check valve 24 for the positioning balloon 16. The balloon is inflated to the recommended volume and the syringe is disengaged to close check valve 24. A gentle traction is applied to ihe expander cathcler shaft to urge the positioning balloon against the bladder neck. With a palpating index finger in the rectum, the physician can determine if the nodule 62 is at the apex of the prostate, which indicates correct sizing of the expander. While maintaining gentle traction on the positioning balloon, the expander balloon 18 is inflated. To fill the expander the physician uses a syringe with sterile fluid and engages it to the Luer fitting on the check valve 28 for the expander balloon. The syringe is equipped with a pressure gauge to indicate the intraluminal pressure of the expander balloon. Fluid should be introduced into the expander and withdrawn several times, with the external sphincter positioned superior to the prostate, to evacuate any air. The physician then inflates the expander to recommended pressure; checks the fit of the expander after inflation by palpating the locating nodule 62; and disengages the syringe which closes the expander balloon check valve

28.

When the physician uses a patient pump (Figure 10), it is filled with sterile fluid and connected to the expander balloon check valve 28. -23- An appropriate Lucr Lock fitting on the pump tube secures the pump to check valve 28. The pump bulb is squeezed and the expander is inflated to the predetermined pressure.

Alternatively, if the embodiment (pump Figure 9) with optional adjustable regulator valve is used, the physician uses a Luer adapter to attach the syringe and gauge to the pump. The optional adjustment tool 100 is then inserted through ihe pump bulb and into the adjustment screw 104 on the regulating pump valve 88. The physician then applies fluid pressure with the syringe and observes the pressure required to open the regulating valve 88. The regulating pressure is then adjusted by turning the adjustment screw 104 to cither increase or decrease the pressure of the regulating valve 88. The adjustment tool is withdrawn and the pump is filled and the syringe and Luer adapter arc disconnected. The pump is then secured to check valve 28 using an appropriate Luer Lock fitting which may be provided on the pump tubing. The physician squeezes the pump bulb and the expander is inflated to the physician determined pressure. The patient is instructed to periodically squeeze the pump bulb to maintain the desired intraluminal pressure on the expander balloon. Periodic squeezing of the pump bulb will replenish fluid lost to osmosis, restore fluid pressure which may have been depleted due to tissue expansion, or physiologically induced pressure spikes which may have caused regulating valve 88 to activate. Optimum expander balloon intraluminal pressure will vary. However, it is anticipated that the pressure range will be 1-1/2 to 10 psi.

ASTM standard for soft tissue expanders requires that the injection site septums not leak when tested with 120 mm Hg (2.32 psi). Previous testing of prior art tissue expander injection sites resulted in leakage around 5 psi. which would indicate tissue expansion occurs below 5 psi. Maximum urethral pressure from urine flow is reported to be 100 cm H₂0 which is 1.42 psi.

Various modifications can be made to the present invention without departing from the apparent scope hereof.

Claims

What is claimed is as follows:

1. A Prostatic tissue expander comprising: expansion means for expanding prostate tissue from within the prostatic urethra and maintaining the expansion over an extended lime period; catheter means carrying said expansion means for insertion into the urethra of a male body through the end of the penis and positioning the expansion means within the prostatic urethra thereof; control means carried by the catheter means at a proximal portion thereof for controlling the operation of the expansion means; and, drainage means associated with the catheter means for draining urine from the bladder during the time period which the expansion means is expanding the prostate tissue.

2. The prostatic tissue expander of claim 1 including further means associated with the catheter means or aiding in the positioning of the expansion means in the prostatic urethra and maintaining it there during expansion.

3. The device of claim 1 wherein at least a portion of the surface of the device contacting tissue is modified to include a material selected from the group consisting of hydrogels, hydrophilics, antibiotics, and combinations of any of the foregoing.

4. A prostatic tissue expander comprising: a flexible multi-lumen catheter adapted for insertion into the urethra of a male to the prostate and bladder; a first balloon positioned with respect to a distal end on said catheter and in communication with a first lumen; means for inflating and deflating the first balloon; means for maintaining inflation of the first balloon at a selected volume; a distensible tissue expander second balloon positioned with respect to said first balloon on said catheter and in communication with a second lumen; means for inflating and deflating said tissue expander second balloon; means for maintaining inflation of the second balloon at a selected pressure; and, means constructed and arranged to drain urine through the catheter from the distal end thereof.

5. The tissue expander of claim 4 wherein the first balloon is a Foley balloon.

6. The device of claim 4 wherein at least a portion of ihe surface of the device contacting tissue is modified to include a material selected from the group consisting of hydrogels, hydrophilics, antibiotics, and combinations of any of the foregoing.

7. A prostatic tissue expander comprising: a multi-lumen catheter; a positioning balloon positioned wilh respect to a distal end on said catheier; a means for inflating and deflating said positioning balloon; a distensible tissue expander balloon positioned with respect to said positioning balloon on said catheter; a means for selectively inflating and deflating said tissue expander balloon to a variety of diameters; and, a urine port associated with the distal end of the catheter.

8. The device of claim 7 wherein at least a portion of the surface of the device contacting tissue is modified to include a material selected from the group consisting of hydrogels, hydrophilics, antibiotics, and combinations of any of the foregoing.

9. A method for expanding prostatic tissue comprising the steps of: inserting tissue expander means into a male urethra; positioning the expander means within the prostatic portion of the urethra within the prostate; expanding the expander means to cause tissue expansion of the prostate and prostatic urethra without substantial trauma or commissurotomy; maintaining the expanded condition over an extended period of time sufficient to effect tissue expansion; and, draining urine from the bladder as needed during the time period.

10. The method of claim 9 wherein the expansion is gradual and is carried out in a plurality of successive steps over time.

11. A method for expanding a prostatic tissue expander comprising the steps of: inscrting a flexible multi-lumen catheter having a positioning balloon and a proximally spaced distensible second balloon into the urethra of a male until the distal tip of the catheter and the positioning balloon arc in the bladder and the second balloon is in the prostatic urclhra and prostate; inflating the positioning balloon; applying mild traction to the catheter to draw the positioning balloon against the bladder neck; gradually inflating the second balloon while positioned in llic prostalic urethra and prostate and maintaining the inflated balloon in position over a predetermined period of time; and, draining urine through an opening in the distal tip of the catheter through a lumen therein.

12. In combination with a tissue expanding device adapted for expanding prostatic tissue by means of a distensible inflation balloon through a lumen with a check valve, a pump including a squeeze bulb for supplying fluid through the check valve to the balloon, a pump valve body to which the squeeze bulb is connected for fluid flow thereto and an outlet connected to the valve body for flow of fluid from the bulb to the check valve, the valve body including first and second check valves for controlling output flow from the bulb and return flow.

13. The combination of claim 12 wherein the second check valve in the valve body of the pump is a regulator valve.

14. The combination of claim 13 wherein the regulator valve is constructed and arranged to regulate at predetermined pressure.

15. The combination of claim 14 wherein the regulator valve is adjustable.