CN111629773B

CN111629773B - Catheter system with improved retention structure and enhanced urine drainage

Info

Publication number: CN111629773B
Application number: CN201880087323.5A
Authority: CN
Inventors: 赛德·伊斯梅尔·哈基; 谢琳·赛德·哈基; 舍兰·赛德·伊斯梅尔·哈基; 萨哈尔·马蒂·纳赛尔
Original assignee: SA HaerMadiNasaier; She LanSaideYisimeierHaji; Xie LinSaideHaji; Sai DeYisimeierHaji
Current assignee: SA HaerMadiNasaier; She LanSaideYisimeierHaji; Xie LinSaideHaji; Sai DeYisimeierHaji
Priority date: 2018-01-24
Filing date: 2018-01-24
Publication date: 2022-07-19
Anticipated expiration: 2038-01-24
Also published as: CN111629773A; MY195351A; WO2019147231A9; WO2019147231A1

Abstract

A catheter with a dual-action retention mechanism having (a) a retention mechanism with a reinforced retention body that can be converted to a deployed flower-like configuration when the catheter is inserted into a body cavity, and (b) a stabilizer that secures the catheter to the body of a patient to maintain a stable position. The retention mechanism for securing the catheter is configured with a thickened or reinforced wall portion that retains the body. The internal channel of the catheter body is wider than conventional catheters, thus enabling better drainage and better fluid flow. Due to the enhanced flower-shaped configuration, inadvertent removal of the catheter without the flower-shaped configuration being fully deployed does not cause serious injury. When the catheter is to be removed, the catheter body is disengaged from the stabilizer and the retention mechanism controllably collapses the flower-shaped configuration of the retention body, thereby converting the catheter into a configuration suitable for removal of the catheter from the body lumen.

Description

Catheter system with improved retention structure and enhanced urine drainage

Technical Field

The present invention relates to surgical devices, and more particularly to catheters that are introduced into a body cavity to drain bodily fluids therefrom, and for delivering drugs into the body cavity for irrigation and treatment.

More particularly, the present invention relates to a urinary catheter configured for improved safety to a patient by using a reliable retention mechanism.

In addition, the present invention relates to a urine voiding apparatus (urinary catheter) that provides enhanced urine flow without urine remaining in the bladder of a patient, thereby reducing the occurrence of catheter-related urinary tract infections (CAUTI).

Background

Indwelling catheters are widely used in acute and chronic clinical cases. In acute clinical cases, a urinary catheter is usually inserted into the bladder of a patient through the urethra. Urine is drained from the bladder and collected in a urine bag to measure the urine volume. This is a standard procedure used during major surgery or in intensive care units.

The measurement of urine volume is indicative of the state of renal excretion. Therefore, the measurement of urine volume is very important for the correlation with the continuous measurement of patient vital signs, including blood pressure, heart rate, body temperature and pulse rate of the patient.

In an acute situation, the catheter may be left in the bladder for hours to days. In some cases, the catheter may be left in place for a longer period of time.

After performing prostate or bladder surgery, bleeding may occur with or without a clot. Clots can plug the exhaust port of the catheter. If the bladder drainage is impeded, the patient can experience severe pain, which if sustained can lead to shock. Therefore, the clot must be washed away and the blood must be diluted with a fluid to prevent further coagulation of the blood.

In cases of continuous bleeding or severe hematuria, three-way indwelling catheters with three ports are commonly used. One of the ports (i.e., the first port) is configured as a smaller first tube that is built into the wall of the catheter body. One end of the first tube is connected to an infusion bag so that fluid can be injected directly into the bladder through the other end of the first tube. With the aid of this mechanism, the clot is washed away and the blood is diluted to prevent further coagulation.

The second port of the three-way catheter is configured as a smaller second tube, which is also built into the wall of the catheter body. The second tube is connected at one end to a balloon that serves as a retention mechanism for securing the catheter within the bladder. The other end of the second tube is connected to a two-way valve that, when operated, inflates the balloon with sterile fluid, or deflates the balloon by removing sterile fluid from the balloon to allow removal of the catheter from the bladder.

The third port of the three-way catheter is associated with an internal passage of the catheter body through which urine is drained from the bladder to a urine collection bag.

Sometimes, two-way or three-way catheters are used to administer drugs into the bladder to treat certain pathologies of the bladder, such as superficial bladder cancer.

In chronic clinical situations, urinary catheters are generally used in a permanent manner in patients who cannot urinate themselves. In this chronic case, the preferred method of introducing the catheter into the bladder is known as suprapubic catheterization, in which a catheter is inserted into the anterior abdominal wall of the patient. According to this method, the catheter is connected into the bladder through the anterior abdominal wall and left in place for months, years or perhaps for an extended period of time for the lifetime of the patient.

Currently, there are several types of urinary catheters used for urological patients, such as: (a) a straight catheter for intermittent catheterization, (b) a Foley urine balloon catheter, and (c) a balloon-less "lotus-shaped" catheter. Foley and balloon-free catheters are the only two catheters that can be held within the bladder (indwelling). The principles of Foley urine balloons and balloon-free "lotus-shaped" catheters are described in detail in U.S. Pat. Nos. 4,813,935 and 8,177,741, respectively.

As shown in fig. 1A, 1B and 1C, Foley urine balloon catheter 10 is provided with a retention mechanism that operates with an inflatable/deflatable balloon 12 configured to hold the catheter in place when inserted into bladder 18. The Foley urine balloon catheter 10 is formed with an elastic tube 14 having a proximal tip 16 for insertion into the bladder 18 through the urethra 19.

A two-way valve mechanism 20 is disposed at a distal end 22 of the catheter 10. The two-way valve 20 has a port 24 through which sterile fluid 25 is injected into or withdrawn from the balloon 12.

As shown in fig. 1A, depicting the catheter 10 in a passive configuration, the balloon 12 is deflated and the catheter 10 is adapted for insertion into or removal from the bladder 18 through the urethra 19.

In addition, a urine bag 34 is attached to the distal end 22 of the tube 14, operatively coupled to the urine discharge port 32, through which urine from the bladder is removed from the catheter into the urine bag 34.

As shown in fig. 1B, depicting the activated state of the catheter, to activate the retention mechanism of the Foley urinary balloon catheter 10, sterile fluid 25 is injected by a syringe (not shown) into a port 24 of a two-way valve mechanism 20 that is fluidly connected to the balloon 12 by a channel 26 extending within the tube 14 of the catheter 10. Sterile fluid 25 injected into port 24 flows through channel 26 to balloon forming membrane 27 and inflates balloon 12. When the balloon 12 is inflated, the balloon secures the catheter 10 in place within the bladder 18 so that the catheter 10 is secured within the bladder 18 for the necessary duration.

In the event that the balloon 12 is inflated by injecting sterile fluid 25, the two-way valve 20 prevents the fluid 25 from escaping from the inflated balloon 12 while the catheter 10 remains indwelling within the patient's bladder 18.

The Foley catheter 10 relies entirely on the bladder neck to remain in place within the bladder 18. This would make Foley catheters extremely unsafe to inadvertently remove due to water (incompressible) accumulation in the balloon (20 c.c. -30c.c. volume). Unfortunately, it is common for Foley catheters to be inadvertently removed when the balloon is fully inflated in patients with dementia, patients recovering from anesthesia, psychiatric patients, or semi-comatose or confused patients. With the balloon 12 fully inflated, inadvertent removal of the Foley catheter from the bladder can immediately cause pain and bleeding due to tearing of the bladder neck and urethra. With the balloon fully inflated, the force required to inadvertently remove the Foley catheter ranges between 25 lbf to 50 lbf or greater. When such forces are applied, removal of the catheter upon inflation of the balloon is extremely dangerous and may cause further complications, primarily manifested as urinary incontinence or urethral stricture, with the rest of the patient.

When the Foley catheter 10 is intended to be removed, the previously injected sterile fluid 25 is withdrawn from the balloon 12 by a syringe (not shown in fig. 1A-1B) via the port 24 of the two-way valve 20. Withdrawal of the sterile fluid 25 deflates the balloon so that the catheter can be removed from the bladder 18.

The proximal tip 16 of the catheter 10, which is introduced into the bladder 18 through the urethra 19, is formed with a urine discharge port 28. Through the urine drain port 28, urine 29 drains from the bladder 18 through the lumen 30 of the catheter 14 to a drain port 32 at the distal end 22 of the catheter 14, which terminates in a urine collection bag 34.

Although Foley catheters are widely used, they rely on a liquid filled balloon located at the bladder neck/trigone. As described in the previous paragraph, this makes Foley catheters unsafe.

Foley urine balloon catheters also have other disadvantages, one of which is the constant problem with balloons that do not deflate after sterile fluid is withdrawn. This situation may require surgical intervention to rupture the balloon under anesthesia. Another problem is that the balloon in Foley catheters sometimes inadvertently inflates inside the urethra, causing bleeding and urethral tears, and possibly long term urethral strictures.

Furthermore, when indwelling, the balloon 12 of the Foley balloon catheter 10 typically leaves a significant amount of residual urine in the bladder, as shown in fig. 1B, due to the fact that the exhaust port 28 of the Foley balloon catheter is located a considerable distance above the bladder neck. This results from the positioning of the exhaust port 28 near the tip 16 of the catheter 10 (as depicted in fig. 1A) and over the balloon 12.

Residual urine collected at the bottom of the bladder below the level of the drain port 28 cannot be removed and remains in the bladder. The amount of residual urine in the bladder can range from 20c.c. to 50c.c. or greater. Residual urine 29 may continue to irritate the bladder and initiate CAUTI (catheter-related urinary tract infection).

Furthermore, the presence of large amounts of residual urine in the bladder adds to the weight of the balloon (1 gram per cubic centimeter of sterile fluid injected, whereas sterile fluid 25 injected in the bladder is typically 20c.c. -30c.c.), while the weight of the Foley catheter (about 18 grams) results in a large total weight of the indwelling catheter, thereby constantly forcing the patient to urinate and possibly causing bladder and urethra spasms. In addition, this weight often causes constant irritation to the trigone and neck of the bladder. This also increases CAUTI conditions.

Another type of catheter that is widely used is the balloon-free "lotus" catheter, which has been clinically tested and has shown the ability to eliminate some of the problems associated with Foley catheter use.

As shown in fig. 2A, 2B, and 2C, a balloon-free "lotus-shaped" urinary catheter 40 has a catheter 42 extending between a proximal end 44 and a distal end 46 of the catheter. As shown in fig. 2A, which depicts the catheter 40 in its passive configuration, at the proximal end 44 the catheter 40 is provided with several, typically two to four, longitudinal slits 48 between portions 58 of the catheter wall.

Adjacent the distal end 46, the catheter 40 is provided with a plastic bellows portion 50. The bellows portion 50 is shown in fig. 2A in its closed position (compressed state) when the catheter is not in use or during introduction (or removal) of the balloon-less catheter into the bladder 56 through the urethra 55, with the tip of the proximal end 44 of the catheter 40 being introduced into the bladder 56 through the urethra 55. Urine drain port 52 at distal end 46 connects to and terminates in a urine collection bag 54.

A plastic rod 60 is mounted inside the conduit 42. The plastic rod is fixed (glued or bonded) at its opposite ends to the tip (at proximal end 44) of the catheter and the bellows portion 50, respectively.

After introducing the balloon-less "lotus-shaped" catheter 40 (in its closed position shown in fig. 2A) into the bladder 56, the catheter 40 is activated by pulling (stretching) the plastic bellows portion 50 open. Stretching of the bellows portion 50 causes the plastic rod 60 to displace toward the distal end 46. The displacement of the plastic rod 60 causes the tip 44 of the catheter 40 to be pulled downward such that a Maelcot (or flower-shaped) configuration 62 is formed by the folded sections (wings) 58 of the catheter between the longitudinal slits 48 at the proximal end 44 of the catheter 42, as shown in fig. 2B-2C.

As seen in fig. 2B-2C, the flower-shaped configuration 62 is formed by the resilient material (wing portion 58) of the catheter 42 being separated at the proximal end 44 by a stretched (open) slit 48. The flower-shaped configuration 62 represents an expanded configuration that supports the retention of the balloon-less "lotus-shaped" catheter 40 within the bladder 56.

When the slits 48 are opened and the elastic section 58 between the slits 48 is folded to form the flower-shaped configuration 62, the discharge opening 64 of the conduit 42 is exposed because the flower-shaped configuration 62 is fully deployed. The discharge opening 64 is fluidly connected to the discharge port 52 at the distal end 46 of the tube 42 of the catheter 40. Urine 53 is discharged from the bladder 56 through the discharge opening 64 and inside the tube 42 of the balloon-less "lotus" catheter 40 and out through the urine discharge port 52 into the urine collection bag 54.

The bellows portion 50 is shown in an expanded (stretched or stretched) position in fig. 2B and 2C. When the balloon-free "lotus-shaped" catheter 40 is removed from the bladder 56, the bellows portion 50 retracts from the open position (as shown in fig. 2B and 2C) to its closed (compressed) position (as shown in fig. 2A), thereby returning the catheter 40 to the passive configuration shown in fig. 2A.

Although the balloon-less "lotus" catheter 40 has been shown to eliminate some of the problems associated with Foley balloon catheter 10, there are still drawbacks that must be addressed.

For patients with dementia, psychiatric patients, or patients with confusion during surgery requiring continuous irrigation, a need exists for a catheter that can withstand inadvertent removal by the patient. In addition, procedures requiring additional channels for continuous irrigation require that the catheter be reliably retained without risk of inadvertent removal.

A balloon-free "lotus" catheter, while solving many of the problems of the prior art devices, still requires a reliable retention mechanism that can withstand being inadvertently removed. The balloon-less "lotus" catheter can be removed by the patient under anesthesia or severe sedation. This can lead to various surgical complications for the patient, as well as possibly damaging the surgery itself and making continuous irrigation difficult.

It would therefore be highly desirable to provide a catheter that does not suffer from the drawbacks of Foley balloon catheters and that improves the operability of the balloon-free "lotus-shaped" catheters presented above.

It would be highly desirable to provide a safe and reliable urinary catheter with an improved retention mechanism that can withstand attempts at inadvertent removal while minimizing damage to the bladder and urethra when removed in the deployed configuration.

Furthermore, it would be highly desirable to provide a urinary catheter that does not leave urine in the bladder after a urine drainage procedure.

In addition, it is highly desirable to provide excellent urine flow, which is important for adequate drainage and reduction of CAUTI occurrences.

Disclosure of Invention

It is therefore an object of the present invention to provide a surgical catheter for insertion and indwelling in a body cavity of a patient, which has improved retention capabilities to withstand attempts to inadvertently remove.

It is another object of the present invention to provide a urinary catheter which is safe for the patient and causes minimal (or no) harm to the patient's body when inadvertently withdrawn from the bladder.

It is another object of the present invention to provide a urinary catheter having a urine discharge port positioned adjacent the bottom of the bladder (or at the neck of the bladder) when the catheter is indwelling in the bladder, which facilitates discharge of residual-free urine, thereby preventing irritation to the patient and bacterial growth in the bladder.

It is another object of the present invention to provide an improved urinary catheter designed on the principle of a lotus-shaped catheter, with the addition of a stabilizer mechanism for securing a fully extended bellows to the thigh of a patient when, in operation, the lotus-shaped catheter is inserted and secured within the bladder, in order to stabilize the catheter in place and prevent inadvertent removal of the catheter from the bladder.

Furthermore, it is an object of the present invention to provide a catheter achieving excellent flow rates by a wider inner diameter of the inner channel of the catheter without affecting the outer diameter (or size) of said catheter.

In one aspect, the present invention relates to a surgical catheter adapted for insertion into a body lumen of a patient. The catheter of the present invention is designed with an elongated catheter body having a wall extending between a proximal end and a distal end of the elongated catheter body. The wall of the elongate catheter body defines an internal channel extending along a longitudinal axis of the elongate catheter body.

The catheter has a first retention mechanism positioned at the proximal end of the elongate catheter body. The first retention mechanism is actuated after insertion of the proximal end of the elongate catheter body into the body lumen of interest. The first retention mechanism is configured with a retention body that is substantially cylindrical and a reinforcement mechanism that forms a reinforcement wall of the retention body.

The catheter of the present invention further comprises a stabilizer mechanism that fixes the elongated catheter body of the indwelling catheter to the body of the patient outside the body cavity. Upon actuation of the first retention mechanism, the stabilizer mechanism is removably engaged with the elongate catheter body at a predetermined region between the proximal end and the distal end of the elongate catheter body.

The reinforcement wall of the retention body defines an internal passage of the retention body that extends along the longitudinal axis of the retention body.

The reinforcing wall of the holding body is formed by at least two wall portions of the reinforcing wall. The two wall portions have wall side edges extending in a longitudinal direction and forming at least two respective longitudinal slits extending in spaced relation along the at least two wall portions, the longitudinal slits extending between a common tip of the retention body and the proximal end of the elongate catheter body. The retention body is secured to the proximal end of the elongate catheter body, wherein the internal passage of the retention body is positioned in alignment with the internal passage of the elongate catheter body along a common longitudinal axis of the internal passage of the retention body and the internal passage of the elongate catheter body.

The internal channel of the retention body terminates at an exhaust port positioned substantially at the bottom of the body cavity and below the first retention mechanism. The exhaust port is in fluid communication with an exhaust port of the catheter defined by an edge of a wall at the distal end of the elongate catheter body.

When positioned in the body lumen, a first retention mechanism is actuated to assume a deployed configuration causing the at least two wall portions of the reinforcing wall of the retention body to elastically bend and displace radially outward from each other causing the longitudinal slit to open and the discharge port of the internal channel of the retention body to be exposed to fluid collected in the body lumen to draw fluid from the body lumen through the internal channels of the retention body and the elongate catheter body, respectively, toward the discharge port positioned at the distal end of the elongate catheter body.

The reinforcing means may comprise at least two elongate reinforcing members, each elongate reinforcing member being fixed (by any suitable means) to a respective one of the at least two wall portions of the wall of the retention body and extending along the length of the wall portion.

Alternatively, the reinforcing mechanism is provided by the wall of the retention body being formed from a layer of resilient material having a thickness greater than the thickness of the wall of the elongate catheter body.

The surgical catheter of the present invention further comprises a bellows unit formed on the elongated catheter body adjacent the distal end of the elongated catheter body.

A plastic rod is coupled at one end to the common tip of the retention body and at the other end to the bellows unit.

When the bellows unit is expanded, the rod is displaced toward the distal end of the elongated catheter body causing the common tip of the retention body to be controllably displaced, thereby causing actuation and conversion of the first retention mechanism into the deployed configuration. In the deployed (activated) configuration, the wall portions of the retention body are displaced radially outwardly from one another to assume a curved, wing-like configuration which bears against the inner wall of the body lumen, thereby anchoring the catheter in the body lumen.

After deployment of the first retention mechanism, the stabilizer mechanism is actuated to engage the bellows unit to stabilize the elongated catheter body in a fixed position.

The stabilizer mechanism may have a variety of configurations. For example, the stabilizer mechanism may include an adhesive pad for securing to the patient's body and a stabilizer housing attached to the adhesive pad. The stabilizing case may be formed with a bottom wall and an upper wall displaceably secured to the bottom wall. The bottom wall and the upper wall form a receiving channel therebetween that extends longitudinally along the stabilizer housing. Once the catheter is indwelling in the body cavity with the first retention mechanism actuated, the bellows unit may be removably secured in the receiving channel between the bottom wall and the upper wall of the stabilizer housing.

The surgical catheter system of the present invention further includes a urine collection bag attached to the drain port of the elongated catheter body. The system drain port and the internal passages of the retention body and the elongate catheter body, respectively, form a urine passageway from the body lumen to the drain port.

The surgical catheter of the present invention is configured to operate intermittently in a passive mode of operation and a deployment mode of operation. In the passive mode of operation, the surgical catheter is configured for removal from or insertion into the body lumen. When in the passive mode of operation, the wall portion of the retention body extends substantially parallel to the longitudinal axis of the retention body, thereby assuming a configuration that is most suitable for insertion or removal of the catheter into or from the body cavity.

The wall portion of the retention body may be integrally formed with the wall of the elongate catheter body. Alternatively, the wall portion of the holding body is fixed (glued or welded) to the wall of the elongated catheter body.

The surgical catheter of the present invention further includes a multi-port valve mechanism positioned at the distal end of the elongate catheter body in fluid communication with the internal passage of the retention body to open the passageway for urine from the bladder when the pressure in the bladder reaches a predetermined level.

In another aspect, the present invention relates to a method of operating an improved surgical catheter by:

configuring the surgical catheter with an elongate catheter body having a wall extending between a proximal end and a distal end of the elongate catheter body,

defining an internal passage through the walls and extending between the walls along a longitudinal axis of the elongate catheter body; and

a first retention mechanism is formed at the proximal end of the elongate catheter body. The first retention mechanism has a retention body configured with a wall extending between a tip and an opposite edge and defining an internal passage of the retention body.

The method also takes the following steps:

forming said first retaining mechanism wherein at least two wall portions of the wall of said retaining body are interrupted by at least two longitudinal slits extending in spaced relation along the wall portions for a predetermined length, and

reinforcing the wall portion of the retention body.

The method of the present invention further comprises:

providing an exhaust port at one end of the internal channel of the retention body, the exhaust port being positioned below the bottom of the first retention mechanism and in fluid communication with an exhaust port positioned at the distal end of the elongate catheter body,

forming a bellows unit on the elongated catheter body between the proximal end and the distal end of the elongated catheter body,

connecting one end of a plastic rod to the tip of the holding body and the other end to the bellows unit; and

the catheter is operated intermittently in a passive mode of operation and an active mode of operation.

The method of the present invention further comprises:

inserting the catheter into a body lumen of interest in the passive mode of operation; and

after inserting the catheter into the body lumen, switching the catheter to the active operating mode by:

extending the bellows thereby causing the rod to displace toward the distal end of the elongate catheter body and displacing the tip of the retention body thereby transitioning the first retention mechanism to the deployed configuration.

The method of the invention also comprises the following steps:

securing a second securing mechanism to the patient's body, an

Engaging the second retention mechanism with the bellows unit to stabilize the elongate catheter body in position.

The method of the invention is further contemplated by performing the following steps:

configuring the second securing mechanism with an adhesive pad and stabilizer housing unit,

attaching the adhesive pad to the patient's body and securing the stabilizer housing unit to the adhesive pad;

forming the stabilizer housing having a bottom wall and an upper wall attachable to the bottom wall, wherein the bottom wall and upper wall form a receiving channel therebetween extending longitudinally along the stabilizer housing; and

securing the bellows unit in a receiving channel between a bottom wall and an upper wall of the stabilizer housing unit after the catheter is indwelling in the body cavity with the first retention mechanism activated.

These and other objects of the present invention will become more apparent upon reading the detailed description of the preferred embodiments of the invention in conjunction with the patent drawings set forth in the specification.

Drawings

Fig. 1A, 1B and 1C are schematic illustrations of a prior art Foley balloon catheter in passive (fig. 1A) and deployed (fig. 1B-1C) configurations, respectively;

FIGS. 2A, 2B and 2C are schematic illustrations of a prior art balloon-less "lotus" catheter in passive (FIG. 2A) and deployed (FIGS. 2B-2C) configurations, respectively;

fig. 3A, 3B, 3C and 3D represent urinary catheters of the invention in a passive (fig. 3A-3B) and deployed (fig. 3C-3D) configuration, respectively, wherein fig. 3B and 3D depict the reinforcing wings of the retention mechanism;

fig. 4A-4B show alternative embodiments of the reinforcing mechanism of the urinary catheter of the present invention in a passive (fig. 4A) and deployed (fig. 4B) configuration, respectively;

fig. 5 shows a longitudinal section of a catheter of the invention with a wide internal channel; and

6A, 6B, 6C, 6D and 6E depict the stabilizer unit of the improved lotus shaped catheter of the invention in a closed position (FIG. 6A) and an open position (FIGS. 6B-6C); and showing the opened stabilizer unit and the bellows of the unfolded catheter of the invention received in the stabilizer unit (fig. 6D), and the stabilizer unit holding the bellows of the unfolded catheter of the invention (fig. 6E).

Detailed Description

The catheter of the present invention may be used in a variety of surgical and therapeutic procedures and is suitable for indwelling in a variety of body lumens. However, for clarity, the catheter of the present invention is described herein as a urinary catheter for indwelling in a patient's bladder, as one of many exemplary applications, without limiting the scope of the invention and the field of its application.

Referring to fig. 3A, 3B, 3C, and 3D, the residue-free urinary balloon catheter 100 of the present invention includes an elongate tubular catheter body 102 and a retention mechanism 104 (also referred to herein as a first retention mechanism) positioned at a proximal end 106 of the catheter body 102. The catheter body 102 is made of a surgically acceptable elastic biomaterial such as silicone elastomer, polyvinyl chloride (PVC), latex rubber, and the like.

The distal end 108 of the tubular catheter body 102 houses a urine voiding (or drainage) port 110 that is positioned in fluid communication with and terminates in a urine collection bag 112 (as best shown in fig. 3C).

As shown in fig. 3A and 3B, the retention mechanism 104 is configured with a retention body 113 formed with a pair (or two pairs) of longitudinal slits 114 adjacent the proximal end 106 of the catheter body 102. In the passive configuration, the retaining body 113 of the retaining mechanism 104 assumes a cylindrical configuration with the longitudinal slit 114 closed.

The tubular catheter body 102 is formed with a wall 116 that defines and circumferentially surrounds the internal passage 115 of the tubular catheter body 102.

The retention body 113 may be formed as an integral part of the tubular catheter body 102 by cutting the resilient material of the wall 116 of the tubular catheter body 102 a predetermined length from the proximal end 106, as shown in fig. 3A.

Alternatively, as shown in fig. 3B-3D and 4A-4B, the retention body 113 may be formed as a separate cylindrical elastic member (preferably made of the same surgically acceptable elastic biomaterial as the material of the tubular catheter body 102) permanently attached (by any suitable mechanism, such as gluing, welding, etc.) to the rim 118 at the proximal end 106 of the tubular catheter body 102.

The bellows portion 120 is formed proximate the distal end 108 of the tubular catheter body 102. The plastic rod 122 is secured at one end to a tip 124 of the retention body 113 by any suitable mechanism and at the other end to the bellows portion 120, as best shown in fig. 3A, 3C.

To transition to the open (deployed) configuration, the retention mechanism 104 is actuated by extending (stretching ) the bellows portion 120. This action causes the shaft 122 to displace toward the distal end 108 of the catheter body 102, while the tip 124 of the retention body 113 is directed downward. The displacement of the tip 124 causes the wall portions (wings) 126 between the slits 114 to separate and flex, with the longitudinal slits 114 opening, thereby bringing the retention mechanism 104 into a flower-like configuration 140 that constitutes a deployed configuration, as shown in fig. 3C-3D.

The quality of catheter maintenance must be improved when the patient suffers from dementia, confusion or awakening from anesthesia. Furthermore, if continuous irrigation is required, it would be very beneficial to improve the fixation mechanism of the indwelling catheter to the health of the patient.

The thickness (or stiffness) of the flower-shaped configuration 140 is proportional to its holding power. The thicker (or stiffer) the flower-shaped configuration 140, the higher retention force may be achieved by the flower-shaped configuration. Conversely, the thinner and more flexible the flower-shaped arrangement, the weaker the retaining force of the flower-shaped arrangement.

As shown in fig. 3A-3B, better retention may be achieved by reinforcing the flower-shaped configuration 140 with a reinforcing member 128 made of a malleable material (e.g., rubber or plastic with memory) that is positioned parallel to the wall 126 of the retention body 113 in the closed position. The reinforcing member 126 may be welded, glued, or otherwise bonded to the wing 126. The plastic rod 122 and the reinforcing member 126 may be glued together to form a unitary structure. When bellows 120 is stretched, reinforced wing 126/128 will open from about 90 degrees up to about 180 degrees, as shown in fig. 3B-3D.

Alternatively, the retention body 113 may be injected with rubber (or similar elastomer) to change the proximal tip 124 of the catheter 100 from a hollow tube to a solid rod, as shown in fig. 4A-4B. This modification makes the flower arrangement 140 more resistant to accidental displacement and thus provides improved retention.

It is important to note that the thicker, resilient flower-shaped configuration is safer than the rigid or stiff flower-shaped configuration. In the latter instance, a hard (or rigid) flower-shaped configuration may damage the bladder neck or urethra if it is inadvertently pulled out in the fully deployed flower-shaped configuration.

Therefore, it is desirable to form only a predetermined length (e.g., 5 cm) of the tip portion thicker, or to reinforce the wings of the flower-shaped configuration with rubber or a ductile plastic. In this way, an improved and safer holding force can be achieved compared to the prior art devices if the wings are inadvertently pulled out with the wings fully deployed.

To achieve this, the 5 cm long inner diameter of the retention body 113 is reinforced (fig. 3B, 3D), or the inner diameter of the retention body 113 is filled with rubber along the 5 cm length (fig. 4A-4B), for example by injection or impregnation. This process facilitates maintaining a uniform outer diameter throughout the length of the elongated catheter body of the catheter 100 of the present invention.

In addition to the improved retention that may be achieved due to the reinforcement of the retention mechanism 104, a second retention mechanism 142 is provided in the catheter system 100 of the present invention. The second retention mechanism 142 provides a stabilizing function for the indwelling catheter and is therefore also referred to herein as a stabilizer mechanism added for enhanced retention. The stabilizer mechanism is described in detail in other paragraphs related to the description of fig. 3C and 6A-6E.

The catheter 100 of the present invention operates in two modes, including a passive (collapsed) mode of operation (as shown in fig. 3A-3B and 4A) and an active (deployed) mode of operation (as shown in fig. 3C-3D and 4B).

In the passive mode of operation, the retention body 113 of the retention mechanism 104 has a straight (cylindrical) configuration with its wall portion 126 arranged substantially parallel to the longitudinal axis of the tubular catheter body 102 with the longitudinal slit 114 closed. The passive configuration of the catheter 100 of the present invention corresponds to the mode of operation of the catheter being taken for insertion or removal from the bladder.

After insertion into the bladder 134, the catheter 100 is converted into an activated mode of operation for anchoring the catheter 100 in place by actuating (deploying) the retention mechanism 104, as shown in fig. 3C-3D, 4B and 5.

The wall 126 of the retention body 113 extends cylindrically (in the passive mode of operation) and defines an internal passage 130 of the retention body 113 that extends in fluid communication and is aligned with the internal passage 114 of the tubular catheter body 102. The two

channels

115 and 130 aligned with each other form a passageway for urine 135 to move from urine drain port 132 (located at the bottom of retention body 113 of retention mechanism 104) to urine drain port 110 (shown in fig. 3C) located at distal end 108 of tubular catheter body 102 terminating in urine collection bag 112.

In a procedure in which the catheter 100 is inserted into the bladder 134 through the urethra 136 for surgical and/or therapeutic purposes, the tip portion 124 of the retention body 113 is inserted and gently pushed through the urethra 136 until it enters the bladder 134. Once in the bladder 134, the catheter 100 is secured in its indwelling position by the activated retention mechanism 104.

To actuate the retention mechanism 104, the bellows 120 is separated by the physician and the stem 122 secured (glued) to the tip 124 and the distal end 138 of the bellows 120 is displaced toward the distal end 108 of the catheter 100. The reinforced wing portions 126 then flare outwardly, forming a strong flower-like configuration 140, as shown in fig. 3C-3D, 4B, and 5.

As shown in fig. 3C, the urine drain port 132 is positioned in the most relevant lowest portion of the bladder 134. This arrangement facilitates the complete drainage of urine 135 from the bladder 134 with substantially no residual urine in the bladder.

Improved flow rates are achieved by enlarging the diameter of the internal passageway of the catheter of the present invention without affecting the outer diameter.

Improved drainage of the catheter of the present invention may be achieved by (a) locating the drainage site at the most relevant part of the bladder, and (b) providing a wider internal channel within the catheter.

Relative to prior art devices, urine drain port 132 is wider in the inventive catheter, having a diameter of the entire internal passage 130 and 115 (which is wider than the inner diameter of a conventional Foley catheter), because there is no other structure to obstruct the

internal passages

115, 130, as shown in FIG. 5 (compare FIG. 1B). Thus, a faster discharge of urine from the bladder 134 and a faster flow of urine through the catheter 100 into the urine bag 112 may be achieved, which is advantageous for reducing the incidence of CAUTI.

The positioning of the urine voiding port 132 of the inventive catheter 100 at the bottom of the bladder 134 provides for a completely residue-free urine voiding from the bladder 134, combined with faster bladder voiding, and faster flow through the catheter with the tubular elongate body 102Inner partThe alignment of the channel 115 with the internal channel 130 of the retention body eliminates conditions conducive to irritation and bacterial growth in the bladder and other urinary tract, which is highly beneficial to the health of the patient.

In order to provide improved retention, it is also contemplated that the inventive catheter 100 operates with a stabilizer mechanism 142, as depicted in fig. 3C and 6A-6E, in addition to the retention mechanism 104 (which includes wings 126 reinforced by members 128 or thickened wings 126 to achieve secure retention of the catheter 100 in the bladder 134).

The stabilizer mechanism is secured to the thighs (or other parts) of the patient's body by an adhesive breathable material 143, such as an adhesive pad. The stabilizer mechanism may be formed in various structures to fix the catheter main body 102 of the indwelling catheter 100 to the body of the patient.

As one of many examples, the stabilizer mechanism 142 will be described as being formed with a rotating housing unit 144 that is attached to the bonding material 143 to accommodate the bellows 50 when fully inflated, as shown in fig. 3C, 6D-6E. This will prevent the patient from disturbing the lotus catheter.

The stabilizer 142 provides enhanced retention of the catheter 100 by preventing direct impact of the patient's actions on the patient's bladder neck and securing the indwelling catheter in place.

The stabilizer housing 144 may include a bottom wall 148 and an upper wall 146 displaceably (or removably) secured to the bottom wall 148. The

walls

146, 148 may be connected with

latch mechanisms

149, 151 on one side of the housing 144, for example, by a hinge-like connection along the other side of the housing.

A receiving channel 150 is formed between

walls

146, 148 to receive bellows 120 therein to be locked between

walls

146, 148 when desired to provide enhanced stability of indwelling catheter 100.

To intentionally remove the catheter 100 from the body cavity, the stabilizer housing 144 is opened by unlatching the

latch mechanisms

149, 151 and separating the upper wall 146 from the lower wall 148 by a hinge, and the bellows 120 is removed from the receiving channel 150 of the stabilizer housing unit 144, as required by the surgical procedure.

Subsequently, the bellows 120 is compressed such that the shaft 122 secured to the tip 124 and the distal end 138 of the bellows 120 are displaced in a direction away from the distal end 108 of the catheter body 102. This action returns the wings (walls) 126 in the retention mechanism 104 to their straight configuration and closes the longitudinal slit 114, causing the catheter 100 to transition to the passive configuration shown in fig. 3A. In the passive configuration, the catheter 100 may be safely removed from the bladder 134 through the urethra 136.

In chronic cases, for catheters that must be indwelling for months or years, it is important to maintain the physiological state of the bladder 134, i.e., the distending and relaxing properties of the bladder wall. The stretching and relaxing properties of the bladder wall prevent bladder fibrosis (very small volume of the bladder). In permanently indwelling catheters, it is advantageous to add a valve over the urine discharge port connected to the urine bag, which valve will support the release of urine when the bladder is partially filled, i.e. when a certain bladder pressure is reached, thus mimicking normal physiological processes. Under normal physiological conditions, the bladder slowly expands until the person empties his/her bladder. After emptying the bladder, the bladder wall returns to its collapsed position.

The single-pass pressure control valve 152 shown in fig. 5 is beneficial for those patients deemed to have to indwelling a catheter for months, years, or for life. The valve opens at a predetermined pressure of 5-8 cm water, thus allowing the bladder, partially filled with urine, to empty when the bladder exceeds the predetermined pressure.

As shown in FIG. 5, the catheter of the present invention does not use any internal tubing within the channel 115 of the catheter body 102 (as opposed to the Foley catheter shown in FIG. 1B). The space used by the side port 26 in the Foley catheter (fig. 1B) is used in the catheter of the present invention to increase the inner diameter of the tube 102. The inner diameter of the catheter 100 is at least 20% -30% wider compared to the Foley catheter (fig. 1B), which facilitates excellent flow rates in the silicone catheter 100 of the present invention.

The method of making the silicone lotus-shaped conduit (hollow tube) 100 may be by extrusion. The lotus-shaped catheter of the invention can be extruded with a larger inner diameter without affecting the outer diameter. In contrast to Foley catheters, Lotus catheters do not require the use of an internal passage tube to carry fluid into and out of the balloon, and thus, the entire internal passage of the Lotus catheter can be used to carry fluid therethrough.

The increased inner diameter in the improved conduit 100 also helps to increase the diameter of the discharge port 132. Thus, a better drainage is achieved compared to conventional catheters.

In contrast to conventional Foley catheters (which, as shown in Figs. 1A-1C, have their exhaust port positioned above the balloon and thus are unable to completely drain urine from the bladder), the exhaust port in the catheter of the present invention is located at the very bottom of the bladder and thus can completely remove urine from the bladder, thereby eliminating the source of infection and possible bladder irritation.

Furthermore, the surgical catheter of the present invention has a reinforced or thickened flower-shaped configuration compared to conventional balloon-less "lotus-shaped" catheters as shown in fig. 2A-2C.

Moreover, the dual retention mechanism of the present invention (i.e., the thickened or reinforced wing configuration, and the stabilizer mechanism attached to the patient's thigh) allows the inventive catheter to achieve a higher reliability than conventional balloon-less "lotus" catheters, and thus can withstand inadvertent withdrawal of the catheter.

While the invention has been described in connection with specific forms and embodiments thereof, it will be understood that various modifications other than those discussed above may be made without departing from the spirit or scope of the invention as defined by the appended claims. For example, functionally equivalent elements may be substituted for those specifically shown and described, certain features may be used independently of the others, and certain positions of such elements may be reversed or inserted in certain circumstances, without departing from the spirit or scope of the invention as defined in the appended claims.

Claims

1. A surgical catheter adapted to be inserted into a body cavity of a patient, the surgical catheter comprising:

an elongate catheter body having a wall extending between a proximal end and a distal end of the elongate catheter body, wherein the wall of the elongate catheter body defines an internal channel extending along a longitudinal axis of the elongate catheter body;

a first retention mechanism positioned at the proximal end of the elongate catheter body, the first retention mechanism being actuated after insertion of the proximal end of the elongate catheter body into a body lumen of interest, and

a second retention mechanism secured to the body of the patient outside the body lumen and engageable with the elongate catheter body at a predetermined region thereof upon actuation of the first retention mechanism;

the first retention mechanism configured to have a retention body that is substantially cylindrical and a stiffening mechanism operatively coupled to the retention body and configured to form a stiffening wall of the retention body that defines an internal channel of the retention body that extends along the longitudinal axis of the retention body, wherein the stiffening wall of the retention body is formed from at least two wall portions of the stiffening wall of the retention body that have side edges that extend longitudinally and form at least two respective longitudinal slits that extend in spaced relation at the at least two wall portions, the stiffening mechanism being made from a ductile material;

wherein the reinforcing mechanism is formed by the wall of the retention body being formed from a layer of resilient material having a thickness greater than a thickness of the wall of the elongate catheter body;

the at least two wall portions extend between a common tip of the retention body and the proximal end of the elongate catheter body, wherein the retention body is secured to the proximal end of the elongate catheter body, and wherein the internal channel of the retention body is positioned in alignment with the internal channel of the elongate catheter body along a common longitudinal axis, and

wherein the internal channel of the retention body terminates in an exhaust port positioned substantially at the bottom of the body lumen and below the first retention mechanism, and the exhaust port is in fluid communication with an exhaust port of the catheter defined by an edge of a wall of the elongate catheter body at the distal end of the elongate catheter body;

wherein, when positioned in the body lumen, the first retention mechanism is actuated to assume a deployed configuration causing the at least two wall portions of the reinforcing wall of the retention body to elastically bend and displace radially outward from each other causing the at least two longitudinal slits to open and the exhaust port of the internal channel of the retention body to be exposed to fluid in the body lumen to substantially completely withdraw the fluid from the body lumen through the internal channels of the retention body and the elongate catheter body, respectively, to the exhaust port positioned at the distal end of the elongate catheter body.

2. The surgical catheter of claim 1, wherein the reinforcing mechanism includes at least two elongated reinforcing members, each elongated reinforcing member being secured to a respective one of the at least two wall portions of the wall of the retention body and extending along a length of the wall portion.

3. The surgical catheter of claim 1, further comprising:

a bellows formed on the elongate catheter body adjacent the distal end of the elongate catheter body, an

A stem coupled at one end to the common tip of the retention body and at another end to the bellows,

wherein, when the bellows is expanded, the rod is displaced toward the distal end of the elongated catheter body, thereby causing controlled displacement of the common tip of the retention body, and thereby causing actuation of and transformation of the first retention mechanism into the deployed configuration; and is provided with

Wherein the second retention mechanism is actuated to engage and hold the bellows unit in place to stabilize the position of the elongated catheter body.

4. The surgical catheter of claim 3, wherein the second retaining mechanism comprises an adhesive pad for securing to the patient's body, an

A stabilizer housing unit attached to the adhesive pad and rotatably displaceable relative to the adhesive pad, the stabilizer housing unit including a bottom wall and an upper wall removably secured to the bottom wall, the bottom wall and upper wall forming a receiving channel therebetween extending longitudinally of the stabilizer housing unit,

wherein once the catheter is indwelling in the body cavity with the first retention mechanism actuated, the bellows is secured in the receiving channel between the bottom wall and the upper wall of the stabilizer housing in an expanded configuration.

5. The surgical catheter of claim 1, wherein the at least two wall portions of the retention body are displaced radially outward from each other to assume a curved, winged configuration that abuts against an inner wall of the body lumen, thereby anchoring the catheter in the body lumen.

6. The surgical catheter of claim 5, further comprising a urine collection bag attached to the drainage port, wherein the drainage port and the internal passages of the retention body and the elongate catheter body, respectively, form an unobstructed urine pathway from the body lumen to the drainage port.

7. The surgical catheter of claim 5, wherein the surgical catheter is configured to operate intermittently in a passive mode of operation and a deployed mode of operation,

wherein, in the passive mode of operation, the surgical catheter is configured for removal from or insertion into the body cavity, and

wherein, in the passive mode of operation, the at least two wall portions of the holding body extend substantially parallel to the longitudinal axis of the holding body.

8. The surgical catheter of claim 7, wherein in the passive mode of operation, the surgical catheter is configured for insertion into the body lumen.

9. The surgical catheter of claim 7, wherein in the deployed mode of operation, the first retention mechanism transitions to the deployed configuration, thereby anchoring the catheter in the body lumen.

10. The surgical catheter of claim 5, wherein the at least two wall portions of the retention body are integrally formed with the wall of the elongated catheter body.

11. The surgical catheter of claim 5, wherein the at least two wall portions of the retention body are secured to the wall of the elongated catheter body.

12. The surgical catheter of claim 1, further comprising a multi-port valve mechanism positioned at the distal end of the elongate catheter body in fluid communication with the internal passage of the retention body.

13. A method of operating a surgical catheter, the method comprising:

defining an internal passage through the walls, the internal passage extending between the walls along a longitudinal axis of the elongate catheter body;

positioning a first retention mechanism at the proximal end of the elongate catheter body, the retention mechanism comprising a retention body configured with a wall extending between a tip and an opposing edge and defining an internal passage of the retention body;

forming said first retaining mechanism wherein at least two wall portions of the walls of said retaining body are interrupted by at least two longitudinal slits extending in spaced relation along the perimeter of said retaining body for a predetermined length, and

forming the first retention mechanism comprises a reinforcement mechanism operatively coupled to the retention body and configured to form a reinforcement wall of the retention body that defines an internal channel of the retention body that extends along the longitudinal axis of the retention body, wherein the reinforcement wall of the retention body is formed from at least two wall portions of the reinforcement wall of the retention body that have side edges that extend longitudinally and form at least two respective longitudinal slits that extend in spaced relation at the at least two wall portions, the reinforcement mechanism being made from an expanded material;

providing an exhaust port at one end of the internal channel of the retention body, the exhaust port being positioned below a bottom of the first retention mechanism and in fluid communication with an exhaust port positioned at the distal end of the elongate catheter body,

establishing a bellows on the elongated catheter body between the proximal end and the distal end of the elongated catheter body, an

Attaching one end of a rod to the tip of the holding body and the other end of the rod to the bellows unit; and

operating the catheter in a passive mode of operation and an active mode of operation;

the conversion of the passive and active modes of operation is:

extending the bellows, thereby causing the rod to displace toward the distal end of the elongate catheter body and displacing the tip of the retention body, thereby transitioning the first retention mechanism to a deployed configuration;

and engaging a second retaining mechanism with the extended bellows to stabilize the elongated catheter body in position.

14. The method of claim 13, further comprising the steps of:

the second retention mechanism is configured with an adhesive pad and stabilizer housing unit,

the adhesive pad is attachable to the body of a patient, an

Securing the stabilizer housing unit to the adhesive pad;

forming the stabilizer housing with a bottom wall and an upper wall removably securable to the bottom wall, the bottom wall and the upper wall forming a receiving channel therebetween extending longitudinally along the stabilizer housing unit, an

Securing the extended bellows in the receiving channel between the bottom wall and the upper wall of the stabilizer housing unit.

15. The method of claim 14,

in the passive mode of operation, the at least two wall portions of the holding body extend substantially parallel to the longitudinal axis thereof; and

actuating the first retention mechanism to transition the first retention mechanism to the deployed configuration by:

extending the bellows causing the at least two wall portions of the holding body to bend and displace radially outwardly causing the at least two longitudinal slits to open, an

Securing the bellows in the receiving channel of the stabilizer housing unit.

16. The method of claim 13, wherein the method further comprises:

in the deployed configuration, the at least two wall portions are displaced from each other and form a curved, wing-like configuration.

17. The method of claim 16, wherein the method further comprises:

integrally forming the at least two wall portions of the retention body with the wall of the elongated catheter body, or

Securing the at least two wall portions to the wall of the elongate catheter body.

18. The method of claim 13, further comprising the steps of:

mounting a multi-port valve mechanism at the distal end of the elongate catheter body in fluid communication with the outlet port, an

For removing the fluid when the pressure in the body cavity reaches a predetermined level.

19. The method of claim 13, further comprising the steps of:

reinforcing the at least two wall portions of the retention body by a reinforcing mechanism selected from the group consisting of:

at least two reinforcing members, each reinforcing member being secured to a respective one of the at least two wall portions of the wall of the retention body.