Balloon retention catheter or tube with distal safety valve

Abstract

A balloon retention catheter or tube is provided that includes a flexible multi-lumen tubular body having a distal tip coaxially mounted to the distal end of the tubular body with an expandable retention balloon secured to the distal tip and distal end. The distal tip and distal end are configured to move axially away from one another when the balloon is in its expanded configuration and held in place in the body and the tubular body is pulled backward away from the distal tip. Such axial movement reconfigures the distal tip and the distal end into a configuration that provides fluid communication between interior space of the balloon and a first lumen to automatically deflate the balloon. The balloon retention catheter or tube can be adapted for use in a urinary bladder to drain fluid from the bladder, or for use in a stomach to supply nutrients to the stomach.

Description

BALLOON RETENTION CATHETER OR TUBE WITH DISTAL SAFETY VALVEBACKGROUND1. Field

[0001] The following description relates to medical devices. More particularly, the following description relates to balloon retention catheters or tubes, such as balloon retention urinary drainage catheters or balloon retention feeding tubes.2. State of the Art

[0002] Annually, millions of individuals require balloon retention urinary catheters, which are typically referred to as Foley catheters, for temporary or chronic urinary drainage management. Referring to Prior Art Figs. 1 and 2, a prior art Foley catheter 10 includes a catheter shaft 12 having a first lumen extending to a distal end 14 and opening to a drainage port 16, and a second lumen extending to a retention balloon 18. The distal end 14 of the catheter shaft 12 has a distal tip 20 which may be unitary with the catheter shaft 12 or attached by adhesion or other bonding. The proximal end 13 of the catheter shaft 12 is provided with a hub 24 having first and second ports 26, 28 adapted to respectively couple the first lumen to a drainage bag and the second lumen to a syringe with an inflation fluid (such as saline, sterile water, air, or carbon dioxide gas). The distal tip 20 has an ostensibly atraumatic rounded end 22.

[0003] Turning to Prior Art Fig. 3, in use, the distal end 14 / distal tip 20 of the Foley catheter is tracked along the urethra 30 until the retention balloon 18 is passed into the patient’s bladder 32. The retention balloon 18 is then inflated via the second lumen with a fluid supplied by the syringe until the desired volume of fluid has filled the balloon, typically lOcc to 30cc. To remove the Foley catheter, the retention balloon 18 is typically deflated by inserting an empty syringe into corresponding port 28 of the proximal hub 24 to allow the inflation fluid to drain from the interior space of the retention balloon 18 through the second lumen and into the syringe.

[0004] The Foley catheter can induce injuries by inadvertent manipulation of the catheter shaft 12 or dislodging of the retention balloon 18 caused when the catheter shaft 12 is pulled backward away from the bladder 32 due to a sudden jerk or tension. This commonly happenswhen the patient is ambulating or traveling from the bed to the commode or bathroom. The catheter shaft 12 may inadvertently become fixed while the patient is still moving, at which time a sudden jerk is imparted upon the catheter shaft 12 that pulls the retention balloon back into the urethra. This can tear the urethra, causing severe pain and bleeding. Injury caused by the improper, inadvertent, and / or early removal of an inflated balloon catheter is referred to as iatrogenic injury (also referred to as an in-hospital injury). Hundreds of thousands of such iatrogenic injuries occur each year, all of which need to be prevented, not only for patient safety, but also because the cost imposed on the medical health industry for each injury is enormous.

[0005] The Foley catheter can also induce injuries when the patient deliberately pulls on the catheter shaft 12. This can tear the urethra, causing severe pain and bleeding. This commonly happens in confused patients, for example, patients in nursing homes who have a disease or cognitive dysfunction problem, such as Alzheimer's disease, or other diseases that make the patient unable to understand the necessity of having a catheter. Confusion occurs when the patient has a spasm causing pain and a strong urge to urinate. During the spasm, the confused patient often tugs and pulls on a catheter, which results in injury. Like iatrogenic injuries, these self-induced injuries must be prevented. In the particular case of injury caused by catheter withdrawal when the balloon is inflated (either iatrogenic or self-induced), hospitals have categorized such injuries as "never events"- occurrences that should never happen. Under such circumstances, insurance typically does not cover the resulting extensive medical expenses.

[0006] The injuries mentioned herein are not limited to males and will also cause severe damage to the female bladder and urethra. The injuries can also occur post-surgically, which makes the damage even more severe. One common situation where injury is caused is when the patient is medicated with morphine or other analgesics that render the patient confused and unable to make rational decisions. Feeling the foreign body inside the urethra, the confused patient does not know to leave it alone and, instead, gives it the injury-causing tug. These injuries have been well-documented and are not limited to adults. Numerous injuries are documented in pediatric patients.

[0007] Balloon retention feeding tubes, typically referred to as gastronomy tubes or G-tubes, employ a multi-lumen tubular body with a retention balloon mounted to the distal end of thetubular body. The multi-lumen tubular body include a first lumen ("feeding lumen") that is operable to carry nutrition to a discharge port at the distal end of tubular body for feeding the patient and a second lumen (inflation lumen) that is operable to supply inflation fluid to an inflation port at the distal end of tubular body for filling / inflating the retention balloon. The distal end of tubular body is placed surgically or percutaneously into the stomach via a channel in the abdomen made by the physician, and then the retention balloon is inflated with inflation fluid supplied via the inflation lumen such that the expanded balloon keeps the distal end of the tubular body in place. Nutrition is supplied to the stomach via the feeding lumen.

[0008] There are about 100,000 to 200,000 balloon retention feeding tubes placed in the United States each year. Infant formula, liquids, and medications are delivered through the balloon retention feeding tube to provide nutrition to the patient when it is not possible to deliver orally. Balloon retention feeding tubes can be permanent or temporary. Some of the most common complications include accidental dislodgement or pull-out, infection, blockage, or leakage around the tube. The subject invention is intended to address the complications of accidental dislodgement or pull-out. More specifically, the balloon retention feeding tube can induce injuries by inadvertent manipulation of the tubular body or dislodging of the retention balloon caused when the tubular body is pulled backward away from the patient's stomach due to a sudden jerk or tension. This can tear the stomach, causing severe pain and bleeding. It is estimated that 1-4% of balloon retention feeding tubes are accidentally pulled out each year.SUMMARY

[0009] It is accordingly a desire to provide a multi-lumen tubular body (i.e., catheter shaft of a urinary catheter or a feeding tube) with a retention balloon mounted at or near the distal end of the tubular body, wherein the retention balloon automatically and rapidly deflates when the tubular body is pulled backward away from the patient (e.g., away from the patient's bladder or stomach) due to a sudden jerk or tension applied to the tubular body. The automatic and rapid deflation of the retention balloon can avoid risk of injury to the patient that can occur if the retention balloon remains inflated and the sudden jerk or tension is applied to the tubular body as described above.

[0010] With the foregoing and other objects in mind, a medical device in accordance with the present disclosure includes a distal tip coaxially mounted to the distal end of a flexible multilumen tubular body. An expandable retention balloon is secured to an outer surface of the distal tip and to an outer surface of the distal end of the tubular body. The tubular body has a first lumen that extends through the tubular body. The first lumen is in fluid communication with a first port at or near the distal end of the tubular body. The first port provides a fluid pathway between the first lumen and exterior space adjacent to the distal end of the tubular body. The tubular body also has a second lumen (i.e., inflation lumen) that extends through the tubular body. The second lumen is in fluid communication with a second port (i.e., inflation port) at or near the distal end of the tubular body. The second port provides a fluid pathway between the second lumen and the interior space of the retention balloon. The second lumen and the second port are operable to fill the retention balloon with inflation fluid (such as saline, sterile water, air, or carbon dioxide gas) in order to expand the retention balloon into an expanded configuration where the retention balloon retains and holds both the distal tip and the distal end of the tubular body in a desired position inside the body. During deployment of the device inside the body and during inflation of the retention balloon, the distal tip and distal end of the tubular body are configured in a first configuration where the distal tip and distal end of the tubular body do not provide fluid connection between the interior space of the retention balloon and the first lumen that extends through the tubular body. This first configuration enables the inflation fluid to fill the retention balloon and expand the retention balloon into its expanded configuration. The distal tip and distal end of the tubular body are further configured to move axially relative to one another into a second configuration when the retention balloon is in its expanded configuration and the tubular body is pulled backward away from the patient with a sufficient amount of force or tension applied to the tubular body. In the second configuration of the distal tip and distal end of the tubular body, one or more fluid passageways fluidly connect the interior space of the retention balloon to the first lumen that extends through the tubular body. In this second configuration, the retention balloon automatically and rapidly deflates by flow of the inflation fluid out of the retention balloon and into and through the first lumen. In this manner, the distal tip and the distal end of the tubular body (and the relative movement of these two structural elements) function as a safety valve that automatically and rapidly deflates the retention balloonby flow of the inflation fluid out of the retention balloon and into and through the first lumen. The automatic and rapid deflation of the retention balloon can avoid risk and injury to the patient that could otherwise occur if the retention balloon remains inflated in the body with large backward pulling forces or tension applied to the tubular body.

[0011] In embodiments, the distal tip and distal end of the tubular body can be adapted such that pull forces or tension that exceeds a threshold value in the range of 2.5 to 7.5 pounds (and preferably at or near 5 pounds) as applied to the tubular body are required to permit the relative axial movement of the distal tip and distal end of the tubular body into the second configuration that opens the one or more fluid passageways that fluidly connect the interior space of the retention balloon to the first lumen.

[0012] In embodiments, the threshold pull forces or tension required to permit the relative axial movement of the distal tip and distal end of the tubular body into the second configuration (which enables the safety valve function provided by the distal tip and the distal end of the tubular body) can be controlled by the design or other characteristics of an interference fit between the distal tip and distal end of the tubular body. The interference fit produces a joint that holds the distal tip and the distal end of the tubular body together by friction after the parts are pushed together. In embodiments, the dimensional overlap of the two parts at the joint, the material used for the two parts, and possibly other factors can be optimized to permit the desired relative axial movement of the distal tip and distal end of the tubular body in response to the range of pull forces that could otherwise cause injury to the patient. In embodiments, the frictional forces at the joint between the distal tip and the distal end of the tubular body can vary due to the material properties of the distal tip and the distal end of the tubular body, and such variation in frictional forces can cause difficulties in controlling the threshold pull forces or tension required to permit the relative axial movement of the distal tip and distal end of the tubular body. In order to address this issue, one or more surface of distal tip and / or one or more surfaces of the distal end of the tubular body that forms the joint between the distal tip and the distal end of the tubular body can be coated with material (such as a polymeric surface coating) that provides a reduction in these frictional forces that exceeds 50% of that of the uncoated device. For example, the material can be parylene, one or more oils, or one or more hydrophobicor hydrophilic materials. Other suitable surface modifications can be made at the joint. Tn this case, the threshold pull forces or tension required to permit the relative axial movement of the distal tip and distal end of the tubular body can be controlled primarily by the dimensional overlap of the two parts at the joint.

[0013] In other embodiments, the threshold pull forces or tension required to permit the relative axial movement of the distal tip and distal end of the tubular body into the second configuration (which enables the safety valve function provided by the distal tip and the distal end of the tubular body) can be controlled by mechanical mating structures (such as deformable or frangible mating elements or other structures) that permit the desired relative axial movement of the distal tip and distal end of the tubular body in response to the range of pull forces that could otherwise cause injury to the patient.

[0014] In embodiments, the relative axial movement of the distal tip and distal end of the tubular body can result in the distal tip separating from the distal end of the tubular body in the second configuration (which enables the safety valve function provided by the distal tip and the distal end of the tubular body). In this embodiment, the separation of the distal tip from the distal end of the tubular body can expose the first lumen and permit the inflation fluid to flow from the interior space of the retention balloon into the first lumen.

[0015] In other embodiments, the relative axial movement of the distal tip and distal end of the tubular body can expose one or more fluid passageways defined by the distal tip and / or the distal end of the tubular body, where the exposed fluid passageway(s) that provide channel(s) that carry flow of inflation fluid from the interior space of the retention balloon into the first lumen.

[0016] Additionally, the relative axial movement of the distal tip and distal end of the tubular body can be limited by structural features. For example, such structural features can limit the extent of the relative axial movement and / or prohibit separation of the distal tip from the distal end of the tubular body to prevent the distal tip from remaining in the body.

[0017] To prevent injury to the patient due to pulling forces and / or tension applied to the tubular body with the retention balloon inflated in the body, the safety valve function providedby the distal tip and the distal end of the tubular body can be configured to deflate the retention balloon before injury occurs.

[0018] In one embodiment, the medical device is a balloon retention urinary catheter where the first lumen and the fist port are used to drain urinary fluid from the bladder through the tubular body (i.e., catheter shaft) to a drainage outlet at or near the proximal end of the tubular body (i.e., catheter shaft), and the retention balloon is configured, once inflated, to retain and hold the distal tip and the distal end of the tubular body (i.e., catheter shaft) within the bladder of the patient.

[0019] In another embodiment, the medical device is a balloon retention feeding tube where the first lumen and the fist port are used to supply nutrients from a feeding inlet at or near the proximal end of the tubular body and through the tubular body to the patient's stomach, and the retention balloon is configured to retain and hold the distal tip and the distal end of the tubular body within the stomach of the patient.

[0020] Other aspects are described and claimed.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Prior Art Fig. l is a prior art balloon retention urinary catheter.

[0022] Prior Art Fig. 2 is an enlarged distal end of the prior art balloon retention urinary catheter of Prior Art Fig. 1.

[0023] Prior Art Fig. 3 illustrates a prior art balloon retention urinary catheter inserted into the bladder when the bladder is full of urinary fluid.

[0024] Figs. 4 and 5 show the distal part of an exemplary balloon retention urinary catheter according to a first embodiment herein; Fig 4 is a plan schematic view of the distal part of the exemplary balloon retention urinary catheter; and Fig. 5 is a cross-sectional schematic view of the distal part of the exemplary balloon retention urinary catheter along the section line marked 5-5 in Fig. 4.

[0025] Fig. 6A shows the unattached distal tip of the exemplary balloon retention urinary catheter of Figs. 4 and 5.

[0026] Fig. 6B is a schematic plan view of the catheter body of the exemplary balloon retention urinary catheter of Figs. 4 and 5.

[0027] Fig. 6C is a schematic cross-sectional view of the catheter body of the exemplary balloon retention urinary catheter of Figs. 4 and 5.

[0028] Fig. 7 illustrates the exemplary balloon retention urinary catheter of Figs. 4 and 5 deployed within a urinary bladder prior to inflation of the retention balloon.

[0029] Fig. 8 illustrates the exemplary balloon retention urinary catheter of Figs. 4 and 5 deployed within a bladder after inflation of the retention balloon.

[0030] Fig. 9 illustrates initial deformation of the inflated retention balloon of the exemplary balloon retention urinary catheter of Figs. 4 and 5 caused by pull forces that pull the catheter body away from the bladder.

[0031] Fig. 10 illustrates further deformation of the inflated retention balloon as well as relative axial movement and resulting separation of the distal tip and distal end of the exemplary balloon retention urinary catheter of Figs. 4 and 5 that are caused by the balloon deformation and the pull forces that pull the catheter body away from the bladder.

[0032] Fig. 11 illustrates deflation of the retention balloon that results from the axial movement and separation of the distal tip and distal end of the exemplary balloon retention urinary catheter shown in Fig. 10.

[0033] Fig 12 illustrates removal of the exemplary balloon retention urinary catheter of Figs. 4 and 5 through the urethra of the patient with the retention balloon fully deflated.

[0034] Fig. 13 illustrates another exemplary balloon retention urinary catheter according to a second embodiment herein, which has been deployed within a bladder and the retention balloon inflated to retain and hold the distal tip and distal end of the catheter body in position within the bladder.

[0035] Fig 14 illustrates yet another exemplary balloon retention urinary catheter according to a third embodiment herein, which has been deployed within a bladder and the retentionballoon inflated to retain and hold the distal tip and distal end of the catheter body in position within the bladder.

[0036] Fig 15 illustrates deformation of the inflated retention balloon as well as relative axial movement of the distal tip and distal end of the exemplary balloon retention urinary catheter of Fig. 14 that are caused by the deformation of the retention balloon and pull forces that pull the catheter body away from the bladder.

[0037] Fig. 16 illustrates still another exemplary balloon retention urinary catheter according to a fourth embodiment herein, which has been deployed within a bladder and the retention balloon inflated to retain and hold the distal tip and distal end of the catheter body in position within the bladder.

[0038] Fig. 17 illustrates deformation of the inflated retention balloon as well as relative axial movement of the distal tip and distal end of the exemplary balloon retention urinary catheter of Fig. 16 that are caused by the deformation of the retention balloon and pull forces that pull the catheter body away from the bladder.

[0039] Fig. 18 illustrates another exemplary balloon retention urinary catheter according to a fifth embodiment herein, which has been deployed within a bladder and the retention balloon inflated to retain and hold the distal tip and distal end of the catheter body in position within the bladder.

[0040] Fig 19A illustrates still another exemplary balloon retention urinary catheter according to a sixth embodiment herein; Fig. 19A is a cross-sectional schematic view of the distal part of the exemplary balloon retention urinary catheter.

[0041] Fig. 19B shows the unattached distal tip of the exemplary balloon retention urinary catheter of Fig 19 A.

[0042] Figs. 20A to 20D illustrate an exemplary retention balloon that employs longitudinal ribs that are configured to channel urine past the balloon to a drainage port disposed proximal to the retention balloon in accordance with the present disclosure.

[0043] Fig. 21 illustrates the exemplary balloon retention feeding tube in accordance with the present disclosure, which is deployed within a stomach after inflation of the retention balloon.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] Various embodiments of the present invention are described herein. In many of the different embodiments, features are similar. Therefore, to avoid redundancy, repetitive description of these similar features may not be made in some circumstances. It shall be understood, however, that description of a first-appearing feature applies to the later described similar feature and each respective description, therefore, is to be incorporated therein without such repetition.

[0045] With reference to the following description, the terms “proximal” and “distal” are defined in reference to the hand of a user of the device, with the term “proximal” being closer to the user’s hand, and the term “distal” being further from the user’s hand such as to often be located further within a body of the patient during use, and specifically intended to be located within the bladder (or stomach).

[0046] Referring to Figs. 4 and 5, the distal part of an exemplary balloon retention urinary catheter 110 according to a first embodiment hereof is shown. The balloon retention urinary catheter 110 includes a distal tip 111 (Fig. 6A) coaxially and removably attached to the distal end 113 of a flexible multi-lumen catheter body (or tubular body) 115 about a central axis A-A. An expandable retention balloon 117 is secured to an outer annular surface of the distal tip 111 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond (labeled 119A) and to an outer annular surface of the distal end 113 of the catheter body 115 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond (labeled 119B). The catheter body 115 has a first lumen (drainage lumen) 121 that extends through the catheter body 115. The first lumen 121 is in fluid communication with a first port (drainage port) 123 at or near the distal end 113 of the catheter body. In embodiments, the first port (drainage port) 123 can be spaced proximally from the retention balloon 117 as shown. The first port 123 provides a fluid pathway between the first lumen 121 and exterior space adjacent to the distal end 113 of the catheter body 115. In other embodiments, the catheter body 115 can have multiple first ports (multiple drainage ports)that provide multiple fluid pathways between the first lumen 121 and exterior space adjacent to the distal end 113 of the catheter body 115. For example, the multiple drainage ports can be spaced from one another axially and / or circumferentially about the distal end 113 of the catheter body 115.

[0047] The catheter body 115 also has a second lumen (i.e., inflation lumen) 125 that extends through the catheter body 115. The second lumen 125 is in fluid communication with a second port (i.e., inflation port) 127 at or near the distal end 113. The second port 127 provides a fluid pathway between the second lumen 125 and the interior space of the retention balloon 117. The second lumen 125 and the second port 127 are operable to fill the retention balloon 117 with inflation fluid (such as saline, sterile water, air, or carbon dioxide gas) in order to expand the retention balloon 117 into an expanded configuration where the retention balloon retains and holds both the distal tip 111 and the distal end 113 in a desired position inside the bladder of a patient. In other embodiments, the catheter body 115 can have multiple second ports (multiple inflation ports) that provide multiple fluid pathways between the second lumen 125 and the interior space of the balloon 117. For example, the multiple inflation ports can be spaced from one another axially and / or circumferentially about the distal end 113 of the catheter body 115.

[0048] As described with respect to the prior art conventional balloon retention urinary catheter (Fig. 1), the proximal end of the catheter body 115 can be provided with a hub having first and second ports adapted to respectively couple the first lumen (drainage lumen) 121 to a drainage bag and the second lumen (inflation lumen) 125 to a syringe with inflation fluid.

[0049] During deployment of the distal part of the catheter 110 inside the bladder and during inflation of the retention balloon 117, the distal tip 111 and distal end 113 are configured in a first configuration where the distal tip 111 and distal end 113 do not provide fluid connection between the interior space of the retention balloon 117 and the first lumen 121. This first configuration enables the inflation fluid to fill the retention balloon 117 and expand the retention balloon 117 into its expanded configuration where the retention balloon 117 retains and holds both the distal tip 111 and the distal end 113 in a desired position inside the bladder of a patient.

[0050] The distal tip 11 1 and the distal end 113 are further configured to move axially away from one another (in the direction of the central axis A-A) into a second configuration when the retention balloon 117 is in its expanded configuration and the catheter body 115 is pulled backward away from the bladder / distal tip 111 with a sufficient amount of force or tension applied to the catheter body 115. In the second configuration of the distal tip 111 and the distal end 113, one or more fluid passageways fluidly connect the interior space of the retention balloon 117 to the first lumen 121. In this second configuration, the retention balloon 117 automatically and rapidly deflates by flow of the inflation fluid out of the retention balloon 117 and into and through the first lumen 121 for drainage from the proximal (and distal) end of the catheter body 115. In this manner, the distal tip 111 and the distal end 113 (and the relative movement of these two structural elements) function as a safety valve that automatically and rapidly deflates the retention balloon 117 by flow of the inflation fluid out of the retention balloon 117 and into and through the first lumen 121. The automatic and rapid deflation of the retention balloon 117 can avoid injury to the patient that could otherwise occur if the retention balloon 117 remains inflated in the body (urethra) with large backward pulling forces or tension applied to the catheter body 115.

[0051] In embodiments, the distal tip 111 can include a stepped transition from annular surface 11 la to a larger outer diameter annular surface 11 lb, and a further stepped transition from the larger outer diameter annular surface 11 lb to a distal blunt conical-shaped surface 111c as shown in Fig. 6A. The outer diameter annular surface I l la can be sized and shaped for insertion into the interior space of the distal end 113 defined by the inner diameter annular surface of the distal end 113 as shown in the cross-section of Fig. 5. The distal end of the retention balloon 117 can be bonded to the larger outer diameter annular surface 111c, as shown by 119a and the proximal end of the retention balloon 117 can be bonded to the outer diameter annular surface of the distal end 113 as shown in the cross-section of Fig. 5 and by 119b.

[0052] Figs. 6B and 6C shows the catheter body 115 of the balloon retention urinary catheter 110 of Figs. 4 and 5. The catheter body 115 has the inflation lumen 125 spaced from the drainage lumen 121 along the catheter body as illustrated by Fig. 6C.

[0053] In embodiments wherein the retention balloon 117 is inflated, the distal tip 1 11 and the distal end 113 can be adapted such that pull forces or tension that exceeds a threshold value in the range of 2.5 to 5.7 pounds (and preferably at or near 5 pounds) as applied to the catheter body 115 are required to permit the relative axial movement of the distal tip 111 and the distal end 113 into the second configuration that opens the one or more fluid passageways that fluidly connect the interior space of the retention balloon 117 to the first lumen 121. For clarity, when the retention balloon 117 is inflated in the bladder and rests on the opening of the urethra to the bladder, the retention balloon 117 can provide opposing force to the pulling forces that pull the catheter body 115 axially away from the bladder. The opposing forces can cause the distal tip 111 and distal end 113 to effectively separate from one another to expose additional drainage channels that rapidly deflate retention balloon 117 and enable the catheter 110 to exit the bladder and urethra without otherwise injuring the urethra.

[0054] In embodiments, the threshold pull forces or tension required to permit the relative axial movement of the distal tip 111 and the distal end 113 into the second configuration (which enables the safety valve function provided by the distal tip 111 and the distal end 113) can be controlled by the design or other characteristics of an interference fit between the distal tip 111 and the distal end 113. For example, the interference fit can be provided by the inner diameter annular surface of the distal end 113 and an outer diameter annular surface 11 la of the distal tip 111 (Fig. 6A). The interference fit produces a joint that holds the distal tip 111 and the distal end 113 of the tubular body together by friction after the parts are pushed together. In embodiments, the dimensional overlap of the two parts at the joint, the material used for the two parts, the thickness of the two parts and possibly other factors can be optimized to permit the desired relative axial movement of the distal tip and distal end of the tubular body in response to the range of pull forces that could otherwise cause injury to the patient. In embodiments, the frictional forces at the joint between the distal tip and the distal end of the tubular body can vary due to the material properties of the distal tip and the distal end of the tubular body, and such variation in frictional forces can cause difficulties in controlling the threshold pull forces or tension required to permit the relative axial movement of the distal tip and distal end of the tubular body. In order to address this issue, one or more surface of distal tip and / or one or moresurfaces of the distal end of the tubular body that forms the joint between the distal tip and the distal end of the tubular body can be coated with material (such as a polymeric surface coating) that provides a reduction in these frictional forces that exceeds 50% of that of the uncoated device. For example, the material can be parylene, one or more oils, or one or more hydrophobic materials or hydrophilic materials. Other suitable surface modifications can be made at the joint. In this case, the threshold pull forces or tension required to permit the relative axial movement of the distal tip and distal end of the tubular body can be controlled primarily by the dimensional overlap of the two parts at the joint.

[0055] In another embodiment, the joint between the distal tip 111 and the distal end 113 of the tubular body can be defined by one or ribs 127a that are received by corresponding grooves 127 as shown in the embodiment of Figs. 19A and 19B. In the embodiment show, the ribs 127a extend radially away from the outer annular surface 11 la' of the distal tip 111 and the grooves 127b extend radially inward at the distal end 113 of the tubular body 115. In other embodiments (not shown), grooves can extend radially inward at the outer annular surface 11 la' of the distal tip 111 and corresponding ribs can extend radially outward at the distal end 113 of the tubular body 115. The size and geometry of the ribs and grooves can be configured to set / control the threshold pull forces or tension required to permit the relative axial movement of the distal tip 111 and the distal end 113 into the second configuration (which enables the safety valve function provided by the distal tip 111 and the distal end 113).

[0056] In other embodiments, the threshold pull forces or tension required to permit the relative axial movement of the distal tip 111 and the distal end 113 to the second configuration (which enables the safety valve function provided by the distal tip 111 and the distal end 113) can be controlled by mechanical mating structures (such as deformable or frangible mating elements or other structures) that permit the desired relative axial movement of the distal tip 111 and the distal end 113 in response to the range of pull forces that could otherwise cause injury to the patient.

[0057] In embodiments, the relative axial movement of the distal tip 111 and the distal end 113 can result in the distal tip 111 separating from the distal end 113 in the second configuration (which enables the safety valve function provided by the distal tip 111 and the distal end 113).In this embodiment, the separation of the distal tip from the distal end of the tubular body can expose the first lumen and permit the inflation fluid to flow from the interior space of the retention balloon into the first lumen (Fig. 10) and rapidly deflate the retention balloon 117.

[0058] Figs. 7 to 12 illustrate deployment of the balloon retention urinary catheter 110 of Figs. 4 and 5 together with operations of the balloon retention urinary catheter 110 wherein the retention balloon 117 automatically and rapidly deflates when the catheter body 115 is pulled backward away from the patient (e.g., away from the patient's bladder 151) due to a sudden jerk or tension applied to the tubular body. The automatic and rapid deflation of the retention balloon 117 can avoid injury to the patient that can occur if the retention balloon 117 remains inflated and the sudden jerk or tension is applied to the tubular body as described above.

[0059] Fig 7 illustrates the balloon retention urinary catheter 110 of Figs. 4 and 5 deployed within a urinary bladder 151 prior to inflation of the retention balloon 117. In this configuration, the distal tip 111 and the distal end 113 of the catheter body 115 are positioned inside the bladder 151 and the catheter body 115 extends proximally through the urethra 153 as shown. Fig. 8 illustrates the exemplary balloon retention urinary catheter of Figs. 4 and 5 deployed within a bladder 110 after inflation of the retention balloon 117. During deployment of the distal part of the catheter 110 inside the bladder and during inflation of the retention balloon 117, the distal tip 111 and distal end 113 are configured in a first configuration where the distal tip 111 and distal end 1 13 do not provide fluid connection between the interior space of the retention balloon 1 17 and the first lumen 121. This first configuration enables the inflation fluid to fill the retention balloon 117 and expand the retention balloon 117 into its expanded configuration where the retention balloon 117 retains and holds both the distal tip 111 and the distal end 113 in a desired position inside the bladder of a patient as shown in Fig. 8.

[0060] Fig. 9 illustrates initial deformation of the inflated retention balloon 117 of the balloon retention urinary catheter of Figs. 4 and 5 caused by pull forces that pull the catheter body 115 away from the bladder 151. Fig. 9 is for illustrative purposes only and the deformation of balloon 117 as illustrated may not match the actual deformation geometry of the balloon in situ.

[0061] Fig 10 illustrates further deformation of the inflated retention balloon 117 as well as relative axial movement and resulting separation of the distal tip 111 and distal end 113 of the balloon retention urinary catheter of Figs. 4 and 5 that are caused by the balloon deformation and pull forces that pull the catheter body 115 away from the bladder 151. The balloon deformation applies forces to the distal tip 111 that are opposite in direction to the pull forces applied to the catheter body 115 and its distal end 113. These opposing forces act to impart relative axial movement of the distal tip 111 and the distal end 113 (in the direction of the central axis A-A of the assembly), which results in the distal tip 111 separating from the distal end 113 in the second configuration. This separation enables the safety valve function provided by the distal tip 111 and the distal end 113 by exposing the first lumen (drainage lumen 121) and permitting the inflation fluid to flow from the interior space of the retention balloon 117 into the first lumen (drainage lumen) 121 as shown in Fig. 10 to rapidly deflate the retention balloon 117.

[0062] Fig. 11 illustrates deflation of the retention balloon 117 that results from the axial movement and separation of the distal tip 111 and the distal end 113 of the balloon retention urinary catheter 110 shown in Fig. 10.

[0063] Fig. 12 illustrates removal of the balloon retention urinary catheter 110 of Figs. 4 and 5 through the urethra 153 of the patient with the retention balloon 117 fully deflated thereby preventing injury to the urethra of the patient.

[0064] Fig. 13 illustrates another exemplary balloon retention urinary catheter 110' according to a second embodiment herein, which has been deployed within a bladder 151 and the retention balloon 117 inflated to retain and hold the distal tip 111 and distal end 113 of the catheter body in position within the bladder 151. In this embodiment, the retention balloon 117 is secured to an outer annular surface of the distal tip 111 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond and to an outer annular surface of the distal end 113 of the catheter body 115 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond. The distal tip 111 has an internal lumen 121a that is coaxially aligned to and in fluid communication with the first lumen 121 of the catheter body 115. The lumen 121a is in fluid communication with a port (drainage port) 123a defined in the distal blunt conical-shaped surface 111c of the distal tip 111. The drainage port 123a is spaced distally from the retention balloon 117 as shown. The drainageport 123a provides a fluid pathway between the lumens 121 / 121a and exterior space adjacent to the distal tip 111. In this embodiment, fluid from the bladder is drained continuously through internal lumen 121a to exit port 26 shown in Fig. 1. In other embodiments, the catheter body 115 can have multiple drainage ports that provide multiple fluid pathways between the first lumen 121 and exterior space adjacent to the distal end 113 of the catheter body 115. For example, one or more additional drainage ports can be spaced axially or radially from the drainage port 123a at the distal end 113 of the catheter body 115.

[0065] The balloon retention urinary catheter 110' of Fig. 13 operates in a manner similar to the balloon retention urinary catheter 110 of Figs. 4 to 12 as described above with the exception that fluid from the bladder 151 enters the drainage port 123a and flows through the lumens 121 / 121 a of the device for drainage through exit port 26 shown in Fig. 1, while the device is deployed in the bladder 151 under normal operating conditions (instead of entering the drainage port 123 in the catheter body for the balloon retention urinary catheter 110 of Figs. 4 to 12).

[0066] Fig. 14 illustrates another exemplary balloon retention urinary catheter 110" according to a third embodiment herein, which has been deployed within a bladder 151 and the retention balloon 117 inflated to retain and hold the distal tip 111 and distal end 113 of the catheter body in position within the bladder 151. Similar to the second embodiment of Fig. 13, the retention balloon 117 is secured to an outer annular surface of the distal tip 111 by adhesive (e g., RTV adhesive), polymer welding or other suitable bond and to an outer annular surface of the distal end 113 of the catheter body 115 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond. The distal tip 111 has an internal lumen 121a that is coaxially aligned to and in fluid communication with the first lumen 121 of the catheter body 115. The lumen 121a is in fluid communication with a drainage port 123a defined in the distal blunt conical-shaped surface 111c of the distal tip 111. The drainage port 123a is spaced distally from the retention balloon 117 as shown. The drainage port 123a provides a fluid pathway between the lumens 121 / 121 a and exterior space adjacent to the distal tip 111. The distal end 113 includes one or more safety valve ports (two shown as 119a, 119b) that extend through the annular wall of the distal end 113 and that are positioned in fluid communication with the interior space of the inflation balloon 117. The one or more safety valve ports (two shown as 120a, 120b) areconfigured to be closed by the outer annular surface 11 la of the distal tip 1 11 when the urinary catheter 110" is deployed within the bladder 151 as shown (configuration 1) and used properly this configuration 1 (including during inflation of the retention balloon 117) without subjecting the urinary catheter 110" to pull forces that could injure the patient (FIG. 15).

[0067] Fig. 15 illustrates deformation of the inflated retention balloon 117 as well as relative axial movement of the distal tip 111 and distal end 113 of the balloon retention urinary catheter 110" that are caused by the deformation of the retention balloon 117 and pull forces that pull the catheter body 115 away from the bladder 151 (configuration 2). Similar to the embodiment illustrated in Fig. 10, the balloon deformation applies forces to the distal tip 111 that are opposite in direction to the pull forces applied to the catheter body 115 and its distal end 113. These opposing forces act to impart relative axial movement of the distal tip 111 and the distal end 113 (in the direction of the central axis A-A of the assembly), which results in the one or more safety valve ports (two shown as 120a, 120b) moving away from the outer annular surface 11 la of the distal tip 111 such that the one or more safety valve ports are open (not closed or blocked) by the outer annular surface 11 la of the distal tip 111. This movement enables the safety valve function provided by the distal tip 111 and the distal end 113 by exposing the one or more safety valve ports and permitting the inflation fluid to flow from the interior space of the retention balloon 117 through the open safety valve port(s) into the first lumen (drainage lumen) 121 as shown in Fig. 15 for deflation of the retention balloon 117.

[0068] The balloon retention urinary catheter 110" of Figs. 14 and 15 operates in a manner similar to the balloon retention urinary catheter 110 of Figs. 4 to 12 as described above with the exception that i) fluid from the bladder 151 enters the drainage port 123a and flows through the lumens 121 / 121 a of the device for drainage while the device is deployed in the bladder 151 under normal operating conditions (instead of entering the drainage port 123 in the catheter body for the balloon retention urinary catheter 110 of Figs. 4 to 12); and ii) the one or more safety valve ports (120a, 120b) provided by the distal end 113 of the catheter body function as a safety valve for deflation of the retention balloon 117 (instead of the separation of the distal tip 119 from the distal end 113 for deflation of the retention balloon 117 for the balloon retention urinary catheter 110 of Figs. 4 to 12).

[0069] Fig 16 illustrates another exemplary balloon retention urinary catheter 1 10'" according to a fourth embodiment herein, which has been deployed within a bladder 151 and the retention balloon 117 inflated to retain and hold the distal tip 111 and distal end 113 of the catheter body in position within the bladder 151. Similar to the third embodiment of Fig. 14, the retention balloon 117 is secured to an outer annular surface of the distal tip 111 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond and to an outer annular surface of the distal end 113 of the catheter body 115 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond. The distal tip 111 has an internal lumen 121a that is coaxially aligned to and in fluid communication with the first lumen 121 of the catheter body 115. The lumen 121a is in fluid communication with a drainage port 123a defined in the distal blunt conical-shaped surface 111c of the distal tip 111. The drainage port 123a is spaced distally from the retention balloon 117 as shown. The drainage port 123a provides a fluid pathway between the lumens 121 / 121 a and exterior space adjacent to the distal tip 111. The distal end 113 includes one or more safety valve ports (120a, 120b) that extend through the annular wall of the distal end 113 and that are positioned in fluid communication with the interior space of the inflation balloon 117. The one or more safety valve ports are configured to be closed by the outer annular surface 11 la of the distal tip 111 when the urinary catheter 110" is deployed within the bladder 151 and used properly (including during inflation of the retention balloon 117) without subjecting the urinary catheter 110"' to pull forces that could injure the patient (FIG. 17). Additionally, the distal tip 111 and the distal end 113 can be equipped with a retention mechanism that limits the extent of the relative axial movement of the distal tip 111 and the distal end 113 and / or prohibits total separation of the distal tip 111 from the distal end 113. In embodiments, the retention mechanism can be embodied by structural features 124a, 124b, respectively, that limit the relative axial movement of the distal tip 111 and distal end 113. For example, the structural features 124a, 124b can limit the extent of the relative axial movement and / or prohibit total separation of the distal tip 111 from the distal end 113. The structural features 124a, 124b can include one or more spring clips and interlocking grooves, magnetic couplers, marker bands, variable sized collars, or other suitable features. The structural feature(s) 124a can be disposed at or near the proximal end of the distal tip 111, and the structural feature(s) 124b can be disposed at or near the distal-most part of the distal end 113 spaced distally from the one or more safetyvalve ports as shown. The structural feature(s) 124a can contact or engage the structural feature(s) 124b when the distal tip 111 moves axially relative to the distal end 113. Such contact or engagement can limit the extent of the relative axial movement of the distal tip 111 and the distal end 113 and / or prohibit total separation of the distal tip 111 from the distal end 113.

[0070] Fig. 17 illustrates deformation of the inflated retention balloon 117 as well as relative axial movement of the distal tip 111 and distal end 113 of the balloon retention urinary catheter 110"' that are caused by the deformation of the retention balloon 117 and pull forces that pull the catheter body 115 away from the bladder 151. Similar to the embodiment illustrated in Fig. 10, the balloon deformation applies forces to the distal tip 111 that are opposite in direction to the pull forces applied to the catheter body 115 and its distal end 113. These opposing forces act to impart relative axial movement of the distal tip 111 and the distal end 113 (in the direction of the central axis A-A of the assembly), which results in the one or more safety valve ports (two shown as 120a, 120b) moving away from the outer annular surface 11 la of the distal tip 111 such that the one or more safety valve ports are open (not closed or blocked) by the outer annular surface 11 la of the distal tip 111. This movement enables the safety valve function provided by the distal tip 111 and the distal end 113 by exposing the one or more safety valve ports and permitting the inflation fluid to flow from the interior space of the retention balloon 117 through the open safety valve port(s) into the first lumen (drainage lumen) 121 as shown in Fig. 17 for deflation of the retention balloon 117. The structural features 124a, 124b can be configured to interface or interact with one another as shown in Fig, 17 in order to limit the extent of the relative axial movement and / or prohibit separation of the distal tip 111 from the distal end 113.

[0071] The balloon retention urinary catheter 110"' of Figs. 16 and 17 operates in a manner similar to the balloon retention urinary catheter 110 of Figs. 4 to 12 as described above with the exception that i) fluid from the bladder 151 enters the drainage port 123a and flows through the lumens 121 / 121 a of the device for drainage while the device is deployed in the bladder 151 under normal operating conditions (instead of entering the drainage port 123 in the catheter body for the balloon retention urinary catheter 110 of Figs. 4 to 12); ii) the one or more safety valve ports (120a, 120b) provided by the distal end 113 of the catheter body function as a safety valve for deflation of the retention balloon 117 (instead of the separation of the distal tip 119 from thedistal end 113 for deflation of the retention balloon 1 17 for the balloon retention urinary catheter 110 of Figs. 4 to 12); and iii) the structural features 124a, 124b limit the extent of the relative axial movement of the distal tip 111 and the distal end 113 and / or prohibit separation of the distal tip 111 from the distal end 113.

[0072] Fig. 18 illustrates another exemplary balloon retention urinary catheter 110"" according to a fifth embodiment herein, which has been deployed within a bladder 151 and the retention balloon 117 inflated to retain and hold the distal tip 111 and distal end 113 of the catheter body in position within the bladder 151. Similar to the third embodiment of Fig. 14, the retention balloon 117 is secured to an outer annular surface of the distal tip 111 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond and to an outer annular surface of the distal end 113 of the catheter body 115 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond. The distal tip 111 has an internal lumen 121b that is coaxially aligned to and in fluid communication with the first lumen 121 of the catheter body 115. The lumen 121b is in fluid communication with a drainage port 123b defined in the distal tip 111. The drainage port 123b is spaced distally from the retention balloon 117 and proximally from the distal blunt conical-shaped surface 111c of the distal tip 111 as shown. The drainage port 123b provides a fluid pathway between the lumens 121 / 121b and exterior space adjacent to the distal tip 111.

[0073] The balloon retention urinary catheter 110"" of Fig. 18 operates in a manner similar to the balloon retention urinary catheter 110 of Figs. 4 to 12 as described above with the exception that fluid from the bladder 151 enters the drainage port 123b and flows through the lumens 121 / 12 lb of the device for drainage while the device is deployed in the bladder 151 under normal operating conditions (instead of entering the drainage port 123 in the catheter body for the balloon retention urinary catheter 110 of Figs. 4 to 12).

[0074] In other embodiments, the features of the distal tip 111 of balloon retention urinary catheter of Fig. 18 can be integrated into the other balloon retention urinary catheters described herein.

[0075] Figs. 19A and 19B illustrate another exemplary balloon retention urinary catheter 110 according to a sixth embodiment herein. Similar to the third embodiment of Fig. 14, theretention balloon 117 is secured to an outer annular surface of the distal tip 1 11 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond and to an outer annular surface of the distal end 113 of the catheter body 115 by adhesive (e.g., RTV adhesive), polymer welding or other suitable bond. The distal tip 111 has an internal lumen 121b that is coaxially aligned to and in fluid communication with the first lumen 121 of the catheter body 115. The lumen 121b is in fluid communication with a drainage port 123b defined in the distal tip 111. The drainage port 123b is spaced distally from the retention balloon 117 and proximally from the distal blunt conical-shaped surface 111c of the distal tip 111 as shown. The drainage port 123b provides a fluid pathway between the lumens 121 / 121b and exterior space adjacent to the distal tip 111.

[0076] The balloon retention urinary catheter 1 10 of Figs. 19A and 19B operates in a manner similar to the balloon retention urinary catheter 110 of Figs. 4 to 12 as described above with the exception that fluid from the bladder 151 enters the drainage port 123b and flows through the lumens 121 / 12 lb of the device for drainage while the device is deployed in the bladder 151 under normal operating conditions (instead of entering the drainage port 123 in the catheter body for the balloon retention urinary catheter 110 of Figs. 4 to 12). Furthermore , the joint between the distal tip 111 and the distal end 113 of the tubular body is defined by one or ribs 127a that are received by corresponding grooves 127 as shown. In the embodiment show, the ribs 127a extend radially away from the outer annular surface 1 I la' of the distal tip 111 and the grooves 127b extend radially inward at the distal end 113 of the tubular body 115. In other embodiments (not shown), grooves can extend radially inward at the outer annular surface I l la' of the distal tip 111 and corresponding ribs can extend radially outward at the distal end 113 of the tubular body 115. The size and geometry of the ribs and grooves can be configured to set / control the threshold pull forces or tension required to permit the relative axial movement of the distal tip 111 and the distal end 113 into the second configuration (which enables the safety valve function provided by the distal tip 111 and the distal end 113).

[0077] In other embodiments, the features of the distal tip 111 and distal end 113 of balloon retention urinary catheter of Figs. 19A and 19B can be integrated into the other balloon retention urinary catheters described herein.

[0078] In embodiments, the retention balloon of the embodiments described herein can be configured with a plurality of longitudinal ribs 200 as illustrated in Figs. 20A to 20D. In the initial deflated state of the retention balloon 117', the longitudinal ribs 200 are configured to extend longitudinally over the length of the expandable portion of the retention balloon 117 (i.e., parallel to the central axis A-A of the assembly) while being spaced circumferentially from one another about the outer surfaces of the retention balloon 117 as shown in Figs. 20A and 20B. The longitudinal ribs 200 can be comprised of the same material comprising the retention balloon 117 and serve to thicken the balloon in the areas where they are placed. The longitudinal ribs 200 serve to restrict elongation of the balloon where they are placed. In the inflated state of the retention balloon 117', the longitudinal ribs 200 restrict uniform inflation of the balloon to provide lobes that are separated by the longitudinal ribs as shown in Figs. 20C and 20D. In this configuration, the longitudinal ribs 200 form dents or channels along the length of the balloon that allow urine to flow past the lobes of the retention balloon 117' and into the drainage port 123.

[0079] In the embodiments described herein, the distal tip and the catheter body can be made from a flexible polymeric material commonly used in the manufacture of catheters. Exemplary materials include but are not limited to silicone rubber, polyurethane, polyolefins, fluorinated polymer, nylons, amorphous nylons, polyesters, amorphous polyesters, and combinations of the above.

[0080] In the embodiments described herein, the retention balloon can be made from a thin sheet of elastomeric polymeric material. Exemplary materials include but are not limited to silicone rubber, polyurethane, polyolefins, fluorinated polymer, nylons, amorphous nylons, polyesters, amorphous polyesters, and combinations of the above.

[0081] In other embodiments, the functionality and features of the safety valve of the catheter body as described above can be adapted for use in other balloon retention medical devices, such as a balloon retention feeding tube. In the balloon retention feeding tube, the functionality and features of the safety valve are provided by a distal tip coaxially mounted to the distal end of a multi-lumen tubular body as shown in FIG. 21. The exemplary balloon retention feeding tube 200 has a distal tip 211 coaxially mounted to the distal end 213 of a multi-lumentubular body 215. The tubular body 215 has a first lumen 221 and first port(s) (not shown) used to supply nutrients from a feeding inlet at or near the proximal end of a tubular body 215 and through the tubular body 215 to the patient's stomach. The tubular body 215 is placed through skin and the abdomen wall 253 such that tubular body 215 enters into the stomach 251 as shown. A retention balloon 217 is attached to the outer annular surfaces of the distal tip 211 and distal end 213 of the tubular body 215. The retention balloon 217 is configured to retain and hold the distal tip 211 and the distal end 213 of the tubular body 215 within the stomach 251 of the patient. The tubular body 215 also includes a second lumen and second port(s) (no shown) used to inflate the retention balloon 217 with inflation fluid.

[0082] During deployment of the device inside the stomach 251 and during inflation of the retention balloon 217, the distal tip 211 and distal end 213 of the tubular body 215 are configured in a first configuration where the distal tip 211 and distal end 213 of the tubular body 215 do not provide fluid connection between the interior space of the retention balloon 217 and the first lumen 221. This first configuration enables the inflation fluid to fill the retention balloon 217 and expand the retention balloon 217. The distal tip 211 and distal end 213 of the tubular body 215 are further configured to move axially relative to one another into a second configuration when the retention balloon 217 is in its expanded configuration and the tubular body 215 is pulled backward away from the distal tip 211 / stomach 251 with a sufficient amount of force or tension applied to the tubular body 215. In the second configuration of the distal tip 211 and distal end 213 of the tubular body 215, the interior space of the retention balloon 217 is fluid connected to the first lumen 221. In this second configuration, the retention balloon 217 automatically and rapidly deflates by flow of the inflation fluid out of the retention balloon 217 and into and through the first lumen 221. In this manner, the distal tip 211 and the distal end 213 of the tubular body 215 (and the relative movement of these two structural elements) function as a safety valve that automatically and rapidly deflates the retention balloon 217 by flow of the inflation fluid out of the retention balloon 217 and into and through the first lumen 221. The automatic and rapid deflation of the retention balloon 217 can avoid risk or cause injury to the patient that could otherwise occur if the retention balloon 217 remain inflated in the body with large backward pulling forces or tension applied to the tubular body 215.

[0083] To prevent injury to the patient due to pulling forces and / or tension applied to a medical device with the retention balloon inflated in the body as described herein, the safety valve function provided by the medical device can be configured to deflate the retention balloon before injury occurs.

[0084] Significant financial benefits arise as well. It is believed that catheter-induced injuries are much more common than public documentation suggests. For example, it is believed that catheter-related trauma occurs no less than once a week in large metropolitan hospitals. Usually, each incident not only increases the patient's hospital stay substantially, but also the expense of the stay. Each incident (which is usually not reimbursed by insurance) can increase the cost to the hospital by thousands of dollars, or even tens or hundreds of thousands of dollars. This is especially true when the patient brings a personal injury action against the hospital, physician(s), and / or staff. And, when additional surgery is required to repair the catheter-induced injury, increased expense to the hospital is not only substantial, if litigation occurs as a result of the injury, damages awarded to the patient can run into the millions of dollars. The catheters and methods of the present invention, therefore, provide a safer catheter that has the possibility of saving the medical industry billions of dollars.

[0085] There have been described and illustrated herein embodiments of balloon retention medical devices. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. It will therefore be appreciated by those skilled in the art that other modifications could be made to the provided invention without deviating from its scope as claimed.

Claims

WHAT IS CLAIMED IS:

1. A balloon retention catheter or tube comprising: a flexible multi -lumen tubular body having a distal end and a first lumen that extends through at least part of the tubular body; a distal tip coaxially mounted to the distal end of the tubular body; and an expandable retention balloon secured to an outer annular surface of the distal tip and to an outer annular surface of the distal end of the tubular body; wherein the distal tip and the distal end of the tubular body are configured to move axially away from one another when the retention balloon is in its expanded configuration and held in place and the tubular body is pulled backward away from the distal tip, wherein such axial opposing movement reconfigures the distal tip and the distal end into a configuration that provides fluid communication between the interior space of the retention balloon and the first lumen in order to automatically deflate the retention balloon by flow of inflation fluid out of the retention balloon and into and through the first lumen.

2. A balloon retention catheter or tube according to claim 1, wherein: the retention balloon is molded to the outer annular surface of the distal tip, and the retention balloon is molded to the outer annular surface of the distal end of the tubular body; or the retention balloon is secured to the outer annular surface of the distal tip by adhesive, polymer welding or other suitable bond, and the retention balloon is secured to the outer annular surface of the distal end of the tubular body by adhesive, polymer welding or other suitable bond.

3. A balloon retention catheter or tube according to claim 1, wherein: the first lumen is in fluid communication with at least one first port at or near the distal end of the tubular body, wherein the at least one first port is spaced proximally from the retention balloon, and wherein the first port provides a fluid pathway between the first lumen and exterior space adjacent to the distal end of the tubular body.

4. A balloon retention catheter or tube according to claim 1 , wherein: the distal tip has at least one first port spaced distally from the retention balloon and a lumen or bore that provides for fluid communication between the first port and the first lumen of the tubular body, and wherein the first port provides a fluid pathway between the first lumen and exterior space adjacent to the distal tip.

5. A balloon retention catheter or tube according to claim 1, wherein: the tubular body has a second lumen that extends through at least part of the tubular body, wherein the second lumen is in fluid communication with at least one second port at or near the distal end of the tubular body, wherein the at least one second port provides a fluid pathway between the first lumen and interior space of the retention balloon; and the first lumen and the at least one first port are operable to fill the retention balloon with inflation fluid in order to expand the retention balloon into an expanded configuration.

6. A balloon retention catheter or tube according to claim 1, wherein: the distal tip and the distal end of the tubular body are configured such that the distal tip blocks fluid communication between the interior space of the retention balloon and the first lumen when the distal tip is mounted to the distal end of the tubular body; and the configuration of the distal tip and the distal end of the tubular body that provides fluid communication between the interior space of the retention balloon and the first lumen involves separation of the distal tip from the distal end to expose the interior space of the retention balloon and place the interior space of the retention balloon in fluid communication with the first lumen.

7. A balloon retention catheter or tube according to claim 1, wherein: the distal tip and the distal end of the tubular body are configured such that the distal tip or the distal end closes at least one valve port that provides fluid communication between the interior space of the retention balloon and the first lumen when the distal tip is mounted to the distal end of the tubular body; andthe configuration of the distal tip and the distal end of the tubular body that provides fluid communication between the interior space of the retention balloon and the first lumen involves opening the at least one valve port to place the interior space of the retention balloon in fluid communication with the first lumen.

8. A balloon retention catheter or tube according to claim 7, wherein: the at least one valve port is formed in an annular wall of the distal end of the tubular body and selectively closed by an annular wall of the distal tip that moves axially relative to the at least one valve port, or the at least one valve port is formed in an annular wall of the distal tip and selectively closed by an annular wall of the distal end of the tubular body that that moves axially relative to the at least one valve port.

9. A balloon retention catheter or tube according to claim 1, wherein: the distal tip and distal end of the tubular body are adapted such that pull forces or tension that exceeds a threshold value in the range of 2.5 to 7.5 pounds (and preferably at or near 5 pounds) as applied to the tubular body are required to permit the relative axial movement of the distal tip and distal end of the tubular body into the configuration that provides fluid communication between the interior space of the retention balloon and the first lumen in order to automatically deflate the retention balloon.

10. A balloon retention catheter or tube according to claim 1, wherein: the distal tip and the distal end of the tubular body have a retention mechanism that limits axial movement of the distal tip and the distal end away from one another in order to prevent total separation of the distal tip from the distal end of the tubular body.

11. A balloon retention catheter or tube according to claim 10, wherein: the retention mechanism comprises structural features that limit the relative axial movement of the distal tip and the distal end of the tubular body and / or prohibit total separation of the distal tip from the distal end of the tubular body; and / orthe structural features include one or more spring clips and interlocking grooves, magnetic couplers, marker bands, variable sized collars, or other suitable features; and / or the structural features are disposed at or near the proximal end of the distal tip and at or near the distal-most part of the distal end of the tubular body.

12. A balloon retention catheter or tube according to claim 1, wherein: at least one of the distal tip and distal end of the tubular body have a coating or other surface modification for controlling the pull forces or tension that result in axial movement of the distal tip and the distal end away from one another.

13. A balloon retention catheter or tube according to claim 3, wherein: the retention balloon is configured with ribs that provides channels for fluid flow around the retention balloon in its expanded configuration to the at least one first port spaced proximally from the retention balloon.

14. A balloon retention catheter or tube according to claim 1, which is adapted for use in a bladder to drain fluid from the bladder via the first lumen.

15. A balloon retention catheter or tube according to claim 1, which is adapted for use in a stomach to supply nutrients to the stomach via the first lumen.

16. A method of retaining and releasing a catheter or tube within an organ of the human body, the method comprising: providing a catheter or tube having i) a flexible multi-lumen tubular body having a distal end and a first lumen that extends through at least part of the tubular body, ii) a distal tip coaxially mounted to the distal end of the tubular body, and iii) an expandable retention balloon secured to an outer annular surface of the distal tip and to an outer annular surface of the distal end of the tubular body; locating the distal tip and the retention balloon of the catheter or tube within the organ of the human body;inflating the retention balloon into an expanded configuration that secures the distal tip and retention balloon of the catheter or tube within an organ; and with the retention balloon is in its expanded configuration, moving the distal tip and the distal end of the tubular body axially away from one another in response to the tubular body being pulled away from the distal tip, wherein such axial opposing movement reconfigures the distal tip and the distal end into a configuration that provides fluid communication between interior space of the retention balloon and the first lumen in order to automatically deflate the retention balloon by flow of inflation fluid out of the retention balloon and into and through the first lumen.

17. A method according to claim 16, wherein: the distal tip and distal end of the tubular body are adapted such that pull forces or tension that exceeds a threshold value in the range of 2.5 to 7.5 pounds (and preferably at or near 5 pounds) as applied to the tubular body are required to permit the relative axial movement of the distal tip and distal end of the tubular body into the configuration that provides fluid communication between the interior space of the retention balloon and the first lumen in order to automatically deflate the retention balloon.

18. A method according to claim 16, further comprising: limiting axial movement of the distal tip and the distal end away from one another in order to prevent total separation of the distal tip from the distal end of the tubular body.

19. A method according to claim 16, wherein: the organ is a bladder, and the catheter or tube is adapted to drain fluid from the bladder via the first lumen.

20. A method according to claim 16, wherein: the organ is a stomach, and the and the catheter or tube is adapted to supply nutrients to the stomach via the first lumen.

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