CN-122028947-A - Balloon indwelling catheter or tube with distal safety valve

Abstract

A balloon-retaining catheter or tube is provided that includes a flexible multi-lumen tubular body having a distal tip coaxially mounted to a distal end of the tubular body, an inflatable indwelling balloon secured to the distal tip and distal end. The distal tip and distal end are configured to axially move away from each other when the balloon is in its inflated configuration and held in place within the body and the tubular body is pulled back away from the distal tip. This axial movement reconfigures the distal tip and distal end into a configuration that provides fluid communication between the interior space of the balloon and the first lumen to automatically deflate the balloon. The balloon indwelling catheter or tube may be adapted for use with the bladder to drain fluid from the bladder, or for use with the stomach to provide nutrients to the stomach.

Inventors

• B. M. Pingqiu Ke

Assignees

• 英诺凯尔泌尿外科有限责任公司

Dates

Publication Date

20260512

Application Date

20241009

Priority Date

20231010

Claims (20)

1. 1. A balloon indwelling catheter or tube comprising: A flexible multi-lumen tubular body having a distal end and a first lumen extending through at least a portion of the tubular body; A distal tip coaxially mounted to the distal end of the tubular body, and An expandable indwelling 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 for axial movement away from each other when the indwelling balloon is in its expanded configuration and held in place and the tubular body is pulled back away from the distal tip, wherein such axial relative movement reconfigures the distal tip and the distal end into a configuration that provides fluid communication between the internal space of the indwelling balloon and the first lumen for automatic deflation of the indwelling balloon by flowing inflation fluid out of the indwelling balloon and into and through the first lumen.
2. 2. The balloon indwelling catheter or tube according to claim 1, wherein: The indwelling balloon is molded to the outer annular surface of the distal tip and the indwelling balloon is molded to the outer annular surface of the distal end of the tubular body, or The indwelling balloon is secured to the outer annular surface of the distal end by an adhesive, polymer weld, or other suitable bonding agent, and the indwelling balloon is secured to the outer annular surface of the distal end of the tubular body by an adhesive, polymer weld, or other suitable bonding agent.
3. 3. The balloon indwelling catheter or tube according to claim 1, wherein: The first lumen is in fluid communication with at least one first port located at or near the distal end of the tubular body, wherein the at least one first port is proximally spaced from the indwelling balloon and the first port provides a fluid pathway between the first lumen and an external space adjacent the distal end of the tubular body.
4. 4. The balloon indwelling catheter or tube according to claim 1, wherein: The distal tip has at least one first port spaced distally from the indwelling balloon and a lumen or aperture providing fluid communication between the first port and the first lumen of the tubular body, and the first port providing a fluid passageway between the first lumen and an external space adjacent the distal tip.
5. 5. The balloon indwelling catheter or tube according to claim 1, wherein: The tubular body having a second lumen extending through at least a portion 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 an interior space of the indwelling balloon, and The first lumen and the at least one first port are operable to fill the indwelling balloon with inflation fluid in order to expand the indwelling balloon into an expanded configuration.
6. 6. The balloon indwelling catheter or tube according to claim 1, wherein: The distal tip and the distal end of the tubular body are configured such that when the distal tip is mounted to the distal end of the tubular body, the distal tip blocks fluid communication between the interior space of the indwelling balloon and the first lumen, and The configuring of the distal tip and the distal end of the tubular body to provide fluid communication between the interior space of the indwelling balloon and the first lumen involves separating the distal tip from the distal end to expose and place the interior space of the indwelling balloon in fluid communication with the first lumen.
7. 7. The balloon indwelling catheter or tube according to claim 1, wherein: The distal tip and the distal end of the tubular body are configured such that when the distal tip is mounted to the distal end of the tubular body, the distal tip or the distal end closes at least one valve port providing fluid communication between the interior space of the indwelling balloon and the first lumen, and The configuring of the distal tip and the distal end of the tubular body to provide fluid communication between the interior space of the indwelling balloon and the first lumen involves opening the at least one valve port to place the interior space of the indwelling balloon in fluid communication with the first lumen.
8. 8. The balloon indwelling catheter or tube according to claim 7, wherein: The at least one valve port is formed in the annular wall of the distal end of the tubular body and is selectively closed by the annular wall of the distal tip moving axially relative to the at least one valve port, or The at least one valve port is formed in the annular wall of the distal tip and is selectively closed by the annular wall of the distal end of the tubular body that moves axially relative to the at least one valve port.
9. 9. The balloon indwelling catheter or tube according to claim 1, wherein: The distal tip and the distal end of the tubular body are adapted such that a pulling or tensioning force exceeding a threshold value in the range of 2.5 pounds to 7.5 pounds (and preferably 5 pounds or nearly 5 pounds) needs to be applied to the tubular body to allow the distal tip and the distal end of the tubular body to move relatively axially into the configuration providing fluid communication between the interior space of the indwelling balloon and the first lumen.
10. 10. The balloon indwelling catheter or tube according to claim 1, wherein: The distal tip and the distal end of the tubular body have a retaining mechanism that limits axial movement of the distal tip and the distal end away from each other so as to prevent complete separation of the distal tip from the distal end of the tubular body.
11. 11. The balloon indwelling catheter or tube according to claim 10, wherein: the retaining mechanism includes structural features that limit the relative axial movement of the distal tip and the distal end of the tubular body and/or inhibit complete separation of the distal tip from the distal end of the tubular body, and The structural features include one or more spring clips and interlocking slots, magnetic couplers, marker bands, variable-size collars or other suitable features, and/or The structural feature is disposed at or near a proximal end of the distal tip and at or near a distal-most portion of the distal end of the tubular body.
12. 12. The balloon indwelling catheter or tube according to claim 1, wherein: at least one of the distal tip and the distal end of the tubular body has a coating or other surface modification for controlling the pulling or tension forces that result in axial movement of the distal tip and the distal end away from each other.
13. 13. The balloon indwelling catheter or tube according to claim 3, wherein: the indwelling balloon is configured with ribs that provide channels for fluid flow around the indwelling balloon in its expanded configuration to flow the fluid to the at least one first port proximally spaced from the indwelling balloon.
14. 14. The balloon indwelling catheter or tube according to claim 1, which is adapted for use in a bladder to expel fluid from the bladder via the first lumen.
15. 15. The balloon indwelling catheter or tube according to claim 1, wherein said balloon indwelling catheter or tube is adapted for use in the stomach to supply nutrients to the stomach via said first lumen.
16. 16. A method of retaining and releasing a catheter or tube within a human organ, the method comprising: providing a catheter or tube having i) a flexible multi-lumen tubular body having a distal end and a first lumen extending through at least a portion of the tubular body, ii) a distal tip coaxially mounted to the distal end of the tubular body, and iii) an expandable indwelling balloon secured to an outer annular surface of the distal tip and an outer annular surface of the distal end of the tubular body; positioning the distal tip of the catheter or tube and the indwelling balloon within the human organ; Expanding the indwelling balloon to an expanded configuration securing the distal tip of the catheter or tube and the indwelling balloon within an organ, and Moving the distal tip and the distal end of the tubular body axially away from each other in response to the tubular body being pulled away from the distal tip with the indwelling balloon in its expanded configuration, wherein such axially opposite movement reconfigures the distal tip and the distal end into a configuration that provides fluid communication between the indwelling balloon's interior space and the first lumen to automatically deflate the indwelling balloon by flowing inflation fluid out of the indwelling balloon and into and through the first lumen.
17. 17. The method according to claim 16, wherein: The distal tip and the distal end of the tubular body are adapted such that a pulling or tensioning force exceeding a threshold value in the range of 2.5 pounds to 7.5 pounds (and preferably 5 pounds or nearly 5 pounds) needs to be applied to the tubular body to allow the distal tip and the distal end of the tubular body to move relatively axially into the configuration providing fluid communication between the interior space of the indwelling balloon and the first lumen.
18. 18. The method of claim 16, wherein the method further comprises: axial movement of the distal tip and the distal end away from each other is limited to prevent complete separation of the distal tip from the distal end of the tubular body.
19. 19. The method according to claim 16, wherein: the organ is a bladder and the catheter or tube is adapted to expel fluid from the bladder via the first lumen.
20. 20. The method according to claim 16, wherein: The organ is a stomach and the catheter or tube is adapted to supply nutrients to the stomach via the first lumen.

Description

Balloon indwelling catheter or tube with distal safety valve Technical Field The following description relates to medical devices. More particularly, the following description relates to balloon indwelling catheters or tubes (e.g., balloon indwelling urinary catheters or balloon indwelling feeding tubes). Background Each year, millions of people require balloon indwelling urinary catheters (commonly referred to as Foley urinary catheters) for temporary or chronic urine drainage management. Referring to prior art fig. 1 and prior art fig. 2, a prior art Foley catheter 10 includes a catheter shaft 12 having a first lumen extending to a distal end 14 and leading to a drainage port 16 and a second lumen extending to an indwelling balloon 18. The distal end 14 of the catheter shaft 12 has a distal tip 20, which distal tip 20 may be integral with the catheter shaft 12 or attached by adhesive or other bonding means. The proximal end 13 of the catheter shaft 12 is provided with a hub piece (hub) 24, which hub piece 24 has a first port 26 and a second port 28 adapted to 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, respectively. The distal tip 20 has a superficially atraumatic rounded end 22. 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 indwelling balloon 18 is delivered into the patient's bladder 32. The indwelling balloon 18 is then inflated with fluid supplied by the syringe via the second lumen until the desired volume of fluid has filled the balloon (typically 10cc to 30 cc). To remove the Foley catheter, the indwelling balloon 18 is typically deflated by inserting an empty syringe into the corresponding port 28 of the proximal hub 24 to allow inflation fluid to be expelled from the interior space of the indwelling balloon 18 through the second lumen into the syringe. Foley catheters may be damaged by inadvertent manipulation of the catheter shaft 12 or by causing displacement of the indwelling balloon 18 when the catheter shaft 12 is pulled back away from the bladder 32 due to a sudden impact or tension (tension). This typically occurs when a patient walks from a bed or travels to a bathroom or bathroom. While the patient is still moving, the catheter shaft 12 may become inadvertently immobilized, at which time an impact may be applied hard on the catheter shaft 12, which catheter shaft 12 pulls the indwelling balloon back into the urethra. This tears the urethra, resulting in severe pain and bleeding. The damage caused by improper, unintentional and/or premature removal of the inflated balloon catheter is referred to as iatrogenic damage (also referred to as intracorporal damage). 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 each injury incurs significant costs to the healthcare industry. The Foley catheter may also cause injury when the patient intentionally pulls on the catheter shaft 12. This tears the urethra, resulting in severe pain and bleeding. This typically occurs in unconscious (confused) patients (e.g., patients in nursing homes with disease or with cognitive dysfunction problems (e.g., alzheimer's disease or other diseases that make the patient unintelligible as to the necessity of a catheter). In such cases, the insurance does not typically cover the high medical costs incurred by the patient's cramp, which can cause pain and intense urge to urinate, the unconscious patient typically pulls the catheter during the cramp, which can result in injury. The injuries mentioned herein are not limited to men, but can also cause serious injuries to the bladder and urethra in women. Injury may also occur post-operatively, which makes the injury more serious. A common situation where injury is caused is when the patient takes morphine or other analgesic that the patient feels unconscious and makes no reasonable decision. A patient with unconsciousness is unaware of the presence of foreign matter in the urethra and, instead, gives it a tug that causes injury. These lesions have been well documented and are not limited to adults. Pediatric patients have many records of injuries. Balloon indwelling feeding tubes (commonly referred to as mei-esophageal or G-tubes) employ a multi-lumen tubular body with an indwelling balloon mounted at the distal end. The multi-lumen tubular body includes a first lumen ("feeding lumen") operable to deliver a nutrient to a discharge port at the distal end of the tubular body for feeding a patient and a second lumen (inflation lumen) operable to supply inflation fluid to an inflation port at the distal end of the tubular body to fill/inflate the indwelling balloon. The distal end of the tubular body is surgically or percutaneously placed into the stomach via the physician's canal mad