Closed-system bladder drug administration catheter and methods for administering drugs in a closed system
A closed-system, drug administering catheter assembly includes a transfer adapter, a stopcock, a medicament injector containing chemotherapy medicament, a medicament pressure reservoir, and a urethral balloon catheter comprising a drain lumen and a distal tip, all connected together in a closed-system. The medicament injector is configured to inject the chemotherapy medicament through the stopcock, the drain lumen, and into an environment of the distal tip within a patient's organ without leakage of the chemotherapy medicament from the patient into an environment of the patient. The medicament pressure reservoir is configured to store negative pressure that withdraws from the organ used chemotherapy medicament through the drain lumen and the stopcock and holds the used chemotherapy medicament in the medicament pressure reservoir without leakage of the used chemotherapy medicament into the environment of the patient.
1. A closed-system, drug administering catheter assembly, comprising:
a transfer adapter, a stopcock, a medicament injector containing chemotherapy medicament, a medicament pressure reservoir, and a urethral balloon catheter comprising a drain lumen and a distal tip, all connected together in a closed-system;
the medicament injector being configured to inject the chemotherapy medicament through the stopcock, the drain lumen, and into an environment of the distal tip within a patient's organ without leakage of the chemotherapy medicament from the patient into an environment of the patient; and
the medicament pressure reservoir being configured to store negative pressure that withdraws from the organ used chemotherapy medicament through the drain lumen and the stopcock and holds the used chemotherapy medicament in the medicament pressure reservoir without leakage of the used chemotherapy medicament into the environment of the patient.
2. The assembly according to claim 1 , wherein the organ is a human bladder.
3. The assembly according to claim 1 , wherein the transfer adapter comprises:
a distal connector comprising a distal orifice;
a proximal connector comprising a proximal orifice; and
an intermediate pressure-equalization valve fluidically connecting the distal orifice to the proximal orifice and configured to equalize pressure across the transfer adapter without leakage of liquid therein.
4. The assembly according to claim 1 , wherein the stopcock comprises:
an introductory flow state that permits fluidic flow between the medicament injector and the organ through the drain lumen;
a closed state that substantially prevents liquid from travelling through the stopcock; and
a drainage flow state that permits fluidic flow between the organ and the pressure reservoir through the drain lumen.
5. The assembly according to claim 1 , wherein the stopcock is a three-way stopcock valve.
6. The assembly according to claim 1 , wherein the stopcock comprises:
a hollow first connector comprising a first internal lumen;
a hollow second connector comprising a second internal lumen;
a hollow third connector comprising a third internal lumen;
a body defining an interior plenum fluidically connected to the first, second, and third internal lumens and a diverter orifice; and
a diverter rotatably attached to the body in the diverter orifice and fluid-tightly sealed therein, the diverter configured to rotate and, thereby, fluidically connect or disconnect any number of the first, second, and third internal lumens.
7. The assembly according to claim 6 , wherein:
the first connector is connected to the transfer adapter;
the second connector is connected to the medicament injector; and
the third connector is connected to the pressure reservoir.
8. The assembly according to claim 7 , wherein the diverter comprises:
an administration state in which the internal lumens of the first and second connectors are fluidically connected to one another to permit medicament from the medicament injector to enter the second connector and exit through the first connector; and
a drainage state in which the internal lumens of the first and third connector are fluidically connected to one another to permit fluid within the catheter drain lumen and the environment surrounding the distal tip to be drawn out from the environment, through the catheter, through the third connector, and into the pressure reservoir.
9. The assembly according to claim 6 , wherein the diverter comprises a handle shaped to permit a user to turn the diverter between positions within the body and, thereby, fluidically connect or disconnect any number of the first, second, and third internal lumens.
10. The assembly according to claim 1 , wherein the medicament injector has a lock that prevents fluid flow through independent of a position of the stopcock.
11. The assembly according to claim 1 , wherein the chemotherapy medicament is hazardous liquid chemotherapy medicament.
12. The assembly according to claim 11 , wherein the chemotherapy medicament is at least one of mitomycin and gemcitabine.
13. The assembly according to claim 1 , wherein the chemotherapy medicament:
is first stored in a solid form; and
is then reconstituted in the medicament injector.
14. The assembly according to claim 1 , wherein the pressure reservoir is of a fortified material substantially impervious to the chemotherapy medicament.
15. The assembly according to claim 14 , wherein the material is at least one of di(2-ethylhexyl) phthalate (DEHP), dioctyl phthalate (DOP), and bis(2-ethylhexyl) phthalate (BEHP).
16. The assembly according to claim 1 , wherein the pressure reservoir is a surgical drain bulb.
17. The assembly according to claim 16 , wherein the negative pressure is created by a compression of the drain bulb.
18. The assembly according to claim 1 , wherein the pressure reservoir is configured:
to hold a level of negative pressure for a given amount of time at least as long as a chemotherapy treatment procedure; and
to store the chemotherapy medicament after completing the chemotherapy treatment procedure and at least up until ultimate disposal of the used chemotherapy medicament.
19. The assembly according to claim 1 , wherein:
the balloon catheter comprises a proximal medicament port fluidically connected to the drain lumen;
the transfer adapter comprises:
a distal connector comprising a distal orifice;
a proximal connector comprising a proximal orifice; and
an intermediate pressure-equalization valve fluidically connecting the distal orifice to the proximal orifice and configured to equalize pressure across the transfer adapter;
the stopcock comprises:
a body defining a plenum;
a first connector fluidically connected to the proximal connector of the transfer adapter;
a second connector;
a third connector; and
a central body disposed in the plenum and configured to selectively connect at least one of the second and third connectors to the first connector;
the medicament injector:
is filled with the chemotherapy medicament;
comprises a distal medicament output fluidically connected to the second connector; and
is configured to inject the medicament through the stopcock, the drain lumen and into an environment of the distal tip;
the medicament pressure reservoir comprises:
a reservoir input fluidically connected to the third connector; and
a body:
defining an interior fluidically connected to the reservoir input; and
configured to exert a negative pressure upon the third connector such that, responsive to fluidically connecting the drain lumen to the third connector through the stopcock, the negative pressure in the interior draws fluid in the environment of the distal tip through the drain lumen, through the transfer adapter, and into the interior of the pressure reservoir; and
the catheter, the transfer adapter, the stopcock, the medicament injector, and the pressure reservoir together comprise a disposable closed-system responsive to being connected together with the medicament in the medicament injector.
20. The assembly according to claim 1 , wherein the closed-system of the transfer adapter, the stopcock, the medicament injector, the chemotherapy medicament, the medicament pressure reservoir, and the urethral balloon catheter is disposable.
21. The assembly according to claim 1 , wherein the closed-system of the transfer adapter, the stopcock, the medicament injector, the chemotherapy medicament, the medicament pressure reservoir, and the urethral balloon catheter is billable:
by a provider under a medical insurance plan; and
by a pharmacy provider dispensing the closed-system product for a drug component in addition to the medicament accompanying the closed-system product.
22. The assembly according to claim 21 , wherein the closed-system product is:
first a registered medical device; and
then is a registered combination medical device with drug to be processed by manufacturers and pharmaceutical suppliers.
23. A closed-system, drug administering catheter assembly, comprising:
a urethral balloon catheter comprising a drain lumen and a distal tip;
a transfer adapter fluidically connected to the drain lumen;
a stopcock fluidically connected to the transfer adapter;
a medicament injector fluidically connected to the stopcock;
a medicament pressure reservoir fluidically connected to the stopcock; and
the transfer adapter, the stopcock, the medicament injector, the medicament pressure reservoir, and the balloon catheter connected together in a closed-system such that hazardous liquid chemotherapy medicament in the medicament injector is configured to be:
injected through the stopcock, the drain lumen, and into an environment of the distal tip within a patient's human bladder;
left in the bladder for a given amount of time; and
then withdrawn from the bladder through the drain lumen and the stopcock and into the medicament pressure reservoir by negative pressure stored in the medicament pressure reservoir, without leakage of the chemotherapy medicament from the patient into an environment of the patient.
24. The assembly according to claim 23 , wherein the transfer adapter comprises:
a distal connector comprising a distal orifice;
a proximal connector comprising a proximal orifice; and
an intermediate pressure-equalization valve fluidically connecting the distal orifice to the proximal orifice and configured to equalize pressure across the transfer adapter without leakage of liquid therein.
25. The assembly according to claim 23 , wherein the stopcock comprises:
an introductory flow state that permits fluidic flow between the medicament injector and the bladder through the drain lumen;
a closed state that substantially prevents liquid from travelling through the stopcock; and
a drainage flow state that permits fluidic flow between the bladder and the pressure reservoir through the drain lumen.
26. The assembly according to claim 23 , wherein the stopcock is a three-way stopcock valve.
27. The assembly according to claim 23 , wherein the stopcock comprises:
a hollow first connector comprising a first internal lumen;
a hollow second connector comprising a second internal lumen;
a hollow third connector comprising a third internal lumen;
a body defining an interior plenum fluidically connected to the first, second, and third internal lumens and a diverter orifice; and
a diverter rotatably attached to the body in the diverter orifice and fluid-tightly sealed therein, the diverter configured to rotate and, thereby, fluidically connect or disconnect any number of the first, second, and third internal lumens.
28. The assembly according to claim 27 , wherein:
the first connector is connected to the transfer adapter;
the second connector is connected to the medicament injector; and
the third connector is connected to the pressure reservoir.
29. The assembly according to claim 28 , wherein the diverter comprises:
an administration state in which the internal lumens of the first and second connectors are fluidically connected to one another to permit medicament from the medicament injector to enter the second connector and exit through the first connector; and
a drainage state in which the internal lumens of the first and third connector are fluidically connected to one another to permit fluid within the catheter drain lumen and the environment surrounding the distal tip to be drawn out front the environment, through the catheter, through the third connector, and into the pressure reservoir.
30. The assembly according to claim 27 , wherein the diverter comprises a handle shaped to permit a user to turn the diverter between positions within the body and, thereby, fluidically connect or disconnect any number of the first, second, and third internal lumens.
31. The assembly according to claim 23 , wherein the medicament injector has a lock that prevents fluid flow through independent of a position of the stopcock.
32. The assembly according to claim 23 , wherein the chemotherapy medicament is hazardous liquid chemotherapy medicament.
33. The assembly according to claim 32 , wherein the chemotherapy medicament is at least one of mitomycin and gemcitabine.
34. The assembly according to claim 23 , wherein the chemotherapy medicament:
is first stored in a solid form; and
is then reconstituted in the medicament injector.
35. The assembly according to claim 23 , wherein the pressure reservoir is of a fortified material substantially impervious to the chemotherapy medicament.
36. The assembly according to claim 35 , wherein the material is at least one of di(2-ethylhexyl) phthalate (DEHP), dioctyl phthalate (DOP), and bis(2-ethylhexyl) phthalate (BEHP).
37. The assembly according to claim 23 , wherein the pressure reservoir is a surgical drain bulb.
38. The assembly according to claim 37 , wherein the negative pressure is created by a compression of the drain bulb.
39. The assembly according to claim 23 , wherein the pressure reservoir is configured:
to hold a level of negative pressure for a given amount of time at least as long as a chemotherapy treatment procedure; and
to store the chemotherapy medicament after completing the chemotherapy treatment procedure and at least up until ultimate disposal of the used chemotherapy medicament.
40. The assembly according to claim 23 , wherein:
the balloon catheter comprises a proximal medicament port fluidically connected to the drain lumen;
the transfer adapter comprises:
a distal connector comprising a distal orifice;
a proximal connector comprising a proximal orifice; and
an intermediate pressure-equalization valve fluidically connecting the distal orifice to the proximal orifice and configured to equalize pressure across the transfer adapter; the stopcock comprises:
a body defining a plenum;
a first connector fluidically connected to the proximal connector of the transfer adapter;
a second connector;
a third connector; and
a central body disposed in the plenum and configured to selectively connect at least one of the second and third connectors to the first connector; the medicament injector:
is filled with the chemotherapy medicament;
comprises a distal medicament output fluidically connected to the second connector; and
is configured to inject the medicament through the stopcock, the drain lumen and into an environment of the distal tip;
the medicament pressure reservoir comprises:
a reservoir input fluidically connected to the third connector; and
a body:
defining an interior fluidically connected to the reservoir input; and
configured to exert a negative pressure upon the third connector such that, responsive to fluidically connecting the drain lumen to the third connector through the stopcock, the negative pressure in the interior draws fluid in the environment of the distal tip through the drain lumen, through the transfer adapter, and into the interior of the pressure reservoir; and
the catheter, the transfer adapter, the stopcock, the medicament injector, and the pressure reservoir together comprise a disposable closed-system responsive to being connected together with the medicament in the medicament injector.
41. The assembly according to claim 23 , wherein the closed-system of the transfer adapter, the stopcock, the medicament injector, the chemotherapy medicament, the medicament pressure reservoir, and the urethral balloon catheter is disposable.
42. The assembly according to claim 23 , wherein the closed-system of the transfer adapter, the stopcock, the medicament injector, the chemotherapy medicament, the medicament pressure reservoir, and the urethral balloon catheter is billable:
by a provider under a medical insurance plan; and
by a pharmacy provider dispensing the closed-system product for a drug component in addition to the medicament accompanying the closed-system product.
43. The assembly according to claim 42 , wherein the closed-system product is:
first a registered medical device; and
then is a registered combination medical device with drug to be processed by manufacturers and pharmaceutical suppliers.