Implantable device with intravesical tolerability and methods of treatment
Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.
1. A drug delivery device for deployment within the bladder of a human patient which is well tolerated by the patient, comprising:
an elongated elastic body comprising a first end, an opposed second end, an annular portion disposed between the first end and the second end, and a drug reservoir lumen defined at least in part by the annular portion; and
a drug formulation loaded in the drug reservoir lumen, the drug formulation comprising a drug,
wherein the device has a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the device from entering the orifices of the ureters, wherein the retention shape has a maximum dimension in any dimension of 6 cm or less when in an uncompressed state, and wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension in any dimension of 3 cm.
2. The device of claim 1 , further comprising a retention frame portion which comprises an elastic wire and biases the device into the retention shape, wherein the elongated elastic body and the retention frame portion are longitudinally aligned and coupled to one another along their lengths.
3. The device of claim 1 , wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension in any dimension of 1.5 cm.
4. The device of claim 1 , wherein the device is configured to provide controlled release of the drug by diffusion through a wall of the elastic body.
5. The device of claim 1 , wherein the device is configured to provide controlled release of the drug through an aperture in the elastic body, driven at least in part by an osmotic pressure in the drug reservoir lumen.
6. The device of claim 1 , wherein the retention shape has a maximum dimension in any direction that is less than 5 cm when in an uncompressed state.
7. The device of claim 1 , wherein the retention shape has a maximum dimension in any direction that is less than 4 cm when in an uncompressed state.
8. The device of claim 1 , wherein the elastic body is elastically deformable to take a low-profile shape having an outer diameter in one direction that is less than about 4 mm.
9. The device of claim 1 , wherein the drug formulation is in a solid or semi-solid form.
10. The device of claim 9 , wherein a cross-sectional shape of the drug formulation corresponds to a cross-sectional shape of the drug reservoir lumen.
11. The device of claim 9 , wherein the drug formulation has a circular cross-sectional shape, and wherein the drug reservoir lumen has a circular cross-sectional shape.
12. The device of claim 1 , wherein the drug formulation is in a liquid form.
13. The device of claim 1 , wherein the retention shape is coiled.
14. The device of claim 1 , further comprising a retention frame portion, wherein the retention frame portion comprises an elastic wire.
15. The device of claim 1 , wherein the elastic body comprises silicone, polyurethane, or a combination thereof.
16. A method of treatment of a human patient comprising:
selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern;
deploying the drug delivery device of claim 1 into the patient's bladder through the patient's urethra; and
controllably releasing the drug into the bladder from the deployed drug delivery device over a treatment period.
17. The method of claim 16 , wherein the patient cannot feel the deployed device within his or her bladder during at least a majority of the treatment period.
18. The method of claim 16 , wherein the selected patient is indicated to be in need of treatment for overactive bladder, painful bladder syndrome, and/or interstitial cystitis.
19. The method of claim 16 , wherein the selected patient is indicated to be in need of treatment for an infection of the bladder, prostate, or urethra.
20. The method of claim 16 , wherein the selected patient is indicated to be in need of treatment for neurogenic bladder.
21. The method of claim 16 , wherein the selected patient is indicated to be in need of treatment for prostatitis or urethritis.
22. The method of claim 16 , wherein the selected patient is indicated to be in need of treatment for perioperative or postoperative pain associated with a urological surgery on the patient.
23. The method of claim 16 , wherein the drug comprises lidocaine or another anesthetic agent.
24. The device of claim 1 , wherein the drug formulation is able to move within the drug reservoir lumen.
25. The device of claim 1 , wherein the drug reservoir lumen has a cylindrical shape.
26. The device of claim 1 , wherein the drug reservoir lumen comprises a first end and an opposed second end, and wherein the first end and the second end of the drug reservoir lumen are sealed.
27. The device of claim 1 , wherein the drug reservoir lumen is substantially filled by the drug formulation.
28. A drug delivery device for deployment in and mobility within the bladder of a human patient, comprising:
an elongated elastic body comprising a first end, an opposed second end, an annular portion disposed between the first end and the second end, and a drug reservoir lumen defined at least in part by the annular portion; and
a drug formulation disposed in the drug reservoir lumen, the drug formulation comprising a drug,
wherein the device is elastically deformable between (i) a deployment shape for passage of the device through a urethra of the patient and (ii) a retention shape for preventing voiding of the device through the urethra, the retention shape having a maximum dimension in any dimension of 6 cm or less when in an uncompressed state, and
wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension in any dimension of 3 cm.
29. The device of claim 28 , wherein the retention shape comprises an overlapping coil.
30. The device of claim 29 , further comprising a retention frame portion which comprises an elastic wire and biases the device into the retention shape.
31. The device of claim 30 , wherein the elongated elastic body and the retention frame portion are longitudinally aligned and coupled to one another along their lengths.
32. The device of claim 30 , wherein the elastic wire comprises a superelastic alloy.
33. The device of claim 29 , wherein the device is configured to provide controlled release of the drug through a single aperture in the device.
34. The device of claim 29 , wherein the device has an overall exterior shape which is curved and a cross-sectional shape which is rounded.
35. The device of claim 34 , wherein the first end and the second end lie within an interior region of the device when the device is uncompressed in the retention shape.
36. The device of claim 29 , wherein the retention shape has a maximum dimension in any direction that is less than 4 cm.
37. The device of claim 29 , wherein the retention shape has a maximum dimension in any direction that is less than 3 cm.
38. A device for deployment in and mobility within the bladder of a human patient, comprising:
a retention frame portion which comprises an elastic wire and biases the device into a retention shape; and
an electronic component attached to the retention frame portion,
wherein the device is elastically deformable between (i) a deployment shape for passage of the device through a urethra of the patient and (ii) the retention shape which prevents voiding of the device through the urethra, the retention shape having a maximum dimension in any dimension of 6 cm or less when in an uncompressed state, and
wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension in any dimension of 3 cm.
39. The device of claim 38 , wherein the electronic component comprises a camera or a sensor.