Hand tool for aiding in insertion of a trans-round window membrane catheter for micropump-mediated acute and chronic inner-ear drug delivery
The present solution provides systems and methods for trans-round window membrane drug delivery. As an overview, a system can include a micropump that is connected to a flexible cannula. The cannula can be threaded through a handpiece that can be used to pierce the round window membrane of a patient. Using the handpiece, the cannula can be inserted through the round window membrane to improve the distribution of the delivered drug throughout the inner ear. The present solution can function as a small implantable or wearable device that can be used for both chronic and acute trans-round window membrane drug delivery. With this configuration, the micropump can constantly or intermittently deliver, over a period of days to months, small volumes of drugs from an internal reservoir.
1. A system, comprising:
a cannula comprising a first end coupled with a micropump and a second end comprising a cannula tip and a stopper positioned at a first predetermined distance from the cannula tip, the stopper configured to enable the cannula tip to be inserted through an anatomic membrane and into a cochlea of a patient, the cannula tip comprising a coating configured to create a seal with the anatomic membrane responsive to insertion of the cannula tip through the anatomic membrane; and
a handpiece configured to introduce the cannula to the patient, the handpiece comprising:
a channel defined by a tool shaft of the handpiece, the channel configured to receive the cannula;
a tip portion coupled with the tool shaft and comprising an outlet in communication with the channel, the tip portion configured to pierce the anatomic membrane of the patient; and
a collar coupled with the tip portion at a second predetermined distance from the outlet, the collar configured to seat with an anatomic structure of the patient and control a distance that the tip portion can project into the cochlea of the patient,
wherein the handpiece is configured to be withdrawn from an ear of the patient responsive to seating the cannula into the anatomic structure of the patient, and
wherein the micropump comprises one or more first layers defining one or more fluid channels, a fluid storage capacitor, and a reservoir, and one or more second layers comprising a pump, the one or more first layers separated from the one or more second layers by a membrane, the membrane forming a ceiling of the fluid storage capacitor, the micropump configured to:
pump a first fluid from the reservoir into the cochlea of the patient using the pump and the fluid storage capacitor, the first fluid pumped via a micropump outlet coupled to the one or more fluid channels and the cannula, and
subsequently withdraw a volume of a second fluid from the cochlea of the patient via the micropump outlet and the cannula.
2. The system of claim 1 , wherein the micropump is configured for implantation in the patient, and the reservoir is a drug reservoir storing the first fluid.
3. The system of claim 2 , wherein the micropump is further configured to pump the first fluid from the drug reservoir to the cochlea of the patient via the cannula.
4. The system of claim 3 , wherein the one or more first layers of the micropump further comprise a loading chamber and the one or more second layers of the micropump further comprise a first actuator of a first valve and a second actuator of a second valve, and wherein the micropump is configured to:
draw the first fluid from the drug reservoir into the loading chamber by opening the first valve via the first actuator and activating the pump; and
force the first fluid through the micropump outlet to the cannula by closing the first valve via the first actuator, opening the second valve via the second actuator, and activating the pump.
5. The system of claim 1 , wherein the handpiece further comprises an angled portion coupling the tip portion to the tool shaft, the angled portion having a second channel in communication with the channel and the outlet of the tip portion.
6. The system of claim 5 , wherein at least one of the angled portion or the tip portion are separable from the tool shaft, and the angled portion and the tip portion are configured to couple together using one or more of a snap-on connector, a friction fit connection, a press-fit connection, a knurled nut, or a Luer lock connection.
7. The system of claim 5 , wherein the angled portion, the tip portion, and the tool shaft are manufactured from a single contiguous piece of material comprising at least one of stainless steel or a plastic.
8. The system of claim 5 , wherein at least one of the angled portion or the tip portion can rotate, while coupled to the tool shaft, around an axis parallel to a length of the tool shaft.
9. The system of claim 1 , wherein the tip portion of the handpiece further comprises a needle tip portion, and wherein the needle tip portion is configured to pierce the anatomic membrane of the patient.
10. The system of claim 1 , wherein the outlet of the tip portion is positioned at a distal end of the tip portion, the distal end of the tip portion forming an angle between the outlet of the tip portion and a proximal end of the tip portion, wherein the angle is between 70 degrees and 170 degrees, between 75 degrees and 130 degrees, between 90 degrees and 120 degrees, or between 110 degrees and 120 degrees.
11. The system of claim 1 , wherein a length of the tool shaft is between about 130 mm and about 170 mm, between about 140 mm and about 160 mm, or between about 140 mm and about 150 mm.