IP Library › Granted Patent US 9,381,111
Granted Patent B2
US 9,381,111 · App. 13/525,336 · Granted Jul 5, 2016

Delivery and extraction devices

Inventors: Dyson Hickingbotham (Wake Forest, NC); Norman Radtke (Louisville, KY)
A61F9/0017A61B17/3468A61F9/00781A61M1/12A61M5/14276
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Quick Facts
Patent No.
US 9,381,111
App. No.
13/525,336
Granted
Jul 5, 2016
Kind
B2
Abstract

This invention provides a device for delivering substances such as medical implants and tissues. The device comprises a mandrel and a mandrel guide whereby substances are delivered by retracting the mandrel guide relative to the mandrel. Included among the various embodiments are devices specialized for delivering retinal pigment epithelial (RPE) cells or nanoplates containing RPE cells to the retina, devices with precise control of delivery, devices with specialized mandrels and/or nozzles, and multifunctional devices adapted to provide additional functions such as infusion and/or suction, illumination, and diathermy.

Claims (82)

1. A device for implanting a substance comprising:

(a) a delivery unit comprising:

(i) a mandrel guide, wherein the mandrel guide has an open distal end suitable for discharging a substance when loaded therein; and

(ii) a longitudinally elongated mandrel disposed internally to the mandrel guide, whereby relative longitudinal movement of the mandrel through the mandrel guide towards the open distal end biases the loaded substance to move longitudinally towards the open end;

(b) a delivery unit support providing support to the delivery unit, wherein at least one of the mandrel and the mandrel guide is not fixed to the delivery unit support to allow longitudinal movement there about;

(c) a delivery unit biasing member imparting a force on the delivery unit to bias the delivery unit for the relative longitudinal movement;

(d) a delivery unit engagement means for opposing said force on the delivery unit, wherein

(i) when the delivery unit engagement means can be engaged and disengaged with the delivery unit;

(ii) when the delivery unit engagement means is engaged with the delivery unit, the delivery unit engagement means opposes said force on the delivery unit, thereby preventing the relative longitudinal movement of the delivery unit; and

(iii) when the delivery unit engagement means is disengaged with the delivery unit, the delivery unit engagement means does not prevent the relative longitudinal movement of the delivery unit; and

(e) a delivery controller configured to engage and disengage the delivery unit engagement means from the delivery unit,

wherein:

the mandrel can move longitudinally relative to the mandrel guide from a first longitudinal position to a second longitudinal position and to plurality of longitudinal positions intermediate of the first longitudinal position and the second longitudinal position;

the delivery controller is configured for operation by a user's operating member such that:

engagement of the user's operating member with the delivery controller disengages the delivery unit engagement means from the delivery unit; and

disengagement of the user's operating member from the delivery controller engages the delivery unit engagement means with the delivery unit, thereby stopping the relative longitudinal movement; and

the delivery unit engagement means is configured to engage and disengage the delivery unit when the mandrel is at each of the plurality of longitudinal positions relative to the mandrel guide, whereby the delivery unit engagement means can be controlled by the delivery controller to start and stop the relative longitudinal movement when the mandrel is at each of the plurality of longitudinal positions relative to the mandrel guide.

2. The device of claim 1 , wherein the longitudinally elongated mandrel is a conductive mandrel comprising:

(a) a distal end and at least a first distal port positioned at the distal end;

(b) at least a first proximal port positioned proximal to the at least first distal port; and

(c) a conductive member linking the at least first distal port and the at least first proximal port, wherein the conductive member is configured to conduct one or more of a fluid and a wave between the at least first distal port and the at least first proximal port.

3. The device of claim 2 , wherein the conductive member comprises:

(a) a fluid-conducting tube;

(b) an electrically conductive wire;

(c) a wave-transmitter;

(d) a fiber optic cable;

(e) a combination of a fluid-conducting tube and an electrically conductive wire;

(f) a combination of a fluid-conducting tube and a wave-transmitter or a combination of a fluid-conducting tube and a fiber optic cable; or

(g) a combination of a fluid-conducting tube, an electrically conductive wire, and a wave-transmitter or a combination of a fluid-conducting tube, an electrically conductive wire, and a fiber optic cable.

4. The device of claim 2 , wherein the distal end of the conductive mandrel comprises a plurality of fluid-conducting tubes disposed laterally of each other and a surface area-increasing member that increases the lateral surface area of the conductive mandrel.

5. The device of claim 1 , wherein the delivery controller comprises a toggle configured to interface a finger of a user thereof.

6. The device of claim 1 wherein the delivery controller comprises a biasing member for biasing the delivery unit engagement means to engage the delivery unit when the delivery unit engagement means is disengaged with the delivery unit; whereby applying a user force to the delivery controller disengages the delivery unit engagement means from the delivery unit to allow the relative longitudinal movement.

7. The device claim 3 , wherein the delivery controller comprises a toggle configured to interface a finger of a user thereof.

8. The device of claim 4 , wherein disengagement of the delivery unit engagement means requires less than about 3 lbs of force on the delivery controller from the user, optionally, wherein said less than about 3 lbs of force is:

less than about 2 lbs of force, less than about 1 lb of force, or less than ¾ lb of force; or

about any of 0.25 lb to 2 lb, 0.25 lb to 1 lb, or 0.25 lb to 0.75 lb; and about 200 g to about 500 g of force.

9. The device of claim 5 , further comprising a safety switch configured to be in an engaged state and a disengaged state, wherein the user can operate the safety switch to change the state of the safety switch, wherein:

when in the engaged state, the safety switch opposes the force of the delivery unit basing member, thereby preventing said relative longitudinal movement of the delivery unit irrespective of whether the delivery unit engagement means is engaged; and

when in the disengaged state, the safety switch does not oppose the bias of the delivery unit basing means, thereby allowing said relative longitudinal movement of the delivery unit when the delivery unit engagement means is disengaged from the delivery unit.

10. The device of claim 9 , wherein the delivery controller comprises an engagement biasing means for biasing the delivery unit engagement means to engage the delivery unit; whereby applying a user force to the delivery controller disengages delivery unit engagement means from the delivery unit to allow the relative longitudinal movement.

11. The device of claim 6 , wherein the safety switch comprises:

a pin fixed to the delivery unit and configured to move along a longitudinal path with the delivery unit, and

a latch disposed laterally of said longitudinal path, wherein the pin is configured to be movable into the latch, and thereby becomes longitudinally immobilized, wherein said relative longitudinal movement is prevented when the pin is longitudinally immobilized.

12. The device of claim 1 , wherein:

the delivery unit engagement means comprises a traction pad wherein said opposing said force on the delivery unit comprises opposing said force on the delivery unit with a friction force; or

the delivery unit engagement means comprises a knife edge lock, the delivery unit comprises a ratchet rack comprising a plurality of ratchet teeth, and the engagement of the delivery unit engagement means with the delivery unit comprises engagement of the knife edge lock with a ratchet tooth of the ratchet rack.

13. The device of claim 1 , wherein at least a distal portion of at least of one of the elongated mandrel and the mandrel guide are flexible or curved.

14. The device of claim 13 , wherein said distal portion is flexible or curved enough to slide under the retina into the subretinal space when inserted through the pars plana of the eye.

15. The device of claim 1 , wherein the mandrel guide comprises a proximal length of guide and a nozzle coupled thereto, wherein the proximal length of guide comprises:

a modular mandrel guide base; and

a nozzle holder, wherein:

the modular mandrel guide base and the nozzle holder are coupled to each other such that the modular mandrel guide base and the nozzle holder can be connected to each other and disconnected from each other; and

the nozzle holder is coupled to a nozzle.

16. The device of claim 1 , wherein the mandrel guide comprises a transparent nozzle.

17. The device of claim 1 , wherein:

a) the mandrel guide comprises a nozzle at a distal end of the mandrel guide;

b) the delivery controller is operably linked to the delivery unit at a location proximal of the nozzle; and

c) the delivery controller is operably linked to the delivery unit inside the delivery unit support.

18. A device for implanting a substance comprising:

(a) a delivery unit comprising:

(i) a mandrel guide, wherein the mandrel guide has an open distal end suitable for discharging a substance when loaded therein; and

(ii) a longitudinally elongated mandrel disposed internally to the mandrel guide, whereby relative longitudinal movement of the mandrel through the mandrel guide towards the open distal end biases the loaded substance to move longitudinally towards the open end;

(b) a handpiece providing support to the delivery unit, wherein the mandrel or the mandrel guide is not fixed to the handpiece; wherein the mandrel or the mandrel guide is a non-fixed delivery unit member to allow longitudinal movement there about;

(c) a spring that biases the non-fixed delivery unit member for said relative longitudinal of the mandrel through the mandrel guide towards the open distal end;

(d) a delivery unit engagement means fixed to the handpiece that engages and disengages with the non-fixed delivery unit member; and

(e) a push button operably linked to the delivery unit engagement means to cause said engagement and disengagement of the delivery unit; wherein:

when the delivery unit engagement means is engaged with the non-fixed delivery unit member, the delivery unit engagement means opposes said spring bias, thereby preventing said relative longitudinal of the mandrel through the mandrel guide towards the open distal end; and

when the delivery unit engagement means is disengaged with the non-fixed delivery unit member, the delivery unit engagement means does not oppose said spring bias, thereby not preventing said relative longitudinal of the mandrel through the mandrel guide towards the open distal;

the mandrel can move longitudinally relative to the mandrel guide from a first longitudinal position to a second longitudinal position and to plurality of longitudinal positions intermediate of the first longitudinal position and the second longitudinal position;

the delivery unit engagement means is configured to engage and disengage the non-fixed delivery unit member when the mandrel is at each of the plurality of longitudinal positions relative to the mandrel guide, wherein, by causing the delivery unit engagement means to engage and disengage the non-fixed delivery unit member, the push button can be used to start and stop the longitudinal movement of the mandrel relative to the mandrel guide when the mandrel is at each of the plurality of longitudinal positions relative to the mandrel guide.

19. The device of claim 18 , wherein:

the delivery unit engagement means comprises a traction pad wherein said opposing said force on the delivery unit comprises opposing said force on the delivery unit with a friction force; or

the delivery unit engagement means comprises a knife edge lock, the delivery unit comprises a ratchet rack comprising a plurality of ratchet teeth, and the engagement of the delivery unit engagement means with the delivery unit comprises engagement of the knife edge lock with a ratchet tooth of the ratchet rack.

20. The device of claim 18 , further comprising:

a pin fixed to the non-fixed delivery unit member such that the pin travels along a longitudinal path when the mandrel moves longitudinally relative to the mandrel guide;

a latch disposed laterally of said longitudinal path and fixed in position relative to the handpiece,

wherein the pin is configured to be movable from laterally, from said longitudinal path, into the latch, and thereby becomes longitudinally immobilized, wherein said longitudinal movement of the mandrel relative to the mandrel guide is prevented when the pin is longitudinally immobilized by the latch.

21. The device of claim 18 wherein the device comprises a biasing member for biasing the delivery unit engagement means to engage the non-fixed delivery unit member when the delivery unit engagement means is disengaged with the non-fixed delivery unit member; whereby applying a user force to the push button disengages the delivery unit engagement means from the delivery unit to allow the relative longitudinal movement.

22. The device of claim 18 , wherein:

a) the mandrel guide comprises a nozzle at a distal end of the mandrel guide;

b) the push button is operably linked to the non-fixed delivery unit member at a location proximal of the nozzle; and

c) the push button is operably linked to the non-fixed delivery unit member inside the handpiece.

Continuity (3)
Continuation PCTUS2010060622 · Dec 16, 2010
Provisional Application 61286788 · Dec 16, 2009
Related Publication 20130178822A1 · Jul 11, 2013