DRUG DELIVERY DEVICE AND APPLICATIONS OF SAME

• US 20140051972A1
• Filed: 10/23/2013
• Published: 02/20/2014
• Est. Priority Date: 07/21/2004
• Status: Active Grant

• Current Assignee: Vanderbilt University
• Original Assignee: Vanderbilt University
• Inventors: Mawn, Louise A., Galloway, Robert, DeLisi, Michael P.
• Granted Patent: US 10,610,406 B2
• Time in Patent Office: Days
• US Class Current: 600/409
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 2009/00851 Optical coherence topography [OCT]
• CPC Class Codes: A61F 2009/00897 Scanning mechanisms or algorithms
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61F 9/00802 for photoablation
• CPC Class Codes: A61F 9/00821 for coagulation
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

A drug delivery device includes a catheter having first and second ends; a flexible membrane having a rim securely connected to an inner surface of the catheter to define a first volume between the first end and the flexible membrane, and a second volume between the flexible membrane and the second end, such that the second volume is substantially the same as a desired drug volume; and a pressurizable member coupled to the catheter for operably delivering a drug. In use, a desired volume of the drug is preloaded into the second volume of the catheter that in turn is slid into a guidance device, when the guidance device is placed in a target of interest, the pressurizable member applies a pressure into the first volume to exert a force upon the flexible membrane to operably squeeze the second volume, thereby unloading the drug into the target.

Claims

1. A drug delivery device for delivering a desired volume of a drug into a target of interest of a human or an animal, comprising:

(a) a catheter having a first end and an opposite, second end, being slidable into a guidance device;

(b) a flexible membrane having a rim securely connected to an inner surface of the catheter at a position proximal to the second end of the catheter to define a first volume inside the catheter between the first end and the flexible membrane, and a second volume inside the catheter between the flexible membrane and the second end, such that the second volume is substantially the same as the desired volume of the drug, wherein the first volume and the second volume are operably and complementarily changeable; and

(c) a pressurizable member coupled to the catheter for operably changing the first volume and the second volume of the catheter,

wherein in use, the desired volume of the drug is preloaded into the second volume of the catheter that in turn is slid into the guidance device, and when the guidance device is placed in the target of interest, the pressurizable member applies a pressure into the first volume of the catheter to exert a force upon the flexible membrane so as to operably reduce the second volume of the catheter, thereby unloading the desired volume of the drug into the target of interest.

2. The drug delivery device of claim 1, wherein the first volume of the catheter is filled with fluid comprising benign gas or liquid.

3. The drug delivery device of claim 2, wherein the fluid comprises saline.

4. The drug delivery device of claim 2, wherein the flexible membrane is made of an elastic material that is compatible with both the fluid in the first volume and the preloaded drug in the second volume.

5. The drug delivery device of claim 2, wherein the flexible membrane is impermeable to both the fluid in the first volume and the preloaded drug in the second volume.

6. The drug delivery device of claim 1, wherein the catheter is rigid or flexible.

7. The drug delivery device of claim 1, wherein the pressurizable member comprises a syringe coupled to the first end of the catheter and being in a fluid communication with the first volume of the catheter.

8. The drug delivery device of claim 1, wherein the guidance device comprises an endoscope.

9. The drug delivery device of claim 1, being devoid of a flow regulator for regulating a flow of the desired volume of the drug into the target of interest.

10. The drug delivery device of claim 1, being disposable or re-useable.

11. A method for delivering a desired volume of a drug into a target of interest of a human or an animal, comprising:

(a) providing a drug delivery device comprising;

(i) a catheter having a first end and an opposite, second end;

(ii) a flexible membrane having a rim securely connected to an inner surface of the catheter at a position proximal to the second end of the catheter to define a first volume inside the catheter between the first end and the flexible membrane, and a second volume inside the catheter between the flexible membrane and the second end, such that the second volume is substantially the same as the desired volume of the drug, wherein the first volume and the second volume are operably and complementarily changeable; and

(iii) a pressurizable member coupled to the first end of the catheter for operably changing the first volume and the second volume of the catheter;

(b) preloading the desired volume of the drug into the second volume of the catheter;

(c) placing the second end of the catheter in the target of interest; and

(d) applying a pressure onto the first volume of the catheter to exert a force upon the flexible membrane so as to operably reduce the second volume of the catheter, thereby unloading the desired volume of the drug into the target of interest.

12. An endoscope, comprising:

(a) a probe housing having a proximal end, a distal end and a lumen extending between the proximal end and the distal end;

(b) at least one image fiber disposed in the lumen that communicates image information from the distal end of the probe; and

(c) a drug delivery device for delivering a desired volume of a drug into a target of interest, comprising;

(i) a catheter disposed in the lumen, having a first end close to the proximal end of the probe, and an opposite, second end close to the distal end of the probe;

(ii) a flexible membrane having a rim securely connected to an inner surface of the catheter at a position proximal to the second end of the catheter to define a first volume inside the catheter between the first end and the flexible membrane, and a second volume inside the catheter between the flexible membrane and the second end, such that the second volume is substantially the same as the desired volume of the drug, wherein the first volume and the second volume are operably and complementarily changeable, wherein the desired volume of the drug is preloaded into the second volume of the catheter; and

(iii) a pressurizable member coupled to the first end of the catheter for operably unloading the desired volume of the drug into the target of interest; and

(d) an access conduit disposed in the lumen that receives an ablation instrument or a coagulating instrument for performing a surgical procedure.

13. The endoscope of claim 12, wherein the first volume of the catheter is filled with fluid comprising benign gas or liquid.

14. The endoscope of claim 13, wherein the flexible membrane is made of an elastic material that is compatible with both the fluid in the first volume and the preloaded drug in the second volume.

15. The endoscope of claim 13, wherein the flexible membrane is impermeable to both the fluid in the first volume and the preloaded drug in the second volume.

16. The endoscope of claim 12, wherein the pressurizable member comprises a syringe coupled to the first end of the catheter and being in a fluid communication with the first volume of the catheter.

17. The endoscope of claim 12, wherein in use, during the surgical procedure, the pressurizable member applies a pressure into the first volume of the catheter to exert a force upon the flexible membrane so as to operably reduce the second volume of the catheter, thereby unloading the desired volume of the drug into the target of interest.

18. The endoscope of claim 12, wherein the drug delivery device is devoid of a flow regulator for regulating a flow of the desired volume of the drug into the target of interest.

19. The endoscope of claim 12, further comprising:

a magnetic tracking tip disposed proximate the distal end of the probe housing and configured to generate magnetic tracking tip location data identifying a location of the distal end of the probe housing.

20. The endoscope of claim 12, further comprising:

a purge fluid/gas port disposed at the proximal end of the flexible probe that accepts purge fluid/gas; and

a purge fluid/gas conduit disposed in the lumen and in fluid communication with the purge fluid/gas port, the conduit delivering purge fluid/gas to the distal end of the endoscope.

21. The endoscope of claim 12, wherein the ablation instrument is a laser delivery system comprising:

(a) a waveguide disposed in the lumen;

(b) a laser source coupled to a proximal end of the waveguide; and

(c) a lens mounted to a distal end of the waveguide nearest the distal end of the endoscope.

22. The endoscope of claim 21, wherein the laser source is one of a free electron laser source, an Argon laser source, a Dye laser source, a YAG laser source and a carbon dioxide laser source.

23. The endoscope of claim 12, wherein the ablation instrument uses one of radio-frequency waves, microwaves, ultrasonic waves, infrared waves, heat, cryoablation, and a laser to ablate the particular portion of the tissue.

24. The endoscope of claim 12, wherein the coagulating instrument uses one of radio-frequency waves, microwaves, ultrasonic waves, infrared waves, heat, cryoablation and a laser.

25. A method for performing an image-guided surgical procedure with an instrument in a target of interest of a human or an animal and delivering a desired volume of a drug therein during the image-guided surgical procedure, comprising:

(a) guiding an endoscope into the target of interest, wherein the endoscope comprises;

(i) a probe housing having a proximal end, a distal end and a lumen extending between the proximal end and the distal end;

(ii) at least one image fiber disposed in the lumen that communicates image information from the distal end of the probe; and

(iii) a drug delivery device comprising;

a catheter disposed in the lumen, having a first end close to the proximal end of the probe, and an opposite, second end close to the distal end of the probe;

a flexible membrane having a rim securely connected to an inner surface of the catheter at a position proximal to the second end of the catheter to define a first volume inside the catheter between the first end and the flexible membrane, and a second volume inside the catheter between the flexible membrane and the second end, such that the second volume is substantially the same as the desired volume of the drug, wherein the first volume and the second volume are operably and complementarily changeable, wherein the desired volume of the drug is preloaded into the second volume of the catheter; and

a pressurizable member coupled to the first end of the catheter for operably unloading the desired volume of the drug into the target of interest; and

(iv) an access conduit disposed in the lumen that receives the instrument; and

(v) a magnetic tracking tip disposed proximate the distal end of the probe housing and configured to generate magnetic tracking tip location data identifying a location of the distal end of the probe housing;

(b) detecting the magnetic tracking tip in a three dimensional (3D) physical space;

(c) obtaining an image space having a plurality of tomographic images each containing all image information;

(d) determining point-based registrations mapping the 3D physical space to the image space based on points in the 3D physical space and corresponding points in the image space;

(e) determining a location and an orientation of the instrument in the image space based on the magnetic tracking tip location data generated by the magnetic tracking tip in the 3D physical space and the point-based registrations, so as to perform the image-guided surgical procedure;

(f) dynamically displaying, while performing the image-guided surgical procedure, a selected one of the plurality of the tomographic images that overlaps the location of the instrument in the image space and indications of the location and orientation of the instrument in the image space; and

(g) applying a pressure onto the first volume of the catheter of the endoscope to exert a force upon the flexible membrane so as to operably reduce the second volume of the catheter, thereby unloading the desired volume of the drug into the target of interest.

26. The method of claim 25, wherein the image-guided surgical procedure is performed by transmitting a free electron laser (FEL) to surgically ablate a particular portion of a tissue.

27. The method of claim 25, wherein the magnetic tracking tip location data comprises {x, y, z} positional coordinates and orientation angles and a rotation matrix, wherein the image space comprises scanned images that are preoperatively obtained.

28. The method of claim 25, further comprising:

scanning tissue of the human or the animal to acquire, store and process a 3D reference of tissue prior to the tissue being surgically exposed, so as to create a triangularized mesh based on the scanned tissue, determine the volumetric center of a particular portion of the tissue to be ablated, coagulated or medicated during the surgery, and implement an algorithm using the triangularized mesh and the physical space data collected by the instrument to determine the point-based registrations.

29. An apparatus for performing an image-guided surgical procedure with an instrument in a target of interest of a human or an animal and delivering a desired volume of a drug therein during the image-guided surgical procedure, comprising:

(a) an endoscope comprising;

(i) a probe housing having a proximal end, a distal end and a lumen extending between the proximal end and the distal end;

(ii) at least one image fiber disposed in the lumen that communicates image information from the distal end of the probe; and

(iii) a drug delivery device comprising;

a catheter disposed in the lumen, having a first end close to the proximal end of the probe, and an opposite, second end close to the distal end of the probe;

a flexible membrane having a rim securely connected to an inner surface of the catheter at a position proximal to the second end of the catheter to define a first volume inside the catheter between the first end and the flexible membrane, and a second volume inside the catheter between the flexible membrane and the second end, such that the second volume is substantially the same as the desired volume of the drug, wherein the first volume and the second volume are operably and complementarily changeable, wherein the desired volume of the drug is preloaded into the second volume of the catheter; and

a pressurizable member coupled to the first end of the catheter for operably unloading the desired volume of the drug into the target of interest; and

(iv) an access conduit disposed in the lumen that receives the instrument; and

(v) a magnetic tracking tip disposed proximate the distal end of the probe housing and configured to generate magnetic tracking tip location data identifying a location of the distal end of the probe housing;

(b) a magnetic tracking system configured to detect the magnetic tracking tip in a three dimensional (3D) physical space; and

(c) an image data processor configured to

obtain an image space having a plurality of tomographic images each containing all image information;

determine point-based registrations mapping the 3D physical space to the image space based on points in the 3D physical space and corresponding points in the image space;

determine a location and an orientation of the instrument in the image space based on magnetic tracking tip location data generated by the magnetic tracking tip in the 3D physical space and the point-based registrations; and

dynamically display, while performing the image-guided surgical procedure, a selected one of the plurality of the tomographic images that overlaps the location of the instrument in the image space and indications of the location and orientation of the instrument in the image space.

30. The apparatus of claim 29, wherein the instrument is configured to transmit a free electron laser (FEL) that surgically ablates a particular portion of a tissue, and comprises a laser delivery system including a waveguide and a lens mounted to a distal end of the waveguide adjacent to the distal end of the endoscope, wherein a proximal end of the waveguide is coupled to a laser source.

31. The apparatus of claim 29, wherein the magnetic tracking tip location data comprises {x, y, z} positional coordinates and orientation angles and a rotation matrix, wherein the image space comprises scanned images that are preoperatively obtained, wherein the image data processor provides the scanned images for display while the image-guided surgery is being performed.

32. The apparatus of claim 29, wherein in use, during the image-guided surgical procedure, the pressurizable member applies a pressure into the first volume of the catheter to exert a force upon the flexible membrane so as to operably reduce the second volume of the catheter, thereby unloading the desired volume of the drug into the target of interest.

33. The apparatus of claim 29, further comprising:

a scanning device for scanning tissue of the patient to acquire, store and process a 3D reference of tissue prior to the tissue being surgically exposed, wherein the image data processor creates a triangularized mesh based on the scanned tissue, determines the volumetric center of a particular portion of the tissue to be ablated, coagulated or medicated during the surgery, and implements an algorithm using the triangularized mesh and the physical space data collected by the instrument to determine the point-based registrations.