Medical Device And Delivery Method Onto Offset Surface Of Mammal Tissue

• US 20150202408A1
• Filed: 07/24/2013
• Published: 07/23/2015
• Est. Priority Date: 07/25/2012
• Status: Active Grant

• Current Assignee: Fibralign Corporation
• Original Assignee: Fibralign Corporation
• Inventors: McMurtry, David H., Paukshto, Michael V., Zaitseva, Tatiana S.
• Granted Patent: US 10,639,450 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00792 Plastic surgery
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/320056 Tunnelers
• 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: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

A novel medical device and method for delivery of a scaffold for treatment of secondary lymphedema and ischemia is provided. In some embodiments a catheter medical device and magnetic guidance method are provided for delivering cell-seeded implants for guided lymphatic regeneration.

Claims

1. A method of delivery of a medical device having proximal and distal ends into a mammal tissue comprising the steps of:

forming a guide line on the surface of the tissue;

placing a guiding device that can move along the guide line on the surface of the tissue;

deploying the medical device distal end into the mammal tissue at a desired depth d;

coupling between the guiding device and the medical device distal and/or proximal end; and

introducing the medical device distal end along the normal projection of the guide line to the offset surface of mammal tissue located at the distance d from the tissue surface.

4. The method according to claim 1, wherein the medical device distal end is introduced under control of the guiding device and/or the medical device proximal end.

5. The method according to claim 1, wherein the guiding device has a sensor and the medical device distal end generates a signal which can be sensed by the guiding device and used to control the position of the medical device distal end.

6. The method according to claim 1, wherein the guiding device has magnetic sensors and the medical device distal end generates a magnetic field which can be sensed by the guiding device and used to control the position of the medical device distal end.

7. The method according to claim 1, wherein the medical device is a steerable catheter comprised of a flexible tube into which flexible devices can be inserted at the proximal end.

8. The method according to claim 1, wherein the proximal end can carry the steering and insertion mechanism and the distal end can carry a sensing target, signal generator, steering ring with attached wires, drill bit, tissue shaver, slicer, rasp, laser waveguide, one or more orifices for discharging liquid, one or more orifices for inhaling debris, fiber optic, implant, forceps, drug delivery reservoir, probe or diagnostic device.

9. The method according to claim 1, wherein the introduction and the movement of the distal end are achieved by any one or more of:

drilling, slicing, shaving or abrading of the tissue using mechanical means, or evaporating of the tissue using a laser system, or by tearing the tissue under a tension applied from the proximal end.

10. The method according to claim 1, wherein the medical device can deliver a piece of tissue, scaffold, biopolymer thread or micro-thread, biopolymer filament, gel, micro-particles, decellularized tissue, fragments of lymphatic system including fragments of autologous lymph node or decellularized lymph node of animal origin, bioactive components like live cells, growth factors, peptides, drugs or drug releasing carriers.

11. The method according to claim 1, wherein the guide line on the surface of the tissue is determined by the following method:

attaching a flexible grid over the selected area on the surface of the target tissue, that creates a grid image having positive or negative contrast during one of the diagnostic procedures like MRI, CT scan, or PET-CT;

obtaining images of the target tissue and the grid by one of the diagnostic procedures indicated above;

deriving a projection image of the target tissue onto the grid image; and

making the guide line on the surface of the tissue using the grid attached to the surface and the images of the target tissue with the grid.

12. The method according to claim 1, wherein the mammal tissue is a mammal organ or skin.

13. The method according to claim 1, wherein the guiding device is comprised of a hollow, flexible track held in intimate contact with the surface of the tissue by the force of vacuum operating through holes in the bottom of the track and positioned on top of the guiding line and having a rail geometry which captures a carriage containing one or more sensors.

14. The method according to claim 13, wherein the carriage carrying the sensors is actuated along the flexible track by a flexible actuator rod with a cross-sectional geometry which is constrained by the track geometry so that the actuator rod follows a path governed by the track.

15. The method according to claim 14, wherein the flexible actuator rod is rigidly connected to the proximal end of the catheter such that the carriage advances the same distance as the catheter.

16. The method according to claim 15, wherein the proximal end of the flexible actuator rod is advanced by a servo mechanism in response to the magnetic field at the distal end of the catheter such that the normal distance between the sensors and the source of the magnetic field is maintained at the desired depth d.

2. A method of delivery of a medical device having proximal and distal ends into a mammal tissue comprising:

a guide line on the surface of the tissue and guiding device that can move along the guide line on the surface of the tissue such that the medical device distal end and the guiding device are coupled to move the medical device distal end into the mammal tissue at a constant distance from the guiding line.

3. A method of delivery of a medical device having proximal and distal ends onto the offset surface of mammal tissue comprising:

a guide line on the surface of the tissue and a guiding device moving along the guide line on the surface of the tissue such that the medical device distal end and the guiding device are coupled to move the medical device proximal end and the guiding device to the same distance.

17. A medical device system for delivery of material into mammal tissue, comprising

a medical device having proximal and distal ends;

a guiding device configured to move along a guide line defined on the surface of mammal tissue, said guiding device comprised of a flexible guide rail and a carriage carried by the guide rail;

wherein the distal end of the medical device and the guiding device are coupled to move the distal end of the medical device into the mammal tissue at a constant distance d from a guide line defined on the surface of the mammal tissue.

18. The medical device system according to claim 17 wherein:

the flexible guide rail is comprised of;

a base having an internal vacuum plenum formed therein, said base having a plurality of holes formed in a bottom surface of the base and configured to provide contact with the surface of the tissue by the force of vacuum operating through the holes in the bottom of the base; and

the carriage houses one or more magnetic sensors.

19. The medical device system according to claim 18 further comprising;

a flexible actuator rod having cross-sectional geometry configured to be constrained by the guide rail so that the actuator rod follows a path governed by the guide rail.

20. The medical device system according to claim 17 wherein the medical device is configured to generate a magnetic field at its distal end which is sensed by the guiding device and used to control the position of the medical device distal end.

21. The medical device system according to claim 19 wherein a proximal end of the flexible actuator rod is advanced by a servo mechanism in response to a magnetic field at the distal end of the medical device such that the normal distance between the sensors and the source of the magnetic field is maintained at the desired depth d.

22. The medical device system according to claim 19 wherein the flexible actuator rod is rigidly connected to the proximal end of the medical device such that the carriage advances the same distance as the medical device.

23. A device system, comprising:

a boring device having proximal and distal ends;

a guiding device configured to move along a boring path defined on a surface, said guiding device comprised of a flexible guide rail and a carriage carried by the guide rail;

wherein the distal end of the boring device and the guiding device are coupled to move the distal end of the boring device along the boring path at a constant distance d form the surface.