IN-SITU MATERIAL DELIVERY DEVICES AND METHODS

• US 20160166817A1
• Filed: 09/14/2015
• Published: 06/16/2016
• Est. Priority Date: 09/19/2014
• Status: Active Grant

• Current Assignee: TransMed7, LLC
• Original Assignee: TransMed7, LLC
• Inventors: VETTER, James William, Vetter, Eugene H.
• Granted Patent: US 9,999,758 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• 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
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61N 2005/1008 Apparatus for temporary insertion of sources, e.g. afterloaders
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body

Abstract

An in-situ material delivery device for handheld, stereotactic table or MRI stage use may comprise a work element configured to selectively open and close at least one articulable beak configured to penetrate tissue to a target delivery site, or follow a central lumen of another device or other guiding modality, and then to deliver selected materials. Such a device may deliver a variety of materials such as markers, radio-active pellets, medications, other devices, and other materials of solid, liquid or gaseous form to a target site, and materials of similar nature may also be captured and removed from a target site. A single tube with or without coatings or an inner sheath and an outer sheath which may be co-axially disposed relative to a work element may be configured to actuate a beak or beaks and internal delivery mechanisms simultaneously. One embodiment of this device may be applicable to field use or one time use.

Claims

1. A device, comprising:

a handle;

a work element coupled to the handle, the work element defining a proximal end closest to the handle and a distal end furthest from the handle, the work element comprising at least one articulable beak that is normally closed, the work element being formed from a single tube-shaped piece of material and configured to enclose, within a lumen thereof, a plurality of discrete items to be delivered to a target site within tissue;

a rod element partially engaged within the lumen from the proximal end thereof and configured to contact and push against one of the plurality of discrete items to be delivered; and

an actuation assembly coupled to the work element and configured to selectively open the at least one beak and cause the rod element to push and deliver a predetermined number of the discrete items out from the distal end of the work element to the target site before enabling the at least one beak to close.

2. The device of claim 1, wherein the actuation assembly is configured to be manually turned, pushed or pulled in pre-selected increments to enable an operator of the device to cause the delivery of only the predetermined number of discrete items.

3. The device of claim 1, wherein the actuation assembly further comprises a first manually rotatable assembly configured to cause the at least one beak to open and deliver only the predetermined number of discrete items to the target site before closing.

4. The device of claim 1, further comprising a dog element coupled to the work element and a manually rotatable ratchet wheel disposed against the dog element and comprising a plurality of land portions and a plurality of notch portions, such that the at least one beak remains closed when the dog element is engaged within one of the notches and is pushed open when the ratchet wheel is rotated such that the dog element rides on one of the land portions.

5. The device of claim 1, wherein rod comprises a rack and wherein the actuation assembly comprises a corresponding pinion coupled to the rack, the pinion being configured to rotate and cause the rod element to push against the plurality of discrete elements.

6. The device of claim 1, wherein the actuation assembly is partially enclosed by the handle and comprises a manually-operable portion at least partially external to the handle.

7. The device of claim 1, wherein the rod element is configured to be removable to enable one of an occlusion-crossing rod and a guidewire to be inserted into the lumen of the work element.

8. The device of claim 1, wherein the at least one beak is configured to flex via a portion of the single tube-shaped piece of material configured as a living hinge.

9. The device of claim 1, further comprising a plurality of cuts defined in the work element to define the at least one articulable beak.

10. The device of claim 1, further comprising a plurality of cuts defined in the work element to define the at least one articulable beak, at least one tendon and at least one tendon actuating tab coupled to the at least one articulable beak and to the at least one tendon.

12. The device of claim 1, further comprising one of an outer tube or covering disposed over at least a portion of the work element.

13. The device of claim 1, wherein the work element is formed by selective removal of material from the single tube-shaped piece of material.

11. (canceled)

14-34. -34. (canceled)

14. A method, comprising:

providing a device comprising a handle, a work element coupled to the handle that comprises at least one articulable beak that is normally closed, the work element being formed from a single tube-shaped piece of material that is configured to enclose, within a lumen thereof, a plurality of discrete items to be delivered to a target site within tissue;

a rod element disposed within the lumen, and an actuation assembly coupled to the work element;

inserting at least a portion of the work element into tissue such that a distal end thereof is within the target site; and

responsive to a single first action by an operator of the device;

causing the rod element to push against one of the plurality of discrete items;

opening the at least one articulable beak;

delivering a predetermined number of the plurality of items to the target site; and

closing the at least one articulable beak after the last of the predetermined number of items is delivered to the target site

18. (canceled)

21. (canceled)

22. (canceled)

24-34. -34. (canceled)

35. A method, comprising:

providing a device comprising a handle, a work element coupled to the handle that comprises at least one articulable beak that is normally closed, the work element being formed from a single tube-shaped piece of material that is configured to enclose, within a lumen thereof, a plurality of discrete items to be delivered to a target site within tissue;

a rod element disposed within the lumen, and an actuation assembly coupled to the work element;

inserting at least a portion of the work element into tissue such that a distal end thereof is within the target site; and

responsive to a single first action by an operator of the device;

causing the rod element to push against one of the plurality of discrete items;

opening the at least one articulable beak;

delivering a predetermined number of the plurality of items to the target site; and

closing the at least one articulable beak after the last of the predetermined number of items is delivered to the target site

15. The method of claim 35, wherein providing is carried out with the at least one beak being configured to flex via a portion of the single tube-shaped piece of material configured as a living hinge.

16. The method of claim 35, wherein providing is carried out with a plurality of cuts in the work element defining the at least one articulable beak.

17. The method of claim 35, wherein providing is carried out with a plurality of cuts in the work element defining the at least one articulable beak, at least one tendon and at least one tendon actuating tab coupled to the at least one articulable beak and to the at least one tendon.

19. The method of claim 35, wherein providing is carried out with one of an outer tube or covering being disposed over at least a portion of the work element.

20. The method of claim 35, wherein providing is carried out with the work element being formed by selective removal of material from the single tube-shaped piece of material.

23. The method of claim 35, further comprising:

moving the distal end of the device to another location within the target site; and

responsive to a single second action by the operator of the device;

causing the rod element to push against one of remaining ones of the plurality of discrete items;

opening the at least one articulable beak;

delivering the predetermined number of the plurality of items to the other location within the target site; and

closing the at least one articulable beak after the last of the predetermined number of items is delivered to the other location within the target site.

36-48. -48. (canceled)