Device and method for delivering therapeutic agents to an area of the body

• US 8,083,720 B2
• Filed: 05/13/2008
• Issued: 12/27/2011
• Est. Priority Date: 05/13/2008
• Status: Active Grant

• Current Assignee: C2C Development, LLC, Engineering Resources Group, Inc.
• Original Assignee: Chris Ross, Martin L. Brady, Matthew S. Solar, Raghu Raghavan
• Inventors: Solar, Matthew S., Ross, Chris, Brady, Martin L., Raghavan, Raghu
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Scott, Brandy C
• Application Number:
  US12/152,280
• Publication Number:
  US 20090287141A1
• Time in Patent Office: 1,323 Days
• Field of Search: 604/164.01, 604/44, 604/96.01, 604/523
• US Class Current: 604/164.01
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• 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 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• 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

Abstract

A device, system and method deliver an agent to a soft mass, such as an area of the body, and more specifically the brain. One aspect includes creation of one or more channels, tunnels or grooves in tissue using a relatively small diameter, minimally-invasive stylet and then removing the stylet prior to infusion. The stylet-created channels become paths of increased hydraulic conductivity, through which the infusate will tend to flow and produce a predictable infusion pattern. Infusate will be carried into these channels with relatively low resistance, and then infuse outward from these channels into the surrounding tissue. By carefully positioning these channels, one can control and modify the preferred paths and duration of distribution.

Claims

1. A method of delivering a substance to a region of the body comprising:

inserting a stylet as a tissue-penetrating device into tissue,

removing the tissue penetrating device, thereby creating a channel in the tissue, and

delivering the substance into that channel while the stylet is at its deepest penetration into the tissue or after the stylet has been completely withdrawn from its deepest penetration into the tissue;

where the cannula and stylet or obturator are delivered through a secondary outer cannula or catheter, such that when the channel has been created, the first cannula and stylet or obturator are removed and the substance is delivered through the secondary outer cannula or catheter.

5. The method of claim 1 where the stylet is used to perform an additional function other than creating the channel, and the additional function is selected from the class of performing diagnostics, taking measurements and delivering therapy prior to being retracted or removed.

9. The method of claim 1 wherein the substance is selected from the group consisting of a liquid, a drug cells, and a viral vector.

13. The method of claim 1 wherein after the stylet penetrates the tissue, drug is delivered in a region about the channel formed by the penetration of the stylet.

2. A method for introducing a substance to a region of a body through a cannula without introducing bubbles into the region of the body comprising:

purging the cannula of bubbles with the substance,

placing a device comprising a stylet or obturator into the cannula,

again purging any bubbles with additional amounts of the substance,

inserting the cannula into the body while maintaining a seal between the stylet and the cannula and

then retracting or removing the stylet to form a channel while providing a volumetric flow rate of the substance into the cannula and out of an outlet from the catheter and into the channel;

where the stylet and cannula are inserted into a secondary, outer cannula or catheter prior to inserting the stylet or cannula into the body.

6. The method of claim 2 where the stylet is used to perform an additional function other than creating the channel, and the additional function is selected from the class of performing diagnostics, taking measurements and delivering therapy prior to being retracted or removed.

10. The method of claim 2 wherein the substance is selected from the group consisting of a liquid, a drug cells, and a viral vector.

14. The method of claim 2 wherein after the stylet penetrates the tissue, drug is delivered in a region about the channel formed by the penetration of the stylet.

3. A method for introducing a substance to a region of a body through a cannula without introducing bubbles into the region of the body comprising:

purging the cannula of bubbles with the substance,

placing a device comprising a stylet or obturator into the cannula,

again purging any bubbles with additional amounts of the substance,

inserting the cannula into the body while maintaining a seal between the stylet and the cannula and then retracting or removing the stylet to form a channel while providing a volumetric flow rate of the substance into the cannula and out of an outlet from the catheter and into the channel;

where the stylet and cannula are first inserted into a catheter and the catheter is then purged with the substance prior to inserting the stylet or cannula into the body.

7. The method of claim 3 where the stylet is used to perform an additional function other than creating the channel, and the additional function is selected from the class of performing diagnostics, taking measurements and delivering therapy prior to being retracted or removed.

11. The method of claim 3 wherein the substance is selected from the group consisting of a liquid, a drug cells, and a viral vector.

4. A method for introducing a substance to a region of soft mass through a cannula without introducing bubbles, by first inserting a device such as a stylet or obturator in to the cannula, purging any bubbles with the substance, inserting the cannula into the soft mass while maintaining a seal around the stylet, and then retracting or removing the stylet or obturator to form a channel while maintaining a volumetric flow rate of the substance in to the cannula and into the channel where a secondary, outer cannula or catheter is first purged with the substance and the stylet is then inserted into the secondary, outer cannula or catheter prior to inserting the stylet or into the body.

8. The method of claim 4 where the stylet is used to perform an additional function other than creating the channel, and the additional function is selected from the class of performing diagnostics, taking measurements and delivering therapy prior to being retracted or removed.

12. The method of claim 4 wherein the substance is selected from the group consisting of a liquid, a drug cells, and a viral vector.