Active delivery and flow redirection: novel devices and method of delivery of materials to patients

• US 7,998,128 B2
• Filed: 05/15/2006
• Issued: 08/16/2011
• Est. Priority Date: 05/15/2006
• Status: Active Grant

• Current Assignee: Therataxis, LLC
• Original Assignee: Therataxis, LLC
• Inventors: Brady, Martin L., Poston, David, Raghavan, Raghu
• Primary Examiner(s): Stigell; Theodore J
• Assistant Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US11/434,080
• Publication Number:
  US 20070276340A1
• Time in Patent Office: 1,919 Days
• Field of Search: 604/101.01, 604/101.05, 604/103.03, 604/116, 604/164.01, 604/174, 604/500, 604/506, 604/508, 604/509, 604/511, 604/513, 604/514, 604/523, 604/93.01, 604/96.01, 604/507, 604/908, 604/912, 604/915
• US Class Current: 604/506
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Abstract

A medical device for delivering material through tissue into a defined area of a patient may comprise: a material delivery element through which the material may flow out of a delivery end; the delivery end having an opening that can be inserted through a surface of the tissue; and a sealing system proximal to the delivery end that can extend away from the material delivery element along the surface of the tissue and apply pressure to the tissue after the material delivery element has been inserted through the surface of the tissue. A physical barrier may be provided on the material delivery device to reduce back flow loss of delivered material.

Claims

1. A method for the provisioning and positioning of a flowable material selected from the group consisting of a flowable drug medication material into a region of a patient comprising:

identifying a region of a patient to be viewed or treated;

identifying a region between the pia and the cortex wherein the region forms a potential volume between two opposed different and distinct tissue surfaces;

penetrating at least one of the two opposed different and distinct tissue surfaces selected from the pia and the cortex with a flowable drug medication material delivery device; and

providing flowable material from the flowable drug medication material delivery device into the potential volume between the pia and the cortex to create a volume containing at least delivered flowable drug medication material between the at least two different and distinct tissue surfaces; and

performing a medical procedure of delivery of the drug medication;

wherein the material delivery device forms an at least partial seal around the entire puncture formed by penetration of only one of the at least two opposed different and distinct tissue surfaces;

wherein the seal is formed covering a surface area extending away from and entirely around a diameter of the material delivery device immediately adjacent the pia or the cortex.

2. The method of claim 1 wherein the volume is mass transfer stable in that less than 80% by volume of delivered material is removed from the created volume by natural biological activity in less than 5 minutes and a non-invasive visual examination selected from the group consisting of MRI, PET or fluoroscopy is used during penetration of the at least one of the two opposed surfaces or while providing the flowable drug medication material to create the volume.

3. The method of claim 1 wherein the seal is formed on both sides of the puncture relative to the only one of the at least two opposed different and distinct tissue surfaces penetrated.

4. The method of claim 1 wherein a structure forming the seal is inflated to assist in sealing the puncture and the seal is circumferentially around the puncture.

5. The method of claim 1 wherein a structure forming the seal is flexible and distorts to apply pressure over the puncture.

6. The method of claim 1 wherein the seal is formed by expansion of a component on the material delivery device around a region of the puncture created by the penetration.

7. The method of claim 1 wherein there is a second seal formed against at least one surface in addition to the pia.

8. A method for the provisioning and positioning of a flowable medication material comprising a medical drug into a region of a patient comprising:

identifying a region of a patient between the pia and the cortex to be viewed or treated;

identifying a region wherein the region forms a potential volume between two opposed different and distinct tissue surfaces consisting of the pia and the cortex;

penetrating at least one of the two opposed different and distinct tissue surfaces with a flowable material delivery device; and

providing the flowable material delivery device into the potential volume to create a volume containing at least delivered flowable material between the at least two different and distinct tissue surfaces;

wherein the material delivery device forms an at least partial seal around a puncture formed by penetration of only one of the at least two opposed pia and cortex surfaces; and

performing a medical procedure consisting essentially of delivery of the medical drug; and

wherein the seal is formed covering a surface area extending circumferentially away from and entirely around a diameter of the material delivery device immediately adjacent the pia or the cortex.

9. The method of claim 8 wherein an amount of cortical fluid is removed while flowable material is delivered to minimize pressure increases in local fluids.

10. The method of claim 9 wherein the seal is formed on both sides of the puncture relative to the only one of the at least two opposed different and distinct tissue surfaces penetrated.

11. The method of claim 8 wherein an amount of cortical fluid is removed while flowable material is delivered so that there is a zero pressure increase in cortical fluids.