Catheter for cell delivery in tissue

• US 6,758,828 B2
• Filed: 12/10/2001
• Issued: 07/06/2004
• Est. Priority Date: 12/10/2001
• Status: Active Grant

• Current Assignee: Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: Regents of The University of Minnesota (University of Minnesota)
• Inventors: Conroy, Mark J., Hammer, Bruce E.
• Primary Examiner(s): Thanh, Loan H.
• Application Number:
  US10/013,636
• Publication Number:
  US 20030109849A1
• Time in Patent Office: 939 Days
• Field of Search: 604/23-26, 604/27-28, 604/43-45, 604/500, 604/506, 604/522, 604/93.01, 604/264, 604/272, 435/284.1, 435/325-326
• US Class Current: 604/43
• CPC Class Codes: A61B 2017/00969 used for transplantation
• CPC Class Codes: A61K 35/00 Medicinal preparations containing materials or reaction products thereof with undetermined constitution
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

An apparatus delivers an agent to a treatment region, the apparatus having an outer cannula or lumen that has an internal surface and an external surface, the external surface being substantially smooth to penetrate tissue whereas the distal end is tapered; an inner cannula, or lumen coaxial to the outer cannula, providing a common fluid path (that is the same fluid passes through both the inner cannula and outer cannula) at the distal end with the inner surface of the outer cannula; a source of fluid to be passed through the common fluid path, the source of fluid comprising at least a reservoir of nutrients and/or gases for maintaining cells contained in a lumen coaxial and internal to the inner cannula; a semipermeable membrane comprises the surface of the lumen, thus allowing controlled material transport across the lumen surface; a source of cells or other biologically active material mass flow connected to the proximal lumen so that the cells or other biologically active material can exit the distal portion upon entering the target tissue; and a first flow distributor located at the proximal end of the outer cannula to provide substantially uniform flow through the outer cannula.

Claims

1. An apparatus for delivering an agent to a treatment region, whereas the apparatus comprises:

(i) an outer cannula that has an internal surface and an external surface, the external surface being substantially smooth to penetrate tissue whereas the distal end is tapered

(ii) an inner cannula, coaxial to the outer cannula, providing a common fluid path at the distal end with the inner surface of the outer cannula,

(iii) a source of fluid to be passed through the common fluid path, the source of fluid comprising at least a reservoir of nutrients and gases for maintaining cells contained in a lumen coaxial and internal to the inner cannula,

(iv) a semipermeable membrane comprises the surface of the lumen, thus allowing transport across the lumen surface,

(v) a source of cells or other biologically active material mass flow connected to the proximal lumen so that the cells or other biologically active material can exit the distal portion upon entering the target tissue

(vi) a first flow distributor located at the proximal end of the outer cannula to provide substantially uniform flow through the outer cannula

(vii) a second flow distributor located at the proximal end of the inner cannula to provide substantially uniform flow through the inner cannula

(viii) a fluid path from the proximal end to the distal end along the outer surface of the semipermeable lumen to facilitate mass transport between the cell or active material within the lumen and the reservoir.

2. The apparatus of claim 1 also having a repository for waste products and gases from cells or other biologically active materials contained in the lumen coaxial and internal to the inner cannula.

3. The apparatus of claim 1, further comprising

(i) a proximal fitting to insert fluid to the outer cannula

(ii) a proximal fitting to remove fluid from the inner cannula

(iii) a fitting to pass the active agent from proximal to distal region of the device.

4. The apparatus of claim 3 further comprising:

(i) a proximal fitting to remove fluid from the outer cannula

(ii) a proximal fitting to insert fluid to the inner cannula

(iii) a fitting to pass the active agent from proximal to distal region of the device.

5. The apparatus of claim 1, wherein the distal tip is of an acute angle.

6. The apparatus of claim 5, wherein there is a portion in the tip where no transport occurs through lumen of semipermeable membrane to prevent over-oxygenation of biologically active compound.

7. The apparatus of claim 1, wherein the lumen contains a semipermeable membrane.

8. The apparatus claim 7, wherein the membrane material comprises of polysulfone or other polymer for controlling molecular weight cutoff.

9. The apparatus of claim 8, wherein the lumen contains fetal stem cells for treatment of Parkinson'"'"'s disorder.

10. The apparatus of claim 7, wherein the lumen contains cells that secrete an active biological factor.

11. The apparatus of claim 1, wherein fluid in the cannula contains cytokines, nutrients and other compounds necessary for maintenance of cell viability within lumen.

12. The apparatus of claim 11, wherein the fluid contains dissolved gases necessary for cell viability.

13. The apparatus of claim 1, wherein the outer cannula comprises a low friction material for insertion into target tissue.

14. A method for delivering cells from the delivery device of claim 1 to a target location in a subject comprising:

a) surgically defining an access hole in proximity to treatment site;

b) inserting a cell delivery system comprising an at least dual lumen cannula through tissue whereas the distal end of the cannula is at the treatment site, a first lumen carrying cells and a second lumen carrying metabolite or gas that may pass from the first lumen to the second lumen;

c) passing fluid through the second lumen to nourish and/or remove waste products from cells in the first lumen;

d) passing cells and its support medium through the first lumen containing a semipermeable membrane by hydrostatic pressure;

e) maintaining a flow rate of cells through the first lumen at a rate consistent with minimizing shear forces to said cells;

f) maintaining cells within the lumen with oxygenation and nutrient supply from the second lumen;

g) maintaining cell delivery by flowing cell-free media through the first lumen;

h) removing cell delivery system from the treatment site.

15. The method of claim 14 wherein a lumen in the cell delivery device removes waste products while cells are delivered.

16. A method for delivering a biologically active compound or cell to target location in a subject with a material delivery device according to claim 1 having one lumen for delivery of cells to a target site and having two opposed lumens, the two opposed lumens comprising a distal direction flow lumen and a proximal direction flow lumen, the method comprising:

a) surgically defining an access hole in proximity to treatment site;

b) inserting the delivery device through tissue whereas the distal end of the delivery device is at the treatment site;

c) passing cell supportive fluid through the two opposed lumens to nourish cells and remove waste products from cells in the first lumen;

d) passing cells and its support medium through the first lumen containing a semipermeable membrane by hydrostatic pressure;

e) whereas the flow rate of cells through the lumen is maintained at a rate to reduce shear forces to said cells;

f) maintaining cells within the lumen with oxygenation and nutrients, and removal of waste products, during the delivery process;

h) maintaining cell delivery by flowing cell-free media through the lumen; and

l) removing cell delivery system from the treatment site.

17. The method of claim 16 wherein flow of cell supportive liquid through the two opposed lumens so in a counter-current mode.

18. The method of claim 16 wherein flow of cell supportive liquid through the two opposed lumens so in a co-current mode.