Portable equipment for administration of fluids into tissues and tumors by convection enhanced delivery technique
First Claim
1. An apparatus comprising:
- a. an extracorporeal solvent reservoir comprising a distal portion, a proximal port and a lumen extending therethrough;
b. an extracorporeal portable pump comprising a proximal port and a distal port and a lumen therethrough wherein the extracorporeal portable pump is in fluid communication with the extracorporeal solvent reservoir;
c. an infusion catheter configured for insertion into the tumor of the subject, the infusion catheter comprising a length extending from a proximal end for introduction into the tumor to a distal end with a lumen extending between the proximal end and the distal end wherein the infusion catheter is in fluid communication with the solvent reservoir and portable pump; and
d. an intracorporeal access port comprising an access port chamber having a proximal port, a distal port and a lumen extending therebetween, wherein the intracorporeal access port is located proximal from the extracorporeal portable pump and facilitate fluid communication between(i) the extracorporeal solvent reservoir and extracorporeal portable pump and(ii) the infusion catheter; and
(e) means for convection enhanced delivery of a solvent to a target tumor, wherein the solvent delivered by convection enhanced delivery has (i) a flow rate at the target tumor of more than 0.001 ml/h and less than 1 ml/h;
(ii) a total flow volume within one period of any oscillation of less than about 0.5 μ
l; and
(iii) an amplitude of oscillation between about 0.05 ml/h and about 1 ml/h.
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Accused Products
Abstract
The present invention is directed to a device for a portable convection enhanced delivery system that allows administering liquids to specific locations within the body, especially tissues and tumors also allowing outsubject treatment. The application system comprises a portable extracorporal pump with a fluid reservoir that is connected via an infusion system to an infusion catheter placeable to any tissue or tumor the fluid should be administered to by high flow microperfusion. The system enables administration of fluids of any kind by convection enhanced delivery also in out-patient treatment. The system can be used for delivering various drugs, proteins, protein toxins, antibodies-for treatment or imaging, proteins in enzyme replacement therapy, growth factors and viruses or oligonucleotides in gene therapy etc. The application methods as well as the surgical method to implant this device are enclosed to this invention.
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Citations
59 Claims
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1. An apparatus comprising:
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a. an extracorporeal solvent reservoir comprising a distal portion, a proximal port and a lumen extending therethrough; b. an extracorporeal portable pump comprising a proximal port and a distal port and a lumen therethrough wherein the extracorporeal portable pump is in fluid communication with the extracorporeal solvent reservoir; c. an infusion catheter configured for insertion into the tumor of the subject, the infusion catheter comprising a length extending from a proximal end for introduction into the tumor to a distal end with a lumen extending between the proximal end and the distal end wherein the infusion catheter is in fluid communication with the solvent reservoir and portable pump; and d. an intracorporeal access port comprising an access port chamber having a proximal port, a distal port and a lumen extending therebetween, wherein the intracorporeal access port is located proximal from the extracorporeal portable pump and facilitate fluid communication between (i) the extracorporeal solvent reservoir and extracorporeal portable pump and (ii) the infusion catheter; and (e) means for convection enhanced delivery of a solvent to a target tumor, wherein the solvent delivered by convection enhanced delivery has (i) a flow rate at the target tumor of more than 0.001 ml/h and less than 1 ml/h;
(ii) a total flow volume within one period of any oscillation of less than about 0.5 μ
l; and
(iii) an amplitude of oscillation between about 0.05 ml/h and about 1 ml/h. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 21, 22, 23, 24)
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- 13. The apparatus of claim l, wherein at least one of (i) a lumen which contacts the solvent, (ii) an infusion catheter or (iii) an intracorporeal access port is sterile.
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25. A method of using an apparatus to administer a solvent to a tumor in a subject, the apparatus comprises:
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(i) an extracorporeal solvent reservoir comprising a distal portion, a proximal port and a lumen extending therethrough; (ii) an extracorporeal portable pump comprising a proximal port and a distal port and a lumen therethrough wherein the extracorporeal portable pump is in fluid communication with the extracorporeal solvent reservoir; (iii) an infusion catheter configured for insertion into the tumor of the subject, the infusion catheter comprising a length extending from a proximal end for introduction into the tumor to a distal end with a lumen extending between the proximal end and the distal end wherein the infusion catheter is in fluid communication with the solvent reservoir and portable pump; (iv) an intracorporeal access port comprising an access port chamber having a proximal port, a distal port and a lumen extending therebetween, wherein the intracorporeal access ports are located proximal from the extracorporeal portable pump and facilitate fluid communication between (x) the extracorporeal solvent reservoir and extracorporeal portable pump and (v) the infusion catheter; (v) an access port catheter comprising a proximal port, a distal port, and a lumen extending therethrough, wherein the proximal port of the access port catheter is in fluid communication with (x) the infusion catheter lumen and (y) the distal port of the access port chamber; and (vi) an infusion tube configured for connection to the distal port of the access port chamber, the infusion tube comprising a length extending from a proximal end for introduction into the distal end of the access port chamber to a distal port opposite the proximal end, and a lumen extending therethrough; the method of using the apparatus comprising the steps of; a. implanting an infusion catheter into the tumor of a subject; b. implanting an access port catheter and access port chamber into the subject; c. connecting the distal port of the infusion catheter to the proximal port of an access port catheter; d. connecting the distal port of an access port catheter to the proximal port of the access port chamber; e. connecting the distal port of the access port chamber to the proximal end of an infusion tube; f. connecting the proximal port of the portable pump to the distal port of an infusion tube; and g. delivering a solvent to the tumor by convection enhanced delivery having (i) a flow rate at the target tumor of more than 0.001 ml/h and less than 1 ml/h;
(ii) a total flow volume within one period of any oscillation of less than about 0.5 μ
l; and
(iii) an amplitude of oscillation between about 0.05 ml/h and about 1 ml/h. - View Dependent Claims (26, 27, 28, 29, 30, 31)
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32. An apparatus comprising:
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(a) means for injecting a solvent into a tumor or tissue of a subject in fluid communication with an accessory system; (b) an access port having a proximal port, a distal port, and a lumen extending therethrough; (c) an access port catheter having a proximal port, a distal port, and a lumen extending therethrough, the proximal port of the access port catheter is in fluid communication with the distal port of the infusion catheter and the distal port of the access port catheter is in fluid communication with the access port; (d) an infusion catheter configured for insertion into the tissue or tumor of the subject, the infusion catheter having a length extending from a proximal end for introduction into the tissue to a distal end opposite the proximal end, and a lumen extending therethrough; and (e) means for convection enhanced delivery of a solvent to a target tumor, wherein the solvent delivered by convection enhanced delivery has (i) a flow rate at the target tumor of more than 0.001 ml/h and less than 1 ml/h;
(ii) a total flow volume within one period of any oscillation of less than about 0.5 μ
l; and
(iii) an amplitude of oscillation between about 0.05 ml/h and about 1 ml/h. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52)
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53. A method of using an apparatus to administer a solvent to a tissue or a tumor of a subject, the apparatus comprising:
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(i) means for injecting a solvent into a tumor or tissue of a subject in fluid communication with an accessory system; (ii) an access port having a proximal port, a distal port, and a lumen extending therethrough; (iii) an access port catheter having a proximal port, a distal port, and a lumen extending therethrough, the proximal port of the access port catheter is in fluid communication with the distal port of the infusion catheter and the distal port of the access port catheter is in fluid communication with the access port; and (iv) an infusion catheter configured for insertion into the tissue or tumor of the subject, the infusion catheter having a length extending from a proximal end for introduction into the tissue to a distal end opposite the proximal end, and a lumen extending therethrough; the method of using the apparatus comprising the steps of; (a) implanting an infusion catheter into the tissue or the tumor of a subject; (b) implanting the access port catheter and access port chamber into the subject; (c) connecting the distal port of the infusion catheter to the proximal port of the access port catheter; (d) connecting the distal port of the access port catheter to the proximal port of the access port chamber; (e) connecting the distal port of the access port chamber to the proximal end of infusion tube; (f) connecting the means for injecting a solvent to the distal port of the infusion tube; and (g) delivering a solvent to the tissue or tumor of the subject by convection enhanced delivery having (i) a flow rate at the target tumor of more than 0.001 ml/h and less than 1 ml/h;
(ii) a total flow volume within one period of any oscillation of less than about 0.5 μ
l; and
(iii) an amplitude of oscillation between about 0.05 ml/h and about 1 ml/h. - View Dependent Claims (54, 55, 56, 57, 58)
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59. A method of using an apparatus to administer a solvent to a tumor in a subject, the apparatus comprises:
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(i) an extracorporeal solvent reservoir comprising a distal portion, a proximal port and a lumen extending therethrough; (ii) an extracorporeal portable pump comprising a proximal port and a distal port and a lumen therethrough wherein the extracorporeal portable pump is in fluid communication with the extracorporeal solvent reservoir; (iii) an infusion catheter configured for insertion into the tumor of the subject, the infusion catheter comprising a length extending from a proximal end for introduction into the tumor to a distal end with a lumen extending between the proximal end and the distal end wherein the infusion catheter is in fluid communication with the solvent reservoir and portable pump; and (iv) an intracorporeal access port comprising an access port chamber having a proximal port, a distal port and a lumen extending therebetween, wherein the intracorporeal access port is located proximal from the extracorporeal portable pump and facilitate fluid communication between (x) the extracorporeal solvent reservoir and extracorporeal portable pump and (y) the infusion catheter;
the method of using the apparatus comprising the steps of;a. implanting an infusion catheter into the subject; b. implanting access port chamber into the subject; c. connecting the proximal port of the access port chamber to the distal port of infusion catheter such that the proximal port of the access port chamber and the distal port of infusion catheter are in fluid communication; d. connecting the distal port of the portable pump to the proximal port of the solvent reservoir; e. connecting the proximal port of the pump to the distal port of the access port chamber to facilitate fluid communication between the solvent reservoir and the infusion catheter; and f. delivering a solvent to the tumor by convection enhanced delivery having (i) a flow rate at the target tumor of more than 0.001 ml/h and less than 1 ml/h;
(ii) a total flow volume within one period of any oscillation of less than about 0.5 μ
l; and
(iii) an amplitude of oscillation between about 0.05 ml/h and about 1 ml/h.
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Specification