By a News Reporter-Staff News Editor at Drug Week — A patent application by the inventors Comerota, Anthony J. (Perrysburg, OH); Fogarty, Thomas J. (Portola Valley, CA); Olson, Jonathan M. (San Jose, CA); Lotti, Richard A. (Santa Cruz, CA), filed on February 28, 2014, was made available online on July 3, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents (see also Venous Therapy, Inc.).
This patent application is assigned to Venous Therapy, Inc.
The following quote was obtained by the news editors from the background information supplied by the inventors: “The present invention generally relates to medical devices and methods. More particularly, the present invention is related to the delivery of therapeutic agents into the body.
“Infusion catheters are known, which provide the administration of various therapeutic agents in solutions into the peripheral vasculature. Conventional designs usually contain inner and outer catheter shafts. The outer catheter shaft provides a series of holes over a prescribed length through which the agent(s) can be administered to the vessel and surrounding tissue or disease. Conventional technology is focused on the shape and/or density of the holes for infusion, and/or providing a zone of infusion by blocking a segment of the vessel, and/or providing a guide wire lumen. While this technology is promising, improved devices and method are still needed to provide catheters or other therapeutic agent delivery systems that deliver the therapeutic agent to a specific target site and with better control of infusion rates. At least some of these objective will be met by the embodiments disclosed herein.”
In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “One aspect of the invention provides an infusion catheter assembly having the ability to infinitely titrate the length of the infusion section in situ. The infusion catheter assembly provides a length of infusion that can be infinitely varied over a prescribed range, to control the effective infusion length and the rate of infusion. Using the infusion catheter assembly, a physician has the capability to treat only the length of the vessel desired, thereby preventing excessive drug/patient exposures.
“Another aspect of the invention provides an infusion catheter assembly having a porous fluid distribution section that includes an array of spaced apart apertures that vary in size and/or density along the length of the porous fluid distribution section. A barrier mechanism can be provided that is movable along the porous distribution section to establish for the infusion catheter assembly an infinitely variable range of effective infusion lengths between a maximum length and any smaller length along the porous fluid distribution section. The spaced apart apertures vary in size and/or density in a predetermined fashion along the maximum length such that the flow rate remains essentially constant for a given inlet pressure independent of the effective infusion length.
“In another aspect of the present invention an infusion catheter assembly comprises a catheter body having an interior lumen and including a porous fluid distribution section having a predefined maximum length communicating with the interior lumen. The catheter assembly also includes at least one fluid delivery port for dispensing a fluid from an external source into communication with the porous fluid distribution section for infusion through the porous fluid distribution section at a flow rate, and also a barrier mechanism movable within the catheter body to establish for the infusion catheter assembly an infinitely variable range of effective infusion lengths between the maximum length and any smaller length along the porous fluid distribution section.
“In another aspect of the present invention, an infusion catheter assembly may comprise a catheter body having an interior lumen and including a porous fluid distribution section having a predefined maximum length communicating with the interior lumen. The porous discharge section may comprise an array of spaced apart apertures that vary in size and/or density along the length of the porous fluid distribution section. The catheter assembly may also have at least one fluid delivery port for dispensing a fluid from an external source into communication with the porous fluid distribution section for infusion through the porous fluid distribution section at a flow rate.
“The barrier mechanism may comprise an expandable structure which may expand in response to introduction of a fluid. The barrier mechanism may also be movable within the catheter body to establish for the infusion catheter assembly an infinitely variable range of effective infusion lengths between the maximum length and any smaller length along the porous fluid distribution section. The spaced apart apertures may vary in size and/or density in a predetermined fashion along the maximum length such that the flow rate remains essentially constant for a given inlet pressure independent of the effective infusion length. The assembly may further include a lumen in the catheter body to accommodate passage of a guide wire, and the barrier mechanism may also include a lumen to accommodate passage of the guide wire. A first radiopaque marker may be disposed on the barrier mechanism and a second radiopaque marker may be disposed on the catheter body to visualize the effective infusion length by radiographic imaging.
“The porous fluid distribution section may be sized and configured for weep or pulse-spray infusion of the fluid. The catheter body may be sized and configured for intravascular introduction, intramuscular introduction, or introduction into a tissue mass or organ. The fluid dispensed by the fluid delivery port may include a therapeutic agent such as a thrombolytic agent.
“The barrier mechanism may include an inner catheter body sized and configured to be manipulated by sliding within the catheter body along the maximum length of the porous fluid distribution section. The inner catheter body may include the at least one fluid delivery port. A barrier structure may be carried by the inner catheter body proximal of the fluid delivery port. The barrier structure may have a reduced dimension condition, which accommodates the sliding manipulation of the inner catheter body along the maximum length of porous fluid distribution section. The barrier structure may have an increased dimension condition, which presses against the interior lumen and forms a barrier wall that blocks flow of the dispensed fluid into communication with the porous fluid distribution section proximal of the barrier wall. The assembly may also have a mechanism to selectively reduce and increase the barrier structure within the outer catheter body anywhere along the maximum length of the porous fluid distribution section to establish for the infusion catheter assembly an infinitely variable range of effective infusion lengths between the maximum length and any smaller length along the porous fluid distribution section.
“In yet another aspect of the present invention, an infusion method comprises (i) providing an infusion catheter assembly comprising a catheter body having an interior lumen and including a porous fluid distribution section having a predefined maximum length communicating with the interior lumen. The porous discharge section comprises an array of spaced apart apertures that vary in size and/or density along the length of the porous fluid distribution section. The infusion catheter assembly further comprising at least one fluid delivery port for dispensing a fluid from an external source at an inlet pressure into communication with the porous fluid distribution section for infusion through the porous fluid distribution section at an infusion flow rate, and a barrier mechanism movable within the catheter body to establish for the infusion catheter assembly an infinitely variable range of effective infusion lengths between the maximum length and any smaller length along the porous fluid distribution section. The spaced apart apertures vary in size and/or density in a predetermined fashion along the maximum length such that the flow rate remains essentially constant for a given inlet pressure independent of the effective infusion length. The method also comprises (ii) moving the barrier mechanism within the catheter body to establish a desired effective infusion length, and (iii) infusing a fluid through the desired effective infusion length of the porous fluid distribution section.
“The infusing step may include visualizing the effective infusion length by radiographic imaging of a first radiopaque marker on the catheter body and a second radiopaque marker on the barrier mechanism. Infusing may be performed in a blood vessel, a tissue mass or organ, and may include delivery of a therapeutic agent, anesthesia or treatment of an occlusion of thrombus in the vasculature, or treatment of a tumor.
“In still another aspect of the present invention, an infusion method comprises (i) providing an infusion catheter assembly comprising a catheter body having an interior lumen and including a porous fluid distribution section having a predefined maximum length communicating with the interior lumen. The infusion catheter assembly further comprises at least one fluid delivery port for dispensing a fluid from an external source into communication with the porous fluid distribution section for infusion through the porous fluid distribution section, and a barrier mechanism movable within the catheter body to establish for the infusion catheter assembly an infinitely variable range of effective infusion lengths between the maximum length and any smaller length along the porous fluid distribution section. The method also comprises (ii) moving the barrier mechanism within the catheter body to establish a desired effective infusion length, and (iii) infusing a fluid through the desired effective infusion length of the porous fluid distribution section.
“In still another aspect of the present invention, an infusion catheter assembly comprises an outer catheter body having an interior lumen and including a porous fluid distribution section having a predefined maximum length communicating with the interior lumen. The assembly also comprises an inner catheter body sized and configured, when in use, to be inserted into the outer catheter body and manipulated by sliding within the outer catheter body along the maximum length of the porous fluid distribution section. The inner catheter body includes at least one fluid delivery port for dispensing a fluid from an external source into communication with the porous fluid distribution section for infusion through the porous fluid distribution section. The assembly includes a barrier structure carried by the inner catheter body proximal of the fluid delivery port. The barrier structure has a reduced dimension condition, which accommodates the sliding manipulation of the inner catheter body along the maximum length of porous fluid distribution section, and an increased dimension condition, which presses against the interior lumen and forms a barrier wall that blocks flow of the dispensed fluid into communication with the porous fluid distribution section proximal of the barrier wall. The assembly also includes a mechanism to selectively reduce and increase the dimension of the barrier structure within the outer catheter body anywhere along the maximum length of the porous fluid distribution section to establish for the infusion catheter assembly an infinitely variable range of effective infusion lengths between the maximum length and any smaller length along the porous fluid distribution section.
“The infusion catheter assembly may further include an outer radiopaque marker on the outer catheter body and an inner radiopaque marker on the inner catheter body to visualize the effective infusion length by radiographic imagining. The assembly may have a lumen in the inner catheter body to accommodate passage of a guide wire, and the outer catheter body may also include a lumen to accommodate passage of the guide wire. The porous fluid distribution section may comprise an array of axially spaced-apart apertures or pores that communicate with the interior lumen along the maximum length of the porous fluid discharge section. The porous fluid discharge section may be sized and configured for weep or pulse-spray infusion of the fluid.
“In another aspect of the present invention, an infusion method comprises (i) providing an outer catheter body having an interior lumen and including a porous fluid distribution section having a predefined maximum length communicating with the interior lumen. The method also includes (ii) inserting into the outer catheter body an inner catheter body having at least one fluid delivery port for dispensing a fluid from an external source into communication with the porous fluid distribution section for infusion through the porous fluid distribution section. The inner inner catheter body includes a barrier structure proximal of the fluid delivery port, the barrier structure having a reduced dimension condition and an increased dimension condition. The method also includes (iii) manipulating the inner catheter body by sliding the inner catheter body within the outer catheter body when the barrier structure is in a reduced dimension condition along the maximum length of the porous fluid distribution section; (iv) manipulating the inner catheter body by placing the barrier structure in an increased dimension condition to press the barrier structure against the interior lumen and form a barrier wall that blocks flow of the dispensed fluid into communication with the porous fluid distribution section proximal of the barrier wall; (v) performing (iii) and (iv) to selectively reduce and increase the dimension of the barrier structure within the outer catheter body along the maximum length of the porous fluid distribution section to establish for the infusion catheter assembly a desired effective infusion length, wherein the desired effective infusion length is infinitely variable between the maximum length and any smaller length along the porous fluid distribution section; and (vi) infusing a fluid through the desired effective infusion length of the porous fluid distribution section. Step (v) may be performed using a guide wire.
“These and other aspects and advantages of the invention are evident in the description which follows and in the accompanying drawings.”
URL and more information on this patent application, see: Comerota, Anthony J.; Fogarty, Thomas J.; Olson, Jonathan M.; Lotti, Richard A. Assemblies, Systems, and Methods for Infusing Therapeutic Agents into the Body. Filed February 28, 2014 and posted July 3, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1792&p=36&f=G&l=50&d=PG01&S1=20140626.PD.&OS=PD/20140626&RS=PD/20140626
Keywords for this news article include: Technology, Venous Therapy Inc.
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