US20090259213A1 - Injection tube for jet injection device - Google Patents

Abstract

A non-metal, polymeric tubular device for delivering a therapeutic fluid to a treatment site within a patient. The non-metal, polymeric tubular device can be fabricated using suitable high strength polymers and in some versions can be reinforced through the inclusion of reinforcement materials or braiding. The non-metal, polymeric tubular device can be fabricated so as to have a burst strength exceeding at least about 2,000 psi. The non-metal, polymeric tubular device can be fabricated so as to have distention properties, wherein an orifice or jet port located at a distal end of the polymeric tubular device retains its shape and/or size without suffering swelling that can have a detrimental impact on a fluid jet used to deliver the therapeutic fluid at the treatment site.

Description

PRIORITY CLAIM
• The present application claims priority to U.S. Provisional Patent Application No. 60/866,741, filed Nov. 21, 2006 and entitled, “INJECTION TUBE FOR JET INJECTION DEVICE, which is herein incorporated by reference in its entirety.
FIELD OF THE INVENTION
• The present invention relates generally to jet injection devices for the delivery of therapeutic fluids to a treatment site. More specifically, the present invention relates to a non-metal reinforced polymeric injection tube having performance characteristics compatible with minimally invasive jet injection devices.
BACKGROUND OF THE INVENTION
• A wide variety of medical treatments are at least partially performed through the delivery and introduction of therapeutic compositions to a treatment location. In home or outpatient settings, typical delivery methods can comprise oral delivery, via liquid or solid forms, as well as a variety of inhalant style devices. In clinical or hospital settings, therapeutic fluids can be injected using needle based or in some minimally invasive procedures, the therapeutic fluid can be delivered through a tubular device such as a catheter or endoscope based systems.
• One way in which therapeutic fluids can be delivered internally is through the use of a tubular device configured to provide a jet-injection of the therapeutic fluid at a desired treatment site. Generally, a remote injector is utilized to deliver the therapeutic fluid from an external reservoir located at a proximal end of the tubular device such administration can occur at a distal end of the tubular device. Due to the relatively long travel length of the therapeutic fluid through the tubular device, the remote injector must generally be capable of pressurizing the therapeutic fluid to pressures exceeding about 2,000 psi. In order to accommodate these pressures, the tubular devices have been fabricated of alloys such as NiTi or stainless steel or with metal-reinforced polymers such as the braided tubes typically found in catheters. While the use of alloys and metal reinforced polymers satisfy the operational requirements related to burst pressure and distention strength, they are generally of limited flexibility making them difficult to navigate within the tortuous paths often found in the human body such as, for example, the urogenital tract.
SUMMARY OF THE INVENTION
• The present invention comprises a non-metal, polymeric tubular device for delivering a therapeutic fluid to a treatment site within a patient. The non-metal, polymeric tubular device can be fabricated using suitable high strength polymers including, for example, polyimide, polyetherimide available from General Electric under the trade name Ultem® and linear aromatic polymers such as PEEK™ available from Victrex plc. In some embodiments, the non-metal, polymeric tubular device can be reinforced through the inclusion of materials including nano-particles, clays and/or glass. In some presently contemplated embodiments, the non-metal, polymeric tubular device can be reinforced with one or more polymers such as, for example, tubes braided with carbon fiber, synthetic para-aramid fiber such as Kevlar available from E.I. du Pont de Nemours and Company or other high-strength polymers. The non-metal, polymeric tubular device can be fabricated so as to have a burst strength exceeding at least about 2,000 psi and in some embodiments, having a burst strength within a range of about 2,000 psi to about 5,000 psi. The non-metal, polymeric tubular device can be fabricated so as to have distention properties, wherein an orifice or jet port located at a distal end of the polymeric tubular device retains its shape and/or size without suffering swelling that can have a detrimental impact on a fluid jet used to deliver the therapeutic fluid at the treatment site.
• In one aspect, the present disclosure is directed to a non-metal, polymeric tubular device for delivering a therapeutic fluid to a treatment site within the body wherein the non-metal, polymeric tubular device has a burst strength within a range of about 2,000 psi to about 5,000 psi. The non-metal, polymeric tubular device can be fabricated using suitable high strength polymers including, for example, polyimide, polyetherimide available from General Electric under the trade name Ultem® and linear aromatic polymers such as PEEK™ available from Victrex plc. In some embodiments, the non-metal, polymeric tubular device can be reinforced through the inclusion of materials including nano-particles, clays and/or glass. In some presently contemplated embodiments, the non-metal, polymeric tubular device can be reinforced with one or more polymers such as, for example, tubes braided with carbon fiber, synthetic para-aramid fiber such as Kevlar available from E.I. du Pont de Nemours and Company or other high-strength polymers. In some embodiments, the non-metal, polymeric tubular device can have a tube length ranging from about 18 to about 72 inches. In some embodiments, the non-metal, polymeric tubular device can include an orifice functioning as a jet nozzle, wherein the non-metal, polymeric tubular device has sufficient strength to avoid distention at the orifice.
• In another aspect, the present disclosure is directed to a method of delivering a therapeutic fluid comprising providing a non-metal, polymeric tubular device having a burst strength range of about 2,000 psi to about 5,000 psi, delivering the therapeutic fluid through the non-metal, polymeric tubular device and administering the therapeutic fluid to the treatment site with a jet orifice located at a distal end of the non-metal, polymeric tubular device. The method can further comprise positioning the non-metal, polymeric tubular device through an internal lumen within a patient such as a patient's urogenital tract.
• In yet another aspect of the present disclosure, a therapeutic fluid delivery system can comprise an injector device and a non-metal, polymeric tubular device for delivery a therapeutic fluid to a treatment location within a patient's body. The non-metal, polymeric tubular device can have a burst strength ranging from about 2,000 psi to about 5,000 psi so as to prevent tube failure and to similarly, avoid distention at a jet orifice located at a distal end of the non-metal, polymeric tubular device.
• The above summary of the various representative embodiments of the invention is not intended to describe each illustrated embodiment or every implementation of the invention. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the invention. The figures in the detailed description that follows more particularly exemplify these embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
• FIG. 1 is a perspective view of an embodiment of a therapeutic fluid delivery system for delivering a therapeutic fluid to a treatment location according to the present disclosure.
• FIG. 2 is a side view of an embodiment of a non-metal, polymeric tubular device according to the present disclosure.
• FIG. 3ais a section view of the non-metal, polymeric tubular device ofFIG. 2 taken at line3-3 ofFIG. 2.
• FIG. 3bis a side view of a portion of an embodiment of a non-metal, polymeric tubular device according to the present disclosure.
• FIG. 4 is an illustration of the non-metal, polymeric tubular device positioned for delivery of a therapeutic fluid within a patient's urogenital tract.
• FIG. 5 is a side view of a prior art polymeric tube suffering distention at a jet orifice located at a distal end of the prior art polymeric tube.
• FIG. 6 is a side view of a non-metal, polymeric tubular device of the present invention delivering a therapeutic fluid through jet injection from a jet orifice at a distal end of the non-metal, polymeric tubular device.
• While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives.
DETAILED DESCRIPTION OF THE DRAWINGS
• In the following detailed description of the present invention, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be obvious to one skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as to not unnecessarily obscure aspects of the present invention.
• A needlelessfluid delivery system100 is illustrated generally inFIG. 1. Needlelessfluid delivery system100 can comprise an injector102 and an applicator lumen104. Injector102 can be as simple as manually activated syringe or injector102 can comprise an automated injector103 including auser interface106 and a connector member108. Connector member can include asurface opening109 and atherapeutic fluid supply110.User interface106 can comprise an input means for selectively delivering a pressurized fluid through the connector member108. Representative input means can includefoot pedal107, switches, buttons or a touch-screen capable of receiving touch commands as well as displaying system information including a mode of operation as well as operating parameters.
• As seen inFIGS. 2 and 3a, the applicator lumen104 can comprise a non-metal, polymerictubular device200 having aproximal attachment end202 and adistal treatment end204. Non-metal, polymerictubular device200 can have atube length206 that corresponds to a type of treatment to be performed within a patient's body. For example, when non-metal, polymerictubular device200 is configured to perform a cytoscopic or endoscopic procedure, thetube length206 can range from about 18 to about 72 inches in length.
• Non-metal, polymerictubular device200 is generally formed so as to have a burst strength of at least about 2,000 psi. In a preferred embodiment, the non-metal, polymeric tubular device is formed to have a burst strength ranging from about 2,000 psi to about 5,000 psi. In one representative embodiment, non-metal, polymerictubular device200 is formed of a single high strength polymer such as, for example, a polyimide, polyetherimide available from General Electric under the trade name Ultem® and linear aromatic polymers such as PEEK™ available from Victrex plc. Alternatively, the non-metal, polymerictubular device200 can be formed from a reinforced polymer that is reinforced with reinforcingmaterials207 such as, for example, nano-particles, clays or glass. In another embodiment as shown inFIG. 3b, the non-metal, polymerictubular device200 is reinforced with a reinforcingfiber209 such as, for example, tubes braided with carbon fiber, synthetic para-aramid fiber such as Kevlar available from E.I. du Pont de Nemours and Company or other high-strength polymers braided within non-metal, polymerictubular device200. Generally, the non-metal, polymerictubular device200 is extruded though other appropriate fabrication methods including molding can be utilized as well.
• As illustrated inFIG. 4, non-metal, polymerictubular device200 can be configured as acytoscope300 to deliver therapeutic fluid to atreatment location302 such as, for example, theurinary bladder304.Distal treatment end204 generally accesses the urogenital tract through the urethra306 wherein thedistal treatment end204 enters theurinary bladder304.Cytoscope300 can include a fiber optic scope such that a medical professional can verify thedistal treatment end204 is positioned proximate thetreatment location302.
• In positioning the non-metal polymerictubular device200 attreatment location302, it will be understood that a medical professional frequently employs a medical imaging system such as, for example, computer axial tomography (CAT), magnetic resonance imaging (MRI), or in the case of treatment of a prostate gland, the preferred imaging means is transrectal ultrasound (TRUS) so as to achieve the desired position ofadministration orifice208. Through the use of a medical imaging system, a medical professional can verify that the therapeutic fluid is in fact administered at thetreatment location302.
• Once thedistal treatment end204, and more specifically, theadministration orifice208 is positioned with respect to thetreatment location302, the injector102 can be actuated so as to begin delivery of atherapeutic fluid308 as illustrated inFIG. 6. Generally, injector102 directstherapeutic fluid308 through the non-metal, polymerictubular device200 at low velocities and high pressures generally between about 2,000 psi to about 5,000 psi. The high pressures supplied by the injector102 are necessary due to the pressure losses experienced in the relatively, small diameter non-metal, polymerictubular device200. As thetherapeutic fluid308 reachesdistal treatment end204, thetherapeutic fluid308 is rapidly accelerated through theadministration orifice208 to form afluid jet310. Usingfluid jet310,therapeutic fluid308 can be controllably dispensed directly at thetreatment location302 so as to reduce the potential for exposure to other non-desired areas. As thefluid jet310 moves away from theadministration orifice208, the pressure offluid jet310 is rapidly lost.
• By using non-metal, polymerictubular device200, problems associated with using conventional polymeric tubing can be avoided. With reference toFIG. 5,conventional polymeric tubing400 can suffer a variety of failure modes including, for example, distention or swelling of theconventional polymeric tubing400 at anadministration orifice402. When distention occurs, the changing dimensional characteristics of the administration orifice cause uncontrolled variations in the characteristics of afluid jet404 as well as potential failure and rupture of theconventional polymeric tubing400.
• While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives.

Claims (29)

1-16. (canceled)

17. A method for delivering a therapeutic fluid to a treatment location with a non-metal, polymeric tubular device comprising:

providing a non-metal, polymeric applicator body having a distal end and a proximal connection end, wherein an administration orifice is positioned proximate the distal end, and wherein the applicator body comprises polymer selected from the group consisting of: a polyimide polymer, a polyetherimide polymer, and a linear aromatic polymer;

positioning the administration orifice proximate a treatment location; and

generating a fluid jet through the administration orifice for dispensing a therapeutic fluid at the treatment location.

18. The method ofclaim 17, further wherein:

the non-metal, polymeric applicator body comprises reinforcing materials.

19. The method ofclaim 17, further wherein:

the non-metal, polymeric applicator body comprises reinforcing fiber.

20. The method ofclaim 17, wherein generating the fluid jet comprises pressurizing the therapeutic fluid with an injector attached to the proximal connection end.

21. The method ofclaim 17 wherein the applicator body has a burst pressure of at least about 2,000 psi.

22. The method ofclaim 17 wherein the applicator body comprises polyether ether ketone.

23. The method ofclaim 17 wherein the applicator body is formed of non-reinforced polyether ether ketone polymer.

24. The method ofclaim 17 wherein the applicator body is formed of reinforced polyether ether ketone polymer.

25. The method ofclaim 17 comprising placing the applicator body in a patient's urogenital tract.

26. The method ofclaim 17 comprising passing the applicator body within a urethra.

27. The method ofclaim 17 wherein the treatment location comprises tissue of a bladder.

28. The method ofclaim 17 comprising injecting therapeutic fluid into tissue at the treatment location.

29. The method ofclaim 17 wherein the applicator body comprises a polymeric tubular device comprising sidewalls defining a lumen, the sidewalls and lumen terminating at a distal lumen end, wherein the distal lumen end is closed and the administration orifice is a bore through the sidewall, the bore being located along a length of the tubular device on a proximal side of the distal lumen end.

30. The method ofclaim 29 wherein the applicator body comprises polyether ether ketone, the method comprising placing the applicator body in a patient's urethra and injecting therapeutic fluid into tissue at the treatment location.

31. The method ofclaim 30 wherein the treatment location comprises tissue of a bladder.

32. A method for delivering a therapeutic fluid to a treatment location with a non-metal, polymeric tubular device comprising:

providing a non-metal, polymeric applicator body having a distal end and a proximal connection end, wherein an administration orifice is positioned proximate the distal end;

positioning the administration orifice proximate a treatment location; and

generating a fluid jet comprising therapeutic fluid through the administration orifice to inject therapeutic fluid into tissue at the treatment location.

33. The method ofclaim 32 comprising placing the applicator body in a patient's urogenital tract.

34. The method ofclaim 32 wherein the treatment location comprises tissue of a bladder.

35. The method ofclaim 32 wherein the applicator body comprises a polymeric tubular device comprising sidewalls defining a lumen, the sidewalls and lumen terminating at a distal lumen end, wherein the distal lumen end is closed and the administration orifice is a bore through the sidewall, the bore being located along a length of the tubular device on a proximal side of the distal lumen end.

36. The method ofclaim 35 wherein the applicator body comprises polyether ether ketone, the method comprising placing the applicator body in a patient's urethra and injecting therapeutic fluid into tissue at the treatment location.

37. A method for delivering a therapeutic fluid to a treatment location with a non-metal, polymeric tubular device comprising:

providing a non-metal, polymeric applicator body having a distal end and a proximal connection end, wherein an administration orifice is positioned proximate the distal end, and wherein the applicator body has a burst pressure of at least about 2,000 psi;

positioning the administration orifice proximate a treatment location; and

generating a fluid jet through the administration orifice for dispensing a therapeutic fluid at the treatment location.

38. The method ofclaim 37 comprising placing the applicator body in a patient's urogenital tract.

39. The method ofclaim 37 wherein the treatment location comprises tissue of a bladder.

40. The method ofclaim 37 wherein the applicator body comprises a polymeric tubular device comprising sidewalls defining a lumen, the sidewalls and lumen terminating at a distal lumen end, wherein the distal lumen end is closed and the administration orifice is a bore through the sidewall, the bore being located along a length of the tubular device on a proximal side of the distal lumen end.

41. The method ofclaim 37 wherein the applicator body comprises polyether ether ketone, the method comprising placing the applicator body in a patient's urethra and injecting therapeutic fluid into tissue at the treatment location.

42. The method ofclaim 17 wherein during generating a fluid jet through the administration orifice, dimensional characteristics of the administration orifice remain constant under the influence of the fluid jet.

43. The method ofclaim 32 wherein during generating a fluid jet through the administration orifice, dimensional characteristics of the administration orifice remain constant under the influence of the fluid jet.

44. The method ofclaim 37 wherein during generating a fluid jet through the administration orifice, dimensional characteristics of the administration orifice remain constant under the influence of the fluid jet.

Images