Injection Tube for Jet Injection Device
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.
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 INVENTIONThe 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 INVENTIONA 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 INVENTIONThe 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 PEEKTM 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 PEEKTM 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.
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:
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 DRAWINGSIn 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 needleless fluid delivery system 100 is illustrated generally in
As seen in
Non-metal, polymeric tubular device 200 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, polymeric tubular device 200 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 PEEKTM available from Victrex plc. Alternatively, the non-metal, polymeric tubular device 200 can be formed from a reinforced polymer that is reinforced with reinforcing materials 207 such as, for example, nano-particles, clays or glass. In another embodiment as shown in
As illustrated in
In positioning the non-metal polymeric tubular device 200 at treatment location 302, 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 of administration orifice 208. Through the use of a medical imaging system, a medical professional can verify that the therapeutic fluid is in fact administered at the treatment location 302.
Once the distal treatment end 204, and more specifically, the administration orifice 208 is positioned with respect to the treatment location 302, the injector 102 can be actuated so as to begin delivery of a therapeutic fluid 308 as illustrated in
By using non-metal, polymeric tubular device 200, problems associated with using conventional polymeric tubing can be avoided. With reference to
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
1. A non-metal, polymeric tubular device for delivering therapeutic fluids to treatment locations within a patient's body comprising:
- an applicator body defining a lumen, the applicator body including 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 such that dimensional characteristics of the administration orifice remain constant under the influence of a fluid jet.
2. The non-metal, polymeric tubular device of claim 1, wherein the applicator body is fabricated of a polymer selected from the group consisting of: a polyimide polymer, a polyetherimide polymer and a liner aromatic polymer.
3. The non-metal, polymeric tubular device of claim 1, wherein the applicator body is fabricated of a polymer having a reinforcing material selected from the group consisting of: nano-particles, clay particles and glass particles.
4. The non-metal, polymeric tubular device of claim 1, wherein the applicator body is fabricated of a polymer having a reinforcing fiber selected from the group consisting of: carbon fiber and a synthetic para-aramid fiber.
5. The non-metal, polymeric tubular device of claim 1, wherein the applicator body has a tube length of about 18 inches to about 72 inches.
6. The non-metal, polymeric tubular device of claim 1, wherein the applicator body comprises an extruded applicator body.
7. The non-metal, polymeric tubular device of claim 1, wherein the burst pressure of the applicator body is about 2,000 to about 5,000 psi.
8. A needleless fluid delivery system comprising:
- an injector; and
- an applicator body defining a lumen, the applicator body including 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 about 2,000-5,000 psi such that dimensional characteristics of the administration orifice remain constant under the influence of a fluid jet.
9. The needleless fluid delivery system of claim 8, further comprising:
- a medical imaging system for visualizing the position of the administration orifice at a treatment location.
10. The needleless fluid delivery system of claim 8, wherein the injector comprises a syringe.
11. The needleless fluid delivery system of claim 8, wherein the injector comprises an automated injector having a user interface and a connector member attaching to the proximal connection end.
12. The needleless fluid delivery system of claim 8, wherein the applicator body is fabricated of a polymer selected from the group consisting of: a polyimide polymer, a polyetherimide polymer and a liner aromatic polymer.
13. The needleless fluid delivery system of claim 8, wherein the applicator body is fabricated of a polymer having a reinforcing material selected from the group consisting of: nano-particles, clay particles and glass particles.
14. The needleless fluid delivery system of claim 8, wherein the applicator body is fabricated of a polymer having a reinforcing fiber selected from the group consisting of: carbon fiber and a synthetic para-aramid fiber.
15. The needleless fluid delivery system of claim 8, wherein the applicator body has a tube length of about 18 inches to about 72 inches.
16. The needleless fluid delivery system of claim 8, wherein the applicator body comprises an extruded applicator body.
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 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 such that dimensional characteristics of the administration orifice remain constant under the influence of the fluid jet.
18. The method of claim 17, further comprising:
- reinforcing the non-metal, polymeric applicator body through the inclusion of reinforcing materials.
19. The method of claim 17, further comprising:
- reinforcing the non-metal, polymeric applicator body through the inclusion of a reinforcing fiber.
20. The method of claim 17, wherein generating the fluid jet comprises pressurizing the therapeutic fluid with an injector attached to the proximal connection end.
Type: Application
Filed: Nov 21, 2007
Publication Date: May 22, 2008
Inventor: Justin M. Crank (Maple Grove, MN)
Application Number: 11/944,081
International Classification: A61M 25/00 (20060101);