Patent Application
20110224625
The present invention relates to the delivery of fluid, powder, gas or gel to a lumen within the body for irrigation, delivery of biologically active materials or for the delivery of medication.
Catheters and other devices such as trochars intended to deliver irrigants, medication or biologicals within the body have conflicting requirements of pushability to deliver the tip of the catheter or device while at the same time not causing inadvertent damage to tissue, including but not limited to punctures, abrasions or contusion to structures in or near the target area.
Inadvertent puncture of the mucosal lining of the body lumen can result in the inadvertent delivery of materials to areas of the body other than the target areas, which can result in significant harm or even death to the patient. For example, intranasal delivery of drugs intended for mucosal delivery that are in advertently delivered into the sub-mucosal space may occlude the ocular veins, which can result in blindness. As another example, materials delivered to the lower esophageal sphincter region which are inadvertently delivered across the esophagus and into the thoracic or abdominal space have been shown to migrate to the aorta and cause rupture and subsequent death.
Soft devices require guide wires or guide catheters to stiffen them, and devices that are stiff enough to advance into the lumen without such guide wires or catheters may be too stiff and cause inadvertent damage as described above. Therefore, it would be desirable to have a method and device for the topical delivery of materials to lumenal structures in the body, specifically structures accessed by open orifices including the nose, mouth, ear urethra and anus, that does not suffer from the risks of inadvertent injury associated with prior art devices.
The present invention provides a method and device for irrigation and topical delivery of materials within body lumens accessible by natural orifices. The device includes a catheter body containing a delivery lumen for transporting material. The catheter body is pre-shapeable at room temperature and holds its shape during insertion into body lumen. In one embodiment, the catheter body also includes a wire lumen that runs parallel to the delivery lumen and holds a malleable wire used for pre-shaping the catheter body before use. A connector such as a luer lock connector is located at the proximal end of the catheter body for connecting the device to a reservoir, and a tip is located at the distal end of the catheter body for insertion into body lumen. The tip includes axial and/or radial exit holes for delivery of therapeutic material transported through the catheter body. The tip is larger in diameter than the catheter body, thereby diffusing insertion pressure across a wider area, thus minimizing abrasion, contusion and accidental puncture of body tissue. The proximal end of the tip is tapered to the diameter of the catheter body to allow withdrawal of the tip without causing tissue trauma.
The tip may have a durometer that is softer than target tissue in the body lumen, causing the device to deflect away from the tissue when it makes contact, thereby preventing tissue damage and is made from biocompatible materials such as, e.g., polycarbonate, PVC, silicone, thermoplastic polyurethane (TPU) and thermoplastic elastomers (TPE) such as PEBAX®. The tip can be a molded tip that is attached to the distal end of the catheter body or made from an extension of the catheter body material.
The novel features believed characteristic of the invention are set forth in the appended claims. The invention itself, however, as well as mode of use and advantages thereof, will best be understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying drawings, wherein:
The present invention improves upon current delivery systems and provides a method of delivering materials directly to bodily lumens reached by natural orifices while protecting the soft tissue found in these lumens from inadvertent abrasion, contusion or puncture. Examples of targets areas of treatment include the nasal cavity and sinuses, the digestive syste, the urinary system, the ear canal, the lower respiratory system, the lacrimal canal, and the Eustachian tube.
The tip 103 includes exit holes 104 (shown in more detail in
The larger surface of the tip 103 diffuses the insertion pressure across a wider area of tissue and is shaped to float on the surface of the body lumen. A taper section 203 at the proximal end of the tip 103 provides a smooth transition between the narrower diameter of the catheter body 102 and the larger diameter of the tip 103 (shown more clearly in
This configuration enables the tip lumen 320 to act as a manifold that equalizes the pressure of the material to be delivered so that it flows out of each exit hole 201, 202 at an equal rate, all other things being equal. The wire lumen 311 (see
The taper section 203 at the proximal shoulder of the tip mates smoothly with the outside surface 312 of the catheter body 102 to allow atraumatic withdrawal of the tip 103, as explained above. The tip 103 also features an inner stop 321 that stops the catheter body 102 from infringing too deeply into the tip lumen 320.
As explained above, the tip of the device can be a molded tip that is attached to the body. The tip can be a softer durometer tip that is softer than the target tissue in the body lumen so that the tissue deflects the device when it comes into contact, thereby preventing inadvertent abrasion, contusion or puncture. This softer durometer tip can be isodiametric with the body so that the device is easily compatible with guide catheters, endoscopes or other introducers. The tip can be made from a variety of biocompatible materials including, e.g., polycarbonate, PVC, silicone, thermoplastic polyurethane (TPU) and thermoplastic elastomers (TPE) such as PEBAX®.
Alternatively, the tip of the delivery device can be a formed tip made from an extension of the body material. This embodiment is shown in
In another embodiment, the body is a simple tube with adequate stiffness. The tube is made of a suitable polymer that can be shaped by the user at room temperature and hold its shape.
In yet another embodiment, shown in
The description of the present invention has been presented for purposes of illustration and description, and is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art. The embodiment was chosen and described in order to best explain the principles of the invention, the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use contemplated. It will be understood by one of ordinary skill in the art that numerous variations will be possible to the disclosed embodiments without going outside the scope of the invention as disclosed in the claims.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/312,942 filed Mar. 11, 2010 the technical disclosures of which are hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61312942 | Mar 2010 | US |
