Patent Application
20130226094
The technical field of this invention is implantable medical devices, and in particular, a dilator and sheath useful for performing percutaneous nephrostomy procedures.
Minimally-invasive surgery has evolved to a point where procedures that were unimaginable a few years ago are now routinely performed on a daily basis. These procedures may involve a physician operating internally on a patient's body through a relatively small opening. Access to the small opening may be obtained percutaneously by opening a tract into a patient's body and inserting a sheath through the tract. The sheath helps to maintain the patency of the tract and facilitates the insertion, placement and removal of endoluminal devices to the target area.
One particular procedure involving the introduction of a sheath for the performance of minimally-invasive surgery is a percutaneous nephrostomy. Percutaneous nephrostomy is a procedure that can be used to provide percutaneous access to the upper urinary tract by creating an opening between the renal pelvis and the outside of the body. Additionally, percutaneous nephrostomy may be used to remove or dissolve renal calculi, to obtain direct access to the upper urinary tract for various endourologic procedures, to diagnose ureteral obstruction, filling defects, and anomalies via antegrade radiography, to deliver chemotherapeutic agents to the renal collecting system, and to provide prophylaxis after resection for local chemotherapy in patients with tumors of the renal pelvis. Prior to inserting the sheath, generally a small tract is made with a needle through a patient's body and into the renal pelvis. Following creation of the tract, a physician inserts one or more dilation catheters to increase the size of the tract to the kidney and to allow for proper introduction of the sheath. Because axial pressure is required to advance and place the sheath, care must be taken to avoid kinking the sheath too far and perforating the renal pelvis. The procedure also requires multiple steps to provide access to the target area. Furthermore, for obese patients, the procedure provides the possibility that the sheath may get displaced within subcutaneous layers of fat tissue, which may result in difficulties in performing the procedure, and cause the patient additional trauma.
The present disclosure relates to an introducer assembly. The introducer assembly includes an introducer sheath having a proximal end. A lumen is disposed longitudinally through the interior of the introducer sheath. A hub is attached about the proximal end of the sheath. The hub includes an opening disposed through its center. The opening is in fluid communication with the lumen of the introducer sheath. A dilator clip is releasably attached to the hub of the introducer sheath. The dilator clip comprises a base having a proximal portion and a distal portion. Disposed on the distal portion of the dilator clip is a dilator. The dilator is coaxially positioned within the lumen of the introducer sheath while the dilator clip is attached to the hub.
In one aspect, the introducer sheath includes one or more attachment locations for securing the hub to the skin surface of a patient. For one example, the one or more attachment locations may comprise a plurality of apertures configured to receive sutures. In other aspects, the dilator clip includes engaging members configured to interlock with receiving members of the hub. The engaging members may include one or more clasps that engage the receiving members of the hub. In another aspect, the dilator clip includes one or more flanges extending proximally from the base of the dilator clip to manipulate the dilator. The flanges may have an ergonomic profile and may include ergonomic features such as nubs, grooves, and the like.
In another aspect, a hub for an introducer assembly includes a main body. At least one opening is disposed through the main body. The hub further includes one or more receiving members disposed about the periphery of the main body. The one or more receiving members are configured to receive a dilator clip. In one aspect, the hub has a concave configuration. In another example, the hub further includes a wire guide receiving member. The wire guide receiving member may include a plurality of hooks to secure the wire guide during the procedure.
In further aspect, an introducer assembly includes an introducer sheath having a proximal end. A lumen is disposed longitudinally through the interior of the introducer sheath. A hub is attached about the proximal end of the sheath. The hub includes a main body having at least one opening disposed through its center in fluid communication with the lumen of the introducer sheath. The hub further includes a wire guide receiving member attached about a periphery of the main body. A dilator clip is releasably attached to the hub of the introducer sheath. The dilator clip comprises a base having a proximal portion and a distal portion. Disposed on the distal portion of the dilator clip is a dilator. The dilator is coaxially positioned within the lumen of the introducer sheath while the dilator clip is attached to the hub. In some embodiments, the dilator is integral with the dilator clip.
Other systems, methods, features and advantages of the invention will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be within the scope of the invention, and be encompassed by the following claims.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.
The term “prosthesis” means any device for insertion or implantation into, or replacement, for a body part or function of that body part. It may also mean a device that enhances or adds functionality to a physiological system. The term prosthesis may include, for example and without limitation, a stent, stent-graft, filter, valve, balloon, embolization coil, and the like.
The term “endoluminal” refers to or describes the internal or inside of a lumen, duct, and other passageways or cavities located in a human or other animal body. A lumen or a body passageway may be an existing lumen or a lumen created by surgical intervention. As used in this specification, the terms “lumen” or “body passageway,” and “vessel” are intended to have a broad meaning and encompass any duct (e.g., natural or iatrogenic) or cavity within the human body and may include, without limitation, blood vessels, respiratory ducts, gastrointestinal ducts, such as the biliary duct, intestines, the esophagus, the pericardial cavity, the thoracic cavity, the pericardial cavity, and the like. Accordingly, the terms “endoluminal device” or “endoluminal prosthesis” describe devices that can be placed inside or moved through any such lumen or duct.
The terms “patient,” “subject,” and “recipient” as used in this application may refer to any animal, particularly humans.
The term “biocompatible” refers to a material that is substantially non-toxic in the in vivo environment of its intended use, and that is not substantially rejected by the patient's physiological system (i.e., is non-antigenic). This can be gauged by the ability of a material to pass the biocompatibility tests set forth in International Standards Organization (ISO) Standard No. 10993 and/or the U.S. Pharmacopeia (USP) 23 and/or the U.S. Food and Drug Administration (FDA) blue book memorandum No. G95-1, entitled “Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing.” Typically, these tests measure a material's toxicity, infectivity, pyrogenicity, irritation potential, reactivity, hemolytic activity, carcinogenicity and/or immunogenicity. A biocompatible structure or material, when introduced into a majority of patients, will not cause a significantly adverse, long-lived or escalating biological reaction or response, and is distinguished from a mild, transient inflammation which typically accompanies surgery or implantation of foreign objects into a living organism.
The term “medical device” means any object that is itself or that includes a component that is intentionally inserted into the body of a patient as part of a medical treatment, and that comprises a structure adapted for introduction into a patient. The medical device can be a tool, such as, without limitation, a catheter, a wire guide, a forceps, or a scissors used to affect a surgical procedure at and/or deliver a second medical device to a treatment site in a patient. An alternative medical device of the present invention is one that is commonly intended to be a permanent implant, such as a stent.
In the following discussion, the terms “proximal” and “distal” will be used to describe the opposing axial ends of the assembly, as well as the axial ends of various components thereof. The term “proximal” is used in its conventional sense to refer to the end of the assembly (or component thereof) that is the closest to the operator during use of the assembly. The term “distal” is used in its conventional sense to refer to the end of the assembly (or component thereof) that is initially inserted into the patient, or that is closest to the patient during use.
In some aspects, the introducer assembly 10 is intended to deliver endoluminal devices, such as a ureteral stent, into a patient through a percutaneous nephrostomy procedure in which the introducer assembly 10 is advanced through a person's skin to reach the calices of the kidney directly. However, the introducer assembly 10 is not limited for use in a percutaneous nephrostomy procedure but may be used in other procedures. For instance, if a path to a bile duct is needed, the physician may access the bile duct through an endoscope via the mouth, esophagus, stomach and intestines, or via laparoscopic methods directly through the skin (percutaneous). If vascular access is desired, a physician may access the blood vessel through an opening, such as an opening manufactured in the femoral artery.
The introducer sheath 12 may be made from any suitable biocompatible material, for example polytetrafluoroethylene (PTFE), nylon, or polyethylene. In this embodiment, the introductory sheath 12 includes an outer layer 18. The outer layer 18 may comprise a low friction non rigid or semi rigid material. The outer layer 18 of the introducer sheath 12 may include one or more discrete PEBAX sections that vary in durometer from a high durometer at the proximal end 14 of the sheath 12 to a lower durometer at the distal end 16 of the sheath 12. The introducer sheath 12 may optionally include a flat wire coil or braid disposed between or incorporated into the one or more layers to the introducer sheath 12 with increased pushability and kink-resistance as the introducer sheath 12 is introduced into the body lumen or cavity, as described in U.S. Pat. Nos. 5,380,304 and 5,700,253, which are incorporated herein by reference in their entirety. To increase lubricity, the outer layer 18 of the introducer sheath 12 may be coated with a hydrophilic coating.
The introducer sheath 12 further includes a hub 20 positioned at its proximal end. The hub 20 is used to maintain the introducer sheath 12 in the desired position upon the outer skin surface of the patient. The hub 20 may be comprised from materials having a high flex modulus such as ABS plastic and nylon. The hub 20 may be manufactured using any suitable process conventionally used to shape polymeric materials such as thermoplastic and elastomeric materials. Examples of such shaping processes include, but are not limited to, injection molding, insert molding, calendaring, and casting.
A dilator 19 may be introduced simultaneously, or jointly, with the introduction of the introducer sheath. The dilator 19 is used by the physician to dilate a tract, or passage, for the introducer sheath 12. The dilator 19 has a tubular shaft body having a proximal end 21 and a distal end 23. A lumen (not shown) may be disposed completely therethrough from the proximal end 21 to the distal end 23. The dilator 19 is generally sized to fit within the inner diameter of the sheath 12, and has a length greater than the length of the sheath 12. Accordingly, the outer diameter of the dilator 19 should be sized to be smaller than the inner diameter of the introducer sheath 12. The size of the dilator 19 may range from about 6 Fr to about 30 Fr.
As shown in the embodiment of
The pair of are configured to engage with the portions of a dilator clip 30, as will be discussed below. As shown in this embodiment, the receiving members comprise two recessed areas positioned on opposite sides of the hub 20. Each receiving member 24 has generally a “U-Shape,” which provides a recess formed between a pair of walls 28 to receive the corresponding engaging members of the dilator clip 30. The distance between the walls 28 may be about 0.47 cm. Other embodiments of the hub 20 may comprise receiving members having different configurations. In one aspect, the receiving members 24 may include regions configured to engage with corresponding teeth on the dilator clip 30. The hub 20 also includes attachment regions 26 disposed about the periphery of the hub 20. The attachment regions 26 are positioned on opposite sides of the hub 20 that do not include a pair of receiving members 24. The attachment regions 26 may comprise a pair of apertures, which may receive sutures or other devices in order to secure the hub 20 to the skin of the patient. The attachment regions 26 may have a diameter of about 0.20 cm. In other embodiments, the hub 20 may be secured to the skin surface of a patient through the use of biocompatible adhesives or other connecting devices.
The engaging members 34 are manipulated by the pair of flanges 38 attached to the proximal portion 31 of the base 32 and extending in a proximal direction from the base 32 of the dilator clip 30. The flanges 38 may be formed integrally with the base 32 of the dilator clip 30, or alternatively, may be separately attached to the base 32. In a preferred embodiment, the flanges 38 are insert molded during the manufacturing process of the dilator clip 30. The flanges 38 may be provided with an ergonomic grip shape. The ergonomic shape allows a physician to conveniently grasp and manipulate both the dilator 19 and the introducer sheath 12 during introduction of both of those devices when the dilator clip 30 is attached to the hub 20. In addition to the ergonomic profile, the flanges 38 may also include additional ergonomic surfaces, such as nubs, grooves, and the like, disposed about the exterior of the flanges 38. The flanges 38 of the dilator clip 30 may have a length of about 0.58 cm. Alternative embodiments of the dilator clip 30 may include flanges 38 having lengths greater than 0.58 cm in order to accommodate the user of the dilator clip 30. The dilator clip 30 may have an associated connecting adaptor 40 disposed on the proximal portion 31 of the base 32. The connecting adaptor 40 has a central opening 41 that is in fluid communication with the lumen of the dilator 19. The connecting adaptor 40 preferably has a male Luer lock thread to facilitate the attachment of tubing or a syringe to the dilator clip 30.
A method of using the introducer assembly 10 is described below. Prior to performing the procedure, the physician introduces an interventional device, such as a cannula and stylet, into the body of the patient to create an access tract. A guide wire is then inserted into the body opening over, or through, the cannula and stylet. Following the insertion of the access tract, a guide wire is introduced into the patient. With the dilator clip 30 attached to the hub 20 of the introducer sheath 12, the physician introduces the introducer sheath 12 and the dilator 19 simultaneously over the guide wire. The dilator 19 is used to expand the tract to accommodate the introducer sheath 12. As the dilator 19 is advanced into the body, the access tract gradually increases in diameter as a result of the shape of the distal end 23 of the dilator 19. The hub 20 is secured to the outer skin surface of the patient by placing sutures through the attachment regions 26 of the hub 20. Following the expansion of the tract, the physician may remove the dilator 19 from the body of the patient by utilizing the flanges 38 on the dilator clip 30 to release the engaging members 34 from the receiving members of the hub 20. The physician may then introduce a prosthesis, such as a stent, into the body of the patient through the introducer sheath 12. After the prosthesis is implanted, the physician can detach the hub from the patient's skin and retract the introducer sheath 12.
The hub 42 further includes a pair of receiving members 50. The receiving members may comprise a plurality of configurations. In the embodiments shown in
Throughout this specification various indications have been given as to preferred and alternative embodiments of the invention. However, the foregoing detailed description is to be regarded as illustrative rather than limiting and the invention is not limited to any one of the provided embodiments. It should be understood that it is the appended claims, including all equivalents, that are intended to define the spirit and scope of this invention.
The present application claims priority to U.S. Provisional Patent Application Ser. No. 61/604,329 filed Feb. 28, 2012, the entirety of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61604329 | Feb 2012 | US |
