Patent Application
20130053783
Implantable medical devices may be implanted in a patient to perform a therapeutic function for that patient. Non-limiting examples of such devices include pace makers, access ports (such as vascular access ports, infusion ports, and ports used with gastric band systems, etc.) and gastric pacing devices. Such implants may need to be attached, perhaps subcutaneously, in an appropriate place in order to function properly. It may be desirable that the procedure to implant such devices be quick, easy and efficient.
Ports may be placed beneath the skin of a body for injecting fluids into or withdrawing fluids from the body. By way of example, vascular access ports may be used for infusing medication, blood draws, and many other applications. Injection ports may be used for adding or withdrawing fluid in adjustable gastric band systems. These various access ports may include an implantable port housing coupled to a fluid conduit which delivers fluid to or withdraws fluid from a location in the patient's body (e.g., a vein or a gastric band, etc.).
Gastric band systems are operable to restrict the flow of food from the esophagus into the stomach. Some gastric bands include a fluid-filled elastomeric bladder with fixed endpoints that encircles the stomach just inferior to the gastro-esophageal junction. When fluid is added to the bladder, the band expands against the stomach, creating a food intake restriction or stoma in the stomach. To decrease this restriction, fluid is removed from the bladder. Examples of gastric bands are disclosed in U.S. Pat. No. 7,416,528, entitled “Latching Device for Gastric Band,” issued Aug. 26, 2008, the disclosure of which is incorporated by reference herein. Another example of such an adjustable gastric band is disclosed in U.S. Pat. No. 6,067,991, entitled “Mechanical Food Intake Restriction Device,” issued May 30, 2000, the disclosure of which is incorporated by reference herein.
To the extent that an adjustable gastric band system includes an injection port configured to receive the needle of a syringe assembly in order to add or withdraw fluid to or from the gastric band, those of ordinary skill in the art will appreciate that it may be desirable in some settings to locate both the injection port and, more specifically, the center of the injection port (e.g., when the septum of the injection port is at the center of the injection port). Locating the approximate center of the injection port with some degree of accuracy may facilitate addition or withdrawal of fluid via the injection port to adjust the gastric band system. One example of a system and method for identifying the location of an injection port is disclosed in U.S. Pub. No. 2006/0211914, entitled “System and Method for Determining Implanted Device Positioning and Obtaining Pressure Data” published Sep. 21, 2006, the disclosure of which is incorporated by reference herein.
Those of ordinary skill in the art will appreciate that it may be advantageous in certain circumstances to sense pressure, strain, and/or other parameters associated with operation of a gastric band device. In some settings, it may be desirable to obtain data indicative of the pressure of fluid in a gastric band. Various examples of methods and devices for obtaining pressure data and other types of data are disclosed in U.S. Pub. No. 2006/0189888, entitled “Device for Non-Invasive Measurement of Fluid Pressure in an Adjustable Restriction Device,” published Aug. 24, 2006, the disclosure of which is incorporated by reference herein. Additional examples of methods and devices for obtaining pressure data and other types of data are disclosed in U.S. Pub. No. 2006/0199997, entitled “Monitoring of a Food Intake Restriction Device,” published Sep. 7, 2006, the disclosure of which is incorporated by reference herein. Such parameter data may be obtained before, during, and/or after adjustment of a gastric band, and may be useful for adjustment, diagnostic, monitoring, or other purposes, and may also be obtained with respect to a mechanically actuated gastric band. In settings where a fluid-filled gastric band is used, pressure data may be used to determine whether the amount of fluid in the gastric band needs to be adjusted; and/or for other purposes.
While a variety of implantable access ports and gastric band systems have been made and used, it is believed that no one prior to the inventor(s) has made or used an invention as described herein.
While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:
The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. For example, while various embodiments of ports having tissue in-growth promoting surfaces and/or features are depicted and described as being part of a gastric band system, the tissue in-growth surfaces and features may be employed with other types of implantable medical ports or other medical devices. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
I. Exemplary Gastric Band System
Port housing (14) may comprise a unitary structure (e.g., a one piece housing insert molded about septum (16), etc.). Alternatively, port housing (14) may be assembled from two or more mating components such as a port body that at least partially receives a port base therein. Port housing (14) may be formed of titanium, plastic, or any other suitable material or combination of materials. Septum (16) may be formed of silicone or any other suitable material or combination of materials.
Injection port (12) may be subcutaneously secured over a patient's sternum, to the patient's abdominal fascia, or in any other suitable location. By way of example, port (12) may be sutured in place using the suture apertures (15) located about the periphery of port housing (14). In some other versions, injection port (12) may be configured and operable in accordance with the teachings of U.S. Pub. No. 2005/0283118, entitled “Implantable Medical Device with Simultaneous Attachment Mechanism and Method,” published Dec. 22, 2005, the disclosure of which is incorporated by reference herein. For example, injection port (12) may be configured to include a plurality of fasteners that are selectively deployed from the injection port in order to secure the port in place within a patient, as further described in U.S. Pub. No. 2005/0283118. Alternatively, injection port (12) may have any other suitable configuration and/or operability.
Gastric band (20) of the present example comprises an inflatable bladder (22) that is secured to a flexible strap (24). Inflatable bladder (22) may be formed of silicone or any other suitable material or combination of materials. Catheter (18) provides fluid communication between bladder (22) and the reservoir of injection port (12). Catheter (18) may be formed of silicone or any other suitable material or combination of materials. In the present example, catheter (18), bladder (22), and injection port (12) form a closed fluid circuit. Accordingly, a needle that is inserted through septum (16) into the underlying reservoir may be used to add fluid to or withdraw fluid from inflatable bladder (22) in order to adjust the restriction created by gastric band (20) as described in greater detail below. In some versions, gastric band (20) is configured and operable in accordance with the teachings of U.S. Pat. No. 7,416,528, entitled “Latching Device for Gastric Band,” issued Aug. 26, 2008, the disclosure of which is incorporated by reference herein. Alternatively, gastric band (20) may have any other suitable configuration and/or operability.
In some settings, gastric band (20) is applied about the gastro-esophageal junction of a patient. In particular, and as shown in
As shown in
It may be desirable to have a way of determining whether catheter (18) is properly coupled with the barbed stem of injection port (12). For example, in some instances, if catheter (18) is not properly secured over the barbed stem, catheter (18) may leak as fluid is being delivered from injection port (12) to gastric band (20). In examples described herein, suture apertures (15) are used to suture injection port (12) into place within the patient. Thus, it may be desirable to prevent injection port (12) from being fully sutured in place until catheter (18) and the barbed stem are in fact sufficiently secured together. Various examples will be described below that relate to structures for preventing injection port (12) from being fully sutured in place until catheter (18) and the barbed stem are in fact sufficiently secured together. Other examples will be apparent to those of ordinary skill in the art in view of the teachings herein.
II. Exemplary Locking Connector with Suture Holes
Injection port (112) also defines suture apertures (115) through which sutures may be used to secure injection port (112) within a patient. As shown in
In an exemplary use, a user may grasp locking connector (100) and press locking connector (100) against injection port (112) to establish a fluid tight connection between catheter (118) and injection port (112) by coupling catheter (118) and barbed stem (127). Once suture apertures (115) and complementary apertures (103) are aligned, the user may use that alignment as verification that locking connector (100) is properly connected with injection port (112) and that it is appropriate to pass sutures through suture apertures (115) to secure injection port (112) to the patient's tissue.
In some other exemplary versions, before complementary apertures (103) align with suture apertures (115), a hinged member or other suitable member may block suture apertures (115) until locking connector (100) is fully engaged with injection port (112). Once fully engaged, the hinged member is rotated by locking connector (100) thereby moving aside to reveal suture apertures (115). As yet another merely illustrative variation, catheter (118) may directly engage the hinged member to thereby move the hinged member to reveal suture apertures (115).
III. Exemplary Safety Trigger for Suture Holes
In some exemplary versions, as shown in
Locking connector (200) further comprises engagement feature (202) operable to engage cover (230). In particular, engagement feature (202) is configured and positioned to push cover (230) along the bottom of housing (214) as locking connector (200) is pressed against injection port (212).
IV. Exemplary Injection Port with Locking Members
Locking members (304) further define a pair of complementary apertures (303) that complement suture apertures (315) formed in housing (314) of injection port (312). Complementary apertures (303) and suture apertures (315) are positioned such that complementary apertures (303) and suture apertures (315) are only aligned when locking members (304) are in the fully closed position as shown in
V. Exemplary Rotating Feature
Injection port (412) of the present example further comprises a septum (416) that is operable to receive a needle for providing fluid to catheter (418) via barbed stem (427). Disc (413) encircles septum (416) such that a needle may still be inserted into septum (416) even with disc (413) mounted on injection port (412). Disc (413) defines a plurality of disc openings (415), which form a circular pattern around the periphery of disc (413). However, any suitable arrangement for disc openings (415) may be used as would be apparent to one of ordinary skill in the art in view of the teachings herein. Disc openings (415) correspond to suture openings (417) that are formed in a lower annular flange of injection port (412). Disc (413) is rotatable between an open position and a closed position to selectively reveal suture openings (417) of injection port (412). When disc (413) is rotated to a closed position, as seen in
In some versions, locking member (404) is operable to engage a switch, trigger, or other feature within injection port (412) to toggle disc (413) between the open and closed positions. For instance, disc (413) may be resiliently biased to the closed position (e.g., by a ribbon spring, etc.), and features of injection port (412) and/or locking member (404) may transition disc (413) to the open position, against the resilient bias, upon locking member (404) being fully seated against injection port (412). In some versions, simply engaging and securing the connection between locking member (404) and injection port (412) may be sufficient to switch disc (413) from open to closed and vice versa. In some other exemplary versions, engaging injection port (412) with locking member (404) may simply unlock disc (413) such that the user may manually turn disc (413) to either an open or closed state. It is also contemplated that injection port (412) may be configured such that disc (413) must be rotated in order to properly secure locking member (400) to injection port (412). In other words, if disc openings (415) and suture openings (417) are not aligned, then locking member (400) and injection port (412) cannot be properly secured. Other suitable ways of conditionally engaging locking member (400) with injection port (412) will be apparent to one of ordinary skill in the art in view of the teachings herein.
VI. Exemplary Injection Port with Hinge Feature
While the present example shows catheter (518) and hinge feature (504) interacting directly, in some other versions, the engagement with hinge feature (504) may be indirect through, for example, a retention sleeve, a flange, or any other suitable component as would be apparent to one of ordinary skill in the art in view of the teachings herein.
It should be understood that while the various examples described herein relate to the use of suture apertures and sutures to secure injection port (12) to a patient's tissue, the teachings herein may be readily applied to injection ports that are secured to a patient's tissue in various other ways. By way of example only, the teachings herein may be readily applied to injection ports that include integral fasteners, such as the injection ports disclosed in described in U.S. Pub. No. 2005/0283118, the disclosure of which is incorporated by reference herein. For instance, such injection ports may prevent the fasteners from being deployed until a catheter and/or retention sleeve, etc., is fully secured to the injection port. Various suitable ways in which the teachings herein may be combined with teachings of U.S. Pub. No. 2005/0283118 will be apparent to those of ordinary skill in the art in view of the teachings herein. Similarly, other suitable variations will be apparent to one of ordinary skill in the art in view of the teachings herein.
As mentioned previously, the injection ports described herein may be used as part of a gastric band system. By way of example, a gastric band is positioned in a patient in the manner described previously, and an injection port of the type described herein also implanted in the patient. One end of a fluid conduit is attached to the injection port, such as by mounting one end of the conduit over the injection port stem, and then fitting the retention sleeve attached to the housing over at least a portion of the conduit mounted to the stem such that the flexible fingers in the retention sleeve help prevent the conduit from being pulled off of the stem. The other end of the conduit is coupled to the gastric band in order to provide fluid communication between the gastric band and the reservoir of the injection port. The conduit may be coupled to the injection port and/or the gastric band either before or after those structures are implanted in the patient.
As yet another example, gastric band system (10) may include an implanted pump/reservoir system (not shown) instead of including an injection port (12). Such a pump/reservoir system may be controlled to selectively vary the amount of fluid in gastric band (20). Examples of such a system are described in U.S. Pat. No. 7,390,294, entitled “Piezo Electrically Driven Bellows Infuser for Hydraulically Controlling an Adjustable Gastric Band,” issued Jun. 24, 2008, the disclosure of which is incorporated by reference herein. Other examples of such a system are described in U.S. Pat. No. 7,351,240, entitled “Thermodynamically Driven Reversible Infuser Pump for Use as a Remotely Controlled Gastric Band,” issued Apr. 1, 2008, the disclosure of which is incorporated by reference herein. Such systems may include a catheter or other type of conduit coupling the pump/reservoir with gastric band (20). Accordingly, such systems may include any of the various suture opening alignment features described herein. Similarly, it should be understood that gastric band (20) may include any of the various suture opening alignment features described herein. Various suitable ways in which the suture opening alignment features described herein may be incorporated into a pump/reservoir and/or into a gastric band (20) will be apparent to those of ordinary skill in the art in view of the teachings herein.
It should be understood from the foregoing that conduit/catheter retention features such as those described herein may be incorporated into virtually any type of implanted device. The above described examples of gastric band systems are mere illustrations. The inventors' contemplation is not limited to components of gastric band systems. By way of example only, conduit/catheter retention features may be incorporated into an implanted drug infusion port, chemotherapy port, or any other type of implantable port that is used to deliver medication. Still other types of implanted devices that may incorporate conduit/catheter retention features will be apparent to those of ordinary skill in the art in view of the teachings herein.
It will become readily apparent to those skilled in the art that examples described herein may have applicability to other types of implantable bands. For example, bands are used for the treatment of fecal incontinence. One such band is described in U.S. Pat. No. 6,461,292, entitled “Anal Incontinence Treatment with Wireless Energy Supply,” issued Oct. 8, 2002, the disclosure of which is incorporated by reference herein. Bands can also be used to treat urinary incontinence. One such band is described in U.S. Pat. No. 7,621,863, entitled “Urinary Incontinence Treatment with Wireless Energy Supply,” issued Nov. 24, 2009, the disclosure of which is incorporated by reference herein. Bands can also be used to treat heartburn and/or acid reflux. One such band is described in U.S. Pat. No. 6,470,892, entitled “Mechanical Heartburn and Reflux Treatment,” issued Oct. 29, 2002, the disclosure of which is incorporated by reference herein. Bands can also be used to treat impotence. One such band is described in U.S. Pat. No. 7,442,165, entitled “Penile Prosthesis,” issued Oct. 28, 2008, the disclosure of which is incorporated by reference herein. Various ways in which the teachings herein may be incorporated with the teachings of these patent references will be apparent to those of ordinary skill in the art.
Versions of the present invention have application in conventional endoscopic and open surgical instrumentation as well as application in robotic-assisted surgery.
Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
