Briefly summarized, embodiments of the present invention are directed to fixation and protective components for use with implantable medical devices, such as access ports and catheters. In one embodiment, configurations for directly securing an implantable medical device within a tissue pocket of the patient are disclosed. In another embodiment, indirect securement of the medical device within the pocket using a fixation component is disclosed. In yet another embodiment, a protective sleeve is employed about a catheter so as to ensure patency of the catheter lumen, even in areas prone to excess catheter tube compression and pinch-off.
For example, a catheter assembly in one embodiment comprises an elongate catheter tube that defines at least one lumen. A protective mesh sleeve is disposed about an external portion of the catheter tube so as to cover at least a portion of the longitudinal length of the catheter tube. The protective sleeve is configured to distribute a compressive load on the catheter tube so as to ensure patency of the at least one lumen of the catheter tube, thus enabling fluids to acceptably flow through the catheter tube.
These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale.
For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a clinician using the device to be described herein, while the word “distal” refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”
Embodiments of the present invention are generally directed to fixation and protective components for use with implantable medical devices, such as access ports and catheters. In one embodiment, configurations for directly securing an implantable medical device within a tissue pocket of the patient are disclosed. In another embodiment, indirect securement of the medical device within the pocket using a fixation component is disclosed. In yet another embodiment, a protective sleeve is employed about a catheter so as to ensure patency of the catheter lumen, even in areas prone to pinch-off.
Reference is first made to
In greater detail, both the port 20 and the catheter 30 are disposed beneath the patient's skin after placement by a health professional. The port 20 is typically disposed within a subcutaneous pocket defined within the tissue of the patient. Note that the particular placement of the port shown in
In accordance with one embodiment, the port 20 is secured directly to the tissue pocket 40 via use of an adhesive 50 interposed between a bottom surface 22A of the port and a surface of the pocket. Thus adhesive 50 thus prevents undesired movement of the port 20 within the pocket 40. In one embodiment, therefore, the tissue pocket 40 is first created by the health care professional. The adhesive 50 is then applied to the bottom (or other suitable) surface 22A of the port 20, the pocket surface, or to both surfaces. The port 20 is then placed into the pocket 40 and pressed into place, if needed. In one embodiment, the port 20 is manually or otherwise temporarily secured until the adhesive cures. The stem 26 of the port 20 is attached to the proximal end 32A of the catheter 30 if the catheter has been previously inserted into the vein 12 (
The adhesive 50 can include any biocompatible substance that is sufficient for securing the port 20 in place. Examples of suitable adhesives include wound closure adhesives, a silicone-based MG 7-9850 AB adhesive available from Dow Corning, butyl-Z-cyanoacrylate, 2-Octyl-cyanoacrylate, and DERMABOND™ adhesive available from Ethicon, Inc. Of course, other suitable substances may also be used. In another embodiment, the adhesive may be absorbable/resorbable, or may include biocompatible epoxy, light-cured, heat-cured, or time-cured adhesives.
The size and shape of the holes defined by the mesh, as well as the size and material type of the strands can vary, but in one embodiment the mesh size is selected so as to promote tissue in-growth into the mesh. As such, the representation of the mesh sheet shown and described here is merely one example and is not meant to be limiting. In one embodiment, the strand diameter is about 0.005 inch or less to provide flexibility to the sheet. In one embodiment, the size of the mesh openings is about two millimeters or less. In yet another embodiment, the size of the mesh openings is about 0.1 millimeter.
In one embodiment, the material from which the mesh of the sheet 60 is made includes an absorbable/resorbable material. Examples of resorbable materials include L-lactide and Co DL-lactide materials, cellulose, fibrin, collagen, etc. In another embodiment, a tyrosine-based resorbable polymer, available from TYRX, Inc., Monmouth Junction, N.J., can be employed for the mesh. Other biocompatible materials can also be acceptably used.
As seen in
It is appreciated that the mesh sheet can be secured to tissue within the pocket by other modes, including adhesives (such as those discussed above in connection with
In one embodiment, the mesh structure of the sheet 60 is employed as a “scaffold” to facilitate tissue in-growth into the sheet and further secure the medical device to the patient's tissue. In the case that it is absorbable/resorbable, the mesh sheet 60 need not be removed when the port 20 is removed from the patient after treatment is complete. In such a case, the fasteners 64 or other fixation component used to secure the mesh sheet 60 in place can be employed as temporary fixation components until tissue in-growth occurs and can be absorbable/resorbable in one embodiment.
It is appreciated that in other embodiments the sheet can be configured as a substantially solid structure (woven or unwoven). It is further appreciated that in one embodiment the mesh sheet includes an antimicrobial substance to reduce or prevent microbial infection of the access port or other implantable device. In one embodiment the antimicrobial substance can include a dual component mixture of Minocycline and Rifampin, available from TYRX, Inc. In another embodiment, a coating including silver and/or iodine can be employed. These and other antimicrobial treatments are therefore contemplated.
As shown in
More generally, note that rings, ridges, bands, and other structures can be added to the mesh sheet or other suitable fixation device to enhance connection of the fasteners therewith and/or to facilitate insertion/removal of the medical device from the pocket. These structures can include absorbable/resorbable materials, in one embodiment. Also, the mesh sheet or other fixation component can be manufactured in a variety of sizes, shapes, thicknesses, etc., to accommodate differently-sized implantable devices. In one embodiment, the mesh sheet as a fixation component can fully envelop the medical device and can include a closure device to prevent escape of the medical device therefrom. Again, in one embodiment the mesh sheet can include antimicrobial properties in addition to fixation properties.
Reference is made to
In one embodiment, the sleeve mesh has a satin-type weave configuration, though other weaves may also be acceptably used. In the present embodiment, the filamentary material from which the sleeve is made includes a diameter of about 0.001 inch or less, though it is appreciated that a variety of material diameters may acceptably be used.
The sleeve 90 can be placed at any point along the longitudinal length of the catheter tube 32, such as the position shown in
In accordance with one embodiment, one possible position for the sleeve 90 along the length of the catheter tube 32 is proximate a point where the catheter tube passes near or through an obstruction that may expose the catheter tube to unintended compression, also referred to herein as pinch-off.
The sleeve 90 positioned as shown in
In one embodiment, a tissue growth enhancer can be applied to or otherwise included with the sleeve so as to enhance repair and healing of tissue surrounding the subcutaneous tunnel through which the catheter tube is passed, such as the tunneled portion shown at 34 in
Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application is a division of U.S. patent application Ser. No. 13/428,913, filed Mar. 23, 2012, now U.S. Pat. No. 9,295,809, which claims the benefit of U.S. Provisional Patent Application No. 61/467,330, filed Mar. 24, 2011, and titled “Antimicrobial Fixation Device for an Implantable Medical Device,” each of which is incorporated herein by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
4294647 | Strickler | Oct 1981 | A |
4934226 | Dacey, Jr. | Jun 1990 | A |
5190544 | Chapman | Mar 1993 | A |
5217493 | Raad et al. | Jun 1993 | A |
5316348 | Franklin | May 1994 | A |
5389091 | Moorehead | Feb 1995 | A |
5466253 | Doan | Nov 1995 | A |
5624704 | Darouiche et al. | Apr 1997 | A |
5800450 | Lary et al. | Sep 1998 | A |
5902283 | Darouiche et al. | May 1999 | A |
5906596 | Tallarida | May 1999 | A |
5984857 | Buck et al. | Nov 1999 | A |
6120491 | Kohn et al. | Sep 2000 | A |
RE37160 | Kohn et al. | May 2001 | E |
6379816 | De Loose et al. | Apr 2002 | B1 |
6427089 | Knowlton | Jul 2002 | B1 |
D501539 | Dyer, III | Feb 2005 | S |
6974462 | Sater | Dec 2005 | B2 |
7766880 | Spinoza | Aug 2010 | B1 |
7905874 | Miller et al. | Mar 2011 | B2 |
8315700 | Citron et al. | Nov 2012 | B2 |
8591531 | Buevich et al. | Nov 2013 | B2 |
20040138683 | Shelton | Jul 2004 | A1 |
20060173424 | Conlon | Aug 2006 | A1 |
20060200111 | Moehle et al. | Sep 2006 | A1 |
20060235410 | Ralph | Oct 2006 | A1 |
20070093684 | Peters | Apr 2007 | A1 |
20070198040 | Buevich et al. | Aug 2007 | A1 |
20080128315 | Buevich et al. | Jun 2008 | A1 |
20080132922 | Buevich et al. | Jun 2008 | A1 |
20080241212 | Moses et al. | Oct 2008 | A1 |
20080262406 | Wiener | Oct 2008 | A1 |
20090018559 | Buevich et al. | Jan 2009 | A1 |
20090088548 | Moses et al. | Apr 2009 | A1 |
20090198197 | Bischoff et al. | Aug 2009 | A1 |
20100015237 | Moses et al. | Jan 2010 | A1 |
20100130478 | Moses et al. | May 2010 | A1 |
20110294760 | Bahulekar et al. | Dec 2011 | A1 |
20120052292 | Pulapura et al. | Mar 2012 | A1 |
20130072901 | Sheetz et al. | Mar 2013 | A1 |
Number | Date | Country |
---|---|---|
0022370 | Jan 1981 | EP |
0194980 | Sep 1986 | EP |
H07-47139 | Feb 1995 | JP |
2009-173037 | Aug 2009 | JP |
9818506 | May 1998 | WO |
2009085281 | Jul 2009 | WO |
2012129516 | Sep 2012 | WO |
Entry |
---|
EP 12760194.6 filed Aug. 28, 2013 Extended European Search Report dated Aug. 7, 2014. |
Louis, P., “Resorbable mesh as a containment system in reconstruction of the atrophic mandible fracture” J Oral Maxillofac Surg. Jun. 2004;62(6):719-23 (Abstract). |
PCT/US12/30394 filed Mar. 23, 2012 International Preliminary Report on Patentability dated Oct. 3, 2013. |
PCT/US12/30394 filed Mar. 23, 2012 International Search Report dated Aug. 17, 2012. |
PCT/US12/30394 filed Mar. 23, 2012 Written Opinion dated Aug. 17, 2012. |
TYRX Website, “Our Technology: Bioresorbable Polymers,” accessible at <<http://www.tyrx.com/technology-our-tech-overview.htm>>, last accessed Jul. 23, 2014. |
TYRX Website, AIGISRx Overview, accessible at <<http://www.tyrx.com/AIGISRx-Clinicians.htm>>, last accessed Jul. 23, 2014. |
U.S. Appl. No. 13/428,913, filed Mar. 23, 2012, Non Final Office Action, dated Jun. 19, 2015. |
JP 2014-501283 filed Sep. 20, 2013 First Office Action dated Feb. 29, 2016. |
JP 2014-501283 filed Sep. 20, 2013 Office Action dated Nov. 16, 2016. |
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20160279403 A1 | Sep 2016 | US |
Number | Date | Country | |
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61467330 | Mar 2011 | US |
Number | Date | Country | |
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Parent | 13428913 | Mar 2012 | US |
Child | 15081777 | US |