Access port identification systems and methods.

(54) Title: ACCESS HOLE IDENTIFICATION SYSTEMS AND METHODS. (54) Title: ACCESS PORT IDENTIFICATION SYSTEMS AND METHODS.

(57) Summary

An access hole for subcutaneous implantation is disclosed. Such an access hole may comprise a body for capturing a septum for repeatedly inserting a needle therethrough into a defined cavity within the body. Furthermore, the access port may include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods for identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Furthermore, the subcutaneously implanted access port can be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is taxed or otherwise defined by the access hole, to be visible after implantation via x-ray imaging technology.

(57) Abstract

An access port for subcutaneous implantation is disclosed. Such an access port may comprise a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. Further, the access port may inelude at least one feature structured and configured for Identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Further, the subcutaneously implanted access port may be identified in response to perceiving the at least one feature. ln one embodiment, an Identification feature is engraved or otherwise defined by the access port, so as to be visible after implantation via x-ray imaging technology.

PATENT TITLE No. 359073

Owner (s): CR BARD, INC.

Address: 730 Central Avenue, Murray Hill, New Jersey, 07974, USA

Name: ACCESS HOLE IDENTIFICATION SYSTEMS AND METHODS.

Classification: CIP: A61M39 / 02

CPC: A61M39 / 02

Inventors): MURTAZA YUSUF ΆΜΙΝ; KEVIN W. SHEEfZ; DAVID M. CISE; MATT DRAPER;

KELLY B. POWERS

REQUEST

Number:

MX / a / 2011/010529

International Presentation Date:

from AM, 2010

PRIORITY

Country: Date: Number:

US, April 7, 2009 12 / 420,028

Validity: Twenty years Expiration Date: April 7, 2030 Issue Date! September 13, 2018

The reference patent is granted on the basis of articles 1 ·, 2º frácc¡Sh V, 0Ϊ Measure »MI, and 59 of the Industrial Property Law.

In accordance with article 23 of I * t, ey de l <Property l ^ urtnaj.Ja presentepptente has a validity of twenty non-extendable years, counted from the filing date of the international application and will be subject to payment of tsfterft to maintain rights in force.

Whoever subscribes to this title does so in accordance with the provisions of articles 6 and 7 and 2 of the Law on Industrial Property (Official Gazette of the Federation (DO.F.) 06/27/1991, amended on 02 / Q8 / 1994 2 & WH996, 12/26/1998, 17/86/1998, 01/26/2004, 06/16/2005, 01/25/2006, 05/06/2009, 06/01/2610, 06/18/2010, 06/28/2010, 01/27/2012, 09M4 / 2012, 01706 / 2aWy 03/13/2018); Articles 1, 3rd section V, subsection a), 4th and 12th sections I and III of the Insiguió Regulation^{* 1} Mexican Industrial Property IGF. 12/14/1999, amended on 07/01/2002, 07/15/2004, 07/28/2004 and 09/07/2007); articles 1 “, 3 °, 4 °, 5 ° fraction V subsection a), 16 tractions t and til and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, recast on 10/1072002, 07/29/2004, 08/04/2004 and 18/69/2007), 1 “, 3“ and S “subsection a) of the Agreement that delegates powers to the Directors General Deputies, Coordinator; Divisional Directors, Titers of the © fiema »Regional, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Me / feaop Institute of Industrial Property. <4 && ΙΜβ / 12/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007)

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 615 2 of the Industrial Property Law; 3 of its Regulations, and 1 fraction III, 2 fraction V, 26 BIS and 26 TER of the Agreement per etque establish the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the Procedures that are indicated.

THE DIVISIONAL DIRECTOR OF PATENTS

NAHANNY CANAL REYES

<img file="MX359073B_D0001.tif" />

Original string:

NAHANNY MARISOL CANAL REYES | 00001000000403252793, Public Administration Service | 1695 || MX / 2018/78901 | MX / a / 2011/010529 | PCT patent title | 1223 | GAGV | Pg (s) lOYRLy ^ ByoReqeiISHS / w + TBSpIS⁵¹

Digital stamp:

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<img file="MX359073B_D0002.tif" />

MX / 2018/78901

ΙΜΡϊ ^ Β ^

MEXICAN INSTITUTE Vl-YES

OF THE BRORITY

INDUSTRIAL

ACCESS HOLE IDENTIFICATION SYSTEMS AND METHODS '^ϊιίΤ'7

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. IA shows a perspective view of an embodiment of an access port according to the present description;

FIG. IB shows a schematic side cross-sectional view of the access hole shown in FIG.

IA;

FIG. 2 shows a perspective view of an embodiment of an access hole according to the present description;

<td></td><td>the</td><td>FIG.</td><td> 3</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td> 4</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td> 5</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td>6A</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td>6B</td><td>shows</td><td>a</td><td colspan="2">side view of the hole</td>

<td colspan="3">Access shown</td><td>in</td><td>FIG.</td><td>6A;</td><td></td><td></td>

<td></td><td>the</td><td>FIG.</td><td> 7</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td colspan="3">8 shows</td><td colspan="2">a perspective view</td>

simplified of a cap to form an access hole for

<img file="MX359073B_D0003.tif" />

MEXICAN INSTITUTE

ΠΧΙ-Λ PROPERTY according to the present description;

FIG. 9 shows a simplified perspective view of a lid to form an access hole in accordance with the present description;

FIG. 10 shows a simplified perspective view of a lid to form an access hole in accordance with the present description;

FIG. 11 shows a simplified perspective view of a lid to form an access hole in accordance with the present description;

FIG. 12 shows a simplified perspective view of a lid to form an access hole in accordance with the present description;

FIG. 13 shows a simplified perspective view of a lid to form an access hole in accordance with the present description;

FIG. 14 shows a simplified perspective view of a lid to form an access hole in accordance with the present description;

FIG. 15A shows a perspective view of one embodiment of an access port in accordance with the present disclosure;

FIG. 15B shows a top elevation view of the access hole shown in FIG. 15A;

FIG. 16 shows a perspective view of a

<img file="MX359073B_D0004.tif" />

<td rowspan="2">orifice</td><td colspan="2">access</td><td rowspan="2">of 17</td><td rowspan="2">agreement shows</td><td rowspan="2">with a</td><td colspan="2">the present description;</td>

<td>the</td><td>FIG.</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td> 18</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td> 19</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td> 20</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

<td></td><td>the</td><td>FIG.</td><td> 21</td><td>shows</td><td>a</td><td>perspective view of</td><td>a</td>

<td>orifice</td><td>of</td><td>access</td><td>of</td><td>agreement</td><td>with</td><td>the present description;</td><td></td>

FIG. 22 shows a perspective view of another embodiment of an access hole in accordance with the present description;

FIG. 23 shows a top elevation view of the assembled access hole shown in FIG. 22;

FIG. 24 shows a simplified representation of a cross section of the access hole shown in FIGS. 22 and 23;

FIGS. 25-51 show perspective views of additional modalities of an access hole.

FIG. 52 shows a bottom perspective view of an access hole according to one embodiment;

FIG. 53A shows a top view of the access hole shown in FIG. 52;

INSTITUTO MEXICAN 'i DE LA PRORIF.DAD

INDUSTRIAL

<img file="MX359073B_D0005.tif" />

FIG. 53B shows a bottom view of the access hole shown in FIG. 52;

FIG. 54A represents a radiographic image of the access hole shown in FIG. 52 when viewed from above the access hole;

FIG. 54B represents a radiographic image of the access hole shown in FIG. 52 when viewed at an angle of approximately 20 degrees;

FIG. 54C represents a radiographic image of the access hole shown in FIG. 52 when viewed at an angle of approximately 50 degrees;

FIG. 55 shows a cross sectional view of the access hole shown in FIG. 52;

FIGS. 56A and 56B show cross-sectional views of exemplary embodiments of the etched features on an access hole surface;

FIG. 57A shows a top perspective view of an access hole according to one embodiment;

FIG. 57B shows a perspective view of the access hole shown in FIG. 57A;

FIG. 57C shows a bottom view of the access hole shown in FIG. 57A;

FIG. 58A shows a perspective view

<img file="MX359073B_D0006.tif" />

<img file="MX359073B_D0007.tif" />

INSTITUTO MtXlCANO DE LA FROI'IEDAD superior of another modality of an orifice of '&amp;' s;¹*¹FIG. 58B shows a view — 5Π — perb'pgcrtva — CTS¹ bottom of access hole shown in FIG. 58A;

FIG. 58C shows a bottom view of the access hole shown in FIG. 58A;

FIG. 59A shows a side view of one embodiment of an access hole;

FIG. 59B shows a bottom view of the access hole shown in FIG. 59A;

FIG. 60A shows a bottom perspective view of a further embodiment of an access port;

FIG. 60B shows a bottom view of the access hole shown in FIG. 60A;

FIG. 61A shows a bottom perspective view of a further embodiment of an access port;

<td></td><td colspan="2">FIG.</td><td>61B</td><td>shows a background view</td><td>of the</td><td>orifice</td>

<td>of</td><td>access</td><td>shown</td><td>in</td><td>FIG. 61A;</td><td></td><td></td>

<td></td><td></td><td>FIG.</td><td colspan="3">62A shows a background view</td><td>of a</td>

<td colspan="2">modality</td><td>add</td><td>of</td><td>an access hole;</td><td></td><td></td>

<td></td><td></td><td>FIG.</td><td>62B</td><td>shows a side view</td><td>of the</td><td>orifice</td>

<td>of</td><td>access</td><td>shown</td><td>in</td><td>FIG. 62A;</td><td></td><td></td>

FIG. 62C shows an end view of the access hole shown in FIG. 62A;

FIG. 63A shows a bottom view of another embodiment of an access port;

_ _ MEXICAN INSTITUTE

63B shows a latei ^ íl ·, ™ ^^ view heard in FIG. 63A; and _ FIG.

of access shown in FIG.

access hole

63C shows an end view of that shown in FIG. 63A.

DETAILED DESCRIPTION

The present description relates generally to percutaneous access, and more specifically to methods and devices associated with percutaneous access. In general, the present description relates to an access hole for subcutaneous implantation. In one embodiment, an access port may allow a physician or other medical personnel to obtain long-term percutaneous access to the interior of a patient's body. The use of an access port for percutaneous access can reduce the possibility of infection by inhibiting fluid connections (which extend into a patient's body) from the patient's skin and the external environment. The access device allows access to the patient's interior without requiring a needle to pierce the skin. Also, internal components, such as a catheter or valve, can be replaced without a surgical procedure. The features or aspects of the present disclosure may apply to any such access port for subcutaneous access to a patient, without limitation. The access hole can be injected by hand (for example, via .urW *,

MEXICAN INSTITUTE

OF THE PROPERTY C ^^ átaíS /

INDUSTRIAL ^ aCSÍ - ^ * ^ of a syringe that includes a water) for example or can be injected and pressurized by medical assistance (for example, a so-called injectable energy port).

The energy injectable orifices can be used in, in other processes, for example, computed tomography (CT) scanning processes. More particularly, a so-called energy injector system can be used to inject contrast media into a peripherally inserted intravenous (IV) line. For example, such power injectors or injection systems may be commercially available from Medrad, Inc., a subsidiary of Schering AG, Germany, and may be sold under the trademark STELLANT. R^MR. Because fluid infusion procedures are frequently defined in terms of desired flow rate of contrast media, such energy injection systems are generally controllable by selection of a desired flow rate.

More specifically, the present disclosure relates to an access port having at least one perceivable or identifiable feature to identify the access port, where the identifiable feature is noticeable after the access port is implanted into a patient . For example, at least one or perhaps multiple identifiable characteristic (s) of a δ

<img file="MX359073B_D0008.tif" />

access port contemplated by the present description can be correlated with the information (for example, a model or manufacturer's design) that belongs to the access port. Thus, an identifiable feature of one access hole of a particular model may be unique relative to most if not all other identifiable features of another access hole of different models or designs. Of course, the at least one identifiable characteristic of an access port contemplated by the present description can be additional correlative with any information of interest, such as type of port, type of catheter, date of manufacture, batches of materials, numbers of parts, etc. In one example, at least one identifiable feature of an access port can be correlated to the access port which is energy injectable. In this way, once the at least one identifiable characteristic of an access hole is observed or otherwise determined, the correlation of at least one identifiable characteristic of an access hole can be achieved and the information that belongs to the access hole.

In one modality, at least one characteristic can be perceived by palpation (that is, to examine by touch), through other physical interaction, or by visual observation. Therefore, a person from jtVjL jf⁷1

MEXICAN INSTITUTE OF PROPERTY

4- - . . ...... INDUSTRIAL -Interes can touch or feel the access hole through the skin to perceive at least one identifying characteristic of it. In another embodiment, at least one identifiable feature can be perceived via the x-ray or ultrasound imaging pathway. In a still further embodiment, at least one identifiable characteristic can be perceived through magnetic, light, or radioenergy interaction or communication with the access port.

Returning to the modality where at least one characteristic can be perceived through palpation, another physical interaction, or visual observation, a topography or external surface characteristic of an access hole contemplated by the present invention can be configured for perception. For example, with reference to FIGS. IA and IB, an exemplary access port 10 contemplated by the present disclosure is shown in FIGS. IA and IB showing a perspective view of a schematic side cross-sectional view, respectively, of an access port 10 to allow percutaneous or otherwise internal access to a patient's body. Access port 10 includes a housing or body 20 defined by a cap 14 and a base 16. Cap 14 and base 16, as shown in the art, can be configured to capture a septum 18 therebetween. shown in FIG. IA,

IMPI

MEXICAN INSTITUTE OF IROPIEDAD

INDUSTRIAL

<img file="MX359073B_D0009.tif" />

cover 14 and base 16 can be closely coupled to each other along a coupling line 15. Cover 14 and base 16 can be secured or fixed to each other by way of mechanical fasteners such as screws or other devices fastening, can be adhesively attached to each other, or can be attached to each other as is known in the art. Furthermore, the cover 14, base 16, and septum 18 can collectively define a cavity 36 in fluid communication with a lumen 29 of the outlet stem 31.

Body 20 can be implanted in a patient 7, as shown in FIG. IB, to dispose cavity 36 subcutaneously within patient 7. Also, suture openings 66 (FIG. IA) can be used to fix access hole 10 within patient 7, if desired. After the body 20 is implanted in a patient 7, the upper surface of septum 18 can be placed substantially flush with the surface of the skin 6 of patient 7 and can be repeatedly operated to create a percutaneous passage from outside the patient's skin within cavity 36. Outlet stem 31 can create a communicative passage of fluid from cavity 36 through outlet stem 31 and into patient 7. A catheter can be coupled to outlet stem 31 for fluid communication of cavity 36 and to transfer fluid from cavity 36 to a desired remote location of cavity 36 and within

<img file="MX359073B_D0010.tif" />

IMPI

MEXICAN INSTITUTE - ot THE PROPERTY patient 7. industrial

Anr-οοη 10 orifice body 20 spike · comprises a biocompatible material such as polysulfone, suitably titanium, any other biocompatible material as is known in the art. Accordingly, body 20 can be formed from a biocompatible plastic material. If desired, body 20 may comprise a penetrable material for penetration of sutures or needles. In another embodiment, and as further discussed below, body 20 may comprise an impenetrable material such as, for example, a metal if desired. Body 20 may include a concave bottom or, in another embodiment, may include a flat bottom without limitation.

In accordance with the present description, the access hole 10 may comprise a body 20 that exhibits at least one identifiable feature. More particularly, as shown in FIG. IA, body 20 may exhibit a generally partial pyramidal shape (i.e., a polygonal base having surfaces for each side of the polygon that extends to a common vertex otherwise known as a trunk). In general, a body 20 of an access hole 10 can exhibit a partial pyramidal shape extending between a generally quadrilateral-shaped base positioned in the reference plane 11 and a generally quadrilateral-shaped upper base in the plane of reference

<img file="MX359073B_D0011.tif" />

9. Reference planes 9 and 11 will not be shown in FIGS. 2-21, for clarity; however, reference to planes 9 or 11 with respect to FIGS. 2-21, as used herein, will be referred to in the corresponding reference planes analogous to reference planes 9 and 11 as shown in FIGS. IA and IB.

As shown in FIG. IA, the exterior of hole 10 is defined substantially by four substantially flat side surfaces 50 connected to each other by radii 32. In addition, the top topography 61 of access hole 10 is defined by top surface 60 in combination with chamfers 46A and 46B and they can be further defined by the upper surface of septum 18. Further explaining, the outer periphery of the upper outer topography 61 cannot be described as a generally quadrilateral outer formed by the lateral regions 54 and having rounded corner regions 30 adjacent to the lateral regions 54. Such a configuration may provide a hole for access that has at least one characteristic that can be perceived by palpation.

It can be seen that there are many variations to the geometry of the access hole 10 as shown in FIG. IA. For example, while the body 20 of the access hole 10 can be described as a partially pyramid shaped or trunk, the present description is not

<img file="MX359073B_D0012.tif" />

INSTITUTO MEXICANO limits in this way. Rather, one or more of the^giir ° ?? fl? l— sides 50 can be oriented as desired, without reference to any other side surfaces 50. Accordingly, for example, one of the surface 50 can be substantially vertical while the remaining surfaces 50 can be orient at selected, respective angles. Additionally, it should be understood that FIG. IA is merely exemplary and that the dimensions and shapes as shown in FIG. IAs can vary substantially as long as they are still included by the present description.

FIG. 2 shows a perspective view of another embodiment of the access hole 10 according to the present description. As shown in FIG. 2, the exterior of the access hole 10 is substantially defined by a generally parallelogram base (positioned in the reference plane 11 as shown in FIGS. IA and IB) extending generally pyramidal to a generally parallelogram-shaped upper surface (positioned in reference plane 9 as shown in FIGS. IA and II). As shown in FIG. 2, radii 42 may be larger than radii 32 as shown in FIG. IA. Additionally, the top topography 61 of the access hole 10 as shown in FIG. 2 may include rounded corner regions 40 that are larger than rounded corner regions 30 as

·. t ...

<img file="MX359073B_D0013.tif" />

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX359073B_D0014.tif" />

shown in FIG. IA. Thus, FIG. 2 shows an exemplary embodiment of an access hole 10 that may be noticeably distinguishable from access hole 10 as shown in FIGS. IA and IB. For example, a difference between an exterior of an access port contemplated by the present disclosure and an exterior of a different access port contemplated by the present disclosure can be determined by palpation.

In another embodiment, in another aspect contemplated by the present description, a template can be used to perceive at least one characteristic of an access hole. For example, a complementary shaped jig can be positioned on and abutting against an access hole contemplated by the present disclosure to determine if the access hole engages or substantially corresponds to the shape of the jig. Such a process can safely indicate or perceive at least one characteristic of an access port contemplated by the present disclosure. Of course, a plurality of templates corresponding to different models of the access holes can be coupled in series with an unknown access hole to perceive at least one characteristic thereof. Such a process may allow the identification (eg, of a model or manufacturer) of an access port contemplated by the present disclosure.

<img file="MX359073B_D0015.tif" />

In another aspect contemplated by the present disclosure, a top topography of an access hole may include at least one feature to identify the access hole. For example, as shown in FIG. 3, the upper surface 60 of the access hole 10 may be non-flat. More specifically, the top surface 60 can be tapered or can extend arcuately downward (ie, toward reference plane 11 as shown in FIGS. 1A and IB) as it extends radially inward toward septum 18. Otherwise, access port 10, as shown in FIG. 3, can be configured substantially as previously described herein with reference to FIGS. 1A and IB. Thus, top surface 60 is an exemplary example of at least one discernible feature for identifying an access port contemplated by the present disclosure.

In a still further embodiment of an access port contemplated by the present disclosure, the lateral regions 54 extending between the rounded corner regions 30 may exhibit at least one discernible characteristic. For example, as shown in FIG. 4, access hole 10 may include one or more lateral regions 54 extending arcuately between adjacent rounded corner regions 30. Otherwise

Λρ] f

way, access hole 10, as shown in FIG. 4, can be substantially configured

INDUSTRIAI as previously described herein with reference to FIGS. IA and IB. The lateral regions 54 can be congruent or symmetrical with respect to each other or, in another embodiment, they can be configured differently with respect to each other, without limitation.

FIG. 5 shows a further exemplary embodiment of an access port contemplated by the present disclosure. More specifically, access hole 10, as shown in FIG. 5, includes side regions 54 that form undercut regions 72 between adjacent rounded corner regions 30. Put another way, top topography 61 may include alternating undercut regions 72 and overhanging regions 70 positioned generally around a periphery of septum 18. Otherwise, access hole 10, as shown in FIG. 5, can be configured substantially as previously described herein with reference to FIGS. IA and IB. Such a configuration can provide an access hole that has at least one identifiable feature.

In a further embodiment of an access port contemplated by the present disclosure, FIGS. 6A and 6B show a perspective view and a side view,

ΙΜΡΪ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY, respectively, of an access hole 10 configured generally as described with reference to FIG. 5 but having an elongated body 20E. More specifically, the elongated body 20E of the access hole 10, as shown in FIGS. 6A and 6B, includes a lateral surface 50E that generally extends from the top topography 61 downward (ie, toward the reference plane 11 as shown in FIGS. IA and IB) and having an inclination (eg, an angle with respect to a vertical axis normal to an upper surface of septum 18) that is different from the other lateral surfaces 50. Otherwise, access hole 10, as shown in FIG. 6, can be configured substantially as previously described herein with reference to FIGS. IA and IB. Such a configuration can provide an elongated body 20E of an access hole 10 having an elongated side portion.

Of course, one or more side surfaces of an access hole in accordance with the present disclosure can be configured to form a body that exhibits a selected shape as desired. A portion of the elongated body of an access port contemplated by the present disclosure may, in combination with other features as described herein above or, in another embodiment, taken alone, form at least one perceivable feature for identification of a

<img file="MX359073B_D0016.tif" />

IMPW

MEXICAN INSTITUTE ,, access hole in accordance with this

FIG. 7 shows an additional embodiment has access hole covered by the present description. Particularly, as shown in FIG. 7, access hole 10 may include an upper body portion 20a and a lower body portion 20b. Additionally, each of the upper body portion 20a and lower body portion 20b may exhibit a partial pyramidal shape (i.e., a trunk), where the body portions 20a and 20b are stacked vertically relative to each other. Accordingly, the body portion 20a can form a feature of a protruding flange 76 that extends along a periphery of access port 10. Further explaining, the lower body portion 20b may have an exterior substantially defined by the side surfaces 50b and the rounded corner regions 30b, while the upper body portion 20a may have an exterior substantially defined by the side surfaces 50a, the regions rounded corner 30a and top topography 61. It can be seen that the protruding rim feature 76 can be dimensioned and configured for perception via the palpation path. Such a configuration can provide an access port suitable for delivery of a beneficial or medicinal substance, the access port which is

<img file="MX359073B_D0017.tif" />

MEXICAN INSTITUTE IS THE PROPERTY identifiable (for example, by the number of? ^ D? L? ·· / · manufacturer, etc.) after implantation.

It should be understood that the present description contemplates access holes having an external geometry that is not quadrilateral in nature. Rather, the present disclosure contemplates that an access port may have an exterior that is generally cylindrical, generally conical, generally elliptical, generally oval, or an exterior that is otherwise arcuate in nature. Specifically, the present disclosure contemplates that an access hole having a substantially rounded or arcuate exterior may include at least one feature configured for identification of the access hole after implantation. For example, as shown in FIG. 8 shows a cover 14 exhibiting an outer surface 78 that is substantially conical. Cap 14 can be assembled to a suitable base (not shown) to capture a septum (not shown) as described herein above to form an access hole 10 as generally described with reference to the

FIGS. 1-7.

The present disclosure further contemplates that at least one protrusion, protruding region, hollow, undercut region, ripple, or adjacent features of different elevation may comprise a feature for

<img file="MX359073B_D0018.tif" />

<img file="MX359073B_D0019.tif" />

ISTITUTO MEXICANO DE VA rtOPlERAD INDUSTRIAL

<img file="MX359073B_D0020.tif" />

invusiiunL, - - identify an access hole contemplated by the present description. More specifically, the upper topography 61C, as shown in FIG. 8, may include a plurality of projections 80. The projections 80 may partially exhibit spherical upper surfaces passing into a lower portion of the cap 14. In further detail, the projections 80 can be spaced circumferentially around the periphery of the septum (not shown ) as desired. In one embodiment, a plurality of protrusions 80 can be spaced symmetrically circumferentially around the periphery of the septum (not shown). More generally, at least one protrusion 80 can be dimensioned, configured, and positioned to form at least one identifiable feature of an access port. Of course, at least one protrusion 80 can be structured to facilitate the comfort of a patient within which the access hole is implanted. As can be appreciated, at least one protrusion 80 or more than one protrusion 80 can be included in a top topography 61C of an access port (not shown) contemplated by the present disclosure.

FIG. 9 shows another embodiment of a cap 14 that includes at least one protrusion 80E for forming and identifying an access port contemplated by the present disclosure after implantation thereof into a patient. 80E projections can be extended

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX359073B_D0021.tif" />

circumferentially around a center of revolution. In this way, the projections 80E can exhibit a body portion 87 that extends circumferentially between the rounded ends 83. In addition, the cap 14 can have an outer surface 78 that is substantially symmetrical about an axis of revolution. More generally, the body 20 can extend from a generally circular, generally elliptical, or generally oval base positioned at a lower extension 71 of the cap 14 to a generally circular, generally elliptical, or generally oval cross section that it is smaller than a cross section of the base and is positioned on an upper extension 73 (without considering the projections 80E) of the cover 14. In addition, the lateral surface 51, as shown in FIG. 9 extends arcuately between the base and top topography 61 of the cap 14. The lateral surface 51 may extend in a generally tapered or conical shape, may exhibit a radius or other arcuate shape, or may otherwise pass between a cross section from the base of the access hole to a cross section close to the upper topography 61C thereof.

Furthermore, FIG. 10 shows an embodiment of a cover 14 for forming an access port contemplated by the present disclosure having a top topography 61C thereof comprising alternating circumferentially extending protrusions 80E and recesses 82 which are • fc.

; ΙΜΡΪ i MEXICAN INSTITUTE '• DE LA PROflÉbAh 1, INDUSTRIAL

<img file="MX359073B_D0022.tif" />

<td>61C</td><td>of</td><td>the</td><td>same as</td>

<td>80E</td><td>than</td><td>I know</td><td>extend</td>

<td> 82</td><td>than</td><td>I know</td><td>extend</td>

circumferentially extending, where the circumferentially extending 'KOE protrusions are circumferentially larger than the circumferentially extending recesses 80E. In another embodiment of an access port contemplated by the present description, FIG. eleven shows a perspective view of a lid 14 having a top topography 61C of comprising altering the projections 80E that are circumferentially and the holes circumferentially, where the projections 80E that are circumferentially extending and the holes that are circumferentially extending are substantially equal in size (circumferential) or extension. In still a further embodiment of a lid 14 to form an access port contemplated by the present disclosure, FIG. 12 shows a perspective view of a cover 14 having a top topography 61C thereof comprising three circumferentially extending protrusions 80E and three circumferentially extending recesses 82, arranged to alternate circumferentially, wherein the circumferentially extending protrusions 80E and the circumferentially extending recesses 82 are substantially equal in size (circumferential).

FIG. 13 shows a perspective view of a further embodiment of a cover 14 to form a hole for

<img file="MX359073B_D0023.tif" />

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX359073B_D0024.tif" />

Access contemplated by the present disclosure ± qr — qcre — includes an upper topography 61C including circumferentially extending protrusions 80T and circumferentially extending voids 82T, wherein transition regions 81 are provided between circumferentially extending protrusions 80T and the circumferentially extending recesses 82T. Such transition regions 81, as shown in FIG. 13, can be tapered or generally smoothly pass between a circumferentially extending ledge 80T and a circumferentially extending gap 82T. Also, FIG. 14 shows a perspective view of a further embodiment of a cap 14 to form an access hole contemplated by the present disclosure that includes a top topography 61C that includes protruding regions 96 and undercut regions 98 passing each other and alternating circumferentially to form a topography undulating comprising the upper topography 61C. Such undulating topography as shown in FIG. 14, passes generally smoothly between the circumferentially adjacent protruding regions 96 and the recessed regions 98.

In a further embodiment of an access port contemplated by the present disclosure, FIGS. 15A and 15B show a perspective view and a top elevation view, respectively, of an access hole 10 κ '= ♦

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX359073B_D0025.tif" />

generally configured as described with reference to

FIG. 5 but may include at least one non-flat side surface. In another embodiment, access hole 10 as shown in FIG. 15 can be configured as shown in FIGS. 1-4 or FIGS. 6-7, or any modality described below, without limitation. More specifically, the elongated body 20 of the access hole 10, as shown in FIGS. 15A and 15B, includes three arcuately extending side surfaces 50R (as shown in FIG. 15B). Such a configuration can provide an access hole 10 that is identifiable subsequent to implantation. In yet another embodiment of an access port contemplated by the present disclosure, FIG. 16 shows a perspective view of an access hole 10 including a side wall 100 that truncates a portion of a radius 32 formed between the side surfaces 50 of the access hole 10. It can also be seen that such access port 10 may include three suture openings 66, which may, taken alone or in combination with at least one additional feature, comprise at least one identifiable feature of an access port contemplated herein. description. Furthermore, as shown in FIG. 16, the outlet stem 31 can extend from the side wall 100.

In an additional embodiment of an access hole

IMPIéSM ¡KJTITUTO MEXICANO

Say LA MOHEDAL; ÍTstoJZ / d IN PU5TEIA t VaOj &lt;&lt; A · contemplated by the present description, FIG. 17 shows a perspective view of an access hole 10 where cover 14 and base 16, when assembled together along mating line 15, form a flange feature or edge feature 102 that extends around at least a portion of the periphery of the access hole 10. As shown in FIG. 17, the edge feature 102 extends substantially around the periphery of the access hole 10, proximate to the coupling line 15 between the 14 and the base 16. Such feature may comprise at least one identifiable feature of an access hole contemplated by the present description. In this way, it can be seen that a peripheral discontinuity between the cover 14 and the base 16 can generally be formed along the coupling line 15 between them. In the embodiment of an access hole as shown in FIG.

7, a protruding rim feature 76 may comprise a peripheral discontinuity or, in the form of an access port as shown in FIG. 17, an edge feature 102 may comprise a peripheral discontinuity.

In a further embodiment of an access port contemplated by the present disclosure, FIG. 18 shows a perspective view of an access hole 10 where

<img file="MX359073B_D0026.tif" />

at least a portion of at least a portion of at least one side surface 50 is concave. As shown in FIG. 18, the concave region 106 of the lateral surface 50 is concave. The concavity (i.e., a concave region 106) can be displayed on at least a portion of a lateral surface of an access port in any of the embodiments as shown herein, without limitation. Thus, at least one side surface 50 of an access hole contemplated by the present disclosure having at least a portion thereof which is concave is an exemplary example of at least one perceivable feature for identifying a hole. of access contemplated by the present description.

In a further embodiment of an access port contemplated by the present disclosure, FIG. 18 shows a perspective view of an access hole 10 where at least a portion of at least one lateral surface 50 is concave. As shown in FIG. 18, region 106 of side surface 50 is concave. The concavity can be exhibited on at least a portion of a lateral surface of an access port in any of the embodiments as shown herein, without limitation. Thus, at least one side surface 50 of an access hole contemplated by the present disclosure having at least a portion of the

<img file="MX359073B_D0027.tif" />

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX359073B_D0028.tif" />

The same that is concave is an example eg Expanded Hp pnr ln minus, a perceptible characteristic for the identification of an access hole contemplated by the present description.

In a further embodiment of an access port contemplated by the present disclosure, FIG. 19 shows a perspective view of an access hole 10 generally configured as described with reference to FIGS. 6A and 6B. More specifically, the elongated body 20ER, as shown in FIG. 19 it includes a side surface 50ER that arches from the top topography 61 of the access hole 10 downward (ie, towards the reference plane 11 as shown in FIGS. 1A and IB). Such a configuration can provide an elongated body 20E of an access hole 10 having an elongated side portion.

It should be understood from the various embodiments of an access port contemplated by the present disclosure described above that many variations, additions, or different features can be encompassed by the present disclosure. Thus, the present description is not limited to the various exemplary embodiments described above.

For example, as shown in FIG. 20, showing a top elevation view of an access hole 10 contemplated by the present description, a

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ΙΜΡΙ

MEXICAN INSTITUTE M LA INDUSTRIAL PROFIEUAD

<img file="MX359073B_D0029.tif" />

access hole 10 may include a 1OD gnp side wall at least partially truncates a radius 32 between side surfaces 50, outlet stem 31 extending from side wall 100, and at least one concave region 106 and one surface arched 50R. Furthermore, as shown in FIG. 20, suture openings 66 can be positioned to identify access hole 10 after subcutaneous implantation.

Additionally, the present description contemplates the access holes that have an external geometry that is polygonal in nature. Specifically, the present disclosure contemplates that an access port contemplated by the present disclosure may exhibit a generally triangular exterior. Thus, as shown in FIG. 21, body 20 may exhibit a generally tapered or pyramidal shape (ie, a polygonal base having surfaces for each side of the polygon that extends to a common vertex). In general, a body 20T of an access hole 10 can extend between a generally triangularly formed base and a relatively smaller generally triangularly formed upper base. . Accordingly, the exterior of the access hole 10 can be substantially defined by three side surfaces (eg, 50, 50R, 102, 50E) having radii 32 extending therebetween. In addition, the superior topography 61

<img file="MX359073B_D0030.tif" />

INSTITUTO MBXICANO DE LA Pkü? ÍE¿&gt; AC of the access hole 10 can be defined stubbornly '* upper surface 60 in combination with the' lateral regions 54 and the rounded corner regions 30. Such a configuration can provide an access hole that has at least one characteristic that can be perceived by palpation.

FIGS. 22 and 23 show a perspective view and a top elevation view of another embodiment of an access hole that includes a generally triangular exterior geometry. More particularly, as shown in FIGS. 22 and 23, a cover 14 and base 16 (collectively form a housing) can capture a septum 118 to form an access hole 10. Furthermore, the outlet stem 31 may include a stem base that can be positioned within and sealed to an outlet recess 93 formed within the base 16. The outlet stem 31 may be in fluid communication with a cavity formed within the orifice. 10. Optionally, suture plugs 89 can be positioned within suture cavities 91 formed in base 16. Suture plugs 8 9 may comprise a flexible material (eg, silicone, rubber etc.) that can provide some resilience between sutures that engage access port 10 (ie, base 16) to a patient. In additional detail, a side periphery 95 (eg, one or more side walls) of access hole 10 may generally be

<img file="MX359073B_D0031.tif" />

triangular. In this way, the cap 14 and the cap may collectively form a generally triangular housing or access port body 10. Also, the present disclosure contemplates that the lateral periphery 95 may increase or decrease in cross-sectional size (eg, by tapering or arcing) between the upper surfaces 161 of the cover 14 and the lower surface 151 of the base 16. As shown in FIGS. 22 and 23, a cross section (taken in a selected plane substantially parallel to bottom surface 151 of base 16) of access hole 10 may be larger proximate bottom surface 151 of base 16 and may be relatively smaller than proximal top surface 161 of cap 14.

Additionally, FIG. 24 shows a simplified representation of a cross section of the access hole 10. As shown in FIG. 24, the lateral periphery 95 of the access hole 10 can define three lateral regions 103 that extend between the associated vertex regions 101. In addition, in one embodiment and as shown in FIG. 24, the lateral periphery 95 can also define a generally triangular, substantially equilateral, shape. As one of ordinary skill in the art will appreciate, the lateral regions 103 may extend between the associated vertex regions 101; of

<img file="MX359073B_D0032.tif" />

in this way, the side regions 103 can form sides of a generally triangular shape. Furthermore, although the vertex region 101 is round, it can be seen that such vertex regions 101 form an intercept between the adjacent lateral regions 103. Accordingly, a person of ordinary skill in the art will appreciate that the phrase "generally triangular" as used herein, encompasses any generally three-sided geometry where adjacent sides intersect, without limitation. For example, the generally triangular phrase encompasses three-sided polygons, circular triangles, equilateral triangles, etc., without limitation.

The present disclosure also contemplates that at least one feature of an access port contemplated by the present disclosure may not be visually or palpably observable but, rather, may be otherwise observable. For example, the present disclosure contemplates that at least one feature of an access port may be observable through interaction with an imaging technology such as x-ray or ultrasound. For example, in one embodiment, a metal feature (eg, a plate or other metal geometry) can be included through an access hole contemplated by the present disclosure; As you can see, this metal characteristic can be represented

ΙΜΡΙ

Mexican INSTITUTE Df LA RROPIEDAD INDUSTRIAL

<img file="MX359073B_D0033.tif" />

on an x-ray generated by exposure of the access hole to x-ray energy while simultaneously exposing the x-ray sensitive film to x-ray energy passing through the access hole. Furthermore, the present disclosure contemplates that the size, shape, or both sizes and shapes of a metal feature of an access hole can be configured to increase the identification of an access hole. For example, assuming that the metal feature comprises a metal plate, a size, shape, or both, they can be selectively adapted for identification of an access hole. Similarly, a feature of an access port contemplated by the present disclosure can be adapted for detection via ultrasound interaction. Such a feature may comprise an exterior topographic feature. In another embodiment, such a feature may comprise a composite structure that includes two or more materials that form an interface surface that can be identified by ultrasound imaging.

An exemplary embodiment of an observable feature through interaction with the imaging technology contemplated by the present disclosure is shown in FIGS. 52, 53A, and 53B. FIG. 52 represents a bottom perspective view of access hole 10.

<img file="MX359073B_D0034.tif" />

OF THE PROPERTY

FIG. 53A shows a top view of port 10 orifi'ffW'Vae, while FIG. 53B shows a 'V'ÜÜ'ta' UU TbíIUb 'UUl the access hole. The access hole 10 of FIGS. 52, 53A, and 53B is similar in some respects to access port 10 as seen in FIGS. 22 and 23, including a cover 14 and a base 16 that cooperate to define a body. In the present exemplary embodiment, however, bottom surface 151 of base 16 includes an identifying feature 200, as seen in FIGS. 52 and 53B. It is contemplated that the identification feature 200 may be one or more alphanumeric characters, such as the represented ether. Additionally, the present description contemplates the use of other marks, such as one more symbols, patterns, characters, designs, or a combination thereof., Etc. Identification feature 200 may be of any size, shape, or both in order to tailor the identification feature for specific identification of one or more of a variety of access port features. Specifically, in one embodiment, the identification feature 200 can take the information to a professional who considers the energy injection capacity of the implanted access port. Note that in the present embodiment, the identification characteristic 200 is defined as a lowered characteristic, while in other embodiments the characteristic

IMPj

MEXICAN INSTITUTE ..

Say THE INDUSTRIAL TROWSDAD

<img file="MX359073B_D0035.tif" />

Identification can be defined in mmo is raised from now on.

As mentioned above, FIG. 53A represents a top view of access hole 10. Note that identification feature 200 is not observable through top surface 161 of cover 14 or through septum 118 without the interaction of imaging technology. As shown in FIG.

53B, the alphanumeric characters of the identification characteristic 200, CT, are engraved in an inverted mirror on the lower surface 151 of the base 16. The CT is engraved in an inverted mirror so that when the imaging technology, such As x-ray imaging, used to identify a subcutaneously implanted access hole, the CT will be visible in the proper orientation. By engraving a desired inverted mirror identification feature on the bottom surface of an access hole, a practitioner will be able to determine if there is a problem with the hole after implantation, such as whether the access hole has been flipped or otherwise it has become disoriented while in the patient's body. In this way, if the identification feature is observed in the inverted mirror or tilted in an x-ray image, the professional can correct the problem before they are made.

MEXICAN INSTITUTE 'OF THE PROH INDUSTRIAL AGE

<img file="MX359073B_D0036.tif" />

attempts to use the access hole.

Although also useful in hole holes where only a portion of a hole includes a metallic material, for example, a metal plate, the etching technique is well suited in one embodiment for access holes that are made up of solid metal, such as titanium, stainless steel, or other materials that are typically radiopaque, that is, non-X-ray transmissive in sufficient thickness. FIGS. 54A-54C are representative images of access port 10 in FIG. 52, which includes titanium or other metallic material, as seen by way of x-ray imaging after implantation in the patient. Access port 10 includes identification feature 200 as seen in FIGS. 52 and 53B. Due to the relative thickness of the access hole 10, the material of the base 16 and the cover 14 that surrounds a periphery of the cavity 36A of the cavity 36, which is a fluid cavity, is substantially non-transmissive to x-rays and by therefore it appears relatively dark in the x-ray image of FIG. 54A. However, the material of the access hole 10 within the periphery of the cavity 36A is relatively thinner through a base of the cavity 220 (as seen in FIG. 55) than through the material of the lid 14 and base 16. In this way, the additional thinning of the material when the

I

<img file="MX359073B_D0037.tif" />

INSTITUTO MEXICANO additional thinning of the quartz material ^ 'g ^ S'SL cSe identification characteristic 200 allows, · ..φι &amp;. Identification characteristic appears relatively more radiographically transmissive than surrounding material at the base of the cavity under x-ray imaging. note that the identification feature 200 in FIG. 54A is visible in the proper orientation, indicating that the hole indicating that the access hole is not flipped.

FIGS. 54B and 54C are additional representative x-ray images of identification feature 200 of access port 10, where the access port is tilted at angles of approximately 20 and 50 degrees, respectively. In this way, the identification feature 200 is also useful in determining the relative orientation of the access hole 10 after implantation.

FIG. 55 shows a cross sectional view taken on line 55-55 of access hole 10 in FIG.

52. In this exemplary embodiment, identification feature 200 is disposed below septum 118 and cavity 36. FIGS. 56A and 56B further depict enlarged cross-sectional views of potential cut profiles of the undercut identification feature 200. FIG. 56A shows a rounded engraving profile 201,

<img file="MX359073B_D0038.tif" />

<img file="MX359073B_D0039.tif" />

ΙΜΡϊ

MEXICAN INSTITUTE σε INDUSTRIAL PROPERTY engraved on the lower surface 151 of base 16 and used for aesthetic purposes and ease of manufacture. For a relatively more defined contrast under imaging technology, however, a sharp edge etching profile 202 can be used, as seen in FIG. 56B. Note that a variety of lowered cross section profiles can be used. The disclosure further contemplates that while engraving is discussed herein, other methods of making the identification feature can be used such as grinding, machining, chemical or laser etching, molding, stamping, etc.

Regardless of the cut profile used, the best overall contrast is achieved with the greatest engraving depth X. The optimum engraving depth X will, however, depend on the thickness of the base of the total cavity 220, which is the portion of the base directly below the cavity 36, as shown in FIG. 55. For example, in an embodiment of an access hole that includes titanium, if the total thickness of the cavity base 220 is approximately

0.020 then sufficient contrast for x-ray imaging purposes can be obtained in one embodiment by recording the identification characteristic 200 at a depth X (FIGS. 56A, 56B) of between about

0.009 and approximately 0.011. In another exemplary embodiment of an access port hole including titanium,

<img file="MX359073B_D0040.tif" />

MEXICAN INSTITUTE OF PROPERTY

INDUSTRIAL

<img file="MX359073B_D0041.tif" />

where the total thickness of the base of the cavity 220 is approximately 0.030, sufficient contrast can be obtained by engraving the identification characteristic 200 at a depth X of between approximately 0.015 and approximately 0.021. A person of ordinary skill in the art will appreciate that the depth of an engraved identification feature can be varied substantially in order to meet the safety requirements of a product and still remain within the scope contemplated by that description. In addition, the depth X of the identification feature may vary according to the position of the feature in the access hole, the thickness of material that is penetrated by imaging technology, the type of material included in the access etc.

Also contemplated by this disclosure is the use of an identification feature on a metal or other radiopaque access hole that can be applied to access holes that have a variety of possible configurations, as seen in FIGS. 57A-58C, for example. FIGS. 57A-57C depict one embodiment, wherein the access hole 10 includes an identification feature 200 on a bottom surface 251 of a base or body 116. The access hole 10 in FIGS. 57A-57C includes a snap ring 230, which seals septum 118 to the base or

INSTITUTOIMRICáNU JS, „, nt the wowboad body 116, over cavity 36. In a modaliifMV^{,To the}Retainer ^ &amp; nd33_'ó 230 snaps on to hold Septum 118 in place. FIGS. 58A-58C show yet another embodiment, where the access hole 10 includes an identification feature 200 on the base of the cavity 220 and where the base of the cavity is flush coupled and fired with a bottom surface 252 of a cover 114 to define a body. In a particular embodiment, the base of the cavity 220 is press-fitted into the cover 114, although other coupling configurations can also be used.

In another embodiment contemplated by the present description, FIGS. 59A and 59B show that the location of identification feature 200 may vary as well. Before placing the identification feature 200 under the cavity 36, it is possible to place the identification feature under another portion of the access hole 10, such as under the outlet stem 31 and between the septum 89 plugs, i.e. close to the outer periphery of the bottom surface of the access hole. Although the total thickness of the access hole structure above identification feature 200 is greater at this location than if engraved under cavity 36, the change in location allows for relatively deeper engraving, which will increase contrast without risk of excessive thinning of the cavity base 220

MEXICAN INSTITUTE I3E LA PMWSÜAL »

INDUSTRIAL

Further,

<img file="MX359073B_D0042.tif" />

In one embodiment, it is possible to define the identification characteristic composite when engraving on both the bottom and top surfaces, such that the engravings are vertically aligned. This allows the remaining material thickness to be reduced substantially in order to provide relatively greater radiographic transmission through the identification feature.

Additionally, the present disclosure contemplates access ports having any desired variety or combination of identification characteristics to indicate the power injection capacity or other characteristic aspect of an access port. Specifically, FIGS. 60A-61B represent different types of identification characteristics 200, according to exemplary modalities. FIGS. 60A-60B represent a symbolic identification feature 200. FIGS.

61A-61B represent an exemplary embodiment of an access port 10 that includes a combination of identification features 200, primarily an alphanumeric identification feature 200A and a pattern identification feature 200B. A symbolic or pattern identification feature can also be used to help indicate the orientation of the hole or for any other desired reason. It is understood here * - · i **. * J * W;

<img file="MX359073B_D0043.tif" />

Description that other symbols, patterns, markings, and alphanumeric characters can be used both alone and in any combination with each other over a variety of access hole configurations.

In additional embodiments, the identification feature may be defined as an interior bottom surface 36B of the cavity 36 of an access hole 10, or in addition to the identification feature 200 provided on the bottom surface 251. In another embodiment, the material surrounding the defining edges of the desired radiopaque alphanumeric character, symbol, pattern, etc., may be removed rather than removed from the desired feature shape itself to define a positive release image of the identifying feature. . Such a positive release identification feature can be defined on the bottom surface of an access port body or on the interior bottom surface of the cavity, for example.

In addition to the various types of symbols, patterns, markings, and alphanumeric characters that are contemplated by the present disclosure, FIGS. 62A-63C disclose additional exemplary modalities for identifying features over access holes that are observable by x-ray or other suitable imaging technology. Specifically, the present description contemplates the use of

MEXICAN INSTITUTE

FROM THE? RCf IEOAÜ

INDUSTRIAL the cavities of the cover 204, where the portions of the access hole 10 are hollowed out. This results in the cavities of the cover 204 extending inward from the bottom surface 251 of the base or body 116 or the bottom surfaces of the corresponding hole of the other embodiments described herein, including the bottom surface 151 of the base. 16, as shown in FIG. 151, and the bottom surface 252 of a cover 114, as shown in FIGS. 58A-58C. This is done by removing the material surrounding cavity 36 without interrupting the periphery of cavity 36A or the outer side surfaces 250 of access hole 10. As seen in FIG. 62B, ribs 240 can be left to support the remaining cover structure of the access hole

10. The definition of such cavities 204 provides a relative difference in the radiopacity of the access hole 10 that can be identified by the x-ray imaging pathway. as such, cavities 204 can be arranged to define a pattern or to form clues for identifying an aspect or characteristics of access port 10. Note that in modalities oysters, cavities can be defined to extend from other surfaces of the access hole, including the top and sides of the access hole.

In an additional aspect contemplated by the

<img file="MX359073B_D0044.tif" />

In this description, it is contemplated that a communication technology can be used where the information is covered by an access hole contemplated by the present description. In general, a communication device (for example, a radio beacon, a light emitting element, an ultrasound emitting transducer, etc.), can be incorporated or otherwise fixed to an access hole contemplated by the present description . Such a communication device can be configured to transmit information in response to a given momentum. More specifically, the present description contemplates that an access hole contemplated by the present description can be exposed to a request signal (for example, a sound, an impact or an acceleration, light, radio waves, etc.). Such a request signal may cause the communication device to transmit information from it via the sound, light path. Radio waves, or in another manner known in the art. Such information can be used to identify an access hole contemplated by the present disclosure.

In an exemplary embodiment, it is contemplated that radio frequency identification technology can be employed for the identification of an access port contemplated by the present disclosure. In particular, so-called active RFID tags are powered by an internal battery and are typically

MEXICAN INSTITUTE CE THE PROPERTY

INDUSTRIAL read / write. Currently, a suitable cell coupled to a suitable low power circuit can ensure functionality for as long as ten or more years, depending on operating temperatures and read / write and use cycles. So-called passive RFID tags operate without a separate external power source and obtain operating power generated from the reader. Passive RFID tags are typically programmed with a unique set of data (usually 32 to 128 bits) that cannot be modified. Read-only labels can operate as a comparable identifier to linear barcodes that can contain specific information for the selected product. In this way, passive RFID tags can be much lighter than active RFID tags, less expensive, and can offer virtually unlimited operational lifetime. The downside is that they have shorter read intervals than active tags and require a more powerful reader.

An advantage of the RFID procedure is the line-of-sight, contactless nature of the technology. Labels can be read through a variety of substances such as snow, mist, ice, paint, crusted dirt, and other visually and environmentally difficult conditions, where other optically readable technologies may be less effective. RFID tags

<img file="MX359073B_D0045.tif" />

ΙΜΡΪ

ΓΝίΤΙΠΠΟ MEXICAN, »5 ΙΑ fNCNfSTRIAl PROPERTY can also be read in difficult circumstances at fast speeds, in most cases responding in less than about 100 milliseconds.

While certain representative modalities and details have been shown for purposes of illustrating aspects contemplated by the present disclosure, it will be apparent to those skilled in the art that various changes in the methods and apparatus disclosed herein can be made without departing from the contemplated scope. by the present description, which are defined in the appended claims. For example, other sizes and shapes of access hole can be used; and various other modalities and structures can be employed to form at least one identifiable feature of an access port contemplated by the present disclosure. In particular, FIGS. 25-51 illustrate a variety of additional exemplary access port 10 modalities. As is evident from these figures, access port 10 can be formed in any variety of shapes and sizes, such that any variety of modifications and changes are possible to any of the modalities described and illustrated herein without departing from the spirit. and scope of the present description.

<img file="MX359073B_D0046.tif" />