Trimmable catheter including distal portion stability features.

(54) Title: CUT-OFF CATHETER INCLUDING DISTANT PORTION STABILITY CHARACTERISTICS. (54) Title: TRIMMABLE CATHETER INCLUDING DISTAL PORTION STABILITY FEATURES.

(57) Summary

A catheter tube is disclosed for insertion into a patient's body. The catheter tube includes a distant portion that remains stable during infusion of fluid into the patient, thereby reducing or eliminating flogging of the distant catheter tip, even during power injection. In one embodiment, the catheter tube defines at least one lumen and is formed of a tube material that defines a proximal portion and a distal portion of the catheter tube. The catheter tube is configured such that the arithmetic product of an elastic modulus and an area moment of inertia for at least a portion of the distant portion of the catheter tube defined by the catheter tube material is greater relative to the product. arithmetic of an elastic modulus and an area moment of inertia for at least a portion of the proximal portion of the catheter tube.

(57) Abstract

A catheter tube for insertion into a body of a patient is disclosed. The catheter tube ineludes a distal portion that remains stable during fluid infusión into the patient, thus reducing or eliminating whipping of the catheter distal tip, even during power injection. In one embodiment, the catheter tube defines at least one lumen and is formed from a tube material that defines a proximal portion and a distal portion of the catheter tube. The catheter tube is configured such that the arithmetic product of an elastic modulus and an area moment of inertia for at least a portion of the distal portion of the catheter tube defined by the catheter tube material is greater relative the arithmetic product of an elastic modulus and an area moment of inertia for at least a portion of the proximal portion of the catheter tube.

PATENT TITLE NO. 339162 me liiíW. or:¹ h *

I KNOW

M CRE IARJA O »KONÜMIA

<img file="MX339162B_D0001.tif" />

Institute

Mexican Property

Industrial

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Owner (s): CR BARD, INC.

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

Denomination: CUT-OUT CATHETER INCLUDING DISTANT PORTION STABILITY CHARACTERISTICS.

Classification: IC.8: A61M25 / 14; H04L1 / 00; H04L1 / 16; H04L1 / 18; H04W72 / 12

Inventor (s): DANIEL B. BLANCHARD; RYAN C. PATTERSON

REQUEST

Number:

MX / a / 2013/000715

International filing date: August 12, 2011

PRIORITY

Date: Number:

August 2010 61 / 373,000 • se · «tí í? = s · 8 t ·

Country:

US

Validity: Twenty years Expiration Date: August 12, 2031

The reference intent is granted based on articles 1, 2 fraction V, 6 fraction III, and 59 of the Industrial Property Law.

In accordance with the articles of the Industrial Property Law, this patent has a validity of twenty non-extendable years, effective as of the date φ presentation of the international law and will be subject to the payment of the fee to keep the rights in force. ^:·?

Whoever subscribes to this title did so based on the provisions of articles 6 fractions III and 7 'bis 2 of the Industrial Pro | age Law (Official Gazette of Ir, Federation (DOF) 06/27/1991, amended on 08/02/1994, 10/25/19968 12/26/1997, 1 «05/1999, 26 /« / 2004, 06/16/2005, 01/25/2006, 06 ^ 5 / 2009.06 / 01/2010, 06/18/2010. 06/28/2010, 01/27/2012 and 04/09/2012);_:Articles 1, 3'lection V ¡nci || a), subsection iii) 4th and 12th failures I and III of the Regulation of the Mexican Institute of Industrial Property (DOF 12/14/1999, restrained on 07/01/2002, 07/15/2004, 2 ^ 07 / 2004 and 09/07/2007); articles 1, 3, 4, 5, section V, subsection a), sub-paragraph iii), 16 sections I and III and 30 | pl Organic Statute of the j / lexlcano Institute of Industrial Property (DOF 12/27/1998, signed on 10/10/2002, 2 ^ 07/2004, 04 / S / 2004 and 13/09/2007); 1 ^ 3 ° and 5 ° Riso a) and antepenultimate paragraph of the Agreement that (Maga faculties in the Deputy Directors General, Coordinator, DSIonal Directors, Head of the Regional Offices, Divisional Deputy Directors, CooájSnadores Defliitamentales and others. Mexican Property Jpdustnaq ID.OF 12/15/1999, .refpjm | do_B.eLOW2 / 2000, 29/97/2004; 08/04/2004 and 09/13/2007). 'i⁸*·- · ^s '⁵"~; Ul¹¹

Issue Date: May 13, 2016

DIVISIONAL DEPUTY DIRECTOR OF EXAMINATION OF PATENT FUND, MECHANICAL, ELECTRICAL AND HFfiicTPns AREAS n_F INDUSTRIAL mcFÚnc AND

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Arenal No 550, Floor 1,

Col. Pueblo Sania María Tepepan, Xochimílco, CP 1602Q,

Mexico City

Tea!. (55) 53 34 07 00 www.impi.qob.mx

<img file="MX339162B_D0004.tif" />

<img file="MX339162B_D0005.tif" />

MX / 2016/37475

33^16^

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INST1

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CUT-OFF CATHETER INCLUDING FEATURES OF Εβτ'Χδϊΐ.ΐα

DISTANT PORTION

BRIEF DESCRIPTION OF THE INVENTION

Briefly summarized, the embodiments of the present invention are directed to a catheter assembly used to access a vasculature or other internal portion of a patient. The catheter assembly includes a catheter tube defining one or more lumens, with at least one lumen optionally with power injection capability, in one embodiment. A proximal portion of the catheter tube is dimensioned and configured to reside within a portion of the vessel that is disposed relatively close to the catheter tube insertion site in the patient. In particular, since such container portions are relatively small in diameter, the proximal portion of the catheter tube is similarly relatively small in diameter and of relatively low rigidity, to prevent substantial occlusion of the vessel by the catheter tube and to reduce damage. to the glass.

Furthermore, a distal portion of the catheter tube is dimensioned and configured such that the distal portion remains stable within the vessel during the infusion of fluids therethrough. In particular, the distal portion of the catheter tube is configured to prevent flagellation of the distal tip within the vessel.

IMPI

INSTITUTO MEXICANO r.'E LA RRl&gt; riEr&gt; AD INDUSTRIAL

<img file="MX339162B_D0008.tif" />

during fluid infusion to prevent ^ -1 dr ^ o glass. This stability of the distal portion of the catheter tube is especially useful during fluid power injection into the vessel.

In one embodiment, stability of the distal tip of the catheter tube is achieved by widening, or by increasing the cross section size of the distal portion of the tube, thereby increasing the size of the area of ​​one or more catheter lumens and improving the moment of inertia of the area of ​​the distant portion. In another embodiment, the elastic modulus, or stiffness, of the distal portion can be increased relative to the proximal portion of the catheter tube. In another embodiment, both the moment of inertia of the area and the module can be modified to improve the stability of the distant portion. Note that these and related parameters can be modified in other ways as well.

Thus, in one embodiment, a catheter tube is disclosed for insertion into a patient's body. The catheter tube includes a distant portion that remains stable during infusion of fluid into the patient, thereby reducing or eliminating flogging of the distant catheter tip, even during power injection. In one embodiment, the catheter tube defines at least one lumen and is formed of a material of

<img file="MX339162B_D0009.tif" />

IMPI

MEXICAN INSTITUTE

THE MONEDAD

INDUSTRIAL tube defining a proximal position and a distant portion of the catheter tube. The catheter tube is configured such that the arithmetic product of an elastic modulus and an area moment of inertia for at least a portion of the distal portion of the catheter tube defined by the catheter tube material is greater relative to the product. arithmetic of an elastic modulus and an area moment of inertia for at least a portion of the proximal portion of the catheter tube.

These and other features of the embodiments of the present invention will be more fully apparent from the following description and appended claims, or can be learned by practicing the embodiments of the invention as set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS A more particular description of the present disclosure will be described with reference to specific embodiments thereof illustrated in the accompanying drawings. It is appreciated that these drawings represent only typical embodiments of the invention and therefore are not to be construed as limiting their scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 is a perspective view of a

IMPI

INSTITUI · »MEXICAN OF THE INDUSTRIAL MIDDLE

<img file="MX339162B_D0010.tif" />

catheter assembly configured according to “coli UfiéT modality;

FIG. 2 is a side view of the catheter tube

<td>of the assembly shown in</td><td>FIG. one;</td>

<td>FIGS. 3A-3C are</td><td>cross section views</td>

<td>catheter tube</td><td>FIG. 2, showing a change</td>

<td>relative in the structure of the</td><td>catheter tube;</td>

<td>FIG. 4 is a</td><td>side view of a tube</td>

<td>catheter configured accordingly</td><td>with a modality;</td>

<td>FIG. 5 is a</td><td>side view of a tube</td>

<td>catheter configured accordingly</td><td>with a modality;</td>

<td>FIG. 6 is a</td><td>side view of a tube</td>

catheter configured according to one embodiment;

FIG. 7 is a cross sectional view of a distal portion of a catheter tube in accordance with one embodiment;

<td></td><td>FIG.</td><td>8 is a side view</td><td>of</td><td>a</td><td>tube</td><td>of</td>

<td>catheter</td><td>agree</td><td>with a modality;</td><td></td><td></td><td></td><td></td>

<td></td><td>FIG.</td><td>9 is a side view</td><td>of</td><td>a</td><td>tube</td><td>of</td>

<td>catheter</td><td>agree</td><td>with a modality;</td><td></td><td></td><td></td><td></td>

<td></td><td>FIG.</td><td>10 is a side view</td><td>of</td><td>a</td><td>tube</td><td>of</td>

<td>catheter</td><td>agree</td><td>with a modality;</td><td></td><td></td><td></td><td></td>

<td></td><td colspan="3">FIGS. 11A and 11B are views</td><td>in</td><td colspan="2">section</td>

<td colspan="3">cross section of the catheter tube of FIG. 10</td><td>z</td><td></td><td></td><td></td>

<td></td><td>FIG.</td><td colspan="2">12 is a side view</td><td>in</td><td colspan="2">section</td>

MEXICAN INSTITUTE OF LA rHOAJEPAO

INDUSTRIAL transverse of a distant portion of an f-nbr »Hp according to one modality;

FIG. 13 is a perspective view of a distant portion of a catheter tube in accordance with one embodiment;

FIGS. 14A and 14B are sectional side views

<td>cross</td><td>of a</td><td>tube</td><td>of</td><td>catheter</td><td>of</td><td>agreement</td><td>with</td><td>a</td>

<td>modality;</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>the</td><td>FIG.</td><td>15 is</td><td>a</td><td>view</td><td colspan="2">side of</td><td colspan="2">section</td>

<td>cross</td><td>of a</td><td>tube</td><td>of</td><td>catheter</td><td>of</td><td>agreement</td><td>with</td><td>a</td>

<td>modality;</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>the</td><td>FIG.</td><td>16 is</td><td>a</td><td>view</td><td colspan="2">lateral in</td><td colspan="2">section</td>

<td>cross</td><td>of a</td><td>tube</td><td>of</td><td>catheter</td><td>of</td><td>agreement</td><td>with</td><td>a</td>

<td>modality;</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>the</td><td>FIG.</td><td>17 is</td><td>a</td><td>view</td><td colspan="2">lateral in</td><td colspan="2">section</td>

<td>cross</td><td>of a</td><td>tube</td><td>of</td><td>catheter</td><td>of</td><td>agreement</td><td>with</td><td>a</td>

<td>modality;</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>the</td><td>FIG.</td><td>18 is</td><td>a</td><td>view</td><td colspan="2">side of</td><td colspan="2">section</td>

<td>cross</td><td>of a</td><td>tube</td><td>of</td><td>catheter</td><td>of</td><td>agreement</td><td>with</td><td>a</td>

<td>modality;</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>the</td><td>FIG.</td><td>19 is</td><td>a</td><td>view</td><td colspan="2">side of</td><td colspan="2">section</td>

<td>cross</td><td>of a</td><td>tube</td><td>of</td><td>catheter</td><td>of</td><td>agreement</td><td>with</td><td>a</td>

<td>modality;</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>the</td><td>FIG.</td><td>20 is</td><td>a</td><td>view</td><td colspan="2">side of</td><td colspan="2">section</td>

<td>cross</td><td>of a</td><td>tube</td><td>of</td><td>catheter</td><td>of</td><td>agreement</td><td>with</td><td>a</td>

ΙΜΡΙ

MEXICAN INSTITUTE • E industrial PROPERTY

<img file="MX339162B_D0011.tif" />

modality;

<td>the</td><td>FIG. 21 is</td><td colspan="2">a sight</td><td>side</td><td>of</td><td>section</td>

<td>cross</td><td>from a tube</td><td>of</td><td>catheter</td><td colspan="2">agree</td><td>with a</td>

<td>modality;</td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>the</td><td>FIG. 22 is</td><td>a</td><td colspan="2">side view of</td><td>a</td><td>tube of</td>

catheter according to one embodiment;

FIGS. 23A-23C are cross-sectional views of the catheter tube of FIG. 22;

FIG. 24 is a side view of a catheter tube according to one embodiment;

<td></td><td></td><td>FIG. 25 is a</td><td>view</td><td>of the</td><td>extreme</td><td>distant from</td>

<td>tube</td><td>of</td><td>FIG. catheter 24</td><td>r</td><td></td><td></td><td></td>

<td></td><td></td><td>FIG. 26 is a</td><td>view</td><td>of the</td><td>extreme</td><td>distant from</td>

<td>tube</td><td>of</td><td>FIG. catheter</td><td>24 in</td><td>a</td><td>first</td><td>setting</td>

rolled up;

<td>the FIG</td><td>. 27 is a</td><td>view</td><td>of the</td><td>extreme</td><td>distant from</td>

<td>catheter tube</td><td>of FIG.</td><td>24 in</td><td>a</td><td>second</td><td>setting</td>

rolled up; and FIGS. 28A and 28B are perspective and end views, respectively, of a catheter tube according to one embodiment.

DETAILED DESCRIPTION OF THE SELECTED MODALITIES

Reference will now be made to the figures where similar structures will be provided with similar reference designations. It is understood that the drawings are

<img file="MX339162B_D0012.tif" />

IMPI _ INSTITUTO MEXICANO / OE LA TEOMEDAL ·

INOtlSTWIAL exemplary diagrammatic and schematic representations of the present invention are neither limiting nor necessarily drawn to scale.

For clarity it is to be understood that the word "proximal" refers to an address relatively closer to a physician using the device described herein, while the word "distant" refers to an address relatively far from the physician. For example, the end of a catheter placed inside a patient's body is considered a distant end of the catheter, while the end of the catheter that remains outside the body is a proximal end of the catheter. Also, the words including, having and having, as used herein, including the claims, will have the same meaning as the word comprising.

The embodiments of the present invention are generally directed to a catheter assembly used to access a vasculature or other internal portion of a patient. The catheter assembly includes a catheter tube defining one or more lumens, with at least one lumen with power injection capability, in one embodiment. A proximal portion of the catheter tube is dimensioned and configured to reside within a portion of the vessel that is positioned relatively close to the catheter tube insertion site in the patient. In particular, since such portions

IMPI

NSTITUTO MEXICANO OC LA PROFIERA D INDUSTRIAL

<img file="MX339162B_D0013.tif" />

of the vessel are relatively small in diameter, the proximal portion of the catheter tube is similarly relatively small in diameter and of relatively low rigidity to allow easy passage of the catheter through the vessel and to prevent substantial occlusion of the vessel through the vessel catheter.

Furthermore, a distal portion of the catheter tube is sized and configured so that it remains stable within the vessel during infusion of fluids therethrough. Particularly, the distal portion of the catheter tube is configured to prevent flogging of the distal tube within the vessel during fluid infusion to prevent vessel damage. This stability of the distal portion of the catheter tube is especially useful during fluid power injection into the vessel.

In one embodiment, stability of the distal tip of the catheter tube is achieved by widening, or by increasing the cross section size of the distal portion of the tube, thereby increasing the size of the area of ​​the one or more lumens of the catheter and improving the moment of inertia of the area of ​​the distant portion. In another embodiment, the elastic modulus, or stiffness, of the distal portion can be increased relative to the proximal portion of the catheter tube. In another mode, both the moment of inertia of the area and the module can be modified to increase

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX339162B_D0014.tif" />

the stability of the distant portion. nb «arvar gup pstns other and related parameters can be modified in other ways as well and additional settings are disclosed to increase the stability of the distant tip. In addition to the catheter tubes described herein as part of catheter assemblies, the disclosed principles can be employed with other tubular medical devices as well.

Reference is first made to FIG. 1, representing various details of a catheter assembly, generally designated 10, in accordance with one embodiment. As shown, the catheter assembly (catheter) 10 includes, an elongated catheter tube 12 formed by an outer wall 13 which, together with a septum 15 (FIGS. 3A-3C) defines one or more lumens 14 extends between a end 12A and a distal end 12B of the tube. A branch 16 couples with catheter tube 12 at proximal end 12A thereof to provide fluid communication between catheter tube and one or more extension legs 18.

FIG. 2 shows additional details of the catheter tube of catheter 10, according to the present embodiment. As shown, tube 12 includes a proximal portion 20 that extends distantly from proximal end 12A and a distant portion 30 extends distantly from the distal end of the proximal portion of distal end 12B of the

<img file="MX339162B_D0015.tif" />

ΙΜΡΪ

I η MEXICAN INSTITUTE ^lu OF THE RRORIEDAD

INDUSTRIAL tube. A tapered region 24 of pnrHóp pmvwai 70_isIt is included in catheter tube 12 and is configured such that the thickness of outer wall 13 and septum 15 decrease from the distal end of 12A to the distal termination of tapered region 24. In addition, the size of the area of ​​each of 14 lumens also decreases distantly over this region. These differences in size can be observed by comparing figures. 3A and 3B, showing cross-sectional views of catheter tube 12 at the proximal end of tapered region 24 (FIG. 3A) and distant from the distant end of tapered region (FIG. 3B).

The proximal tapered region 24 provides sufficient exterior wall thickness and stiffness for the catheter tube 12 of the present embodiment to prevent kinking and allow the tube to conform to an insertion site in the patient's skin during insertion and the

<td>adjustment</td><td>of the</td><td>catheter</td><td> 10.</td><td>Additionally, the</td><td>tapered region</td>

<td>next</td><td>to</td><td>24 serves</td><td>for</td><td>plug the site</td><td>insertion to</td>

<td>through</td><td>of the</td><td>who</td><td>tube</td><td>catheter for in</td><td>the body of the</td>

patient, thereby reducing bleeding or other complications at the site.

The remainder of the proximal portion 20 of the catheter tube 12 resides within the distant portions of the vessel that are typically located relatively close to the catheter insertion site at the extremities of the

ΙΜΡΪ

MEXICAN INSTITUTE Dt THE INDUSTRIAL PROPERTY

<img file="MX339162B_D0016.tif" />

patient, such as the arm. Such spleens¹ porif áriooc_r-— distant, relatively smaller than the largest spleens located deeper within the body in which the portion is distant 30 of the catheter tube 12 is placed. In this way, the proximal portion 20 of the catheter tube 12 distant from the tapered region 24 is similarly sized relatively small, so that this portion can reside in the relatively small vessel without occluding a significant portion thereof, which in turn reduces the risk of thrombus. Furthermore, the smaller size of the proximal portion 20 allows it to more easily bend during insertion into the vessel along a potentially tortuous path, resulting in less trauma and damage to the vessel.

As best seen in FIG. 2, the distal portion 30 of the catheter tube 12 includes a distal tapered region 34 that provides a size transition for the tube from the distal end of proximal portion 20 and the remainder of distal portion 30. Specifically, the distal tapered region 34 allows the dimensions of the catheter tube 12 to change from the cross sectional configuration corresponding to the proximal portion 20 shown in FIG. 3B to that of the distal portion 30 shown in FIG. 3C, where the thickness of the outer wall 13 and septum 15, together with the size of the lumen area 14, is increased. This increase in overall portion size

<img file="MX339162B_D0017.tif" />

MEXICAN INSTITUTE • Ε THE PROPERTY

INDUSTRIAL

<img file="MX339162B_D0018.tif" />

<img file="MX339162B_D0019.tif" />

distant from catheter tube 30 is provided with improved lability · for this portion of catheter tube 12, which in turn prevents oscillatory movement, or flagellation, of the distant tip of the tube during fluid infusion through the catheter into the vessel in which catheter 10 is placed. This in turn reduces the likelihood that the vessel will be damaged by repetitive tube impacts from the catheter tube flogging.

In greater detail, it is appreciated that an unsupported stable length, L, of a distant portion of a catheter tube can be characterized by:

(1) where p is the density of the injected fluid, Q is the flow rate of the injected fluid, A is the area of ​​the lumen of the cross section of the catheter tube, E is the elastic modulus of the catheter tube material from which the outer wall 13 and septum 15 are formed, I is the moment of inertia of the area of ​​the outer wall and the septum material, and C is a constant of proportionality.

From equation (1), it is observed that the stability length L of the catheter tube 12 can be increased by one or more of the parameters Ε, I and A. The increased size of the distal portion 30 of the catheter tube 12 and the portions of lumens 14 define it (FIGS. 1 and 2)

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX339162B_D0020.tif" />

it serves to increase both the moment of inertia of the area 'T and the area of ​​lumen A, which in turn improves the stability length L, which corresponds to a more stable tip inside the vessel during fluid injection. This stability of the tip of the distal portion 30 of the catheter tube 12 is especially useful during a power injection of fluids into the spleen, where the flow rate of the catheter fluid Q can be exceeded by about 5 cc / second. Under such conditions, the ability to preserve tip stability and reduce or eliminate tip flagellation is specifically.

As discussed above, an increase in the size of the distal portion 30 and / or other portions of the catheter tube 12 increases the moment of inertia of area I and thereby improves tip stability. Notice that I is directly related by the fourth power of the radius of the catheter tube. Like tai, a relatively small increase in the cross-sectional size of the catheter tube can have a significant effect on I, which improves the stability of the distant tip. Also note that I can be beneficially improved by increasing the thickness of the outer wall and / or septum of the catheter tube while not increasing the area A of the lumen (s) of the tube.

Also, the flexural stiffness defined as the product of parameters E and I, is higher in the portion

IMPI

MEXICAN INSTITUTE »AND INDUSTRIAL PROPERTY

<img file="MX339162B_D0021.tif" />

distant 30 relative to that of proximal portion 20, in one embodiment, to provide stability at the distant tip during fluid infusion. This can be accomplished by increasing the elastic modulus and / or the moment of inertia of the area for the distant portion over that of the proximal portion in any of the forms planted herein, or other forms contemplated by one skilled in the art.

Again in the foregoing, an increase in the size of the distal portion 30 and / or other portions of the catheter tube 12 increases the area A of the lumens 14 and thus improves tip stability. Observe

<td>than in another</td><td>modality the</td><td>area</td><td>of the</td><td>lumen A</td><td>It can</td>

<td>increase</td><td>desirably</td><td>in</td><td>others</td><td>shapes</td><td>too,</td>

<td>including: a</td><td>weight loss</td><td>of the</td><td>wall</td><td>Exterior</td><td>and except</td>

while care was taken not to reduce the moment of inertia of area A of the distant part; increase the lumen area while maintaining the outside diameter of the catheter tube constant, etc.

Although it can be formed to a variety of lengths to accommodate different uses and applications, in one embodiment the proximal tapered region 24 of the proximal portion 20 is approximately 4 cm in length, the remainder of the proximal portion is approximately 20 to approximately 25 cm, the distant tapered region 34 of portion 30 is approximately 4 cm, and the remainder of the distant portion is

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY·

<img file="MX339162B_D0022.tif" />

about 35 cm. Of course, lengths can be used for the variation segments described above.

On the other hand, the lengths, cross sectional sizes of, and relative size differences between the various segments may also vary from what is shown and described herein, as appreciated by one of skill in the art. In the present embodiment, the approximate diameter, wall thickness, and septum thickness (in inches) for each of the cross-sectional views shown in FIGS. 3A-3C are, respectively:

.095, .011, .008 (FIG. 3A); .063, .0070, .0055 (FIG. 3B), and .070, .0080, .0060 inches (FIG. 3C). Note that these are just one possible example of size settings for catheter tube 12. In fact a variety of sizes, including various French sizes, can be employed for the catheter tube. In one embodiment, for example, the proximal catheter position defines a size in the range of 2-6 French while in the distant portion it defines a size in the range of 2.5-8 French. It should be further appreciated that the number, size, and other configuration of the catheter lumens may vary from what is shown herein. For example, the principles of the present description with triple and quadruple lumens. Furthermore, although the 14 lumens shown in FIGS. 3A-3C are

IMPI • nstituto ^m«'CAWJ

FROM PROPERTY Λκχ_5ϊ&gt; ΪΓ &lt;INDUSTRIAL symmetrically, arranged in another embodiment, ios rumeliCo can be included in a centering configuration to provide one or more relatively larger lumens for power injection, if desired.

In this and several other embodiments described herein, catheter 12 is extruded and otherwise formed from one or more of a variety of suitable materials, including thermoplastic polyurethanes sold under the trademarks TECOFLEX (type 93AB30) and TECOTHANE (type 95A. ) from LubrizoL Advanced Materials, Inc., and CARBOTHANE (type 95A), the thermoplastic elastomer sold under the trade name PEBAX by Arkema, Inc., silicone, polyesters, polyethylene, etc. Other suitable materials can also be used acceptably, as appreciated by a person skilled in the art.

Note that although the distal portion of the catheters described herein is trimmable, it is desirable that the length of the distal portion remain after trimming is at least as long as the stable length does not support L as determined by equation ( 1), above. In one embodiment, this length is from about 3 to about 10 cm, although other stable lengths are possible, by equation (1).

FIG. 4 shows the catheter tube 12 according to another form of embodiment, including as before the portion

IMPI

INSTITUTO MEXICANO DE LA FROEIEDAD INDUSTRIAL proximal 20 and the distal portion 30 joined by a tapered region 35. As shown, the distal portion 30 is widened in size from that of the proximal portion 20, thereby providing improved tip stability during power injection or other fluid infusion into the spleen. Also note that, while the catheter tube design of FIG. 2 provides distant trimming of the tube, the catheter tube of FIG. 4 it is both proximal and distantly cuttable to adjust the length of the tube to the patient's anatomy. Note that one embodiment the trimmed amount of the distal end 12B catheter tube of FIG 12. 4 should be such that the remaining portion of the flared distal portion 30 is long enough to ensure stability of the distal tip during fluid infusion, as suggested by equation (1).

FIGS. 5 and 6 give additional possible examples of flared catheter tubes 12, wherein the

FIG. 5 includes a relatively short proximal portion 20 and a relatively short distal portion 30 extends to the distal end 12B. As shown, in this embodiment, the entirety of the distal portion 30 serves as the distal taper portion 34 such that the cross-sectional size of the distal portion is increased steadily toward the distal end of the tube.

In FIG. 6, the tapered region 35 extends to the

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX339162B_D0023.tif" />

full length of catheter tube 12 such that the entire tube includes a taper. As such, both the proximal portion 20 and the distal portion 30 are tapered, or widened. As before, in taper disclosed in FIGS. 5 and 6 provides a relatively small and flexible proximal portion suitable for placement in the smallest portions of the vessel relatively close to the catheter insertion site, while also providing a stable distal portion that reduces or eliminates flagellation of the distant tip during power or other injection or fluid infusion through the distal end of the catheter tube. Such catheter tubes as those described herein in connection with FIGS. 5 and 6 or in other embodiments herein may include one, two, or more lumens. Also note that the catheter tube modalities shown in FIGS. 5 and 6 and various other modalities herein are remotely trimmable to fit the patient's vasculature.

With reference to FIGS. 2 and 3C, note that one embodiment a relationship between the thickness of the outer wall 13 and the radius of the cross section at the distal portion 30 of the catheter tube 12 is established, where the thickness of the outer wall equals approximately 0.24 multiplied by the outer radius of the catheter tube in the distant portion. In this configured way, the portion

MEXICAN INSTITUTE OF LA NttWEDA »INOIJSTWAL

<img file="MX339162B_D0024.tif" />

Distant 30 offers much improved tip stability 'dls' during power injection. Put another way, for a one lumen power injectable catheter tube the product of I and A (and therefore tube stability) can be maximized where the catheter tube outer wall thickness equals about 0.24 of catheter radius in the distant portion thereof. This ratio can be extrapolated for multi lumen catheter tubes as well. This ratio can also be used in a catheter tube without considering without the distal portion thereof being widened as shown in

FIGS. 2, 4, 5, 6, etc. In another embodiment, the thickness of the outer wall may be equal to the product of the outer radius of the catheter tube and a number within a range of about 0.2 to about 0.3.

It is further appreciated that other catheter factors can be adjusted to maximize stability of the distal tip for catheter tube 12, including the length of the widened distal portion alone and as a function of the total catheter tube length, the density of the catheter tube material, the degree of widening of the distal portion relative to the non-widened tube portions, the modulus interaction, area moment of inertia, and lumen area in the widened portion, etc.

FIG. 7 shows a single lumen of the catheter tube

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX339162B_D0025.tif" />

according to a modality, where the dictanko lapunsión. 30 includes the distant tapered portion 34 such that a flared outer diameter 13B is defined by the outer wall 13. An inner diameter 13A defined by the lumen 14 remains substantially constant across the distant portion 30. The resulting increase in outer wall thickness provides stability for the distal portion 30 during infusion of fluid into the spleen, thereby reducing or preventing unwanted flagellation of the distal tip.

FIG. 8 shows that, in one embodiment, proximal portion 20 and distal portion 30 of catheter tube 12 can be configured to display different levels of stiffness, or elastic modulus, (see equation (1)). For example, in the present embodiment the proximal portion 20 includes a relatively soft material while the distal portion 30 includes a relatively stiff material to provide extra strength at the distal end to increase the elastic modulus E of the distal portion, reducing or in turn preventing the flagellation of the distant tip. In yet another embodiment, the proximal portions and

<td>distant</td><td>they can</td><td>to show</td><td>rigidity</td><td>similar to</td><td>temperature</td>

<td>environment,</td><td>but</td><td>they can</td><td>to show</td><td colspan="2">stiffness after</td>

<td colspan="2">implantation and</td><td>subjection</td><td>at</td><td>temperatures</td><td>body</td>

<td>internal.</td><td></td><td></td><td></td><td></td><td></td>

In one modality, both the proximal portions and

<img file="MX339162B_D0026.tif" />

distant are formed of a similar material, where the distant portion is to be treated to make it more rigid relative to the proximal portion. Examples of such treatment of the distal portion include irradiation, application of a solvent or activator, heat treatment, etc. In another embodiment, it is the proximal portion that is treated to show a less rigid elastic modulus.

In one possible embodiment, the entire length of the catheter tube can be treated to show a relatively stiff modulus. In another embodiment, the catheter tube can be extruded from two different materials to provide a soft proximal portion and a relatively stiffer distant portion. In yet another embodiment, a soft proximal tube portion can be attached through adhesion to a relatively more rigid preformed distal portion. These and other variations are therefore contemplated.

FIG. 9 shows details of the catheter tube 12 according to another form of embodiment, wherein the distal portion 30 of the outer wall of the tube 13 defines a plurality of flared segments 40 each including a point of maximum annular diameter 42. The tube Catheter 12 at this point is a double lumen tube with lumens 14 separated by septum 15. The plurality of flared segments gives catheter tube 12 a knobby appearance.

ΙΜΡΙ

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX339162B_D0027.tif" />

The annular flange segments 4 0 are 'dUllfiguiadcrs — fe-crl · that any of the segments can be cut to approximately the point of respective maximum diameter 42, thereby shortening the length of the catheter and providing relatively large distant end fluid outlets and stable for lumens 14. Again, due to its flared configuration for each of the catheter tube 14 lumens, the distal portion 30 of the catheter tube 12 shows relatively larger values ​​for both the size of area A of the lumens and the moment of inertia of the area I. The number, size, and placement of the widened segments may vary according to the application or configuration of the catheter.

FIG. 10 shows details of catheter tube 12 according to another embodiment, where the tube defines first and second lumens 14A and 14B separated by septum 15. As shown, the outer wall 13 of catheter tube 12 remains cylindrical than the septum. 15 at the distal portion 30 includes a plurality of waveforms 46 that together define an undulating pattern. The distal portion 30 of the catheter tube 12 at this point is trimmable such that the lumen size configuration at the trimmed distal tip can be specifically selected. This is shown in FIGS. 11A and 11B, where if the

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IMPI

MEXICAN INSTITUTE OE INDUSTRIAL PROPERTY

<img file="MX339162B_D0028.tif" />

catheter 12 is clipped at the indicated location -in ..... 11 A ·¹ 11 A¹ in FIG. 10, lumen 14A will be larger in relative area with lumen 14B at the distant point of the tube (FIG 11A).

In contrast, cutout of catheter tube 12 at the location indicated at 11B-11B in FIG. resulting in the distant tip lumen configuration shown in FIG. 11B, where lumen 14B is larger in area relative to lumen 14a. In this way, a particular lumen 14 of catheter tube 12 can be selected to have a relatively larger distal tip opening in order to stabilize distal portion 30 within the vessel when fluid is infused into the vessel of that lumen.

In this way, it is observed that undulating accept causes the cross section sizes of lumens 14A and 14B to vary inversely with respect to each other as a function of length along the catheter tube 12. Of course, the Catheter tube at this point can also be used if it has been trimmed first.

FIG. 12 shows another trimming configuration of the distant tip for the catheter tube of FIG. 10, where the tube is cut to define a distant stepped tip. Specifically, the distant tip is clipped relative to septum waveforms 4 6 such that the aperture size area 42A and 42B for each lumen 14A and 14B, respectively, is maximized. This results in a

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX339162B_D0029.tif" />

improved stability of the distal tube-decatheter portion 12 within the patient's vessel during fluid infusion due to the increase in the lumen A area at the distant tip of the catheter tube. Of course, they can be used among other stepped tip configurations.

FIG. 13 shows details of a double lumen catheter tube 12 according to another embodiment, wherein the double lumens 14 of the tube are separated by septum 15. At a predetermined distance L from the distal end 12B of catheter tube 12, a slit 50 is defined in spit 15 such that fluid communication is established between lumen 14. In this configured manner, slit 50 allows fluid to pass from one lumen 14 to the other lumen during fluid infusion into the patient's vessel into which catheter tube 12 is placed. This in turn decreases the fluid pressure in the lumen 14 of which passing through the slit 50 and increases the usable lumen area through which the fluid can pass from the catheter tube 12 in the spleen. These effects help increase tip stability and prevent flagellation of the distant tip within the spleen. Note that the size, shape, number, positioning, and other variations of the cleft may change according to other modalities.

FIGS. 14A and 14B show details of catheter tube 12 according to another embodiment, wherein a

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INDUSTRIAL 'Ολ »' proximal portion of the outer wall of the —t-ubo da — r- ^ ptpr 1 3 includes a first non-inflatable material 60. The distal portion 30 of the outer wall 13 includes a second material 70 which is configured to define a shape factor similar to the proximal portions of the catheter tube including the first material 60 prior to insertion into the patient's body. In contrast to the first material 60, however, the second material 70 is configured to swell to a larger size and is subjected to body heat or moisture after insertion into the patient's vasculature.

In this configured manner, the distal portion 30 of the catheter tube 12 initially defines a similar outer diameter as that of the closest tube portion (FIG. 14A), thereby facilitating the relative ease of insertion of the catheter tube into the patient's vasculature. After placement is complete, the second material 70 of the distal portion 30 swells (FIG. 14B) to a larger inner diameter 13A, and the outer diameter 13B relative to the closest catheter tube portion to provide a larger lumen area and outer wall thickness, which-cooperate - to increase the stability of the distant tip. An example of an inflatable material for use as a second material 70 is a biomaterial including polyurethane and polyethylene oxide.

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MEXICAN INSTITUTE OF INDUSTRIAL RROFIEDAD

<img file="MX339162B_D0030.tif" />

sold under the AQUAVENg trademark of Has ·¹ Fufare · Dermo-Cosmetique. Other inflatable materials, such as suitable hydrophilic and hydraphilic materials can also be used. The use of an inflatable material therefore serves as another example, in addition to other embodiments described herein, to provide a catheter tube with a stable distal portion.

FIGS. 15 and 16 represent other configurations for the use of the inflatable material 70 described above in relation to FIGS. 14A and 14B. In particular, FIG. 15 shows the inclusion of the second inflatable material in the catheter tube 12 to define only an external tubular portion of the distal tube 30 of the catheter tube 12. The inner tubular portion of the distal portion 30, as well as the proximal portions of the catheter tube 12, is defined by the first non-inflatable material 60.

In FIG. 16, the second inflatable material 70 extends proximally beyond the distal portion 30 in the proximal portions of the catheter tube 12 to define at least a portion of the outer surface of the catheter tube. A catheter tube manufactured in this way can be designed to vary in a predetermined and controlled manner the degree of swelling of the catheter tube along its length after insertion into the patient by controlling the amount of material

IMPI

INSTITUTO MEXICANO DE LA PROPIEDAD INDI ISTRIAL inflatable included in the exterior wall * a lu laiyc - «te — telongitud del tube. It is observed that where a hydrophilic material is included in the inflatable material and defines the catheter tube in a similar way to that shown in

FIG. 16, the biocompatibility material of the hydrophilic can improve the catheter tube, under certain circumstances. Further note that the modalities of FIGS. 15 and 16 isolate the inflatable material 70 from direct contact with the fluids passing through the lumen of the catheter tube for infusion into the patient, thereby preventing unintended absorption of fluids by the inflatable material. It is appreciated that the above catheter tube configurations can be formed through extrusion or other suitable method. It is also noted that these configurations are only examples of many possible catheter tube designs including inflatable and non-inflatable materials.

Note that although the distal portions of the catheter tubes described above include both increased outer wall thickness and relative increased lumen area with the proximal portions of the catheter tubes, in other embodiments, the thickness of the outer wall it can vary regardless of lumen area in the distant portion, and vice versa. Also, the relative length and size of the distant portions

<img file="MX339162B_D0031.tif" />

next to the catheter tube you can also vaT'ial of which. She shows and describes in the present. Also note that various single and double lumen catheters are described herein, but other multi-catheters and tubular permanent medical devices may also benefit from the teachings herein.

FIGS. 17-19 show details of catheter tube 12 in accordance with possible embodiments, wherein the catheter tube includes a multi-durometer configuration. In particular, FIG. 17 shows the catheter tube 12 formed by the outer wall 13, a proximal portion of which includes a first relatively hard material (high durometer). The first material 80 extends distally to the distal end 12b of the catheter tube 12 to define an inside diameter at the distal portion 30 of the tube. A second material 90 that is softer (low durometer) relative to the first material 80 includes enzyme from the first material in the distal portion 30 to define an outside diameter surface of the distal portion. Such multi-durometer construction can be achieved through an extrusion / co process, selective extrusion, extrusion of the first material 80 followed by coating or other application of the second material 90, etc. These and other manufacturing methods are contemplated for this and the other modalities represented in

IMPI

MEXICAN INSTITUTE • E INDUSTRIAL PROPERTY

<img file="MX339162B_D0032.tif" />

the following figures.

The design of the catheter tube 12 as shown in FIG. 17 allows the distal portion 30, which is inserted into the patient's vasculature, to be relatively soft to allow the catheter tube to bend and fit easily within the vessel without causing trauma to the vessel. In contrast, the closest portion of catheter tube 12 formed from first material 80 remains external to the patient in the present embodiment and is relatively harder relative to second material 90 to allow it to withstand the relatively higher fluid pressures present in the proximal portion of catheter tube when fluid is infused through it.

FIG. 18 shows another possible catheter tube embodiment, wherein the distal catheter tube portion 12 is formed exclusively from the second relatively soft material 90. The second material 90 also extends proximally from the distal portion 30 of the catheter tube 12 to define an inside diameter of the proximal portions of the tube, while the first relatively harder material 80 extends proximally from the distal portion 30 to define an outer catheter tube surface, as shown. Such a configuration increases the softness and flexibility of catheter tube 12 over its entire length, with

<img file="MX339162B_D0033.tif" />

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INDUSTRIAL substantial softness throughout its portion -dis-tant ^ .- át) ...........

In FIG. 19, another possible embodiment of the catheter tube is shown, where the distal portion of the catheter tube 12 is newly formed exclusively from the second relatively soft material 90. The second material 90 also extends proximally from the distal portion 30 of the catheter tube 12 to define an outer surface of the proximal portion of the tube, while the first relatively harder material 80 extends proximally from the distal portion 30 to define an inside diameter of the catheter tube, as shown. As with the two previous modalities, such a configuration increases the softness and flexibility of the catheter tube 12 along its entire full length, with substantial smoothness along its distal portion 30.

FIGS. 20 and 21 show that, in other embodiments, the multi-durometer catheter tube can also vary in diameter. For example, FIG. 20 shows the distal portion 30 of the catheter tube 12 by including an outer portion of the outer wall 13 formed by the second material 90 and the diameter 13A defined by the first material 80. The first material 80 extends proximally from the distal portion 30 to define the closest portion of the outer wall of tube 13, thereby defining the inner diameter uniformly.

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX339162B_D0034.tif" />

dimensioned 13 along the length meets ugly of the catheter tube 12. The closest portion of the catheter tube 12 defined by the first material 80 is also dimensioned to a larger diameter than the distal portion 30. FIG . 21 shows a similar configuration as that of FIG. 20, with the first material 80 defining a variant inside diameter for catheter tube 12. In this way, these modalities illustrate the various variations possible with multi-durometer catheter tube combinations. It should be appreciated that various other possible configurations are possible, including inverse configurations of those illustrated and described herein. Non-limiting examples of materials that can be employed include the thermoplastics mentioned further in the foregoing including a range of 80-95A durometer for the

<td>second material 90, and</td><td>a</td><td>interval</td><td>durometer</td><td>95A-60D for</td>

<td>the first material 80.</td><td></td><td></td><td></td><td></td>

<td>FIG. 22</td><td colspan="2">show another</td><td>tube of</td><td>catheter</td>

<td>multiple durometer</td><td> 12</td><td>agree</td><td>with a</td><td>modality,</td>

including the outer wall 13 defined by both the first relatively hard material 80 and the second relatively soft material 9U. As shown, the proximal end 12a of catheter tube 12 is completely defined by the first material 80, which is gradually used down in the distant direction to define an increased portion

IMPI

INSTITUTO MEXICANO DE IA FROFIEDAD INDUSTRIAL

<img file="MX339162B_D0035.tif" />

smallest mind of the outer wall 13 (and ..... the · septum / o · i · is present). Correspondingly, second material 90 defines a small portion of catheter tube 12 proximal to proximal end 12A and gradually tapers upward in the distant direction to define an incrementally larger portion of outer wall 13 (and the septum, if it is present), to the distal end 12b the entire catheter tube is completely defined by the second material 90. This variant definition of the outer wall of the catheter tube can be seen in the cross section lists of FIGS. 23A-23C, which are seen at the corresponding indicated locations along the catheter tube shown in FIG. 22. In this way, each point along the length of the catheter tube 12 includes a unique contribution ratio for the composition of the outer wall by the first material 80 and the second material 90. Such a catheter tube as shown at 12 at this point can be manufactured using a co-extrusion or other suitable process.

The definition of catheter tube 12 in the manner shown in FIG. 22 allows the distant portion of the tube to be substantially softer relative to the proximal portions of the tube, which is useful in providing less traumatic insertion of the tube into the patient's vessel, while providing a proximal portion

<img file="MX339162B_D0036.tif" />

IMPI

MEXICAN INSTITUTE

T-3 · Ε THE PROPERTY

INDUSTRIAL relatively hard to withstand the higher féldLl vamg.nb (· »'pressures present in the proximal tube portion during power injection or other fluid infusion procedures. It is appreciated that variations to this design can be employed, including contribution to the exterior wall composition that is varied in a staggered form or is opposite to the continuous form shown in FIG. 22, inverse of the first and second materials, etc.

FIG. 24 gives various details of another configuration of catheter tube 12 according to one embodiment, wherein the tube is the double lumen and the distal portion 30 is widened to define a relative larger diameter than that of the proximal portion 20. Tube 12 in the distal portion 30 includes two single lumen tube structures, each defining one of the lumens 14, which are joined through a fold 94 therebetween, observed in FIG. 25. This configuration offers the same benefits of a widened distant portion, as in the previous modalities, for example, reduction in the flagellation of the distant tip within the vessel.

FIGS. 26 and 27 show that the outer wall 13 defining the distal portion 30 of the catheter tube 12 can be folded or compressed to substantially equal in diameter to the diameter of the proximal portion 20. This allows the catheter tube 12 to be fed through an introducer and into the patient's glass. After that

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MEXICAN INSTITUTE »E THE INDUSTRIAL PROPERTY

<img file="MX339162B_D0037.tif" />

<td>complete</td><td>placement</td><td>of the</td><td colspan="2">catheter tube</td><td> 12</td><td>inside of the</td>

<td>spleen</td><td colspan="2">distant portion</td><td>can</td><td>to deploy</td><td>to</td><td>its size</td>

<td>full</td><td>shown on the</td><td>FIG.</td><td> 25.</td><td></td><td></td><td></td>

<td></td><td>For example,</td><td>the</td><td>FIG. 26</td><td>shows</td><td>than</td><td>Wall</td>

<td>Exterior</td><td>13 that defines</td><td>the</td><td>portion</td><td>distant</td><td colspan="2">30 tube</td>

catheter 12 can be compressed to close lumens 14 and define a substantially serrated, longitudinally extending cavity 96. Cavity 96 is suitable in an embodiment to receive therethrough a guidewire to guide the catheter tube into the spleen. . A dissolvable adhesive or other suitable substance can be applied to the outer wall of catheter tube 13 to keep the tube in the compressed state until placement within the patient's vasculature is complete. The adhesive can then dissolve, allowing the distal portion 30 of the catheter tube 12 to expand to its fully open state.

FIG. 27 shows the outer wall 13 in a rolled configuration that allows the distal portion of the catheter tube 12 to assume a diameter substantially similar to that of the. proximal portion 20 for ease of insertion of the catheter tube into the patient's vasculature. Again, a dissolvable adhesive or other suitable substance can be used to maintain the wall t

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exterior of distant portion 13 in ίο —- @. onf igwracióa. rolled up during insertion. In addition to the configurations shown in FIGS. 26 and 27, other compression settings are possible. Also, catheter tubes that define more or less than two lumens may also be beneficial in the principles described herein. In the illustrated and other embodiments described herein, it is further appreciated that the cross sectional geometry may also vary from proximal to distant ends, such as round to oval, in a non-limiting example.

FIGS. 28A and 28B represent yet another suitable configuration for the distal portion 30 of the catheter tube 12, wherein a plurality of longitudinally extending rigid flanges 98 are positioned on the outer wall 13. Flanges 98 serve to increase the moment of inertia of area I for the distal portion of catheter tube 30, thereby increasing the stability of the tube during fluid infusion through it and reducing or preventing flagellation of the distant tip . Although three flanges are shown positioned around the circumference of catheter tube 12, more or less of these can be employed. Also, the size, shape, length, and placement of the flanges may vary from what is shown in FIGS. 28 A and 28B. In a

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modality, the flanges can be co'lUCdf¹ ' a.

surface of the interior lumen of the distant portion.

In addition to the catheter tubes described herein as part of catheter assemblies, the disclosed 5 principles can be used with other tubular medical devices as well.

The embodiments of the invention can be incorporated in other specific forms without departing from the spirit of the present description. The modalities described are to be considered in all respects only as illustrative, not restrictive. The scope of the modalities is therefore indicative of the appended claims rather than the foregoing description. All changes that fall within the meaning and range of equivalency of the claims will be encompassed within their scope.

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX339162B_D0040.tif" />