Systems and methods to compensate for compression forces in an intravascular device.

(54) Title: SYSTEMS AND METHODS TO COMPENSATE COMPRESSION FORCES IN A DEVICE

INTRAVASCULAR.

(54) Title: SYSTEMS AND METHODS TO COMPENSATE FOR COMPRESSION FORCES IN AN INTRAVASCULAR DEVICE.

(57) Summary

A system and method for providing ventilation channel geometries to compensate for compression forces experienced by a septum (50) within an intravascular device (10).

(57) Abstract

A syslem and method for providing vent channel geomelries is compensated for compression forces experienced by a septum (50) within an intravascular device (10).

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Mexican Property

Industrial

PATENT TITLE NO. 337022

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Owner (s): BECTON, DICKINSON AND COMPANY

Address: 1 Becton Drlve, Mail Code 110, Franklin Lakes, New Jersey, 07417-1880, USA

Name: SYSTEMS AND METHODS TO COMPENSATE COMPRESSION FORCES IN AN INTRAVASCULAR DEVICE

Classification: IC.8: A61M25 / 06

Inventor (s): YIPING MA; MARTY L. STOUT

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Issue Date: February 10, 2016

THE DIVISIONAL DIRECTOR OF PATENTS

I

NAHANNY CANAL REYES

Arenai No. 550, Floor 1,

Coi Puebio Santa María Tepepan, Xochímiico Delegation,

CP 16020, Mexico City

Tei. (55) 53 34 07 00 www.iinpi.gob mx

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MX / 2016/11058

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SYSTEMS 7 METHODS TO COMPENSATE FORCES OF

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INTRAVASCULAR DEVICE

Background of the Invention

Catheters are commonly used for a variety of infusion therapies. For example, catheters are used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition within a patient; draw blood from a patient; o monitor various parameters of the patient's vascular system. Catheters are typically coupled to a catheter adapter that supports the catheter and facilitates IV tube fixation. Generally, by following the placement of the catheter within a patient's vasculature, the catheter adapter can be coupled to a fluid source through an IV tube section to infuse fluids into the patient.

In order to verify proper placement of the catheter within the blood vessel, clinical staff generally confirms that there is return of blood from the patient's vasculature from a catheter return chamber or catheter adapter. Once proper catheter placement is confirmed, clinical staff should either fix the catheter adapter to an IV tube section, or continue to manually obstruct the vein to prevent unwanted exposure to blood. The process of coupling the

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Adapting the catheter to the IV tube section requires clinicians to uncomfortably maintain pressure on the patient's vein while simultaneously coupling the catheter adapter and IV tubes. A common but undesirable practice is to 'allow blood to flow temporarily and freely from the catheter adapter while clinicians locate and couple the IV tube to the catheter adapter. Another common practice is to attach the catheter adapter to the tube.

IV before placing the catheter into the patient's vein. Although this method can prevent undesirable exposure to blood, positive pressure from the IV tube inside the catheter does not allow for desirable return and thus reduces the ability of clinicians to confirm proper catheter placement.

Accordingly, there is a need in the art for a catheter assembly that allows for desirable, controlled return without the risk of encountering undesirable exposure to blood. Such a catheter assembly is described here.

Brief Description of the Invention

In order to overcome the limitations discussed above, the present invention relates to systems and methods for ventilating a septum of the catheter device. In particular, the present invention relates to providing various ventilation geometries to compensate for forces of

IMPI compression experienced by the septum on a device

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assembled intravascular.

In some implementations, a pressure compensating septum device is provided having a proximal end, a distal end, and an outer surface, where a distal portion of the outer surface is chamfered, so that when the septum is adjusted By compression within an intravascular device, ventilation is provided between the beveled portion and the inner surface of the intravascular device. In some cases, a vent opening includes a surface area configured to allow or prevent passage of fluid between a proximal chamber and a distal chamber of the intravascular device.

Furthermore, in some implementations an outer septum surface includes a plurality of voids that form vents for the intravascular device. In other implementations, an interior surface of the intravascular device includes a plurality of voids that form vents for the intravascular device.

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In some implementations, a method is provided for ventilating a septum placed within a catheter adapter of the intravascular device. In particular, in some implementations a ventilation method includes the steps of providing a catheter adapter having a

IMPI

Mexican Institute of Industrial Property

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inner surface; placing a septum inside the inner surface of the catheter adapter; providing ventilation between an outer surface of the septum and the inner surface of the catheter adapter; the vent has a proximal opening and a distal opening; and beveling a distal end of the vent to increase a surface area of ​​the distal opening. In some implementations, the method further includes providing ventilation geometries such that following the intravascular device assembly, a surface area of ​​the proximal ventilation opening is approximately equal to a surface area of ​​the distal ventilation opening.

Furthermore, in some implementations an intravascular device is provided which includes a catheter adapter having an inner surface, a septum that is positioned within the inner surface such that the septum divides the inner surface into a proximal chamber, and a distal chamber, ventilation is provided between an outer surface of the septum and an inner surface of the catheter adapter, the vent has a proximal aperture and a distal aperture to provide smooth communication between the proximal chamber and the distal chamber, and a compression release that forms a portion of the distal vent opening, where one surface of the distal aperture is approximately equal to an area of

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proximal opening surface. In some implementations, the compression release further includes at least one of a chamfered outer surface of the distal end of the septum, and a chamfered inner surface of the distal end of the inner surface.

Brief Description of the Figures

In order that the way in which the aforementioned characteristics and advantages and others of the invention are obtained is easily understood, a more particular description of the invention will be presented briefly described in the foregoing with reference to specific embodiments thereof which are illustrated in the attached figures. These figures illustrate only typical embodiments of the invention and are therefore not to be considered as limiting the scope of the invention.

Figure 1 is a perspective view of an intravascular device in accordance with a representative embodiment of the present invention.

Figure 2 is a perspective view of an intravascular device following the removal of an introducer needle in accordance with a representative embodiment of the present invention.

Figure 3 is an exploded cross-sectional view of an intravascular device in accordance with a representative embodiment of the present invention.

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Figure 4 is a perspective cross-sectional view

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of a compression compensation septum in accordance with a representative embodiment of the present invention.

Figure 5 is a perspective cross-sectional view of an assembled intravascular device incorporating compression release feature in accordance with a representative embodiment of the present invention.

Figure 6 is a detailed perspective cross-sectional view of Figure 5 in accordance with a representative embodiment of the present invention.

Figure 7 is a perspective view of a septum having compression release characteristics in accordance with a representative embodiment of the present invention.

Figure 8A is a cross-sectional view of the septum of Figure 7 in accordance with a representative embodiment of the present invention.

Figure 8B is a cross-sectional view of Figure 8A following the assembly of an intravascular device in accordance with a representative embodiment of the present invention.

Figure 9A is a cross sectional view of a catheter adapter having compression release characteristics and a septum in accordance with a representative embodiment of the present invention.

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I instituted PE Mexican PE INDUSTRIAL PROPERTY

Figure 9B is a cross-sectional view of the catheter adapter of Figure 9A fitted with a septum in accordance with a representative embodiment of the present invention.

Figure 10A is a perspective view of the distal end of a septum that has compression release characteristics before being assembled in accordance with a representative embodiment of the present invention.

FIG. 10B is a perspective view of the distal end of a septum having compression release features as installed in an adapter of an intravascular device in accordance with a representative embodiment of the present invention.

Figure 10C is a proximal end perspective view of a septum having compression release features as installed in a catheter adapter of an intravenous device in accordance with a representative embodiment of the present invention.

The embodiment of the present invention will be better understood by reference to the figures, where similar reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and intended for a wide variety of different

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configurations. Thus, the following more detailed de-juipetion, as depicted in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

Detailed description of the invention

Referring now to Figure 1, an intravascular device 10 is illustrated. Intravascular device 10 generally includes a catheter 12 coupled to a distal end 16 of a catheter adapter 14. Catheter 12 and catheter adapter 14 are integrally coupled. such that an interior lumen of catheter adapter 14 is in fluid communication with an interior lumen of catheter 12.

Catheter 12 generally comprises a biocompatible material that has sufficient rigidity to withstand pressures associated with insertion of the catheter into a patient.

In some embodiments, as shown, catheter 12 is an over-the-needle catheter that is made of a flexible or semi-flexible polymer material and can be used in combination with a rigid introducer needle 22. Rigid introducer needle 22 allows insertion of the catheter over the non-rigid needle inside a patient. Switch needle 22 can be coupled to a needle hub 26 that is selectively coupled to proximal end 18 of catheter adapter 14. Introducer needle 22 typically

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY is inserted through catheter 12 such that a tip of needle 22 extends beyond narrowed tip 20 of catheter 12. Insertion of introducer needle 22 into the patient's vein creates a opening in the vein through which the tapered tip 20 of catheter 12 is inserted. The outer surface of tapered tip 20 allows gradual insertion of catheter 12 into the opening.

In other embodiments, catheter 12 is not an over-the-needle catheter, but rather comprises a rigid, polymeric material, such as vinyl. Rigid catheters can include a beveled cutting surface that is used to provide an opening in a patient to allow insertion of catheter 12 into the patient's vascular system. Accordingly, in some embodiments, catheter 12 comprises a metallic material, such as titanium, stainless steel, nickel, molybdenum, surgical steel, and alloys thereof. Even in other embodiments, surgically implanted catheters can also be used in combination with the present invention.

In some embodiments, catheter 12 is a peripheral-type intravenous catheter that generally comprises a cut or truncated catheter for insertion into a small peripheral vein. Such catheters generally comprise a diameter of approximately a 14 gauge or larger catheter.

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Stubs), are between in length. Catheters typically designed for small (on a scale of approximately 13mm to 52mm peripheral intravenous) are temporary placement. The short length of the catheter facilitates convenient placement of the catheter. In other modalities, catheter 12 is a midline or central line catheter, It can be longer and can be used for longer periods.

Referring now to Figure 2, once catheter 12 is inserted into the patient's vein, introducer needle 22 is removed proximally from carton 12 to provide a fluid line through the lower lumen 36 of the catheter 12, which can be connected to a fluid source. In some embodiments, a catheter portion 12 and / or a catheter adapter 14 is configured to connect to an intravenous tube section 40 to further facilitate fluid delivery to, or removal of fluid from a patient.

In some embodiments, a proximal end 18 of catheter adapter 14 further includes 32 provides a positive surface to allow coupling of a patient line to catheter assembly 10. In some embodiments, flange 32 includes a set of threads 30. The threads 30 are generally provided and configured to compatibly receive a complementary group of a flange 32. The flange which can be configured intravenous tubing 40 or

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threads 44 comprising a portion of a male luer or conduit coupler 42. The conduit coupler 42 is generally coupled to an end portion of the patient conduit 40 in a fluid tight manner. In some embodiments, an inner portion of the conduit coupler 42 extends outwardly to provide a probe member 46.

In some embodiments, probe member 46 is compatibly inserted into proximal end 18 of catheter adapter 14 to activate the septum there, thereby operating a fluid path within catheter adapter 14. In some configurations, following insertion of probe member 46 into proximal end 22 of catheter adapter 14, conduit coupler 42 interlocks with coupler 42 and flange 28 (through thread sets 30 and 44) , such as by rotation. In some embodiments, position ie probe 46 within catheter adapter 14 advances a septum activator 80 through septum 50 of catheter adapter 14, thereby opening a fluid path, as taught in Patent Application Ser. the United States, Serial No. 12 / 544,624, which is incorporated herein by reference.

Referring now to Figure 3, an exploded cross-sectional view of an intravascular device 10 is shown. In some embodiments, the device

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Intravascular 10 comprises a catheter adapter 14 having an interior surface 60 to receive a septum 50. In some embodiments, the interior surface 60 comprises a recessed groove having a length and depth sufficient to incorporate the length and outside diameter of the septum 50 . In addition, the interior surface 60 may include one or more vents 70 that provide fluid communication between a distal chamber 62 and a proximal chamber 64 of the catheter adapter 14. For example, in some embodiments, the vents 70 allow air to pass from the chamber. distal 62 to proximal chamber 64 thereby balancing air pressures within adjacent chambers 62 and 64. This balance prevents accumulation of air pressure within distal chamber 62 that can prevent a desirable return during insertion of catheter 12 into a patient.

In some embodiments, one or more vents 70 are designed to allow air flow and stop blood flow. In some embodiments, septum 50 comprises individual ventilation. In other embodiments, septum 50 comprises a plurality of vents. For example, in some embodiments, septum 50 comprises between two vents and forty vents. In addition, in some embodiments, septum 50 comprises six vents.

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In some embodiments, the vents 70 further comprise a proximal opening 74 and a distal opening 76. A transverse area of ​​proximal and distal openings 74 and 76 can be selected to allow or exclude the passage of air and / or liquid through vents 70. Accordingly, in some embodiments, proximal or distal openings 74 and 73 comprise a cross-sectional area between about 0.000045 to 0.00025 cm.² (0.000007 to 0.000004 inch²). In other embodiments, openings 74 and 76 have a cross-sectional area between about 0.00006 to 0.00019 cm²(0.000001 to 0.000003 inch²) In other embodiments, openings 74 and 76 have a cross-sectional area of ​​approximately 0.00012 cm² (0.00002 inch²). For example, in some modes, openings 74 and 76 have a height of about 0.002 to 0.007 cm (0.001 to 0.003 inches) and a width of about 0.025 cm (0.010 inches). In other modes, openings 74 and 76 have a height approximately 0.005 to 0.007 cm (0.002 to 0.003 inch) and a width of approximately 0.012 cm (0.005 inch).

Similarly, vents 70 between septum 50 and inner surface 60 of catheter adapter 14 can be specifically configured to allow blood and air to pass through it at an estimated range of flow rates. For example, in some embodiments vents 70 allow blood to flow

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through these at a rate between about 10 to 200 ml / hr. In other embodiments, vents 70 allow blood to flow through them at a rate of between about 15 to 150 ml / hr. Even in other cases, vents 70 allow blood to flow through them at a rate of between about 50 to 100 ml / hr. At these rates, the rate of blood flow within proximal chamber 64 can be metered to provide clinical staff with adequate time to correctly locate the catheter within a patient's blood vessel. Accordingly, in some embodiments, vents 70 have a cross-sectional area greater than 0.00019 cm² (0.00003 inch²). In other modalities, the vents 70 have a cross-sectional area greater than 0.00025 cm² (0.00004 inch²). In other embodiments, the vents 70 have a cross sectional area of ​​approximately 0.0006 cm² (0.0001 inch²). In other embodiments, the vents 70 have a cross-sectional area of ​​approximately 0.006 cm² (0.001 inch²).

With continued reference to Figure 3, in some embodiments, septum 50 comprises a membrane 52 that provides an overcoming barrier between distal and proximal chambers 62 and 64. For example, in some embodiments, membrane 52 comprises a slit 56 that is closed deviation due to axial forces,

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Compression applied to the outer surface of septum 50 when fitted within inner surface 60. In other embodiments, membrane 52 comprises a pierceable surface that can be overcome with a sharp instrument, such as a needle point.

Generally, septum 50 comprises a hyperelastic material that, when assembled, interfaces with interior surface 60 through the interference fit. In some cases, the compression forces in the device experienced by the assembly intravascular septum 10 cause the cross-sectional area of ​​vents 70 and openings 74 and 76 to deform, where a portion of septum 50 is forced into adjacent vents 70 . Accordingly, in some embodiments the intravascular device 10 comprises various compression release features to compensate for compression forces experienced due to interference fit.

Referring now to Figures 3 and 4, in some embodiments a distal portion of septum 50 is modified to compensate for the aforementioned deformation due to compressive forces. For example, in some embodiments, a bevel 58 is provided on the distal end of the outer surface of septum 50. In some embodiments, bevel 58 tapers inward in a

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distal direction 72, where the length of bevel 58 corresponds approximately to the thickness 66 of membrane 52. In other words, in some embodiments bevel 58 tapers inward from a proximal surface 68 of membrane 52 to a distal surface 78 of membrane 52. In addition, in some embodiments a radial distance from bevel 58 is approximately equal to maximum deformation of vents 70 under maximum expected compression when assembled. As such, the ventilation geometry will experience minimal effect from compression, as shown in Figures 5 and 6.

Referring now to Figure 7, in some embodiments a plurality of channels or vents 100 are provided on the outer surface 102 of septum 150. Thus, septum 150 may be positioned or seated within a catheter adapter 140 having a smooth interior surface 120 that does not include channels or vents, as shown in Figures 8B and 9A-10C, below. Thus, vent 100 provides smooth communication between distal and proximal chambers 62 and 64, in accordance with the previous discussion. Furthermore, vents 100 comprise distal and proximal openings 172 and 174 having respective surface areas to incorporate fluid passage, as previously discussed.

In some embodiments, a distal portion of

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MEXICAN INSTITUTE OF PROPERTY ventilation 100 is chamfered 158 to compensate for the aforementioned deformation due to compression forces of the interference fit. As shown in Figure 8A, before assembly, bevel 158 provides an enlarged distal opening 172 that tapers outward in a direction proximal to a final vent depth 178. In some embodiments, the compression forces experienced at the proximal end of septum 150 are less than the compression forces experienced at the distal end of septum 150. Accordingly, in some embodiments, proximal opening 174 is configured to have a surface area transverse approximately equal to the transverse surface area of ​​vent 100 of vent depth 178. Thus, the desirable final ventilation depth geometries 178, distal opening 172, and proximal opening 174 are achieved by following the assembly of the intravascular device 10, as shown in Figure 8B.

Referring now to Figure 9A, in some embodiments a distal portion 160 of inner surface 120 is beveled. As such, catheter adapter 140 can be used with septum 180 having a non-beveled distal outer surface 182, as shown. With the assembly, surface 182 deforms due to compressive forces, consequently causing the

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Outer surface 182 is displaced within chamfered portion 160 of inner surface 120, as shown in Figure 9B. As such, the desirable final geometries of vent depth 178, distal opening 172, and proximal opening 174 are achieved.

In some embodiments, septum 250 comprises vent 200 having a distal opening 272 with an initial cross sectional area that is greater than the desired final cross sectional area. Once assembled, the compressive forces reduce the opening area 272, consequently achieving a desired final cross-sectional area, as shown in Figure 10B. Furthermore, in some embodiments the desired final cross sectional area of ​​distal opening 272 is equal to, or approximately equal to, a desired final cross sectional area of ​​proximal opening 274, as shown in Figure 10C.

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Accordingly, the compression release characteristics of the present invention compensate for compression forces thereby preventing obstruction or blockage of flow through the respective openings and vents.

The present invention may be represented in other specific ways without departing from its structures, methods, or other essential features as broadly described herein and claimed hereinafter. The described modalities will be considered in all

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aspects are illustrative only, and not restrictive. The scope of the invention, therefore, is indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and scope of the claims are to be encompassed within their scope.

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