Device and method for connecting a blood pump without trapping air bubbles.

(54) Title: DEVICE AND METHOD TO CONNECT A BLOOD PUMP WITHOUT TRAPPING AIR BUBBLES.

(54) Title: DEVICE AND METHOD FOR CONNECTING A BLOOD PUMP WITHOUT TRAPPING AIR BUBBLES.

(57) Summary

The present invention relates to a disposable purge device (DIP) (300) for connecting cannulas to a cardiac circulatory support device for use in a cardiac circulatory support system, the DIP device (300) comprises: a device body ( 302) having a distal end (304) and a proximal end (306L) an air outlet (310) formed in the device body (302) between the distal end (304) and the proximal end (306); and a radially positioned outer conduit (322) positioned at the air outlet (310); characterized in that the DIP device comprises: an inner semi-closed flexible ring (308) positioned on the inner surface of the device body (302); and wherein the device body (302) includes a detachment section (324) configured to be detachable from the rest of the device body to allow removal of the DIP device once the cannulas have been connected to the device. cardiac circulatory support.

(57) Abstract

The invention relates to an apparatus and method for connecting a medical tube or any other type of fluid conduit (eg cannulas) to a ventricular assist device (VAD) or any other type of pumping device used to pump blood during cardiac circulatory support for vascular surgery . The apparatus and method prevent air bubbles from entering the cardiac circulatory support system when cannulas are being connected to a VAD, which bubbles can subsequently enter a patient's bloodstream during cardiosurgery, as well as purging any air bubbles that do enter the cardiac circulatory support system during a cannula-VAD connection.

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<img file="MX348034B_D0001.tif" />

PATENT TITLE No. 348034

VITALMEX INTERNACIONAL, SA DE CV

Moctezuma 26, Col. Toriello Guerra, 11050, Distrito Federal, MEXICO

DEVICE AND METHOD TO CONNECT A BLOOD PUMP WITHOUT TRAPPING AIR BUBBLES.

CIP: A61M39 / 00

CPC: A61M39 / 00

BENJAMIN DUEÑAS FIGUERQASAPPLICATION

A, '~

Number:

MX / a / 2010/010553. 'ÍFéqM International:

country

US US

-, '-ΙΜμμμ' of entry 802008 March 2009

Number:

61/^40,612

12/413,377

Validity: Twenty yearsV

Expiration Date; SOdeT March 2029

Date of Issue: May 23, 2017. , · ''¹ X, 'rf i-Ó,

The patent of refereneü »sejofcjrga based on articles 1", and 59kle the Law of Industrial Property

In accordance with article 23 of the Industrial Property Law, the patent has a validity of twenty «Rds ^^ Torrogables, counted from the date of filing * the request and will be * m * ta aípaerilMe lymph parameffen ^ existing rights' *,

Whoever signs this title is based on id% isfruest »per ^ $ ^ ιβ (ιΙ &amp; 6 ° fraccidhaflll and 7 ° Ζϋβ the tÜy of Industrial Property (Official Gazette of the Federation φ © ®);, 27/66 / 199t7t &lt;omMiea el« 2KI8 / 1994, fc / 10 / .1-W6, 12/26 / 1f $ 7 * 1 ^ X15 / 1999, 01/26/2004, 06/16/2005, 01/25/2006, 05/06/2009, 06/01 / 2010, 1 * 06/20 * 0, £ 8/06 / 20W27 / d | / 2012) W &lt;* 4/2012 ^ · ΠίΛΜφ * '1 “, 3” fra ^ rfqrí Mrihpisd a), 4 “and 12” sections I and III of the Regulations of the Mexican Institute CM * La Property IncMtflál (Q.QF 14/1 ^ / 1999, -reformed on 01 ^ 7 / &amp; ^ rj «J» 7/2004, 28 / 07/2004 and 7/09/2007); Articles 1, 3, 4, 5 fraction V clause a), U fractions I Μ, III and 30'dahEataMo^youCrganica4et'1nstituMFfflm £ &lt;or of Industrial Property (DOF 12/27/1999, amended 10/10/2002, 29/0 ^ 04 ΚΒΟβΛΟΟ ^ γ ^^ ΟΟΙ ^); 'd ^ Acwdo that delegates powers to the Directors

Deputy Generals, Coordinator, Directors BWMoaale ^ TiMírqa, | e les, Assistant Divisional Directors, Coordinat ors

Departmentals and other subordinates of the krexialilKi Institute 4M la * Ph ^ d¿d ¡J ^ W12 / 1999, reformed 02/04/2000, 07/29/2004,

08/04/2004 and 09/13/2007). *

<img file="MX348034B_D0002.tif" />

This document is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Payment and Electronic Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

DIVISIONAL PATENT DIRECTOR NAHANNY CANAL REYES

Ξ Original Chain:

·&gt; NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Administration Service

Tr¡butaria | 1695 || MX / 2017/42653 | MX / a / 2010/010553 | PCT patent title | 1488 | IAR | Page (s) 1 | PUbJFxqQDzikyOOZSU5glNX / 3fs =

Ξ

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Digital stamp:

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Arenal No 550, Floor 1, Pueblo Santa Mana Tepepan, Xochimilco, 16020, Mexico City.

(55j53340700 vAwcgob.mx/impi

<img file="MX348034B_D0004.tif" />

MX / 2017/42653

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DEVICE AND METHOD TO CONNECT A PUMP

MEXICAN INSTITUTE OF INDUSTRIAL NUWEDAD

<img file="MX348034B_D0005.tif" />

CATCH AIR BUBBLES

FIELD OF THE INVENTION

The present invention relates generally to the interconnection of cannulas used with medical devices, and more particularly, to the connection and purging of devices connected to cannulas for use in medical procedures.

BACKGROUND OF THE INVENTION

As heart disease has become more common in recent decades, for a variety of reasons, which may include nutrition and lifestyle choices, new and improved medical procedures have been developed to combat this medical condition. Procedures to treat or prevent heart failure usually require invasive surgery. Such procedures may involve the use of pumping devices for cardiac circulatory support before, during and after open heart surgery, or as a bypass in the case of a complete cardiopulmonary bypass, for example, a heart transplant. Examples of cardiac circulatory support devices include rotary blood pumps and

Axial IMPIs, as well as INDUSTRIAL assist devices (VAD), which are used to complement the pumping action of the heart during and after surgery.

Cardiac circulatory support devices are connected to a patient's heart using medical tubing (ie, cannulas) which is connected to the heart in appropriate locations, in accordance with standard surgical practices. Some cardiac circulatory support systems include a pneumatic drive unit that connects to an air supply. Cardiac circulatory support systems can also include a pump that is electrically or magnetically energized.

Figures 1A-1C illustrate three examples of VAD configurations implanted in patients. Figure 1A shows a schematic illustration of a VAD 100 implanted in a patient as a left ventricular assist device, or LVAD. The LVAD 100 is connected to an outflow cannula 102, which is surgically connected to the left ventricle of the heart 108. The LVAD 100 is also connected to an inflow cannula 104, which is surgically connected to the patient's aorta 106. The LVAD 100 receives blood from the left ventricle 108 through the outflow cannula 102 and delivers the blood through the flow cannula of IMP the INSTITUTO MEXICANO or the LA rROJMELAO INDUSTRIAL aorta 106 for circulation through the patient's body.

<img file="MX348034B_D0006.tif" />

Figure IB shows a schematic illustration of a VAD 120 implanted in a patient as a right ventricular assist device, or RVAD. The RVAD 120 is connected to an outflow cannula 122, which is surgically connected to the right atrium of the heart 124. The RVAD 120 is also connected to an inflow cannula 126, which is surgically connected to the pulmonary artery 128. The RVAD 120 receives blood from the right atrium 124 through the outflow cannula 122 and supplies the blood through the inflow cannula 126 to the pulmonary artery 128.

Figure 1C shows a schematic illustration of two VADs 14 0a and 14 0b implanted in a patient as a bi-ventricular assist device, or BIVAD. The first VAD 140a is connected to an outflow cannula 142a, which is connected to the right atrium of the heart 124. The first RVAD 140a is also connected to an inflow cannula 144a, which is connected to the pulmonary artery. 128. The second VAD 140b is connected to an outflow cannula 142b, which is connected to the left ventricle of the heart 108. The second VAD 140b is also connected to an inflow cannula 144b, which is connected to the aorta 106 .

The BIVAD 140a,

<img file="MX348034B_D0007.tif" />

right and left ventricle, respectively, of the heart 108 combining the operations of both an RVAD and an LVAD.

Figures 2A-2C illustrate three examples of extra-body VAD configurations. Figure 2A shows a schematic illustration of a VAD 200 extra-corporeal connected to a patient as an LVAD. The LVAD 200 connects to an outflow cannula 202, which is surgically connected to the left ventricle of the heart 208. The LVAD 200 also connects to an inflow cannula 204, which is surgically connected to the aorta 206 . The LVAD 200 is kept outside the patient's body. Outflow and inflow cannulas 202, 204 enter the patient at openings 210, and extend upwardly to left ventricle 208 and aorta 206, respectively.

Figure 2B is a schematic illustration of a VAD 220 extra-bodily connected to a patient as an RVAD. The RVAD 220 is connected to an outflow cannula 222, which is surgically connected to the right atrium 224. The RVAD 220 is also connected to an inflow cannula 226, which is surgically connected to the pulmonary artery 228. Outflow and Flow Cannulas

INSTITUTO MEXICANO Di LA PROPERTY INDUSTRIAL entry 222

226 enter the body in the a:

extend upward to the right atrium 224 and pulmonary artery 228, respectively.

Figure 2C is a schematic illustration of two VADs 240a, 240b extra-bodily connected to a patient as a BIVAD. The first VAD 240a is connected to an outflow cannula 242a, which is surgically connected to the right atrium of the heart 224. The first VAD 240a is also surgically connected to an inflow cannula 244a, which is surgically connected to the pulmonary artery 248. The second VAD 240b is connected to an outflow cannula 242b, which is connected to the left ventricle of the heart 208. The second VAD 240b is also connected to an inflow cannula 244b, which is connected to the aorta 252 The BIVADs 240a, 240b are kept outside the patient's body and assist the right atrium and left ventricle, respectively, of the heart 208, 224 by combining the operation of both an RVAD and an LVAD. Cannulas 242a, 244a, 242b, 244b can enter the patient's body at openings 256, 258, respectively, in the patient's chest.

Some time before, during or after surgery, surgeons must connect a cardiac circulatory support device, such as the VADS shown in Figures 1A to 2C, connected to the patient's heart.

<img file="MX348034B_D0008.tif" />

This connection requires a connector that is precisely matched to the cannulas to reduce turbulence in blood flow within the cardiac circulatory support system, prevent fluids from draining from within the cardiac circulatory support system, and also prevent introduction of air or other unwanted gases within the cardiac circulatory support system. During the connection establishment process, the volume of air in the cannulas can be replaced by saline, blood, or any other acceptable liquid. In general, saline solutions are any sterile solution of sodium chloride in water. These saline solutions are available in various formulations, for different purposes, such as intravenous infusion, contact lens rinse, and nasal irrigation.

The elimination of any residual air within the cannulas or any part of the cardiac circulatory support system is necessary because the introduction of air bubbles, that is, air embolisms, into the patient's circulatory system can result in serious results. complications. For example, air bubbles can block or occlude blood vessels in the brain, thus causing loss of blood.

IMPI ^ function of one or more parts of the body. Vr&gt; 1

INDUSTRIAL ^ ·. ** - · air can also result in venous air embolisms, hypotension, or dysrhythmias, or even death when the entry of air is rapid. Another risk is a pulmonary embolus occlusion, which is the blockage of an artery in the lungs by an air embolism. Air embolism results in increased dead space. Such blockage could result in pulmonary constriction.

Large, rapid volumes of air entering the bloodstream can fill the right atrium and produce air restriction that could result in right ventricular closure, decreased venous return, and cardiac decline. Myocardial ischemia and cerebral ischemia could present in a very short time.

In some cases, even if air replacement has been done properly and carefully, air bubbles can be trapped and remain inside the cannulas. Standard attempts to remove trapped air bubbles involve drawing the bubbles out with a syringe or shaking the cannulas. Both methods are often time consuming and somewhat without inaccuracies.

Various types of apparatus and methods have been developed to purge closed non-circulatory fluids. However,

INSTITUTO MEXICANO LA yfOPJEnAtJ these aparatá ^ V '' '¹ I

<img file="MX348034B_D0009.tif" />

they are usually excessively complex for simple applications, such as cannula flushing during a surgical procedure.

Additionally, the connection itself can create problems during connection of the cannulas with a VAD. Various medical tube connectors and cannulas have been developed to correct such problems. However, they are usually overly complex solutions for simple applications, such as connections to medical terminals. In addition, existing designs to secure connections and to prevent components from moving during operation are generally mitigated against provisioning purge options for the connection. Also, some purging methods make it more difficult to connect in a vertical position with a VAD in a closed circulatory system.

Therefore, there is a need for improved systems and methods for connecting cannulas to a blood pump, which have the ability to purge air from the blood or other fluid within the cannulas and elsewhere through the support system. cardiac circulatory.

SUMMARY OF THE INVENTION

IMPI mexican institute OF INDUSTRIAL PROPERTY

A disposable purging device (DIP) is described for connecting cannulas to cardiac circulatory support devices for use in cardiac circulatory support systems. The DIP device operates to purge air bubbles from the cannulas and the cardiac circulatory support system, and also to prevent entry of air into the cardiac circulatory support system. The DIP device may include a device body having a distal end and a proximal end, with an inner semi-closed flexible ring positioned toward the distal end of the device body, and an air outlet having an external conduit that extends radially from the device body.

A method of using such a DIP device to connect cannulas to a cardiac circulatory support device is also described. In an exemplary method of operation, the DIP devices, in accordance with the invention, are attached to the inflow and outflow ports of a ventricular assist device (VAD) and the DIP / VAD device assembly is filled with a liquid, such as saline solution. Each of the DIP devices is then alternately occluded and filled with additional liquid to expel any air trapped in the _U1 „_ I.WXO5S assembly. Once this is completed, ιν * ι &amp; 1το

FROM THE COIN Om-ZSOÍ industrial DIP / VAD device is maneuvered to allow insertion of the cannulas into the assembly while filling the cannulas and assembly with liquid. After purging any air in the DIP devices, the cannulas are inserted further into the assembly and connected to the VAD, and the DIP devices are then removed from the cannula / VAD assembly.

Other systems, methods, and features of the invention will be or will become apparent to one of ordinary skill in the art upon examination of the following figures and the detailed description. All such additional systems, methods, features, and advantages are intended to be included within this description, be within the scope of the invention, and are protected by the appended claims.

BRIEF DESCRIPTION OF THE FIGURES

The invention can be better understood with reference to the following figures. Components in the figures are not necessarily to scale, however, emphasis is placed on illustrating the principles of the invention. In the figures, like reference numerals designate corresponding parts throughout the different views.

Figure 1A shows an illustrated.

KynTOTO MEXICANO Df LA NOWMI?

nr THE FROHFPAÍ?

a ventricular assist device (WAD ^ T ^ TL ^ laTitacro in a patient as a veritrlcuihb '* · left assist device (LVAD).

Figure IB shows a schematic illustration of a VAD implanted in a patient as a right ventricular assist device (RVAD).

Figure 1C shows a schematic illustration of two VADs implanted in a patient as a bi-ventricular assist device (BIVAD).

Figure 2A shows a schematic illustration of a VAD in use extra-corporeal with a patient as a

LVAD.

Figure 2B shows a schematic illustration of a VAD extra-corporeal connected to a patient as a

RVAD.

Figure 2C shows a schematic illustration of two VADs extra-corporally connected to a patient as a

BIVAD.

Figure 3 shows a transparent perspective view of an example of a disposable purging device (DIP) for connecting cannulas to a cardiac circulatory support device in accordance with the present invention.

DE LA MOHEDAL · INDUSTRIAL

Figure 4 shows a transparent view in parts of the exemplary DIP device shown in Figure 3.

Figure 5A shows a cross-sectional view from the distal end of the exemplary DIP device shown in Figure 3.

Figure 5B shows a cross-sectional view along line AA in Figure 5A.

Figures 6A and 6B illustrate an example of the use of a DIP device in accordance with the invention to connect cannulas to a cardiac circulatory support device.

Figure 7 shows a perspective view of an exemplary assembly including an exemplary DIP device in accordance with the invention, two cannulas, and a VAD.

Figure 8 shows a perspective view in parts of the assembly shown in figure 7.

Figure 9 shows a longitudinal cross-sectional view of the assembly shown in Figure 7.

Figure 10 shows a perspective view of a

Exemplary VAD that can be used in the assembly shown in figure 8.

Figures 11A and 11B illustrate the attachment of DIP devices, according to the example of Figure 10.

<img file="MX348034B_D0010.tif" />

Figures 12A and 12B illustrate the addition of a liquid to the DIP / VAD device assembly in Figure 11B.

Figures 13 and 14 illustrate the occlusion of the DIP devices and the reverse rotation of the DIP / VAD device assembly.

Figures 15A and 15B illustrate adding more liquid to the DIP / VAD device assembly.

Figure 16 shows the DIP / VAD device assembly trapped and filled with fluid prior to connection of the cannulas to the VAD.

Figures 17A, 17B, and 17C illustrate the connection of one of two cannulas, an outflow cannula, to the DIP / VAD device assembly. .

Figure 18 illustrates the outflow cannulas inserted into the DIP / VAD device assembly.

Figure 19 illustrates the removal of the clamp that occludes the DIP device.

Figure 20 illustrates the VAD inflow connection to the outflow cannulas inserted into the distal end of the inflow DIP device.

Figure 21 shows the second cannulas, that is, the inflow cannulas, prior to insertion into the DIP device which is still ocl

<img file="MX348034B_D0011.tif" />

MEXICAN

GIVE THE FROPlFJJAf)

INDUSTRIAL

<img file="MX348034B_D0012.tif" />

Figures 22, 23, and 24 illustrate the connection of the inflow cannulas to the device assembly.

DIP / VAD.

Figures 25A - 25D illustrate an example of a method for removing air bubbles that entered the assembly during insertion of cannulas into DIP devices.

Figure 26 illustrates the removal of the clamp that occludes the second DIP device during insertion of the inflow cannulas to the VAD.

Figure 27 illustrates the inflow cannulas connected to the outflow of the VAD.

Figures 2-8A and 28B illustrate the removal of one of the DIP devices from the connection between the cannulas and the VAD.

Figures 29A and 29B illustrate the removal of the second DIP device.

Figure 30 shows an exemplary connector that can be used to connect cannulas to a VAD as shown in Figure 29B.

Figure 31 shows three (3) examples of cannulas that can be used according to the invention.

Figure 32 shows a flow chart illustrating an exemplary method of operation that uses a DIP device according to cannulas to a device after purging any

<img file="MX348034B_D0013.tif" />

with the inventionJ ^ 4aPcL INSTITUTO MfcXtCANV 'DE LA FP.CFUDAl;

,. INDUSTRIAL, cardiac circulatory support, and air bubbles that may have entered the cardiac circulatory support device / cannula assembly using the DIP device.

DETAILED DESCRIPTION OF THE INVENTION

In the following description of exemplary embodiments, reference is made to the attached figures that form part of the same, and which show, by way of illustration, specific embodiments of the invention that can be used. Other embodiments can be used and structural changes can be made without departing from the scope of the present invention.

Figure 3 shows a transparent perspective view of an example of a disposable purging device (DIP) 300 for connecting cannulas to cardiac circulatory support devices that operate to purge air bubbles from the cannulas and cardiac circulatory support system. and also to prevent the entry of air into the cardiac circulatory support system. Figure 2 shows a perspective view in parts of the device of Figure 3 illustrating how the components of the DIP device 300 are configured relative to each other.

wstituto msxicaN '&gt;

Df INDUSTRIAL PROPERTY

The DIP device 3 00 includes a device body 302 having a distal end 304 and a proximal end 306. The device body 302 may include an inner semi-closed flexible ring 308 positioned toward the distal end 3 04 of the device body 3 02, and an air outlet 310. An external conduit 322 extending radially from the device body 302 between the distal end 304 and the proximal end 306 is connected or linked to the air outlet 310. A female plug 320 may be inserted into the outer conduit 322, with a male plug 326 coupled to, or covering the female plug 320 to allow control of the opening and closing of the air outlet 310 in the outer conduit 322. The body Device 302 includes a release section 324 to allow removal of the DIP device 300 from an air bubble-free connected assembly of cardiac circulatory support devices and medical tubing. Detachment section 324 may include a flap 324A that extends beyond distal end 304 to provide a portion of detachment section 324 on which the user can grip detachment section 324 to allow removal and disconnection of the DIP device. 300.

The device body 302 generates the shape of the tubes that constitute the closed fluidic circuit in which the device 300 is used. The exemplary device body 302 shown in Figures 3 and 4 is a translucent or transparent and flexible tubular body , hollow, and can be made of a natural or synthetic polymeric or elastomeric material. Device body 302 is hollow on the inside, with openings at distal end 304 and proximal end 306. Proximal end 306 connects to a circulatory support device, which can be a blood pump or ventricular assist device (VAD), or any other type of pump or device that is used for circulatory support. The distal end 3 04 connects to a cannula or other type of medical tubing used in medical applications. Device body 302 can also be configured to be occluded somewhere on your body with clamps or other similar surgical instruments. Furthermore, the length of the device body 302 can be easily modified by cutting or detaching the body transversely, in order to obtain a shorter or longer device body 302, as the case may be, in order to facilitate the connection of the cannulas. with the cardiac circulatory support device.

<img file="MX348034B_D0014.tif" />

The DIP 300 device in figu¿al'Bl Ίβθ A

INSTITUTO MEXICAN ·&gt; LA HUJPUPa »

INDUSTRIAL ___ used to connect medical tubing, such as cannulas, that can be surgically implanted in a patient for connection to a cardiac circulatory support device.

The DIP device 300 facilitates the connection of the cannulas with the cardiac circulatory support device. Once connected, the DIP device 300 also allows its users to purge any air bubbles that may have formed in the fluid flowing through the cardiac circulatory support device during connection. Typical cardiac circulatory support devices include an inflow port to receive fluid such as blood, and an outflow port through which blood flows out of the cardiac circulatory support device. The cardiac circulatory support device can pump blood or other fluid that it receives at the inflow port through the outflow port for circulation through the patient's body. A cannula can be implanted in the patient to carry blood to flow to the cardiac circulatory support device and another cannula can be surgically implanted in the patient to carry blood from the cardiac circulatory support device into the outflow port of return to the patient. During the connection of the cannulas to the device i tivaKsTiT'jwetsxicAfiOpd ^^ Dt LA PRiWDAP

INDUSTRIAL cardiac circulatory system, a DIP device 300 receives a cannula at the distal end 304. The proximal end 306 is connected to one of the ports of the cardiac circulatory support device. Another DIP device 300 is used to connect the other cannula to the other port of the cardiac circulatory support device.

The inner semi-closed flexible ring 308 is positioned on the inner surface of the device body 302. The inner semi-closed flexible ring 308 can be made of natural or synthetic polymeric or elastomeric material, and can be attached with adhesive, welding or other. convenient joining method. The inner semi-closed flexible ring 308 can also be molded as part of the device body 302. The inner semi-closed flexible ring 308 includes a sufficient opening to allow insertion of the cannula. The opening is also tight enough around the surface of the cannula to seal, thus preventing the entry of air into the device 300 during insertion of the cannula. This seal, where the cannula contacts the semi-closed flexible ring 308, separates the liquid within the cannula and the device 300 from the air outside the cannula and the DIP device 300.

External conduit 322 can be connected or bonded

<img file="MX348034B_D0015.tif" />

302. The outer conduit 322 can be made of natural or synthetic polymeric or elastomeric material. The external conduit 322 can be filled with a female plug 320, which can be formed to allow insertion of a syringe for removal of fluid and air bubbles from the DIP device 300. In one example, the female plug 320 can be a female luer plug, and can be attached to outer conduit 322 by adhesive or other attachment means. The female plug 320 may also be manufactured, for example, by molding the female plug 320 and the outer conduit 322 with the device body 302 as a single unit. The external conduit 322 may also include a male plug 326, which can be used to cover the female plug 320 or as a bypass to control the inflow and outflow of liquids through the connecting device 300. In an exemplary embodiment, male plug 326 may be a male luer plug that can be locked with female luer plug 320 to allow selective sealing and opening of outlet 310 in device body 302.

The peel section 324 of the device body 302 can be formed with two seams running

IMPI parallel along the length of the bodyÓ ^ l ^^^

02. The seams are formed to allow the user to tear the peel section 324 from the rest of the device body 302. The flap 324a extends from the peel section 324 to provide a grip to facilitate the act of pulling the peel section 324 device body 302. Release section 324 may be made of a polymeric or metallic material, or any other material that can provide a seal with the remainder of device body 302, but allows easy removal of release section 324 from device body 302.

Figure 5A shows a front view from the distal end 304 of the DIP device 300 of Figure 3. The view in Figure 5A shows the semi-closed flexible ring 308, the outer conduit 322, the female plug 320, the male plug 326 , and stripping section 324. The peel section 324 is shown in Figure 3A as that section of the device body 302 located between two notches or cuts where the device body 3 02 is thinner than the rest of the device body 302. __

Figure 5B shows a cross-sectional view of the DIP device 300 on the line AA that is. . .. „_τ .. „IMXL® shown in figure 5A. Figure 5B shows ^^ ros ^! ^^

RmÓustiUal extending from detachment section 324 which allows the user to grasp flap 324a and pull detachment section 324 from device body 302, thus allowing removal of DIP device 300 from a cannula / VAD assembly. Other means may be used to tear or separate the device body 302 to allow removal of the DIP device 300 once the cannulas have been connected to a cardiac circulatory support device.

The DIP device 300 can be used to connect a cardiac circulatory support device to a patient. The cardiac circulatory support device can be a VAD, a blood pump, or any other type of pump or device that is used to pump blood or other fluid during a procedure that requires circulatory support. The examples described below refer to the use of DIP devices in the context of connecting cannulas to a VAD. However, it will also be understood that reference to a VAD is merely for the purpose of providing description and is not intended to be any kind of limitation. Examples of VADs that can be used in the examples described below are described in US Patent No. 7,217,236 to Calderón et al.,²³ IMPI ^

INSTITUTO MEXICANO issued on May 15, 2007, which was incorporated in its entirety. --------

Figures 6A and 6B illustrate an example of the use of a DIP device to connect cannulas to a cardiac circulatory support device. Figure 6A shows a VAD 602 ​​connected to a pair of DIP devices 608, 610. The VAD 602 ​​includes an inflow connector 604 and an outflow connector 606. The first DIP device 608 is connected to the inflow connector 608. input 604 and the second DIP device 610 is connected to the output stream connector 606.

Referring to Figure 6A, a DIP / VAD device assembly 600 is formed by connecting the first DIP device 608 to the input connector 604 of the VAD 602, and the second DIP device 610 to the output connector 606 of the VAD 602. The assembly 600 It can then be filled with a liquid, such as a saline solution, and any air bubbles are removed through the distal openings of the DIP devices 608, 610. As described in greater detail below with reference to Figures 10-15B, liquid is added at the distal end of the DIP devices 608, 610 while the assembly 600 is oriented with the distal ends pointing upward.

The VAD 602 ​​is then positioned to collect the liquid

<img file="MX348034B_D0016.tif" />

... . . , „IMPI that is being poured into the assembly. The industrial assembly 600 shown in Figure 6A is filled with the liquid, any air bubbles can be removed through the opening at the distal ends of the DIP devices 608, 610.

Figure 6B shows the VAD 602 ​​connected to the two DIP devices 606, 608, and to the cannulas 610, 612, which are inserted into the corresponding DIP devices 606, 608. The DIP devices 606, 608 are occluded using a pair of clamps. 620, 622, respectively. The two cannulas 610, 612 can then be surgically implanted into the patient. While cannulas 610, 612 and DIP devices 606, 608 are being filled with liquid, cannulas 610, 612 are inserted into DIP devices 606, 608, respectively. The two cannulas 610, 612 can first be partially inserted into the DIP devices 606, 608, respectively. The ends of the cannulas 610, 612 can be held in the body of the DIP devices 606, 608 through the inner semi-closed flexible ring 108, figure 1. The cannulas 610, 612, the DIP device 606, 608 and the VAD 600 can then form a closed container of liquid. Any trapped air bubbles can be removed through the radially positioned external conduits 614, 616 in the devices.

IMPI

DIP 606, 608, respectively. '"RS' KSÉÍ

INDUSTRIAL ^W

Figure 7 is a perspective view of an exemplary assembly (cannula / DIP / VAD device assembly) 700 that includes two DIP devices 708, 710, two cannulas 712, 714, and one VAD 702. Figure 8 shows a perspective view on parts of the assembly in figure 7 which illustrates how the components fit together. Figure 9 shows a longitudinal cross-sectional view of the assembly shown in Figure 7, which also illustrates how the components fit together. Referring to Figures 7, 8 and 9, the two DIP devices 708, 710 are connected to the VAD 702 through respective connectors that include the input connector 704, which connects to the proximal end 716 of the first DIP device 708, and outlet connector 706, which connects to proximal end 718 of second DIP device 710. The two cannulas 712, 714 are shown inserted into DIP devices 708, 710 at distal ends 720, 722, respectively. .

Figures 10-29B illustrate how examples of a DIP device in accordance with the invention can be used to connect cannulas that have been surgically attached to a patient to a cardiac circulatory support device. Illustrated examples •. ϊ ΑΑ Ρ * Τ show binding to a VAD; However, it is Arajettefa litn ^^ íar,

MEXICAN INSTITUTE

OF THE PROPERTY

INDUSTRIAL similar procedures for other cardiac circulatory support devices.

Figure 10 is a perspective view of an exemplary VAD 1000 that may be used in a cannula / DIP / VAD device assembly such as that shown in Figure 7. Figures 11A and 11B illustrate the joining of two DIP devices 1100a, 1100b to the exemplary VAD 1000 of Figure 10. The 1100a, 1100b DIP devices can be joined through an airtight seal, which can be formed by tightly fitting the elastic material of the 1100a, 1100b DIP devices around the inlet and outlet flow ports of the VAD 1000, respectively. An airtight seal can also be formed using a clamp or other conventional sealing methods. The VAD 1000 and attached DIP devices 1100a, 1100b, once assembled, form a DIP / VAD device assembly 1102 as shown in FIG. 11B.

Figures 12A and 12B illustrate the addition of a liquid 1202 to the DIP / VAD device assembly 1102 of Figure 11B. Liquid 1202 can be added to the distal openings 1204 and 1206 of any of the respective DIP devices 1100a, 1100b as shown in FIG. 12A. As the liquid 1202^andIn the 1102 DIP / VAD device assembly, the 1202 liquid replaces the air inside the 1102 DIP / VAD device assembly. However, air bubbles 1210 may remain or form within the 1102 DIP / VAD device assembly. Liquid 1202 is added to DIP / VAD device assembly 1102 until the level of liquid 1210 in each DIP device 1100a, 1100b is above the air outlet in outer conduit 1212, 1214, which can be closed by means of the engagement of a male locking plug in a closed position. While the 1202 liquid is being added, the DIP / VAD device assembly 1102 should be held in a straight vertical position, with the distal ends facing up. With the 1220 level of the 1202 liquid within the DIP / VAD device assembly 1102, as shown in Figure 12B, the DIP devices 1100a, 1100b can then be occluded below the air outlet in the external conduits 1212, 1214 , respectively, to close the liquid container.

Returning to Figure 11, this figure illustrates the occlusion of DIP devices 1100a, 1100b using a pair of clamps 1102 and 1104, respectively. Figure 14 illustrates the reverse rotation of the liquid container of the closed DIP / VAD device assembly 1102, causing any trapped air bubbles 14 02 £

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OS the wf has p the VAD 1000. If necessary, the ^{, N [}^ ñftám6re = -ee device / VAD 1102 can be used d &lt;TT5 — yWLpeddu to group or unite air bubbles 1402 into a single air bubble.

The air bubbles once collected can then be moved back to one or both of the DIP devices 1100a, 1100b by turning the DIP / VAD device assembly 1102 back, so that the DIP devices 1100a, 1100b once again point towards above, as shown in figure 14. When the DIP / VAD device assembly 1102 was turned upside down in Figure 14, the liquid contained in the space formed between the clamps 1102 and 1104 and the nearby openings of the DIP devices 1100a, 1100b was drained from the DIP devices 1100a, 1100b. Figure 15A illustrates the removal of the clamp 1102 (not shown) from the first DIP device 1100a to allow the addition of more liquid 1502 to the DIP / VAD device assembly 1102. Liquid 1502 can be added to first DIP device 1100a until the level of liquid 1504 rises above the air outlet in outer conduit 1212. As liquid 1502 is added, air bubbles 1506 can be released at the end. distal open end of the first DIP device 1100a. Once the 1504 liquid level has

<img file="MX348034B_D0017.tif" />

convenient and air bubbles 1506 are released, the first DIP device 1100a can be occluded once more with the clamp 1102 as shown in Figure 11.

Figure 15B illustrates the second DIP device 1100b without the clamp 1104, Figure 11, which was sealing the liquid in the DIP / VAD device assembly 1102 against the gap in the second DIP device 1100b. Figure 15B illustrates the addition of more liquid 1510 to the second DIP device 1100b in the DIP / VAD device assembly 1102. Liquid is added as shown in Figure 15B until the liquid level in the second DIP 1100b rises to a desirable level above the outer conduit 1214 of the second DIP 1100b, and any trapped air bubbles are released into the the opening of the distal end of the second DIP device 1100b in the same way as shown in FIG. 15A.

This process of purging the second DIP device

1100b as well as the purging process of the first DIP device 1100a can be repeated as many times as necessary to achieve an air bubble-free DIP / VAD device assembly, filled with liquid 1102. Returning to figure 16, this figure shows the 1102 DIP / VAD device assembly occluded with 1102 and 1104 clamps, and ready for further manipulation, including connection

<img file="MX348034B_D0018.tif" />

to the VAD 1000. The DIP / VAD 1102 device assembly, as shown in Figure 16, is filled with a liquid and is also purged of any air bubbles trapped within the closed liquid container portion of the device assembly. DIP / VAD 1102 between the two clamps 1102 and 1104.

In general, Figures 17A through 27 illustrate connection of cannulas to the DIP / VAD device assembly 1102 of Figure 17A and the purging of air bubbles from the resulting cannula / DIP / VAD device assembly. Figures 17A, 17B and 17C illustrate the connection of a first cannula 1700 to the DIP / VAD device assembly 1102 shown in Figure 16. In FIG. 17A, purged air bubble free DIP / VAD device assembly 1102 is positioned facing the distal end of first cannula 1700 so that first cannula 17 00 is in position for insertion into first DIP device 1100a at its distal end. The first cannula 1700 is an outlet cannula with reference to the heart of the patient as this is always the cannula that is first connected to the VAD (and an inlet cannula with reference to the VAD). During the process of connecting the connector / VAD-cannula assembly, the DIP / VAD 1102 device assembly can be manipulated or handled in

<img file="MX348034B_D0019.tif" />

any position, including vertical! IVjpjenj.

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Although the first cannula 1700 can be surgically clamped to a patient (not shown) at one end of the cannula

1700, unrestricted controllable movements in the connector / VAD-cannula assembly connection process remain possible regardless of which connection method or cardiac circulatory support device may be used.

Figure 17B illustrates the addition of a liquid 1702 to the first cannula 1700 and to the first DIP device 1100a while the first DIP device 1100a remains occluded by the clamp 1102. In Figure 17C, the liquid 1702 is added to both the first cannula 1700 as to the first DIP device 1100a as the open end of the first cannula 1700 and the distal end of the DIP device 1100a are placed in close proximity to each other. Liquid 1702 is poured into both as cannula 1700 is inserted into first DIP device 1100a. This minimizes the possibility of air bubbles entering the space within the first DIP device 1100a.

Figure 18 illustrates the first cannula 1700 partially inserted into the first DIP device 1100a. The cannula 1700 is inserted until the end advances past the inner semi-closed flexible ring 180

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19, the clamp 1102 that occludes the first DTr device 1100a is removed, creating a closed container of liquid in the first cannula 1700, the first DIP device 1100a, the VAD 1000, and the second DIP device 1100b to the point where the clamp 1104 creates the remaining occlusion. Figure 20 illustrates the further insertion of the first cannula 1700 into the first DIP device 1100a until a connection is established at the connector 2000 with the inflow port of the VAD 1000.

Once the outflow cannula is connected to the DIP / VAD device assembly and purged, the process must be repeated for the inflow cannula (with reference to the patient's heart). Returning to FIG. 21, a second cannula 1720 is shown prior to insertion into the second DIP device 1100b that remains occluded by clamp 1104. Figure 22 illustrates liquid 2202 being poured into the distal ends of the second cannula 1720 and the second DIP device 1100b. In Figure 21, liquid 2102 is simultaneously being poured into both the second cannula 1720 and the second DIP device 1100b as the second cannula 1720 is inserted into the second DIP device 1100b, thus preventing the introduction of air into the device assembly. DIP / VAD

1102. In figure 24, the second cannula 172 • WlTUTO MEXICANO DE LA WWeDAD the DIP / VAD device assembly 1102 so *¹ The tip of the second cannula 1720 moves past the inner semi-closed flexible ring 2402. The clamp 1104 remains in place, partially occluding the DIP / VAD device assembly 1102.

As the second cannula 1720 is inserted into the second DIP device 1100b, air bubbles 2502 can form in the space within the second DIP device 1720 as shown in FIG. 25A. These air bubbles can be removed using a syringe that is inserted into the outer conduit 2504 of the second DIP device 1100b after removing the male plug 126 from the female plug 120 (Figures 1, 2 and 3). In Figure 25B, the syringe 2510, filled with a liquid and with the striker 2512 extended, is shown inserted into the outer conduit 2504 of the second DIP device 1100b. In Figure 25C, the striker 2512 of the syringe 2510 is shown depressed down, which injects the liquid into the second DIP device 1100b, thus creating additional pressure in the DIP device 1100b.

Returning to Figure 25D, striker 2510 is shown with striker 2512 extended upward. This causes the air bubbles 2508 to be drawn from the second DIP device 1100b within the time this is done, the syringe 2510

<img file="MX348034B_D0020.tif" />

external conduit 2504 of the second DIP device 1100b, the male plug 126 is snapped back onto the female plug 120 (Figures 1, 2, and 3), and the clamp 1104 is removed, as shown in Figure 26. Figure 27 shows cannula 1720 inserted further into second DIP device 1100b until a connection is established at connector 2004 to the outflow port of the VAD 1000. The result is a 2700 purged air bubble free cannula / DIP / VAD device assembly.

In general, Figures 28A and 28B illustrate the removal of the first DIP device 1100a from the cannula / DIP / VAD device assembly 2700 and Figures 29A and 29B illustrate the removal of the second DIP device 1100b. The first DIP device 1100a is detached from the cannula / DIP / VAD device assembly 2700 by pulling the flap 2802a, leaving the assembly 2700 shown in Figure 28B. This process is repeated for the second cannula 1720 as shown in Figure 29A, with the end result being the VAD / Cannula 2900 assembly shown in Figure 29B, where cannulas 1700 and 1720 are shown connected to the VAD 1000 at through connectors 2902 and 2904, respectively.

Figure 30 shows an exemplary connector 3000 that

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M la rxorisDAO xV-iJTjp - &lt;INOUSTXIAL ^, ~ au ~ like connectors 2902 and 2904 as shown in the figure

29. Connector 3000 has a distal end 3002 and proximal end 3 004 and can be attached to the inflow and outflow ports (not shown) of a VAD, with the distal end 3002 attached to the ports. The DIP devices are then attached at proximal end 3004 and subsequently the distal ends of the cannulas are attached as well. The 3000 connector can be adapted for the cannulas to be attached in a manner that reduces turbulence in the flow of fluid through the cardiac circulatory support system and to avoid drainage of flow from the system or inflow of air to the inside the system. Connector 3000 can be made of stainless steel or other suitable material. Figure 31 shows three (3) examples of cannulas that can be used in accordance with the invention, such as cannulas 1700 and 1720 shown in Figure 29B.

Figure 32 shows a flow chart illustrating an exemplary method of operation using DIP devices in accordance with the invention to connect cannulas to a cardiac circulatory support device and then, using the DIP device, purge any air bubbles that may have been present. entered the cardiac circulatory support device assembly ^ y ^^^^. ^^^^

Df THE OWN INHUSTRIAL method of operation starts at step 33 02 where a DIP device is connected to the inflow and outflow ports of a cardiac circulatory support device, which in this exemplary method is an assistive device ventricular (VAD). This connection is made using connectors that are attached to the ports on the VAD and a DIP device is attached to the proximal end of each connector.

In step 3304, the DIP / VAD assembly is turned upside down from the VAD, and a liquid is poured into both DIP devices. Each of the DIP devices can then be occluded with a clamp. Next, in step 3306, air bubbles are purged from the DIP / VAD assembly by inverting the DIP / VAD assembly, removing one of the clamps from a DIP device, and pouring more liquid into the DIP device to force trapped air out. from the distal end of the DIP device. This sequence of steps is illustrated in Figures 15A and 15B.

At step 3308, the occluded DIP / VAD assembly is maneuvered to position the distal ends of the cannulas facing the distal ends of the assembly, as shown in Figure 17A. In the next step 3310, the cannulas are inserted into the DIP / VAD assembly while on. . . IMPI pours liquid into the distal ends of the eisroaimiasc.

* · DELA 7ROEIF.DA1.

industrial DIP device, and the liquid is also poured over the space that forms between the cannulas and the DIP devices when the cannulas are inserted into the DIP devices.

In step 3312, the air bubbles are purged from each of the DIP devices. More details of this process are shown in Figures 25A, 25B, 25C and 25D. At step 3314, the clamps are removed from the DIP devices and the cannulas are withdrawn further inward from the DIP devices until a connection is established between the cannulas and the connectors attached to the VAD.

At step 3316, the DIP devices are removed from the DIP / VAD device / cannula assembly, as shown in Figures 28A, 28B, 29A and 29B. The process ends at step 3318, with the VAD / cannula assembly shown in Figure 29B.

Although various implementations of the invention have been described, it will be apparent to those skilled in the art that many more embodiments and embodiments are possible and are within the scope of the present invention. Furthermore, it will be understood that the foregoing description of an execution has been presented for purposes of illustration and description. This is not exhaustive and does not limit the

<img file="MX348034B_D0021.tif" />

inventions claimed to the

Modifications and variations are prjcj ^ / ^ J ^ d ^^ í form

INSTITUTO MEXICANO 'ot the p / onsDAn possible in vsüstnsd

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description above or T'pa.ELii can be purchased from the practice of the invention. The claims and their equivalents define the scope of the invention.

ΙΜΡΙ «^

INSTITUTE MtXICAN ^

OF THE INDUSTRIAL WHMN

NOVELTY OF THE INVENTION ___________. .

Having described the invention as above, the content of the following is claimed as property: