MXPA97006271A - Implantable access device - Google Patents

Abstract

The present invention relates to an implantable access device, characterized in that it comprises a housing having at least one inlet duct and at least one outlet duct with a tube extending between them, said housing further comprising a guide channel elongate open inlet disposed therein and communicating with said inlet duct, said channel having a substantially constant cross-sectional area substantially along the length, with the area of substantially constant cross-section, substantially along the length, with said channel being further adaptable to receive a filament for guiding said filament into and into said inlet duct, and with said housing further including a valve assembly disposed and inside said inlet duct, and with said housing further including an assembly valve arranged in said tube, said valve assembly ula being adapted to be driven by said filament after passage of the filament through said inlet duct, the valve assembly being normally closed but adapted to be opened by said filament to allow access through said outlet duct, in wherein said valve assembly comprises a closing element and a valve disposed in said tube, with said closing element being positioned closer to the inlet conduit than said valve, said filament and said closing element coacting to first, creating a closure around of said filament before said valve opens to allow access, and wherein said closure element comprises an elastomeric member with a first end and a second end and an open conduit therebetween, said first end being substantially fixed in position within of said housing, and the second end having a flexible cover fixed thereto, said tap to be adapted to withstand repeated contact, with said filament resisting the passage of said filament, in such a way that when said filament advances through said conduit, the filament makes contact with said cap causing said elastomeric member to stretch and fold around of said filamen

Description

I-IFLIBLE ACCESS DEVICE BACKGROUND OF THE INVENTION The present invention is related to, in general terms, an apparatus that provides access to a living body. More particularly, the invention relates to an improved device for accessing the patient that allows repeated access to an interior region of a patient's body. In the course of a treatment, it may be necessary to repeatedly access * specific places, devices, tissues or fluids within the patient's body. This can be carried out for the infusion, temporary or continuous, of various therapeutic agents, the elimination and treatment of fluids, the injection of different treatment devices such as fiber optic cameras and light sources, ultrasonic probes, and catheters of troinbectomies. Different strategies are currently used to achieve such access, including direct cannulation of vessels, short and long-term catheterization, as well as subcutaneous pump and duct implantation. Direct cannulation of a natural or artificial vessel with a needle it is, perhaps, the simplest and least expensive form of access. However, it has been shown that repeated cannulation of superficial vessels causes thrombosis in said vessels and, in the case of graft cannulation for hernodial s, access stenosis and formation of pse? Doanoup srnas. The accessible vessels of a patient can be quickly annulled by repeated direct cannulation during the course of therapies with aggressive treatments, which limit treatment options and make prognosis difficult. The use of long needles also entails significant lacerations of the vessel, which requires the application of pressure for a few minutes to achieve hernosetasis, particularly in the case of high-pressure vessels or abundant flow such as arteries, central veins and primary fistulas or prosthetic This pressure is uncomfortable for the patient and can lead to premature thrombosis of the vessels, independently of other causes- To tackle the numerous problems derived from direct cannulation < ?, has recut rido to short and long term catheters. These transcutaneous devices are generally flexible cannulas that are inserted percutaneously into the area in question, such as a blood vessel or the peptoneal cavity. The catheters have one or more lumens through which different fluids or devices can pass. Although catheters allow repeated access with a reduced risk of thrombosis, they have a number of important disadvantages. Apart from being unsightly and easy to be accidentally removed, catheters often present complications with infections. The location of the infection is usually the exit orifice at which the catheter passes through the skin. This essentially open wound facilitates a pathway to various dangerous organisms that penetrate the body and cause both local and systematic infections. The infection has also been pointed out by various authors as being responsible for the increase in catheter and vessel thrombosis, another of the usual complications of permanent catheters. As an alternative to transcutaneous catheterization, conduits implanted subcutaneously have been increasingly used. These devices provide a place under the skin that can be accessed with special needles without a core by a percutaneous puncture at the time of the triento. These devices generally consist of a housing that forms a reservoir that communicates with a catheter that reaches the area that requires treatment. A self-closing septum formed with a high-density silicone elastomer extends over the top of the reservoir, creating a continuous barrier against the passage of fluids, such as blood, that is in contact with the conduit. This partition is crossed by the needle to allow access to the tank. Once the needle is removed, the partition closes again creating the continuous barrier. If they are fully implanted (that is, without requiring an opening in the skin), the ducts avoid many of the complications of infection of the catheters. In addition, the conduits are usually better accepted by patients, since they are obstructive, can not be removed accidentally and are easy to maintain. The conduits implanted subcutaneously are also used as means to communicate with other implanted medical devices. For example, infusion pumps that provide a continuous infusion of therapeutic agents into the patient's body often utilize one or more integral conduits or propulsion and filling sites. Other devices, such as prostheses inflab-.es implanted, have taken advantage or may have benefited from the use of conduits. The ducts implanted subcutaneously have a number of important drawbacks that limit their application. In the first place, its useful life is limited by the number of punctures that the septum can resist before starting to leak. The repeated access degrades unable to prevent the passage of fluids or other elements that are in contact with the conduit. Secondly, they could not be accessed with normal needles, requiring special relatively inexpensive core needles that reduce the damage done to the septum. This expense may seem minimal, but it could be important in the case of aggressive therapies or when the therapies are paid mainly by the Federal Health Insurance Program for people over 55 (Medicare). Third, only small needle gauges can be used even with coreless needles, because larger gauge needles quickly destroy the septum. However, small needles are not appropriate in many treatments, such as transfusions or hernodialis that require large blood flows. Some prior art concepts have a plantable patient access conduit that allows the introduction of various filaments in the patient's body, including catheters and needles, without the need for a standard septum. By employing a variety of different valve mechanisms, the presumed bile duct eventually has more applications in more rigorous therapies that require frequent access or abundant flow, ie, therapies previously limited to transcutaneous catheters and direct cannulation. All these ducts incorporate a housing having a generally funnel-shaped inlet orifice, a valve mechanism that is opened by an access filament, allowing its entry, and a tube of s 11da. An important limitation of the preceding concepts is the area of shock, or region in which the medical professional attempting access must hit with the access filament to introduce the device. A large shock area is crucial for simple cannulation and to allow each insertion wound to heal before that region is cannulated again. By nature to increase, the area of shock of a funnel as described in the technique, one must also increase its total size in the three dimensions. An especially important dimension when it comes to ducts is the height, or depth from the skin inwards. The higher a duct, the greater the pressure it exerts on the insertion wound, the more obvious its presence becomes visible and, the greater the potential, the erosion and infection. In this way, increasing the collision area of the funnel also increases the size of the duct in its three dimensions and leads, potentially, into commications. The entry hole in the funnel urine also limits the shock area by providing only one focal point or entry point for the access filament, since the filament always focuses in the same place., the same fabric next to that place of entry is traumatized in each of the accesses. Repeated traumas in the tissues can cause devascularization and necrosis, creating a potential source of infection. Another limitation of the concepts of the prior art is the duration of the valve assembly when using pointed needles or trocars. While there are vain concepts that allow access by means of flexible filaments, such as catheters, or rigid filaments such as needles, all valve assemblies that allow access specifically by means of rigid filaments, or are subject to contact direct with the pointed end of the access gate causing deterioration, or not specifically closing around the access filament before the valve assembly opens or before it closes. In some known devices, the elastome elements forming the valve assembly are in the direct path of the access needle. The hole of the first elastomeric element is smaller in diameter than the access filament, so it will suffer damage each time the access gate is inserted. This damage could ultimately lead to the failure of a valve, which would have catastrophic consequences for the patient. In some prior art designs, the movement of the components of the valve eeta directly linked to the movement of the closure components, whereby the creation of a closure around the access filament requires that the valve be open. The valve leaflets are either in the direct closing position with the filament closure element, or the movements of the two elements are linked directly through an intermediate rigid element. These designs imply that some passage or partial opening of the valve is required before the closure is formed around the access filament or, more importantly, that flow through this partially open valve is allowed and around the valve. of the access filament until the valve has opened enough to create an effective seal. This fact could bring potential between the repeated formation of bruises or the passage of other fluids to the tissue surrounding the device as a result of access. The main object of the present invention is to provide an implantable patient access device that overcomes many of the deficiencies of the prior art conduits. Specifically, in one embodiment, the implantable access device forming this invention uses an open guide channel that allows increases in the impact area of the access filament without increasing the overall height of the device. In addition, the device consists of a valve assembly that allows access to the patient while maintaining a fluid-tight seal around the access filament, usually a needle, at all times. The valve assembly does not allow contact of the cutting front edges of the access filament, especially in the case of a needle, with any of the soft elastoinec members of the valve assembly. In this way, the valve assembly allows repeated access of standard needles of small or large caliber, eliminating many of the access problems that have limited the use of standard conduits with partitions and other prior art devices. In addition, the valve assembly ensures the formation of a closure around the access filament prior to the opening of the valve assembly to allow access to the patient. This is achieved, in one embodiment of the invention, by ensuring that less movement of the access filament is needed to create a closure around the filament than is required to start opening the valve, and in another embodiment of the invention, by completely detaching the creation of closing the movement of the valve. The assembly ensures in this way that there is no leakage of fluids around the access filament at any time during access. Other advantages of the present invention are described below.

SUMMARY OF INVENTION The present invention relates to an implantable patient access device comprising a housing having at least one inlet duct and at least one outlet duct with a tube extending between them, the housing further comprises an open guide channel arranged in the same or in communication with the inlet duct, the channel having a substantially constant cross-sectional area, and this channel being further capable of receiving a filament to guide it towards and into the inlet duct, and also including the housing a valve assembly disposed within the tube, the valve assembly being adapted to be activated by the filament after the passage of the filament through the inlet conduit, the valve assembly being normally closed but adapted to be opened by the filament to allow the access to the patient or to a place, space, device or other object, tissue or fluid within the patient through the filament. The valve assembly comprises a closing element and a valve after the tube, thereby creating this closure element firstly to close around the filament before the valve assembly opens to allow access to the patient through the valve. filament. The closing element maintains the closure around the filament until after the closing of the valve assembly. The channel could generally have a V-shaped cross-section or could have a general transverse section in the form of a U such as a ball pair. The valve could comprise a conical valve or a slit valve, each capable of being opened by the movement of the filament in the valve assembly. Alternatively, the valve could comprise a plug in the closed position seated inside the tube, in combination with a slit valve, the slit valve and stopper being forced from the closed position within the tube by the movement of the filament through the valve. of the tube, additionally, the valve could comprise a plug in closed position inside the tube and an opening proximate the plug, such that, when the plug is forced from the closing relationship with the tube by the movement of the filament through the tube, the opening allows access to the patient or place *, space, device and other object, tissue or fluid within the patient through the filament. The closure element comprises an elastomeric member with a first and a second end and a conduit therebetween, the first end being substantially fixed in its position within the housing and having the second end of a flexible cover attached to the same, is both this cap adapted to resist repeated contact with the filament, resisting the passage of the filament in such a way that, when the filament advances through the conduit, this filament makes contact with the cap causing the elastomeric member to stretch and then fold around the filament. The elastomeric member has an outer dimension, this dimension having in a first position a first quantity that is reduced to an external dimension of a second quantity in a second position, this decrease corresponding to a decrease in the size of the tube in such a way that When the elastomeric member is stretched by the advancement of the filament, the largest outer dimension of the elastoid member is compressed with the access filament in the lower direction of the tube. The housing further possesses means for retaining an access filament in a fixed position within the housing. The outlet duct is capable of being connected to a catheter, a graft or an implanted medical device. The invention further provides an implantable patient access device comprising a housing having at least one inlet duct and at least one outlet duct with a tube extending between both, the inlet conduit being adapted to receive a filament for passage to the tube, the housing further including and arranged in the tube a valve assembly comprising a valve and a closing element, the valve assembly being adapted to be activated by the filament after the passage of the filament through the inlet conduit, thereby creating a closure, independent of the activation of the valve, by means of the closing element around the filament before the valve is opened to allow access to the patient, place, space, device and other object, tissue or fluid within the patient through the filament. The valve could comprise a combo valve or a slit valve, each valve being adapted to be opened by the movement of the filament towards the valve assembly. The valve could comprise an elastomeric stopper in closed position seated within the tube, the stopper being forced from the closed position within the tube by the movement of the filament to -t through the tube. The closure element comprises an elastomeric member with first and second ends and an open conduit therebetween, the first end being substantially fixed in its position within the housing and having the second end of a flexible cover attached to the same, being adapted the cap to resist repeated contact with the filament, resisting the passage of the filament in such a way that, when the filament advances through the conduit, this filament makes contact with the cap causing the elastomeric member to stretch and then fold around the filament. The elastomeric member has an outer dimension, this outer dimension having in a first position a first quantity that is reduced to an external dimension of a second quantity in a second position, corresponding to a decrease in the size of the tube, in such a way that, When the elastomeric member is stretched by the advancement of the filament, the largest outer dimension of this elastomeric member is compressed against the access filament within the smallest dimension of the tube, creating a closure around the filament. The housing could further comprise means for retaining an access filament in a fixed position within the housing. The filament could be a pointed needle, and the housing could also have means for guiding the guide through the conduit and towards the flexible cover in such a way that the tip of the needle contacts only the flexible cap. The outlet conduits in these devices are adapted to be connected to a catheter, a graft or an implanted medical device. The invention further provides an implantable patient access device comprising a housing having a plurality of inlet ducts and a plurality of outlet ducts with a tube extending between each inlet duct and each outlet duct, further comprising the housing a plurality of elongated open guide channels that are disposed therein, each of these guide channels communicating with an inlet conduit, each of the gu channels having a substantially constant cross-sectional area, each being furthermore of these guide channels adaptable to receive a filament to guide it into and into an associated inlet duct, the housing further including a valve assembly disposed in each tube, the valve pack being adapted to be activated by the filament after the of the filament at the entrance duct, the valve assembly being poorly closed but adapted to be opened by the filament to allow access to the patient or to the place, space, device or other object, tissue or fluid within the patient through the filament.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic perspective view of a first embodiment of a patient plan access device according to the principles of the present invention in which an open guide channel is shown in the form Figure 2 is an enlarged longitudinal section of the device depicted in Figure 1. Figure 2A is an enlarged view of a part of the device depicted in Figure 2 showing a partial view of the assembly of valve of the device. Figure 3 is a view very similar to that of Figure 2 but also showing the valve assembly of the device at the moment of being activated by the access filament. Figure 3A is an enlarged view very similar to 2A but showing the valve assembly after being activated by the access filament. Figure 3B is an enlarged view of another part of the device shown in Figure 3 in which a closure created around the access filament is shown. Figure 4 is a view substantially similar to that of Figure 2 but representing an alternate embodiment of the valve of the invention. Figure 5 shows a view substantially similar to that of Figure 3 but showing the arrangement of the valve of Figure 4. Figure 6 is a vist very similar to that of Figure 1 but showing an inlet guide channel normally open in the form of U. Figure 7 is a view similar to that of Figure 1 showing a device with multiple inlet guide channels and outlet ducts. Figure 8 is a view very similar to that of Figures 2 and 4 but showing an alternative embodiment of a valve assembly with the valve assembly closed.

Figure 9 is a view very similar to that of Figure 8 but showing a closure created around the access filament but with the valve closed. Figure 10 is a view similar to that of Figure 9 with the closure maintained but with the valve open. Figure 11 schematically represents an embodiment of the device of the present invention as an integral part of an implanted medical device.

DETAILED DESCRIPTION OF THE INVENTION The description presented here refers to the attached drawings, in which the same reference numbers refer to the same parties in the different views. As for FIG. 1, according to the principles of the present invention, it represents a schematic perspective view of a first embodiment of an implantable device 10 for accessing the patient. The access device 10 includes a housing 1 ?, in which an elongated open guide channel 14 is defined which communicates with the inlet conduit 15 of the housing. In this figure, the guide channel appears with a general V-shaped configuration, but there are other possible configurations. In turn, the conduit 15 is in fluid communication with the outlet conduit 18 of the housing. The internal structure of the device 10 is shown in greater detail in subsequent views.

Returning to Figure 2, there is depicted therein an enlarged longitudinal section of the plantable patient access device 10 i shown in Figure 1. Here, a valve assembly 19 containing an elastomeric member 20 disposed in the tube 22 of the patient is shown. device 10. The elastoid member or closure element 20 includes, in this embodiment, a tap 26, a slit valve 28 and ends in a lid 24. The lid 24 can be made of titanium, stainless steel or any other elastic metal. suitable. The elastomeric member 20 is located within a housing insert 30. The insert 30 of the housing is used to facilitate the manufacture, but it should be understood that it could also be an integral part in the geometry of the housing 12. Here the housing 12, for ease of manufacture, is shown as consisting of the parts 12 'and 12" The member 20 also has a transition zone 32 along which the outer diameter of the elastomeric member 20 decreases from a greater diameter ppmer to a smaller second diameter.The interaction between the elastomeric member 29, specifically its transition zone 32, and the housing insert 30 creates a closure around an access filament, as will be described further on. The elastomeric member 20 has a substantially thinner wall section 34 above the zone. 32 of transition. A filament retention piece 36 also exists inside the tube 22. The outlet conduit 18 extends from the housing part 12"and forms the lumen 22 'which is in fluid communication with the tube 22. The outlet conduit 18 is adapted to be coupled to a catheter *, a graft, another device or conduit that is in and / or in communication with the patient's body There is also a stop 38, shown here as part of the part 12"of the housing, which stops the downward movement of the activated valve assembly. Figure 2A is an enlarged view of the left part of Figure 2. Figure 2A shows the plug 26 at the distal end of the elaketomeric member 20 in a closing relationship with the tube 22, and a slit valve 28 in closed position. Figure 2A also shows lid 24 and tie 2 'of the filament. Returning to Figure 3, the patient access device of Figure 2 is shown with an access filament 40 opening the tap 26 and the slit valve 28. Preferably, the filament is its a cc rigidly. Typically, the filament would be a needle although a catheter or other substantially rigid member could be used. Before the movement of the plug 26 outside the tube? and from the opening of the slit valve 28 which would allow communication between the filament 40 and the lumen 22 ', a closure 33 is first created around the filament 40. The closure 33 is maintained at all times while the cap 26 and the valve 28 of the slit allow communication between the filament 40 and the lumen 22 ', and this closure opens only after the cap 26 returns to the closing relationship within the tube 22. Figure 3A shows an enlarged view of the valve that comprises the plug 26 and the slit valve 28 in the open position. Figure 3B is an enlarged view showing in greater detail the closure 33 around the access filament 40. The closure 33 is generated when the transition zone 32 of the elastomeric member 20 is brought to the smaller diameter 32 'of the insert 30 of the housing, the elastomeric member 20 compressing against the access filament 40. Also shown in Figure 3B is the filament retention piece 36 engaging with the access filament 40. The filament retention piece 36 is configured with an internal dimension smaller than the external dimension of the access filament 40, such that as the access filament 40 is introduced into the inlet conduit 16, the filament retention piece 36 it expands and exerts a force against the access filament 40 to resist its withdrawal from the inlet conduit 16. The piece 36 filament retention can use slot or slots 37 of tension discharge to adjust the force exerted on the access filament 40 and increase its useful life. Figures 4 and 5 are substantially the same as Figures 2 and, and represent the valve assembly 19 ', the main difference being that the slit valve 28 has been replaced by an opening 42 located in the elastomeric member 20. Figure 6 is substantially in the same view as that shown in Figure 1, except that in this the device has been designated 10 'and the guide channel 14' has a generally parabolic or generally U-shaped cross section. A guide channel with a flat rather than curved bottom has been considered to also have a general U-shaped configuration. The U-shaped configuration in general is only one of many possible configurations suitable for the elongated open guide channel of the invention. Figure 7 depicts a configuration of a dual patient access device 10"with two complete devices (each of which has any of the valve assemblies described herein) that have been attached and coupled to a housing 13 to simplify the implantation of the two devices, Figure 7 also shows two saturation orifices 44 for anchoring the mechanism to the patient. The saturation holes 44 are only one of the many possible ways of anchoring these devices. Although not shown, any of the mechanisms forming this invention can utilize anchoring means such as or holes 44 saturate. Figures 8 to 10 depict another embodiment of the present invention and show the valve assembly 19"which employs a conical or duckbill valve 46 instead of the plug 26 and the slit valve 28 or the opening 42. The lid 48, with a filament or shock tie area 48 ', has replaced the lid 24. A latching element 50 helps maintain the bond between the elastomeric member 20' and the lid 48. The elastomeric member 20 'has all the attributes of the elastomeric member 20. Figure 8 shows the valve assembly before its activation. Also shown in this figure 8 is the insert 30 'of the housing which is substantially equal to the housing insert 30. The other structural elements are the same as those described herein in relation to other embodiments of the invention. Figure 9 additionally depicts an access filament 40 moving the lid 48 and the member 20 'to open a seal 33 around the filament 40 before the valve 46 opens. Figure 10 shows the advancement of the filament 40 and the cover 48 that opens the valve 46 to allow access to a patient or to a place, space, device or other object, tissue or fluid within the patient. As shown here and as shown in other embodiments of the invention, the closure 33 is created around the access member before the corresponding valve is opened, the closure is maintained for as long as the valve is open and it does not release until after the closing of the valve. Returning, and finally, to Figure 11, a schematic view of the device 10 of the present invention is shown as an integral functional part of an implantable medical apparatus 52, such as a continuous infusion pump 54. Two devices are shown here. However, it should be understood that one or the other number of devices could be used, such as 10, 10 'and 10. In this view, the pump 54 has been 7 2 implanted under line 56 of the skin of a patient. Also shown is a catheter 58 attached in fluids to a lumen 22 '(not shown in this view). The catheter * is in fluid communication with a vaeo 60, however, this communication could be established with a place, space, tissue, fluid, organ or other implanted device. Although it is not shown in this view, it should also be understood that, as in Figure 11, each of the devices of Figures 1 to 10 are adaptable for inclusion as an integral part of an implanted medical device or can be adapted to be implanted independently under the skin of a patient for communication with a place, space, tissue, fluid, vessel, organ or the like. An important feature of the different valve assemblies is the rate of opening and closing of the valve in relation to the closure formed around * the access filament. Each valve assembly forms a closure around the access filament before the valve opens to allow access to the patient, and then this closure is released only after the valve has closed again. This prevents any possibility of bleeding or reflux of fluids or gases to the outside of the device. The open guide channels forming part of this invention have a number of advantages over the funnels described in the prior art. First, they allow the increase of the shock zone without increasing the overall height of the device. With a device of the configuration shown in Figure 1, the shock zone increases simply by increasing the length of the device. Another advantage of the channel is that it allows the device to simulate better a natural vessel, both in form and in way to access it. This can make the device and its use more readily apparent to the healthcare technician or physician. Finally, an elongated open channel would allow multiple entry points along the length of the channel, unlike a funnel that is limited to a single focal point. By accessing through different entry orifices during a treatment that requires repeated access procedures, the trauma caused to the same or tissue can be reduced to a minimum compared to the funnel of a single focal hole. The device of Figure 3 consists of a three-part housing, a needle retention piece, a wedge closure assembly and a plug valve. A first piece 12 'of the housing could be made of an elastic material such as titanium that could withstand frequent contact with the pointed end of an access filament in the case of a needle. The guide channel which is an integral part of piece 12 'is one of the many possible open channel shapes described by this invention. The channel shown in Figure 3 could be used as a filament guide. The base of this guide channel could be inclined from a first end towards the entry orifice at an appropriate angle that would allow the access filament to slide easily with the contact and also allow reduction of the overall volume of the device. The walls of this channel can be, by nornbrar some configurations, vertical, inclined or rounded. Extending laterally from either side of the piece 12 'of its base, it could make two places of attachment of the suture loops to facilitate the fixation of the device inside the body. Any suitable number of attachment points can be used. Figure 7 represents only a potential configuration of this clamping. Alternatively, the outer surface of the housing may become rougher or more porous, facilitating the internal growth of tissue that helps secure the device within the patient. A second 12"section of the housing can be made either of an elastic material or of a more easily moldable material such as plastic.This part forms many of the flow passages for fluids that could be introduced or disposed of through To reduce the necessary volume of flow and the risk of accumulation of fluid, the diameter of the flow passage is approximately equal to the diameter of the access filament.A third piece 18 is a simple tubular insert that provides a surface along which a catheter or graft can be attached to the patient access device., this piece could be made of both an elastic material and a moldable plastic material. The outlet conduit can provide communication with a device: * 5 i plantable medical and can have another more suitable configuration to optimize its function in a nothing detepni application. The retention piece 36 of the filament is a simple tube with a flanged end. It could be constructed of a material capable of withstanding frequent contact with a pointed access filament. The tube has grooves along all or part of its axial length, and has a diameter to some extent less than the diameter of the access filament. In this way, when the access filament such as a needle is inserted, the tube expands elastically exerting a normal force on the filament around its circumference. This force causes sufficient friction to retain the filament in a latching position during the access procedure. The wedge closure and plug valve assembly consists of three functional parts. The first is a structure (20) or tube mode formed from an elastomer such as silicone rubber. The second is a small lid (24) formed by an elastic material that is fixed to the distal end of the tube, but which can be fixed to the tube in any appropriate place. The third piece is a simple graft (30) which can be a separate piece as represented, or a part of the geometry of the second piece of the housing. The tube is secured in its position at its proximal end, just beyond the inlet and the filament retention part. The tube fits inside the internal structure of the insert. The outer diameter of the tube reflects the inner shape of the insert along most of its length, being larger at the closest end, it is relieved along a short transition length and then remains constant until a point near the distal end. It should be understood that the term, for example referred to in Figure 2, is the place to the right of the figure, while the term distal refers to the place * to the left of the figure. In the distal location of the tube, an annular plug (26) projects radially from the tube to a diameter greater than the corresponding inner diameter of the insert. This plug acts as the valve, exerting closure against fluids or gases when the tube is inserted inside the insert and the plug is compressed against the insert. Just above this plug there is a hole or a slit through the wall of the tube that becomes a passage for the fluids to the filaments when the valve is open. The tube has a larger internal diameter * than the specified access filament. The proximal part has the largest internal diameter, to allow the filament retention piece to fit inside the tube. This part of the tube also has the thinnest wall, thus being the most flexible section. When an access filament is inserted into the device, it only makes contact with the retaining piece and the cap at the distal end of the tube. A further advance of the filament causes the stretching of the elastomeric tube, especially in the thinner proximal section. This stretch attracts the thick transitional part of the tube to the narrowest part of the insert, compressing the tube between the wall of the insert and the circumference of the filament. This understanding creates a closure. When the annular plug in the distal part of the tube is pushed beyond the outer part of the insert, the opening above this plug is exposed to the outlet conduit allowing the introduction and extraction of fluids or instruments that have of being inserted in the patient's body. The valve only closes once the closure has been created around the access filament and closed before the closure breaks. This is ensured by the necessary travel to push the annular plug out of the locking coupling with the inner wall of the insert. This tour is specified as rnas long that the necessary travel to generate a closure around the access filament. The device shown in FIGS. 8 to 10 uses a conical or duckbill valve (46) as the valve element. Typically the conical valve comprises elements or components elesto ép eos. The valve opens when the cap at the distal end of the elastomeric tube is pushed into the valve by the advancement of the filament or needle. This lid could once again be made of an elastic material such as stainless steel, titanium or other appropriate metal. The lid has a small decrease in its inner diameter from the proximal part to the distal part. The larger diameter allows the passage of certain specific filaments or needle gauges, while the smaller diameter acts to limit the passage of these filaments or needles, but allows the passage of fluids. The duckbill valve may have certain advantages over the side hole valve of Figure 4 or the slit valve of Figure 2. It provides fluid flow and an insertion passage of the instruments more directly and potentially as smooth . This can facilitate the insertion of different devices and allow higher flow rates at lower pressures. Another distinctive advantage of this valve assembly is that the creation of the closure around! Access filament does not require movement by the valve. By unlocking the closing element of the valve, and by separating the two elements, the design ensures that the closure around the filament will be created before the opening of the valve begins. The use of the channel is these devices allows the device as a whole to better simulate a natural arterial or vein. Going down the central axis of the device, a channel like the one described here will allow the medical professional to access the canal in a manner very similar to that used to access the peripheral vessels, that is, placing the fingers on both sides of the vessel and pressing for its center. The length of this channel can be chosen to be adapted to the requirements of a specific therapy, allowing an increase in the overall area of shock by increasing the size of the implantable access device in a single dimension.

Claims (25)

NOVELTY OF THE INVENTION CLAIMS

1. - An access-facing device 10 comprising a housing 12 having at least one inlet duct 16 and at least one outlet duct 18 with a tube 22 extending therebetween, said housing further comprising an assembly of v valve 19 arranged in said tube, said valve assembly is adapted to be actuated by means of a filament 40 after passage of the filament through said inlet conduit, the valve assembly is normally closed but is adapted to be * opened by means of said filament to allow access through said outlet conduit, characterized in that said housing has at least one elongated open guide channel 14, 14 ', disposed therein in communication with said inlet conduit. , said channel has a substantially constant cross-sectional area and further said channel is adapted to receive said filament to guide this filament towards, and in, dich or entry conduit.

2. The device according to claim i , wherein said valve assembly comprises a closure element 20 and a valve 28 disposed in said tube, said closing element first creating a closure around said filament before said valve is opened to allow said valve to be opened. access.

3. Device according to claim 2, wherein said closure element maintains said closure around said filament until after said valve is closed.

The device in accordance with the rei indication. wherein said channel has a generally V-shaped cross-section.

5. The device according to claim 1, wherein said channel has a generally U-shaped cross section.

6. The device according to the invention. with claim 2 wherein said valve comprises a valve 46 as ea.

7. The device according to claim 2 wherein said valve comprises a plug 26 seated in a closing fit in said tube, said plug being adapted to be opened by forcing said plug from said closing adjustment by means of the movement of said filament through said tube.

8. The device according to claim 2 wherein said valve comprises a slit valve 28 adapted to be opened by the movement of said filament through said tube.

9. The device according to claim 2, wherein said valve comprises, in combination, a tap n 26 seated in a closing fit within said tube, and a slit valve 28; said plug and said slit valve are adapted to be opened by the movement of said filament through said tube.

10. The device according to claim 2 wherein said valve comprises a plug 26 seated in a closed position within said tube and an opening proximate said plug such that, when said plug is f * From said closing position inside said tube by means of the movement of said filament through said tube, said opening perrn11 said access.

11. The device according to claim 2, wherein said closing element comprises an elastic member with a first end and a second end and an open conduit between both, said first end being substantially fixed in its position inside. of said housing, and said second end having a flexible cover 24 fixed thereto, said cover being capable of supporting-contact repeated with said filament, resisting the passage of said filament of such a method that, when said filament advances through said filament. duct, the filament makes contact with said cap causing said elastomeric member to stretch and fold around said filament.

12. The device according to claim 1 wherein said elastomeric member has an exterior dimensionsaid outer dimension having in a first position a first quantity that is reduced to an external dimension of second magnitude in a second position, said decrease corresponding to a decrease d €? the dimension of said tube in such a way that, when said elastomeric member is stretched by the advance of said filament, the greater external dimension of said elastomenco member is compressed against said access filament within the lower dimension of said tube.

13. The device according to the rei indication i wherein said housing further comprises means for retaining an access filament in a fixed position within said housing.

14. The device according to claim 1 wherein said outlet conduit is capable of being connected to a catheter *, a graft or an implanted medical device.

15. The implantable access device 10 comprising a housing 12 with at least one inlet duct 16 and at least one outlet duct 18 with a tube 22 extending between them, said inlet duct adapted to receive a filament 40 for passage into said tube, said housing and tube including a valve assembly 19 disposed within said tube, comprising a valve 28 and a closure element 20, said valve assembly being adapted to be activated by said filament after passage of said filament through said inlet duct in which a closure is created, independently of the activation of said valve, by said closing element around said filament before said valve is opened to allow access through said valve. said outlet conduit, characterized in that said sealing element comprises a member with the first and second end and? n conduit between the two, said first end is substantially in position inside said housing and said second end has an elastic cover 24 fixed thereto, said cover is adaptable. to resist repeated contact with said filament, re <; -attaching the passage of said filament so that when said filament advances through said conduit, the filament makes contact with said cover causing said elastomeric member to stretch and fold around said row.

16. The device according to the claim 15 wherein said valve comprises a conical valve 46.

17. The device according to claim 15 wherein said valve comprises a plug 26 seated in a closing position inside said tube, said plug being adapted to be opened by forcing said plug from said closing position by means of the movement of said filament through said tube.

18. The device according to claim 15, wherein said valve comprises a slit valve 28 being adapted to be opened by the movement of said filament within said valve assembly.

19. - The device according to claim 1G wherein said housing further has means for retaining an access filament in a fixed position within said housing.

20.- The device according to the claim 15 wherein said outlet conduit is adapted to be connected to a catheter, a graft or an implanted medical device.

21. The device according to claim 15 wherein said filament is a knitted needle and wherein said housing further includes means for guiding said needle through said conduit and said flexible cap such that said tip of said needle makes contact only with the flexi lid.

22. The device according to the claim 15 wherein said elastomeric member has an outer dimension, said outer dimension having in a first position a first magnitude that is reduced to an outer dimension of a second magnitude in a second position, said decrease corresponding to a decrease in the dimension of said tube in such a way that, when said stornenco member is stretched by the advancement of said filament, the greater external dimension of said elastomeric member is compressed against said access filament within the smaller dimension of said tube.

23. The device according to claim 1, wherein said inlet duct and said outlet duct comprise a plurality of inlet and outlet ducts with a tube extending between each inlet duct and each outlet duct, said elongated open guide channel comprises a plurality of guide channels disposed in said housing, each of said guide channels having a transverse cross sectional area substantially consisting of and communicating with an inlet duct, with each of said adapted guide channels. to receive a filament for guiding said filament towards, and in, an associated inlet duct, and a valve assembly is disposed in each of said tubes.

24. The device according to claim 1, wherein said device comprises a fluid infusion apparatus.

25. The device according to claim 1, wherein said device comprises a fluid suction apparatus.