JPH0339694B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a T-shaped blood inlet/output device that is implanted in the blood circulatory system and allows blood to be taken in and out. This device has a wide variety of uses, but is primarily used in the field of blood sampling and treatment of diseases such as diabetes, as well as hemodialysis of chronic uremic patients as a treatment for various types of chemotherapy and overnutrition.

Various methods of fabricating blood access devices for implantation within the body are known in the art, but none are completely satisfactory due to the problems of infection, clotting, and sagging associated with shunt techniques. Although arteriovenous fistulas have several advantages over shunts, they require repeated needle sticks and are susceptible to infection.

The present invention has been made in view of this point, and has the following objects.

The first to third inventions provide a blood inlet/output device that can be implanted into the body, which maintains a sealed state, enables repeated needle insertion, and facilitates cleaning and sterilization of the needle insertion point of the needle shaft. is intended to provide.

In order to achieve the above object, a device according to a first aspect of the present invention includes a main body, an elastomer partition member, a support member, a retaining ring, and a hollow needle member as described in claim 1, and the partition member further includes the main body, an elastomer partition member, a support member, a retaining ring, and a hollow needle member. It is characterized in that a penetrating slit is formed, and the pressure plate is provided with an opening that matches the position of the slit.

When using this device, the connecting tube portion of the main body is connected to the blood vessel so that blood flows through the connecting tube portion, and an elastomer partition member is attached to the needle stem portion, and the connecting tube portion is connected to the blood vessel from the needle stem portion. The main body is implanted into the body with a seal to prevent blood from flowing out.

Since the partition member has a slit passing through it at a position corresponding to the hole in the pressure plate disposed on its upper surface, the hollow needle member can be easily penetrated through the partition member, and the hollow part of the connecting pipe portion can be easily penetrated. By communicating with the outside, a blood sample can be extracted from the body or a medicine can be injected into the circulatory system through this hollow needle member.

According to such a device, the inside of the cavity of the needle shaft portion, into which the hollow needle member is inserted and removed from the partition wall member in the cavity of the needle shaft portion, can be cleaned after each use without going through a troublesome procedure. Can be sterilized.
Therefore, infections that are likely to occur as a result of handling the circulatory system can be greatly reduced.

Further, since the septum member is removable, no surgical operation is required if the septum needs to be replaced after long-term use.

Next, in addition to the above-described configuration, the present device, which is the second invention (described in claim 24), further includes forming an annular groove along the peripheral wall of the partition member, and having a diameter of this groove in the groove. It is characterized in that an elastomer ring member having an inner diameter smaller than that is fitted therein.

According to this device, a groove is formed along the circumferential wall of the septum member, and the presence of this groove allows material displacement of the septum member, so when the hollow needle member is pushed into the septum member through the slit. ,
Since the material of the septum member is separated along the slit, the material of the septum member is less likely to be scraped off by the hollow needle member.

In addition, when the hollow needle member is not pushed into the partition member, compressive force is applied to the partition member by the elastomer ring member from the portion where the groove is formed, so that force is applied to the partition member. The opposing inner walls of the slit are brought into close contact with each other in this portion, and therefore the opening of the partition member formed by the slit can be more tightly sealed.

In addition to the structure of the first invention, the present device, which is a third invention (described in claim 32), further includes a structure in which the hollow needle member can be fitted into and removed from the hollow portion of the needle shaft portion. A plurality of connectors are attached to the needle assembly, each having an upper end inside the needle assembly, and the needle assembly includes a plurality of tubular connectors for connecting with external equipment related to blood inflow and outflow. is attached, and a relay passageway is formed that communicates each of the plurality of tubular connectors with each of the plurality of hollow needle members, and the relay passageway has a distance between the hollow needle members that is larger than the interval between adjacent tubular connectors. It is characterized by being oriented so that the distance between adjacent ones is narrower.

When using this device, by fitting the needle assembly into the hollow part of the needle shaft, multiple hollow needle members can be easily pierced through the septum member at once, and each hollow needle member can be Setting up the external circulation device and this device is easy by simply connecting the pipe of the external circulation device to the connector.

The relay passage within the needle assembly that communicates each connector with each hollow needle member is oriented such that the distance between adjacent hollow needle members is narrower than the distance between adjacent connectors. Therefore, the device main body and the partition wall member can be made smaller accordingly, so the entire device can be made smaller.

One suitable example of the partition member is a backup partition system, which closes the cavity of the needle shaft portion of the main body above the first partition when the first partition starts to malfunction. It is. This back-up bulkhead method uses specially designed spacer members,
It includes a second septum that conforms to the shape of the needle stem cavity above the first septum retaining ring, and a clamp or retaining ring means for retaining and compressing the back-up septum within the needle stem cavity. With this backup method, the first
The circulatory system can be treated continuously until assistance is obtained in replacing the septum.

The final accessory device is a hemispherical implantation cap that protects the needle shaft cavity during implantation of the body into the body.

Referring to the accompanying drawings, FIG. 1 shows a device according to the invention, which has a hollow needle trunk portion 11 and a straight tube portion 12 as a connecting tube portion connectable to a blood vessel. Overall 10
It includes a body consisting of a single T-shaped circular body indicated by . Body 10 is formed from a single piece of biologically compatible material, such as titanium. It is highly advantageous that the body 10 is of unitary construction, eliminating unnecessary cavities at non-unitary assembly points. At least the outer surface of the body 10 can be coated with a continuous layer of pyrolytic carbon to enhance biological compatibility. This is because the surfaces that come into contact with the blood in the tube through which the blood passes are particularly important. Pyrolytic carbon coatings have been found to be biologically compatible materials and have been used in implantable structures. See, eg, US Pat. No. 3,783,868. Alternatively, the body 10 may be made of uncoated titanium or other rigid material. As shown in FIG.
A coating 13 is formed on the inner surface and lines the inside of the tube. It has been found desirable to have a sleeve of graphite serving as a substrate for the pyrolytic carbon to coat the interior of the tube.

1 and 7, a flexible tube 14 is provided to facilitate connection of the body 10 to a blood vessel. This tube 14 is an expanded polytetrafluoroethylene tube and is joined by sliding it over the end of the straight tube section 12.
terephthalate) and other body-compatible polymeric materials. Expanded polytetrafluoroethylene slipped over the end of the straight tube section 12 may be provided as an intermediary to connect the blood vessel to the body 10. A Teflon shrink band 57 helps keep the sleeve in place. Polytetrafluoroethylene, suitably expanded, is commercially available under the trademark Gore-Tex by Doubleu L. Gore, Inc., Newark, Delaware. tube 1
4 is optional and may not be used.

That is, the uncoated main body 10 shown in FIG. 12 can be placed directly into a blood vessel. In such a case,
The blood vessel is divided lengthwise at a distance sufficient to insert the body 10, and the blood vessel is drawn around the body 10 and sutured in place. A collar member 29 is used around a portion of the needle shaft to assist in extending tissue inwardly into the needle shaft portion, as described below.

As best seen in FIGS. 3 and 7, the body 10 extends radially inwardly from the base of the needle shaft portion 11 and has an opening 1 communicating with the cavity of the straight tube portion 12.
6, 17 forming an internal extension 15. The extension portion 15 substantially extends through the hollow portion of the needle shaft portion 11.
It is separated from the cavity of straight tube section 12 except for openings 16 and 17. The internal extension portion 15 is connected to the partition wall member 18.
It becomes a support member that supports the bottom of the. The member 18 is made of an elastomer such as natural rubber, and has a wide oval shape as shown in FIGS. 2, 4, 5, and 6. The purpose of this shape is best understood with reference to FIG.

In FIG. 2, a top view of the needle shaft portion 11 is shown. As seen in this, the needle stem part 1
1 has a generally round opening. The inner shape of the opening along the axis of the straight tube portion 12 matches the cross-sectional shape of the partition member 18, and serves for indexing purposes.

As shown in FIGS. 2, 4, 5, and 6, the partition member 18 is pre-cut into a three-pointed star shape or a three-pointed shape, and a slit 20 is formed therethrough. Although not essential, it is preferred that the holes 21 also extend completely through the partition member 18. These cuts facilitate passage of the needle through septum member 18. The outer surface of the septum member 18 has a countersunk portion 36 for accommodating the needle. Slit 20 is positioned so that it is centered with openings 16 and 17 when member 18 is indexed and inserted into the cavity of needle shaft portion 11. As a preferred alternative, the needle aperture in septum member 18 is formed during septum member fabrication. Compression will occur to seal the hole 21 when the septum member is pressed into position (see also Figures 11 and 12).

What presses down the partition member 18 is a pressure plate 22 made of titanium or the like, which forms an opening 23, which is spaced apart so as to fit into the slit 20 and the openings 16 and 17 at that position. The pressure plate 22 is locked together with the partition member 18 by a C-shaped spring retaining ring 24 inserted from above. At this time, the retaining ring 24 presses the inner circumferential surface of the partition member 18 radially outward due to spring pressure.

The cap member 26 is fitted over the shoulder flanged edge 27 of the needle shaft portion 11, as shown in FIG. 8, and is held sealingly against the shoulder by a retaining ring 28. The lower expanded edge 70 of the cap member 26 will be spaced slightly above the user's skin 25 during use. Compressing the edge 70 to the skin is undesirable as it may cause necrosis. Overall, the exposed exterior of the body 10 is contoured such that there is no risk of catching objects such as clothing. The cap member 26 also
A preservative such as Betadine (iodine polyvinyl pyrrolidone complex) is placed in cavity 30 to provide a means to keep the device sterile between uses.

The cap member 26 is made of a flexible material and has a flat cap surface and an inner protrusion extending downward from the edge of the cap surface and surrounding the needle shaft portion 11.
A groove may be formed on its inner surface to engage and seal with the flanged edge 27 of the needle shaft portion 11. The inner protrusion is formed in the center of the cap member 26 so that the cap member 26 can be aligned with the needle shaft portion 11.

The above assembly is implanted in a patient by known surgical techniques which do not form part of this invention. skin 2
It is desirable that the amount of the needle shaft portion protruding upwardly from the cap member 5 be the minimum amount that can seal the cap member. Implantation can be done in a variety of ways and styles, including anastomosis to the canal 14,
That is, the method includes, but is not limited to, a method of connecting blood vessel ends to both ends of the main body 10. The body 10 may be placed within a blood vessel that has been longitudinally divided a sufficient distance to allow its insertion. In the latter case, the blood vessels are sutured around the assembly to form a seal;
Tube 14 is not used.

To encourage tissue growth in the needle shaft portion 11 beneath the skin 25, a collar member 29 of a foamed plastic material such as polyethylene terephthalate sold by EI Dupont under the trademark Dacron may be used. . The needle shaft portion 11 above the dermal area is uncoated to reduce the risk of infection by bacteria descending along the collar member 29. If the outer surface of the needle stem part 11 is titanium, this titanium has a pear-shaped surface in the area of the collar 29, so that the collar 29 can be dispensed with.

When accessing the blood system, cap 26 is removed. Internal cavity area exposed thereby 3
0 can be cleaned with a suitable disinfectant and, after removing the disinfectant, a needle is inserted through the slit 20, opening 23 and opening 16. Preferably, the disinfectant fills and is retained within cavity 30 during use of the device. This sterilizing solution is applied to cap member 2.
The solution can also be injected through the cap, either by placing it into the cavity 30 before closing it at 6, or by subcutaneous injection. The needles 42, 43 used to penetrate the septum have openings 45, 46 in their sides and preferably have closed, rounded points. A blood sample can be drawn or a substance such as a drug can be inserted through this needle as desired.

The devices described above can be implanted in a patient and remain essentially permanent. However, if the septum member 18 needs to be replaced after long-term use, it can be easily replaced without the need for surgery. A modified forceps 31 has a tip 32 sized to be machined or polished into a hole (or recess) 33 in the retaining ring 24. This ring, together with the pressure plate 22 and the septum member 18, is withdrawn from the needle shaft so that it can be cleaned and/or replaced. Of course, measures must be taken to contain the body's blood pressure and prevent significant blood flow through openings 16 and 17 during assembly or disassembly.

In order to tightly seal the septum member 18 with the inner wall of the needle shaft portion 11, a side wall 35 of the septum member is attached as shown.
It is desirable to have a concave shape. A second purpose of such shaping is to provide for material displacement of septum member 18 resulting from introduction of the needle through the septum.

Although the body 10 can be used with conventional hypodermic injection assemblies, it is preferable to utilize the needle assembly 40 shown in FIG. Even when a simple needle is on a standard syringe, it is preferable for the needle to have a rounded tip as described below. The needle assembly 40 includes the needle stem portion 11
It includes an outer cylinder part 41 formed of a metal cylindrical block that is fitted into the outer cylinder part, and two hollow needle members 42 and 43 are attached to the outer cylinder part 41 for drawing out blood or injecting medicine. It penetrates in a sealed state against. These needle members are connected to the pressure plate 2
It is indexed and arranged by the opening 23 of No. 2. As best seen in FIG. 7, the needle has a rounded closed end 44 with side openings 45, 46, respectively. As shown, the needle is solid (not hollow) below the lower edges of openings 45 and 46. This structure is extremely advantageous. This rounded closed end passes easily through the septum member 18, resulting in less tendency to cut and fracture the septum material over conventional hypodermic needle use. The solid bottom end does not trap air. The needle openings can also be arranged so that when blood flow is in the direction indicated by arrow 47, needle opening 45 is oriented to withdraw blood and opening 46 is oriented to return blood. The top of the needle is coupled to any suitable structure for connection to an external blood flow tube or other type of device.

9 and 10, a needle assembly 50 of the type used with body 10 is illustrated. In this type, a plastic or metal block 51 is provided and is sized to fit into the cavity of the needle shaft portion 11 in a manner similar to that shown in FIG. However, in this case block 51 includes an eccentric through hole 52 which is used as described below. Hollow needle members 53 and 54 pass through block 51 and are associated with some type of tube, syringe, etc. (not shown).
This needle member is of substantially the same form as that described with respect to FIG. At plate 55 there is provided a sheath assembly having two sleeve members 56 and 57, which are of hollow form for sliding over hollow needle members 53 and 54, respectively. Part 5
6 and 57 are welded or otherwise attached to plate 55. In the uncompressed state, the sheath assembly is held in the position shown in FIG. 9 by spring member 58. In this position openings 59 and 60 are covered by sleeve members 56 and 57, as best seen in FIG. As shown in FIGS. 9 and 10, the sleeve member has a rounded shoulder 61 at its lower edge to facilitate passage through the aperture in the septum member 18. The length of sleeve members 56 and 57 is such that the needle does not act as a cutting edge to cut the septum member as it passes through the septum. Once the sleeve passes through the septum member 18 by attaching this sheath assembly to the top of the needle shaft portion 11, the resistance of the pressure plate 22 and retaining ring 24 forces the spring member 58 flat as shown in FIG. Members 56 and 57 no longer cover openings 59 and 60.

As can be seen with reference to Figures 11 and 12, the implanted portion of the device is substantially the same as that previously described with respect to Figures 1-7;
They differ in the absence of a pyrolytic film and other differences described below. The difference lies in the use of a pressure plate 62 having an eccentric locating pin 63 projecting upwardly therefrom, which pin 63 has an eccentric through hole in the needle assembly as shown in FIGS. 9 and 10. 52
are arranged to work together. This locating pin serves two functions. The first is the ability to properly align the needle member with the holes in the pressure plate and septum when using a needle assembly, and the second is when an implantable device is used and cannot be inserted into a blood vessel. The pin 63 serves as another attachment means for attaching the cap 64 (see FIG. 13) to the exposed portion of the needle stem portion 11. As best seen in FIG. 13, the cap member is slid over the edge of the body 10 into sealing engagement therewith. In this case, the retaining ring 28 does not completely surround the cap and needle shaft portion, but the built-in retaining ring 65 aids in gripping the locating pin 63 so that the cap is held tightly to the needle shaft portion 11. As described in connection with FIG. 8, the cavity between the pressure plate 22 and the top of the needle shaft portion 11 is normally filled again with a sterilizing solution so that the device is then actually placed into the blood stream and used. do.

As seen in FIGS. 11 and 12, septum member 18 is shown having precast holes 21 as described above. The partition member 18 is the needle stem portion 1
1, the hole 21 readily opens to accept the needle, but is closed by the inherent resiliency of the septum member 18.

Preferred Embodiment Referring again to the accompanying drawings, FIG. 14 shows a blood access device similar to that shown in FIG.
and a T-shaped tubular body 10 having a T-shaped tubular body 10. Body 10 is formed from a single piece of biologically compatible material such as titanium. At least the outer surface of the body 10 is coated with a continuous layer of pyrolytic carbon to enhance biocompatibility. A tetrafluoroethylene tube 14 is shown expanded and connected to the end of tube section 12.

As clearly shown in Figures 17 and 21,
The body 10 defines an internal extension 115 which substantially separates the interior of the needle shaft portion 11 from the cavity of the straight tube portion 12, except for the opening 116. The extension 115 is the improved elastomeric bulkhead member 1
18 through which a needle or needle pair can enter and exit the blood stream. The member 118 has a wide oval shape. As shown in FIG. 16, the needle stem portion 11 has a round cavity.
However, a straight tube section 119 is provided and the needle stem cavity is provided at the end 120 of the septum member 118 for indexing purposes.
It is designed to have an internal shape that fits the overall shape.

As previously mentioned, a pressure plate 22 of titanium or other substantially biologically compatible material defining the aperture 23 overlies the septum member. In its position, the opening 23 fits into the slit 121 in the septum and the opening 116 in the T-shaped needle stem. Further, the pressure plate 22 is engaged and locked with the partition member 118 by the spring retaining ring 24.

Preferred Septum It is desirable for septum member 118 to have a configuration that maximizes the number of needle penetrations without leakage through the needle passageway. Whereas the previously described septum configuration, which includes a pre-cut three-way star-shaped needle hole and a concave septum edge, provides more reasonable performance with a natural rubber septum, a silicon-based elastomer septum has a lower number of needle penetrations. It has a typical form that causes leakage in less than 10 times. However, silicon elastomers have been found to be preferable to natural rubber for the septum of this invention, since natural rubber is a betadine (iodine polyvinyl pyrrolidine complex) preservative used to sterilize the cavity above the septum. This is because they deteriorate when exposed to chemicals.

The improved septum morphology of this invention substantially improves the life of the septum (as measured by the average number of penetrations before leakage), particularly when silicon-based elastomers are used.

A major problem in maintaining diaphragm life arises from wear and tear of the material on the sides of the diaphragm opening due to coring, tearing, and abrasion. Needles with rounded tips and side holes substantially limit coring problems. However, there remains some possibility of removing septum material as the needle is inserted or withdrawn along the side of the needle passage. This design is
When the needle is inserted through the septum, the additional room for material displacement greatly alleviates the above problem. If the needle is inserted by allowing room for septum material displacement, the septum will be less compressed and, as a result, there will be less tendency for the septum material to be forced into the needle opening as the needle passes through the septum.

Preferred embodiments of the barrier rib configuration are shown in FIGS. 18-20. The previously cut needle openings form two slits 121 that cut through the septum and extend from near the center of the septum to its edge. The distance between the ends 119 is approximately
For a 1.16 cm septum, the unexcised central portion 130 is approximately
It is only 0.1cm wide.

The partition member 118 has a groove 13 along its peripheral wall.
2 is formed in the elastomer ring 1, which groove 132 preferably has an elliptical or circular cross section.
It carries 34. Ring 134, which has an inner circumference smaller than the inner circumference of septum member 118, holds the split septum members 118 together and forces the split surfaces together by applying a radially inward force on the septum members 118. Helps keep it sealed. The oval or circular shape of the ring leaves a gap in the groove into which the septum material enters when inserting the needle.

The septum member 118 also includes an elongated central recess 136 at the bottom and a pair of hemispherical recesses 138 aligned with the holes 23 of the pressure plate 22 at the top when assembled within the blood access device needle stem portion 11 . preferable.

Functionally, the septum member 118 of the form shown in FIGS. 18-20 operates in two ways. When a needle is not inserted into septum member 118, septum member 118 operates in a compressive manner to co-operate with extension 115 and pressure plate 22 to tightly seal the blood vessel. The elastomeric ring 134 is radially compressed and the slit 1
The opening of the partition member 118 formed by 21 is sealed.
One or more needles are inserted into the slit 1 of the septum member 118.
When inserted through 21 , outwardly expanding septum material is received in the space of groove 132 and downwardly expanding septum material is received in recess 136 . The radial force exerted by the elastomeric ring 134 seals the needle or needles between the blood flow and the cavity of the needle shaft portion 11, thus actuating the septum member 118 in a shearing manner. Because the septum member 118 operates in both compression and shear modes, the service life of elastomeric materials, such as preferred silicon-based elastomers, is greatly extended.

The material displacement characteristic of the new partition wall member 118 is the 21st
As shown in the figure. Comparing FIG. 21, in which needle member 162 is inserted through septum member 118, and FIG. 17, which shows septum member 118 in a relaxed state, groove 1
It can be seen that the gap within 32 is substantially filled with displacement diaphragm material and the bottom recess is partially filled. It will also be seen that when the needle member 162 is inserted, the septum material separates along the slit so that the needle is inserted into the side opening as shown in FIG.
When 78 and slit 121 are aligned, the tendency for the septum material to push inwardly into opening 178 and thereby be scraped away is reduced.

While the preferred embodiment of the septum member of this invention has a pair of slits extending in opposite directions all the way through the septum member, other slit configurations have circumferential sides carrying an elastomeric compression ring therein. If grooves are employed, they may be employed without departing from the essence of the embodiments of the present invention. It is particularly contemplated that alternative embodiments could employ oppositely oriented slits that do not extend all the way to the periphery of the septum member, or a single central slit that likewise does not extend all the way to the periphery of the septum member.

As is also clear, the needle stem portion 11 of the main body 10
After inserting the septum member into the slit 121, the slit 121 initially resists penetration by the needle member. Therefore, when the septum member is first inserted into the body, it is preferably inserted through the closure shown in FIG. 15. This obturator is a body 23 that can be inserted into the cavity of the needle shaft portion 11.
0, a pair of blind needles 232 that have rounded bottoms and do not have any holes extending downward from the main body 230 and have the same spacing as the needle receiver structure described later, and a finger rest 234 that allows this device to be easily attached to and detached from the septum member. has. After one or two insertions of the obturator, the septum member gradually reduces the resistance to insertion of the needle member, so that a needle member with side holes reduces the possibility of cutting or coring the slit surface. Can be inserted repeatedly.

Preferred Cap Construction A preferred cap member 140, shown in FIGS. 14 and 22, fits over the flanged edge 142 of the needle shaft of the blood access device. This cap member 140 seals the edge 142 and eliminates the need for a retaining ring. To this end, the cap member 140 is made of a flexible material and provided with a groove 144 on its inner surface, the diameter of which is slightly smaller than the outer diameter of the flanged edge 142 with which the cap surface engages. It is necessary that the cap member 140 be made of a flexible material and fit over the slightly larger flanged edge 142. The preferred cap also has a downwardly projecting central portion 147 that fits into the cavity of the needle shaft portion 11 for centering purposes.

The outwardly projecting surface 146 flares downwardly in a conical shape and, in use, a downwardly extending edge 149 is spaced slightly above the user's skin layer 150 to avoid dislocation due to pressure on the skin. To reduce the pressure exerted by cap member 140 should cap member 140 happen to come into contact with the skin, cap member 140 is
The outwardly protruding surface 146 has a number of slits 140a.
, the slit 140a is provided with an outwardly projecting surface 14
Increase the flexibility of 6. This slit 140a also enhances air circulation below the cap member 140, thereby helping to prevent the spread of infectious diseases on the skin around the needle shaft portion 111 of the body 10.

Preferred Needle Assemblies Preferred needle assemblies are shown in FIGS. 15, 21, and 23. The needle receiver 152 as a needle assembly includes a parallel right-angle tube connector 154 .
has an improved structure, and the needle member 1 can be pressed with the thumb.
The tube 155 can be easily inserted into the device, and the tube 155 can be easily inserted into the device from various directions as in the case of the needle receiver structure described above.
Eliminates the hassle of installing. Maintaining the tube pair parallel, closely spaced and perpendicular to the needle receptacle 152 reduces the risk of tangling and resulting damage during insertion and removal into the blood stream.

However, it is preferable to space the needle members 162 closer together than to space the pair of tubes 155 apart. This is because the farther apart the needle members 162 are, the larger the body 10 will be. Thus, the preferred needle receiver 152 includes an inwardly directed passageway that provides a narrower spacing between the needles than the spacing between the pair of tubes 155.

Needle receiver 152 is most conveniently fabricated as a multi-piece construction. The basic element of the needle receiver 152 is the lower hole 1
60 , the body member 158 having a hole 160 .
A needle member 162 is attached by adhesive or other method. Circular flange 164 provides a mounting surface for a clip, not shown, which clamps the needle assembly to flanged edge 142 on needle shaft portion 11. A male fitting 168 extends above the flange 164. A female opening on the hollow right angle tube connector 154 engages a male fitting 168. The center of the needle member 162 is more than the center of the tube connector 154 and the male fitting 168.
The close spacing is achieved by providing a mounting portion 168 with a non-concentric tapered hole 170 as a relay passageway, as clearly shown in FIG. This inner diameter is the needle member 1
62 and a further spaced tube connector 154 for blood flow.

The needle member 16 is inserted into the slit 121 of the septum member 118.
2, the main body member 158
can be provided with a projection (not shown), which adapts to the internal shape of the cavity of the needle shaft portion 11 shown in FIG.

The needle member 162 of the needle assembly preferably has two or more small side holes 178, one over the other, rather than a single large hole. The entire cross section of this hole 178 must be larger than the inner diameter of the needle member 162. This structure is based on the inner wall surface of the slit 121 of the partition member 118 and the hole 17.
Contact with the periphery of 8 is minimized while maintaining flow.

If needle member 162 is not made of a self-lubricating material, needle member 162 should be provided with a surface lubricant, such as a silicone fluid or oil, to reduce wear as needle member 162 passes through septum member 118.

Other Cooperative Structural Bulkhead Assembly Loading Tools The bulkhead loading tool is a production device that allows for rapid, one-step insertion of the septum member, pressure plate, and retaining ring into the needle stem portion of the body 10. This production device reduces the problem of patient blood loss during septum member replacement because each part does not have to be installed separately.
The loading tool of this invention is a simple device that holds all three sealing elements. These elements are quickly and simultaneously inserted into the needle shaft by inserting the tool into the needle shaft and depressing the plunger with the thumb. The simplicity of the device allows a disposable loading tool containing the retaining ring, pressure plate and bulkhead member to be pre-assembled and packaged at the factory under sterile conditions.

The bulkhead assembly and loading tool is shown in FIGS. 24-27. The basic elements of this tool include a sleeve member 180 that is fitted into the hollow portion of the needle shaft, a plunger member 181 that is inside the sleeve member 180 and extends upward from the sleeve member 180, and a slit hole in the septum member that projects downward from the bottom of the plunger member. It is generally composed of twin pins 182 that serve as partition wall holding pins that pass through. In order to make it easier to manufacture,
Member 180 is made from two separate members 183 and 184. Similarly, plunger member 181 is comprised of two parts: a lower member 185 and an upper member 18.
It is made from 6.

The member 184 has a needle shaft insertion portion 187 as an outer cylindrical portion that matches the inner diameter of the needle shaft portion, and an upper flange portion having a larger diameter than that, and the diameter of the needle shaft insertion portion is as shown in FIG. It is slightly smaller than the diameter of the cavity of the needle shaft portion of the blood inlet/out device main body above the ring retaining ridge portion 188 provided on the inner circumferential surface of the shaft portion, but larger than the diameter of the retaining ridge portion 188 . Accordingly, when a loading tool is inserted into the needle stem portion, the lower surface 189 of the member 180 is attached to the ring retaining ridge 1
Sit on the top of 88.

At the bottom of the sleeve member 180 is a retaining ring 24.
A recess 190 is provided for accommodating the ring by contracting the diameter of the recess 190 , the inner diameter of which is slightly smaller than the diameter of the retaining ridge 188 . When loaded, the retracted retaining ring 24
is retained within member 180 by recess 190.
In this preferred embodiment, the inner portion of member 180 is provided with a shoulder 191 on which retaining ring 2 is attached.
The upper outer part of 4 is seated.

The cross section of the peripheral lower surface 192 of the plunger member 181 is such that when the plunger member 181 is pressed down, the retaining ring 2
It has a width sufficient to engage with at least a portion of the upper side of 4. This engagement is shown in FIG.

Bulkhead retaining pins 182 extend downwardly from the bottom of plunger member 181 to carry pressure plate 22 and septum member 118 and hold them properly aligned for insertion. As shown in FIG. 27, when the plunger member 181 is lowered, the bulkhead member, pressure plate and retaining ring are forced downwardly until the retaining ring fits into the retaining ring groove 196 below the ridge 188. For this purpose, as shown in FIG. 28, it is necessary to compress the partition member 118 to some extent.

Plunger member 181 is held in the retracted position by a rod 198 that passes through a hole 199 in the plunger above the top surface of member 180. stick 1
98 engages the top surface of member 180 and acts as a stop for plunger member 181. When the rod 198 is pulled out, the plunger member 181 can be pushed down.

Needle stem tightening forceps Figures 28 to 31 show the needle stem tightening forceps 200.
, the forceps 200 are implanted blood inlet/output device 1
This is the production equipment used to assemble 0.
The main body of this tightening pin 200 is a standard pin clamp having opposing arms 201 and 202 that open and close around a fulcrum. However, each clamping portion of the arm tip is specifically adapted to engage a flanged edge 142 of the body 10. This is arm 20
Semi-circular clamp parts 2 at the ends of 1 and 202, respectively.
03 and 204 are provided, and these clamp parts 203, 2
04 is sized to fit into the outer diameter of the needle stem portion 11. The inner surface of the clamp portion is provided with central grooves 205 and 206, as shown in FIG. 29, for positive engagement with the flanged edge 142 of the needle shaft portion 11.

The end portion of the forceps 200 configured as a clamping portion also includes opposing finger rests 208;
The finger rest part 208 protrudes upward from the side of the clamp part and has an outwardly curved inverted U shape. As shown in FIG. 32, these ear-like finger pads are designed to be placed against the pads of the fingers, and when the plunger of the bulkhead loading tool is pressed down, the needle is pressed against the downward pressing force applied to the device 10. It is used to hold the trunk section 11. The needle stem clamp 200 is also used to hold the blood access device in place during subcutaneous injections in surgery.

In a preferred form of the forceps of the present invention, the arms 201 and 202 have an S-shape that is crushed so as to rise from the vicinity of the clamp portion to the fulcrum portion of the arm toward the side where the finger rest is located, as shown in FIGS. 30 and 32. It is curved to. This shape allows
Since the clamp part is held in close contact with the skin of the person to be implanted, it can be operated more easily.

Backup Bulkhead Method Although the bulkhead member of the present invention has particularly good sealing properties even after repeated penetrations, it has a variable service life.
In some cases, it is conceivable that leakage may begin before the partition member is replaced. Accordingly, another cooperating structure for the implantable device of the present invention is a clamp for use with a second septum member as a back-up septum member placed in the cavity between the septum retaining ring and the top of the main needle shaft portion. be. The clamp holds the back-up septum member in place and deforms the back-up septum member such that the septum member seals around the inner surface of the needle shaft portion, thereby replacing the leaking first septum member. Seal this device until The backup septum member may also have a needle hole therethrough to permit continuous passage of the needle into and out of the blood stream.

The backup bulkhead clamp shown in Figures 33 and 34 has three major parts. Needle stem part 11
Semicircular clamp members 210 and 211 having internal grooves 212 and 213, respectively, sized to engage the flanged edges 142 of the screws 214 are held together by screws 214.

A spacer member 238, shown in detail in FIGS. 35 and 36, is placed within the cavity of the needle shaft portion 11 and has a peripheral ring 240 and a central recessed portion 242. Spacer member 238 defines two holes 244 through which the needle pair passes. The member 238 is seated above the retaining ring 24, and the outer ring 240 has a continuous circumferential surface;
The lower edge of the backup bulkhead member 218 is pressed against it.

A circular elastomeric septum member 218 is placed within the cavity of the needle shaft portion 11 above the spacer member 238. This partition member is the clamp cap member 220.
It is held in that position by Cap member 22
0 has a central hole 221 and a downward circular protrusion 222 that fits into the opening of the needle stem portion 11. Cap member 220 is held in position by screws 223, which are inserted into holes 2 in cap member 220.
holes 226 and 22 in members 211 and 210 through 25;
7 respectively. As the screw 223 is tightened downward, the protruding portion 222 tightens against the partition wall member 218.
compresses and expands outward. The outward expansion of the septum member 218 is caused by the inner surface of the cavity of the needle shaft portion 11 and the spacer 23.
8 with a septum member to occlude the needle shaft portion until the leaking first septum member is replaced.

When the partition member 218 is provided with a hole or slit that is pre-drilled to align with the center of the hole 23 of the pressure plate 22 and the hole 244 of the spacer member 238,
Continuous access to the circulation system is provided while the backup bulkhead member is in that position. In such a case, the recessed portion 242 of the spacer member 238 allows the septum member 218 to function in the form of a floating septum. This allows the septum member to flex as the needle member is inserted and removed, thus facilitating the insertion and removal of the needle or needles from the blood inlet/output device and the friction of the back-up septum member due to the passage of the needle member. or reduce wear. Although the configuration of the spacer member 238 including the central recessed portion 242 is superior to a single ring having the configuration of the outer ring 240, it
42 substantially fills the void between the pressure plate 22 and the backup bulkhead member 218 while leaving some space in the bulkhead member 218 and deflecting the bulkhead member downwardly, thereby causing the first bulkhead member to This is because it reduces the amount of blood that collects that leaks through the tube.

Alternative Backup Septum Methods As an alternative to the backup septum clamps described above, a second septum member, as backup septum member 260, may be installed within the needle stem cavity of the device 10 by means of a compression ring 262 and a retaining ring 266, as shown in FIGS. 37 and 38. Retained. For this purpose, the upper part of the cavity of the needle shaft part 11 is provided with a groove 264 in which a retaining ring similar to ring 24 but slightly larger is held. The backup bulkhead system of this alternative embodiment also employs a spacer member 238 shown in FIGS. 35 and 36.

Compression ring 262 generally conforms to the shape of the T-shaped cavity such that when retaining ring 266 is in position, compression ring 262 applies sufficient pressure to septum member 260 to cause the septum member to seal the cavity opening. It has a thickness of

By providing passage openings, such as slits 270, in the septum member 260, continuous access to and from the circulation system is achieved.

The septum member 260 may or may not have side grooves carrying elastomeric rings similar to the structure of the preferred septum member 118.

Subcutaneous Infusion Cap Implantation of a blood access device involves cutting a first opening into the body through the skin, connecting the device to the circulatory system, and drilling a tunnel under the skin to a second opening through the skin. pulling the device through the tunnel with suture material wrapped around it;
Preferably, this is done in such a way that the needle shaft portion 11 is pulled up through the second skin opening. In order to accomplish this without filling the cavity of the needle shaft with tissue or blood, the body 10 preferably includes a hemispherical cap 250 shown in FIG. 39 and shown in phantom in FIG. is used to cover the needle shaft portion 11 during implantation.

Cap 250 is a generally hemispherical member with a downward protrusion 252 that fits into a cavity in needle shaft portion 11.
Cap 250 also has a tab 254 at its top defining an opening 256 through which suture material 258 wrapped around body 10 can be threaded. By wrapping the suture material as shown in FIG. 39, the surgeon can pull the body 10 into position at the second skin opening, as described in the previous section.

[Brief explanation of the drawing]

FIG. 1 is an exploded perspective view of a device according to the invention including an implantable portion, a cooperating member of two needles, and a deformable forceps used to assemble and disassemble an implantable septum assembly. FIG. 2 is a top plan view of the implantable T-shaped assembly. 3 is a side view, partially in section, taken along line 3--3 of FIG. 2; FIG. FIG. 4 is a plan view of the partition wall member. FIG. 5 is a cross-sectional view taken along line 5--5 in FIG. FIG. 6 is a plan view of the bottom or inner surface side of the partition member. 7th
1 is a cross-sectional view of a device according to the invention having a cooperating needle assembly operatively engaged with an implantable portion; FIG. 8th
The figure is a partially sectional side view of the T-shaped implantable structure and cover assembly. FIG. 9 is a front view of the needle member and sheath assembly showing the sheath covering the opening of the needle member and being pulled out to expose the opening; FIG. Figure 10 shows the same pod,
FIG. 3 is a front view of the needle and sheath assembly, with the sheath exposing the opening of the needle. FIG. 11 is a top plan view of an assembly including a pressure plate with a centering dowel. FIG. 12 does not include coating with pyrolytic carbon. FIG. 12 is a side cutaway view of the assembly of FIG. 11; FIG. 13 is a partially cutaway side view of the modified sealing cap. 14 is an exploded perspective view of a T-shaped device similar to the device of FIG. 1 and including the preferred septum cap member and needle receiver of the present invention; FIG. FIG. 15 is a perspective view of a closure used with the partition member of the present invention.
FIG. 16 is a top plan view of an implantable T-assembly including a preferred septum member therein; FIG. FIG. 17 shows the subcutaneous infusion cap in dash-dotted lines, and line 1 in FIG.
7-17 is a partially sectional side view taken along line 7-17. 1st
FIG. 8 is a plan view of the top side of the preferred partition member. FIG. 19 is a cross-sectional view taken along line 19--19 of FIG. 18. 20th
The figure is a plan view of the bottom inner surface of a preferred partition member. 21st
FIG. 2 is a cross-sectional view of an implantable blood access device having a preferred needle assembly operatively engaged with a preferred septum member. Second
Figure 2 is a partially sectional side view of the implanted blood inlet/output device and alternative cap structure. FIG. 23 is a side view, partially in section, of a preferred needle assembly of the present disclosure. FIG. 24 is a perspective view of the bulkhead loading tool of the present invention. Figure 25 is the 24th
FIG. 3 is a cross-sectional view of the bulkhead loading tool taken along line 25-25 of the figure. Figures 26A, 26B, 26C and 26D are lines 26A-26A, 26B- of Figure 25, respectively.
26B, 26C-26C and 26D-26D are cross-sectional views of the pointed loading tool. Figure 27 is the second
FIG. 6 is a view of the septum loading tool of FIG. 5 with the tool inserted into the needle shaft portion of the blood inlet/out device and the plunger being pushed down; FIG. 28 is a top plan view of the forceps clamp of this invention. FIG. 29 is a cross-sectional view of the end of the forceps provided with a clamp portion that engages the upper flange of the blood access device needle shaft.
FIG. 30 is a side view of the end of the forceps. FIG. 31 is a view of the forceps taken along line 31-31 of FIG. 30.
FIG. 32 is a perspective view of the forceps held in use. FIG. 33 is an exploded perspective view of the back-up septum system of the present invention having an implantable blood inlet/output device shown in chain double-dashed lines. FIG. 34 is a side view, partially in section, of a back-up septum member, spacer, and clamp that operate in engagement with the T-shaped blood inlet/output device of the present invention. FIG. 35 is a top plan view of a spacer member for the backup bulkhead system. Figure 36 is line 3 in Figure 35.
FIG. 6 is an elevational cross-sectional view of the spacer member taken along line 6-36.
FIG. 37 is a top plan view of the implantable T-shaped assembly as in FIG. 16, but with an alternate backup bulkhead member held in position above the main bulkhead member by a retaining ring; FIG. 38 is a side view, partially in section, taken along line 38--38 of FIG. 37.
FIG. 39 is a perspective view of the blood access device of the present invention showing a subcutaneous infusion cap on the device and a suture wrapped around the device and implanted into the body. DESCRIPTION OF SYMBOLS 10... Main body, 11... Needle trunk part, 12... Straight pipe part, 13... Coating, 14... Extension polytetrafluoroethylene pipe, 57... Sleeve member, 29... Collar member, 16, 17... Opening, 15... Internal extension part , 18
...Partition member, 34...Sleeve member, 22...Pressure plate, 20...Slit, 26...Cap member, 28
... Retaining ring, 70... Lower expanding edge, 30... Cavity, 31... Forceps, 42, 43... Hollow needle member, 5
3, 54... Needle member, 58... Spring member, 63... Pin, 64... Cap, 65... Retaining ring, 118
... partition member, 121 ... slit, 134 ... elastomer ring, 230 ... obturator main body, 140 ... cap member, 181 ... plunger member, 201,
202...Arm, 238...Spacer member, 240
...Outer ring, 218...Backup bulkhead, 22
0... Cap member, 258... Sewing thread material, 254...
tab.

Claims (1)

[Scope of Claims] 1. A main body that is formed of a biologically compatible material and constitutes a T-shaped tube including a connecting tube portion that can be connected to a blood vessel and a hollow needle trunk portion that communicates with the connecting tube portion. a removable elastomer partition member having an outer shape that matches the inner shape of the needle tube portion and press-fitted into the hollow portion of the needle shaft portion to partition the hollow portion of the connecting tube portion from the outside thereof; and the connecting tube portion. a support member forming an opening communicating with the hollow portion of the needle shaft portion and extending radially inward from the base of the needle shaft portion to support the bottom of the septum member; a removable retaining ring that presses the partition member on the support member and is held on the inner circumferential surface of the needle shaft portion by spring pressure; and an outer cylinder portion that is fitted into the needle shaft portion. a hollow needle member, the needle part of which hangs down from the bottom of the assembly and is pierced through the partition member to communicate with the cavity of the connecting tube part and form an inlet/outlet passage for blood, etc.; A blood inlet/out device implantable into the body, characterized in that the partition member has a slit formed therethrough, and the pressure plate is provided with an opening that matches the position of the slit. 2. The device of claim 1, wherein a biologically compatible material surrounds at least a lower portion of the needle shaft portion. 3. The device of claim 2, wherein said material is polyethylene terephthalate. 4. A flexible tube according to claim 1 or 2, comprising a flexible tube having one end joined to both ends of the connecting tube portion and the other end being connectable to a blood vessel. Device. 5. The device of claim 4, wherein the flexible tube is expanded polytetrafluoroethylene. 6. At least the surface of the main body that comes into contact with blood,
5. A device according to claim 1, characterized in that it has a coating of pyrolytic carbon. 7. The inner surface of the connecting tube portion is lined with Kurofune's tubular sleeve member, and the pyrolytic carbon coating covers the surface of the main body and the tubular sleeve that are in the tissue and come into contact with blood during use. An apparatus according to claim 1. 8. The device of claim 1, wherein the body is made of titanium. 9. The device according to claim 1, wherein the opening of the slit formed in the partition member is aligned with the opening of the support member. 10. The needle shaft of claim 1, wherein the needle shaft has a shoulder at its outer upper edge and a sealing cap member for removably sealing the open end of the needle shaft. Device. 11 the cap member comprises a unitary piece of flexible material, the unitary unit comprising a flat cap surface and an inner protrusion extending downwardly from an edge of the cap surface and surrounding the needle stem portion; Claims further comprising a downwardly expanding edge extending conically downward and outwardly a certain distance from the edge of the cap surface so as not to contact the surface of the skin. Apparatus according to clause 10. 12. said cap member has a central protrusion projecting to the back side of the cap surface, said central protrusion having a diameter smaller than the diameter of a cavity within said needle stem portion, such that said cap member is connected to said needle stem portion; Claim 1, which is adapted to be aligned
The device according to item 1. 13. Claim 1, wherein the interior of the needle shaft portion has at least a non-circular portion and has an adapted shape that allows the slit position of the partition member to be determined in a predetermined direction. equipment. 14. Claim 14, wherein the septum member has a concave edge portion to facilitate sealing of the inner wall of the needle shaft portion and to provide for expansion of the septum member when the needle displaces the material of the septum member. The device according to item 1. 15. The needle portion of the hollow needle member disposed in the needle assembly has a lower end portion with a rounded tip, and an opening communicating into the inside of the needle in the lower portion of the needle portion. Device. 16. The device of claim 15, wherein the needle is solid below the side opening. 17 wherein the pressure plate has two openings, the needle assembly includes two hollow needle members, the pressure plate has a locating pin extending upwardly therefrom, and the pin is oriented by the body portion of the needle assembly. 2. The device according to claim 1, wherein the needle portion cooperates with a defined opening to align the center of the opening of the pressure plate. 18 The needle assembly includes a sheath assembly fitted into a needle portion protruding from the bottom, and the sheath assembly is connected to the top surface of the sheath assembly by a plate member that supports a spring member interposed between the needle assembly and the bottom of the needle assembly. 2. The device according to claim 1, wherein the device comprises a pair of sleeve members that are shaped like a needle, and an opening of the needle portion is exposed when the spring member is pressed. 19 The elastomeric septum member is a first septum member, and a second septum member as a back-up septum member is provided above the retaining ring on the septum member, and the second septum member is disposed within the cavity of the needle shaft portion. having attachment means for bringing the material into close contact with the inner surface of the cavity, the means including a circular spacer member disposed within the needle shaft portion and below the second septum member;
The spacer member includes a peripheral ring and a central recessed portion, the central recessed portion defining at least one through hole, and further defining an internal shape of the cavity of the needle shaft portion above the second septum member. 2. A compression ring according to claim 1, further comprising a compression ring having a contour adapted to the compression ring and a further removable retaining ring for locking the compression ring in contact with the second bulkhead member. Device. 20, wherein the needle stem portion has a flange at an upper edge thereof, and the attachment means of the second septum member includes a pair of semicircular clamp members having internal grooves that engage the flanges; and a cap member having a circular protrusion at its central lower portion for pressing against a second septum member which is attached and fitted into a cavity in the upper part of the retaining ring in the needle stem part. Device. 21. The device of claim 1, wherein the circular protruding portion of the cap member is provided with a central hole. 22 The second partition member is adapted to press its lower edge against a circular spacer member provided on the upper surface of the retaining ring, and the spacer member includes an outer ring and a central recessed portion, and the central recessed portion is hollow. 20. The device of claim 19, further comprising at least one hole into which the needle portion of the needle member is inserted. 23. Claims in which the cap member is a hemispherical body that enables subcutaneous injection, has a protrusion at the bottom of the body that fits into the cavity of the needle shaft, and has a tab at the top of the body for passing a suture through. 10th
Apparatus described in section. 24 Made of biologically compatible materials;
and a main body forming a T-shaped tube including a connecting tube portion connectable to a blood vessel and a hollow needle stem portion communicating with the connecting tube portion; a removable elastomer partition member that is press-fitted into the hollow portion of the needle shaft portion and partitions the hollow portion of the connecting tube portion from the outside; a support member extending radially inward from the base and supporting the bottom of the septum member; and a pressure plate in contact with an upper surface of the septum member to press the septum member on the support member to press the septum member on the inner periphery of the needle shaft portion. A needle assembly having a removable retaining ring held by spring pressure on a surface, and an outer cylinder part fitted into the needle stem part, the needle part hanging down from the bottom of the assembly and the septum member. a hollow needle member that is pierced through the hollow portion of the connecting tube portion and forms an inlet/outlet passage for blood, etc.; In the body, a slit is formed and an annular groove is formed along the peripheral wall of the partition member, and an elastomer ring member having an inner diameter smaller than the groove diameter is fitted into the groove. Implantable blood access device. 25. The apparatus of claim 24, wherein said septum member has at its bottom an elongated central recess extending at least halfway through said slit. 26. The device of claim 25, wherein said septum member has at least one hemispherical recess in its top portion aligned with said slit defining the point of insertion of said hollow needle member. 27. The device of claim 24, wherein the elastomer ring is adapted to have an elliptical cross section. 28. The apparatus of claim 24, wherein the elastomeric ring is adapted to have a circular cross section. 29. The apparatus of claim 24, wherein said septum member is oval shaped. 30. The device of claim 24, wherein said partition member is made of a silicone-based elastomer. 31 the partition member has two slits extending in opposite directions from near the center to the edge thereof and penetrating the partition member; and an elongated central recess extending halfway along the slits between the slits at the bottom of the partition member; A pair of hemispherical recesses each centered on each of the slits at the top thereof, the top recess defining an insertion point for a pair of needles, and the elastomer ring having an elliptical cross section. Apparatus according to clause 24. 32 Made of biologically compatible materials;
and a main body forming a T-shaped tube including a connecting tube portion connectable to a blood vessel and a hollow needle stem portion communicating with the connecting tube portion; a removable elastomer partition member that is press-fitted into the hollow portion of the needle shaft portion and partitions the hollow portion of the connecting tube portion from the outside; a support member extending radially inward from the base and supporting the bottom of the septum member; and a pressure plate in contact with an upper surface of the septum member to press the septum member on the support member to press the septum member on the inner periphery of the needle shaft portion. A needle assembly having a removable retaining ring held by spring pressure on a surface, and an outer cylinder part fitted into the needle stem part, the needle part hanging down from the bottom of the assembly and the septum member. a hollow needle member that is pierced through the hollow portion of the connecting tube portion and forms an inlet/outlet passage for blood, etc., the hollow needle member being able to be inserted into and removed from the hollow portion of the needle shaft portion. A plurality of needles are attached to a three-dimensional structure, each of which has an upper end inside the needle assembly, and a plurality of tubular connectors are attached to the needle assembly for connection with external devices related to blood inflow and outflow. A relay passageway is formed that communicates each of the plurality of tubular connectors with each of the plurality of hollow needle members, and the relay passageway is arranged so that the distance between the adjacent hollow needle members is smaller than the distance between the adjacent tubular connectors. 1. A blood inlet/out device implantable into the body, characterized in that the device is oriented such that the distance between the two is narrower. 33. The apparatus of claim 32, wherein the tubular connector extends from the needle assembly substantially perpendicular to the hollow needle member. 34. The device of claim 32, wherein the relay passageway is formed by a non-concentric tapered hole that expands toward the tubular connector. 35. The device of claim 32, wherein the hollow needle member is provided with a surface lubricant. 36. Each of said hollow needle members has a rounded sealed lower end and a number of holes passing through the lower side, one above the other, said holes forming a pre-cut slit in said septum member. 33. The device of claim 32, wherein the hollow needle member is centered to enter the septum member along an axis. 37 non-concentric, wherein the tubular connector extends from the needle assembly substantially perpendicular to the hollow needle member, the hollow needle member includes a surface lubricant, and the intermediate passageway of the needle assembly diverges toward the tubular connector; 37. The device of claim 36, wherein the device is formed by a tapered hole.