US20060015089A1

Movatterモバイル変換

Info

Publication number: US20060015089A1
Application number: US11/230,048
Authority: US
Inventors: Matthew Meglin; Allen Meglin
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-04-04
Filing date: 2005-09-19
Publication date: 2006-01-19
Also published as: US20030191452A1; US7048729B2

Abstract

A catheter comprises a catheter body having a wall defining a lumen therein and having plural holes defined through the wall in a pattern which prevents loculation, migration and blockage of a fluid flow through the lumen, the catheter body having a tissue-puncture resistant shape; and a port having a reservoir capable of multiple needle accesses. The catheter is useful for draining fluids from a patient's body cavity, for example the peritoneal cavity.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application claiming the benefit under 35 U.S.C. §§ 120 and 121 of U.S. application Ser. No. 10/172,160 filed on Jun. 14, 2002, which claims domestic priority under 35 U.S.C. § 119(e) to provisional Patent Application No. 60/370,558 filed Apr. 4, 2002, all of which are hereby incorporated by reference.

BACKGROUND

The present invention relates to devices that permit repeated access to the peritoneal or thoracic cavities. More particularly, the invention relates to a peritoneal and thoracic cavity port catheter.

Certain medical conditions (e.g., ovarian cancer) are treated by infusing a body cavity with a fluid medical preparation through a catheter with one or more infusion holes at a distal end thereof and with an access port or other such device at a proximal end thereof.

In the case of ovarian cancer, the radioactive isotope P₃₂is administered in a fluid medium infused into the peritoneal cavity, in which the patient's ovaries are located. When ovarian cancer metastasizes or spreads from the ovaries, the cancer cells simply fall off of the ovaries and spread around the peritoneal cavity, but generally do not enter the blood stream. Therefore, a therapy, which floods the peritoneal cavity with P₃₂, is effective, without unnecessarily exposing the patient to radioactivity in undesired areas. However, ovarian cancer cells, having somewhat defective cell membranes, leak fluids, called ascites, into the peritoneal cavity. Treatment of ovarian cancer includes removal of this fluid. The procedure for doing so typically uses the same catheter through which the infusion is performed, and takes about four hours, requiring hospitalization, and is performed about once a week.

Because conventional infusion catheters are optimized for infusion, they can only be used to remove fluids from the peritoneal cavity very slowly, resulting in the long, periodic hospitalization for ovarian cancer patients.

There are similar needs under some circumstances to have access to the thoracic cavity or other body cavities, and current devices for obtaining such are similarly limited.

SUMMARY OF THE INVENTION

In accordance with aspects of an embodiment of the invention, there may be provided a catheter, comprising a catheter body having a wall defining a lumen therein and having plural holes defined through the wall in a pattern which prevents loculation, migration and blockage of a fluid flow through the lumen, the catheter body having a tissue-puncture resistant shape; and a port having a reservoir capable of multiple needle accesses.

BRIEF DESCRIPTION OF THE DRAWINGS

In the figures, in which like reference designations indicate like elements:

FIG. 1 is a top view of a catheter and port embodying aspects of the invention;

FIG. 2 is a cross sectional detail view of the catheter ofFIG. 1, taken along line1-1;

FIG. 3 is a perspective view of the catheter ofFIG. 1;

FIG. 4 is a top view of an alternate port configuration embodying aspects of the invention;

FIG. 5 is a top view of an alternate catheter configuration embodying aspects of the invention;

FIG. 6 is a top view of yet another alternate catheter configuration embodying aspects of the invention;

FIG. 7 is a top view of an alternate catheter and port configuration embodying aspects of the invention;

FIG. 8 is an end view of the catheter ofFIG. 7;

FIG. 9 is a top view of the catheter ofFIGS. 7-8, extended by a pusher rod shown in phantom;

FIG. 10 shows a cross section of a patient's peritoneal cavity, into whose wall another configuration of port and catheter has been implanted;

FIG. 11 is a side view of the distal end of the catheter body ofFIG. 10;

FIG. 12 is an end view of the catheter body ofFIG. 10;

FIG. 13 is a perspective view of the port and catheter connection of the embodiment ofFIG. 10;

FIG. 14 is a cross-sectional side view of a removable core access needle used in various embodiments;

FIG. 15 is a side view of a catheterless plug;

FIGS. 16, 17 and18 are side, top and front views, respectively, of an alternate port design;

FIG. 19 is a side view of a combined catheter shape;

FIGS. 20 and 21 are end and side views, respectively, of an alternate combined catheter shape; and

FIGS. 22 and 23 are side and top views, respectively, of a port design having a right-angle outlet.

DETAILED DESCRIPTION OF EMBODIMENTS

In accordance with some embodiments of the present invention, a method and apparatus is provided for removal of fluids from a patient's body, for example draining fluids from a body cavity between multiple drug infusion operations (e.g., during the entire duration of treatment).

Embodiments of aspects of the invention may include a catheter or a catheterless plug having a catheter body and an access port, and a method of extracting fluid from a body cavity. As explained more fully below, the catheterless plug has a body resembling a catheter body, but which can comprise a fully integrated unit. References below to the catheter body apply to the body of the catheterless plug, as well, except where differences are explicitly mentioned.

The catheter body should preferably have a shape that is unlikely to undesirably puncture or injure tissue or organs encountered in or about the body cavity to be drained. The shape of the catheter body, together with the placement of one or more fluid extraction holes in a wall of the catheter body should preferably be such as to avoid the formation of pockets (referred to by those skilled in this art as loculation) and/or to avoid creating a fluid flow that would cause migration of the catheter body, or of tissue or debris, that could block the extraction holes. For example, the extraction holes can be positioned in a protected region of the catheter body, as described below.

The catheter port should preferably be implantable subcutaneously, and/or capable of sufficient extraction needle passages to complete a course of treatment without replacement.

The invention is now illustrated in further detail with reference to some embodiments thereof. In the following description the illustrative example of extracting fluid from the peritoneal cavity is used. However, it should be understood that the invention may be employed in connection with treatments requiring the extraction of fluid from the thoracic cavity or another body cavity.

One aspect of the invention is illustrated in connection with acatheter10 including a catheter body100 (FIGS. 1-3) having a lumen (FIG. 2, 200) that may be closed off at thedistal end101, i.e., having no end hole. This embodiment includesplural holes102 covering a combined surface area suitable for withdrawing fluid, substantially without clogging. Thus, when thecatheter10 is used to extract fluid from the peritoneal cavity, there is no large suction through a dominant single point which could attract occluding masses to migrate to the dominant single point or could attract the catheter itself to migrate into a position where a dominant single point is occluded. Optionally, in another embodiment, an end hole can be provided at thedistal end101 ofcatheter body100, together with one or moreother holes102, provided neither ahole102 nor the optional end hole contributes such a surface area, and consequently large fluid flow, as to induce loculation or migration of thecatheter body100.

In order to provide more room forholes102, thecatheter body100 of this embodiment is quite long. One danger inherent in implanting acatheter10 in many body cavities is the risk of perforating or puncturing an organ, membrane, or other tissue unintentionally. The risk is especially large when along catheter body100 is implanted into a closed cavity such as the peritoneal cavity, with the expectation that the catheter will bunch up like spaghetti.

In the embodiment ofFIGS. 1-3, thecatheter body100 is a self-coiling type to facilitate insertion of such a relatively long catheter into the body. This may be achieved by means known to the skilled practitioner such as molding thecatheter body100 in a desired coil configuration, molding thecatheter body100 on a coiled strength member such as a wire, etc. The coil may be flat, a straight-sided helix, a conical helix, etc.

The embodiment ofFIGS. 1-3 employs a flat coil pigtail configuration, although other coil configurations, as well as configurations that avoid perforation or puncture using other shapes, as explained below, are possible.

As stated above, theholes102 should be positioned to avoid contact with adjacent tissues or occluding masses. Theholes102 of this embodiment are positioned on theinner curve107 of the coil so as to avoid contact between theholes102 and adjacent tissues. Theouter curve108 and thesides109 can be devoid of holes. Thus, theholes102 are in a protected region of the catheter body. As used herein, “inner curve” refers to that part of the surface of a coil-shapedcatheter body100 facing a central axis of the coil of thecatheter body100. Also as used herein, “outer curve” is that part of the surface of the coil-shapedcatheter body100 facing away from a central axis of the coil of thecatheter body100. Finally as used herein, “sides” are surfaces of the coil-shapedcatheter body100 adjacent to both theinner curve107 andouter curve108 and joining them.

As mentioned, other shapes can also avoid puncturing adjacent tissues, organs and membranes, while distributingholes102 to prevent loculation, migration or occlusion. As shown inFIG. 5, an alternate embodiment of acatheter500 has acatheter body501 with a shape such as a simple helix or corkscrew, that avoids punctures.Holes102 are disposed on theinner curve502 of thecatheter body501 to avoid contact between theholes102 and adjacent tissues. Again, theholes102 are located in a protected region of the catheter body. Thiscatheter500 and thecatheter10 ofFIGS. 1-3 can optionally include an end hole (not shown) at thedistal end503 provided the area of the end hole is properly balanced against the areas of theholes102.

Another catheter body shape possessing desirable characteristics of avoiding punctures, loculation, migration and occlusion is shown inFIG. 6. In this example,catheter body600 has a T-bar shape. Theterminuses601 may be closed or may optionally include end holes (not shown) at theterminuses601.

Yet another suitable catheter body shape is shown inFIGS. 7-9. Thiscatheter body700 has what is referred to as a “tulip” shape. The surfaces of the tulip “petals”701 can be opened intoholes702. Thecenter703 of the tulip may be aclosed end nipple704, which captures apusher rod705 by which thecatheter body700 is advanced during implantation. When thepusher rod705 is extended, the end of thecatheter body700 stretches, collapsing thetulip petals701 as shown inFIG. 9. When thepusher rod705 is withdrawn, after implantation, thetulip petals701 expand as shown inFIGS. 7 and 8. This configuration can be shorter then those ofFIGS. 1-3 and5-6 because the shape ofpetals701

permits holes

702 to have a large surface area compared toholes102.

Another suitable arrangement for the catheter body that prevents blockage, puncture or loculation is shown inFIGS. 10-12. This embodiment has ashort body1001 terminating in one or more fluid extraction holes1002. Thefluid extraction holes1002 are surrounded by aspherical cage1003 that prevents organs, e.g. thebowels1004, or debris from blocking the extraction holes1002. Thecage1003 may have other shapes, but aspherical cage1003 presents no sharp edges or steps that are likely to cause problems during implantation or removal. Because thecage1003 surrounds thefluid extraction holes1002, theextraction holes1002 are in a protected region of the catheter body.

Thespherical cage1003 of this embodiment can be formed of plastic, metal, or any other suitable material. If formed of plastic, thecage1003 can be molded integrally with thebody1001 of the catheter, in the expanded spherical shape shown inFIGS. 10-12. If formed of metal, thecage1003 can be preformed, also in the expanded spherical shape shown inFIGS. 10-12. The metal can be Nitinol or another so-called “memory metal” which can be alternately stowed or deployed, for example by alternate application of room ambient temperature and of the patient's own body heat. A metalspherical cage1003 would also be formed integrally with and molded into the plastic ofcatheter body1001. In an alternative method of stowing and deploying the device, as in the case of the tulip design described above in connection withFIGS. 7-9, the spherical shape can be collapsed by a pusher rod engaging anend tab1005 during insertion and extraction. The pusher rod is withdrawn completely from the catheter body while the catheter is in situ in a patient's body.

The catheter body (FIG. 1, 100;FIG. 5, 501;FIG. 6, 600,FIG. 7, 700,FIG. 10, 1001) may be constructed of any suitable materials, using any suitable methods.

Holes

102,702, where applicable, may be molded into the catheter or formed by any other suitable technique, e.g., laser drilling, which can produce holes suitable for rapid fluid extraction. The size, shape and location of the holes should be selected to be suitable for fluid extraction, as explained above. However, infusion can also be performed through the holes. Without limitation, suitable materials include plastics and elastomers such as silicone, polyurethane and polyethylene and the like.

Ports usable in connection with the catheter bodies described above are now described.

In the embodiment ofFIG. 1, theproximal end103 of thecatheter body100 terminates at and is connected for fluid communication to a subcutaneouslyimplantable port104. The port has a membrane (referred to as a septum)105 for percutaneous access to theport104 by a suitably sized extraction needle, e.g., a 14-gauge needle. In one embodiment, theseptum105 is durable enough to permit at least 50 or more non-coring, self-healing passages by a 14 gauge or larger needle. In other embodiments, theseptum105 can withstand at least 100 or more, and preferably 200 or more passages.

Theport104 is constructed of any suitable materials, using any suitable methods. In one embodiment, the side walls and back wall of theport104 may be formed of titanium, but other metals or plastics such as acetal homopolymers that are bioinert can be used, for example. The top surface is theseptum105, which may be formed of silicone or other elastomer or plastic. In embodiments capable of withstanding200 passages by a 14-gauge needle, theseptum105 of silicone has a surface area of about 1-6 cm²and be about 2-4 mm thick. Typically, but without limitation thereto, theseptum105 may have dimensions of about 1-2 cm by 1-3 cm.

The walls andseptum105 of theport104 define a reservoir within that has a low, wide profile to minimize the volume of fluid held in the reservoir, and to maximize the comfort to the patient in whom theport104 is implanted. The port may, without limitation thereto, have overall dimensions of 2 cm by 4 cm by 1 cm. Such aport104 can be implanted in a large pocket formed on the patient's abdominal wall or in another location that avoids interference with patient mobility. Thecatheter body100 andport104 may include any suitable connector feature for connecting one to the other. For example, a conventional hub connection (not shown) can be used.

FIG. 4 shows an alternate embodiment of the invention directed to a multi-septum configuration. This multi-septum configuration is useable in combination with any of the catheter body configurations disclosed herein, and any other catheter body configurations. In the embodiment ofFIG. 4, theport401 at theproximal end103 of thecatheter100 has twochambers402, each have aseptum403, allowing two needles to be placed for more rapid drainage. Thechambers402 may be interconnected404, and may be connected to asingle catheter100 through asingle hub405.

In the alternative embodiment shown inFIG. 13, theport1301 has a ribbedoutlet1302 to which thecatheter body1303 is attached. Aribbed outlet1302 such as shown can be used instead of a conventional hub, such as mentioned above. In this embodiment, theport outlet1302 is disposed opposite theseptum1304, an arrangement also thought to be advantageous in some cases.

Use of aribbed outlet1302 simplifies the construction and assembly of the catheter and port. Theproximal end1305 of thecatheter body1303 is simply slipped over theribbed outlet1302, and is held in place by friction between thecatheter body1303 and theribbed outlet1302.

Placing theribbed outlet1302 opposite theseptum1304 is advantageous at least in that the impedance of the structure to fluid flow is reduced relative to placing the outlet to the side of the port, as in the embodiments ofFIG. 1-7. Moreover, implantation can be simplified using this arrangement because the entire assembly is inserted straight into the cavity to be drained, rather than at an angle or along a convoluted path. Yet another advantage of this arrangement is that the catheter is less likely to kink than in a configuration where the catheter body has to transition from a position parallel to the abdominal wall to one perpendicular to the abdominal wall.

In another alternative embodiment, shown inFIGS. 22 and 23, exhibiting advantages similar to those of the embodiment ofFIG. 13, a right-angle outlet2201 is employed.Port2200 is substantially similar in construction and arrangement to port104 ofFIG. 1. However,outlet2201 makes a right-angle bend towards the direction of implantation of a catheter body (not shown), so that kinks or bends are not introduced into the catheter body.Outlet2201 may terminate in a conventional hub (not shown) or ribbed section (not shown) to grip the catheter body.

The port may also include other useful features. For example, the port may includesuture loops1306 by which the port can be secured to tissue in the patient's body. The port may have funnel shape to further reduce the impedance of the assembly to fluid flow during extraction.

As identified above, the port (FIG. 1, 104) can be accessed through thesystem105 by a conventional access needle, for example a 14-gauge needle. Alternatively, a removablecore access needle1400, such as shown inFIG. 14, can be used. Such a needle may include a large bore, e.g., 14 gauge,hollow point1401. Thepoint1401 may be made of metal, perforated on the sides thereof1402, and have abeveled entry edge1403 to prevent occlusion while in use. Thepoint1401 is affixed to a right-angle end1404 of a suitable type oftubing1405 that resists collapse under suction. In order to control access through such a needle, and to prevent coring of the septum (FIG. 1, 105) during insertion, the removablecore access needle1400 has aremovable stylete1406 that resides within the hollow of thepoint1401 when not accessing the port, and that is withdrawn when accessing the port.Stylete1406 removal is facilitated by providing a diaphragm orseptum1407, through which thestylete1406 passes and may be inserted or withdrawn.

It has been found that no cuff, as is often conventionally provided, is necessary. However, if desired, abacteriostatic cuff106 may provided near theproximal end103 of thecatheter body100, so as to prevent inward migration of an infection. Thecuff106 promotes fibrous tissue ingrowth. Bacteriostatic cuffs of polyester impregnated with bacteriostatic compounds are suitable.

Leaking around the catheter can be prevented by use of a tissue collagen injection at one or more sites around the implanted system. Tissue collagen acts as a kind of biocompatible glue between thecatheter body100 andport104, and the surrounding tissues.

In yet another embodiment, a fully integrated, catheterlessfluid extraction plug1500 is shown inFIG. 15. This embodiment combines several features described above in connection with other embodiments, as now described.

The exemplarycatheterless drainage plug1500 has an expandedport section1501 and anelongated body section1502. Any suitable port section shape can be used in combination with any suitable body section shape, including those shown in the other exemplary embodiments.

The catheterless plug embodiment is advantageous because of its simplicity. Without joints and rough edges that may be found in other designs, there are fewer locations to harbor potentially infectious matter or irritate the implantation site in the patient. The device is also less expensive and easier to manufacture than designs using multiple components and joints.

The devices described herein are all implanted using suitable techniques, including techniques known in the art. One such technique is now described.

First an incision is made in the patient's skin above the location where the device is to be implanted. The incision exposes a small area of the underlying cavity wall. A hollow needle is inserted through the cavity wall until a “fluid flash” is seen, that is an outflow of fluid from within the body cavity. The fluid flash indicates that the needle has been inserted into the desired location. Next, a guide wire is inserted through the needle to provide a defined path for the remainder of the devices employed. The needle is then withdrawn over the guide wire. A sheath and dilator are next inserted, over the guide wire. The dilator enlarges the hole through the cavity wall sufficiently to allow a catheter to be inserted. After the dilator has enlarged the hole, it is removed. The catheter is then slid over the wire and sheath and through the enlarged hole. Finally the sheath, and optionally the wire, is withdrawn, leaving the catheter in place.

Various modifications to the port could now be evident to the skilled artisan. For example, the bottom of the port could be curved to follow the curve of the patient's abdomen, for patient comfort. Alternatively, the port could be “almond-”shaped to leave room for two extraction needles. Preferably, the port shape accommodates a septum large enough to permit rotation of the skin/septum puncture site, so as to avoid skin breakdown as a result of repeated needle punctures. See, for example,FIGS. 16-18. The almond shape would allow room for deep needles, for example needles including side holes. Hollow needles with side holes would permit higher extraction flow rates than hollow needles having only an end hole. Theeyelets1306 may be filled with a membrane or not, as desired.

According to yet other variations, the shapes and features described above, and others, can be combined, as for example as shown inFIGS. 19-21.FIG. 19 shows ahelix1901 combined with apigtail1902.FIGS. 20 and 21 show ahelix2001 combined with astraight section2002. In each case, the geometry is such that it allows straightening followed by self-coiling or bunching, for implantation.

The present invention has now been described in connection with a number of specific embodiments thereof. However, numerous modifications, which are contemplated as falling within the scope of the present invention, should now be apparent to those skilled in the art. Therefore, it is intended that the scope of the present invention be limited only by the scope of the claims appended hereto.

Claims

1. A catheter for removing fluid from a body cavity, comprising:

a catheter body extendible substantially within the body cavity having a wall defining a lumen therein and having at least one hole defined in the catheter body in a location that is within the body cavity when implanted, and which in combination with a shape of the catheter body prevents loculation, migration and blockage of a fluid flow through the lumen when the fluid flow is induced in a direction defined as running from a distal end to a proximal end thereof, the catheter body having a tissue-puncture resistant shape; and

a port having on a first surface a septum capable of multiple needle accesses, and having on a second surface an outlet in communication with the catheter body and arranged so the catheter body extends substantially without bends in a direction perpendicular to the first surface, into the body cavity.

2. The catheter ofclaim 1, wherein the plural holes are located in a protected region of the catheter body.

3. The catheter ofclaim 2, having a pigtail coil shape.

4. The catheter ofclaim 3, wherein the plural holes are located in a protected region defined by an inner curve of the pigtail coil.

5. The catheter ofclaim 2, having a helix coil shape.

6. The catheter ofclaim 5, wherein the plural holes are located in a protected region defined by an inner curve of the helix coil.

7. The catheter ofclaim 2, having a T-bar shape.

8. The catheter ofclaim 7, wherein the plural holes are located in a protected region defined adjacent an angle between a stem and a crossbar of the T-bar.

9. The catheter ofclaim 1, having a tulip shape.

10. The catheter ofclaim 9, wherein the plural holes are located on a broad surface of a petal of the tulip.

11. The catheter ofclaim 10, the tulip collapsible when advanced by a pusher rod.

12. The catheter ofclaim 1, further comprising:

another port coupled to the first port and to the body of the catheter for fluid communication therewith.

13. The catheter ofclaim 1, further comprising:

a cage surrounding at least part of the catheter body including the plural holes.

14. The catheter ofclaim 13, wherein the cage is integral with the catheter body.

15. The catheter ofclaim 13, wherein the cage is memory metal.