US20060084940A1 - Implantable medical connector for medical tubing with anchoring features - Google Patents

Abstract

A connector and method of medical tubing is disclosed. The connector defines a fluid passageway, and the connector includes a first end, a first intermediate portion, a middle portion, a second intermediate portion, and a second end. The middle portion is located between the first intermediate portion and the second intermediate portion, and the first end is adapted to fit inside a proximal connector-receiving portion, and the second end is adapted to fit inside a distal connector-receiving portion. The connector includes at least a first protrusion and a second protrusion projecting from the connector, wherein a first protrusion is located between the first end and the first intermediate portion, and the second protrusion is located between the second intermediate portion and the second end. The connector includes a first tubular strain relief having an extending first portion that extends past the first end of the connector and is adapted to fit over a proximal connection section, and a second tubular strain relief having an extending second portion that extends past the second end of the connector and is adapted to fit over a distal connection section. When the first end of the connector is inserted into a proximal connector-receiving portion a first interlock fit is formed therebetween, and when the second end of the connector is inserted into the distal connector-receiving portion a second interlock fit is formed therebetween, resulting in a fluid tight connection between the proximal connector-receiving portion and the distal connector-receiving portion, and wherein at least the middle portion of the connector is exposed. The middle portion of the connector can include a suture receiving section that can be sutured to tissue of patient.

Description

RELATED APPLICATION
• This application is a divisional of U.S. application Ser. No. 10/127,853, filed on Apr. 23, 2002, which is herein referenced in its entirety.
FIELD OF THE INVENTION
• This invention relates to medical device connectors used for connecting medical tubing. More particularly, the invention is directed to a medical connector for connecting sections of a catheter.
BACKGROUND OF THE INVENTION
• In numerous medical applications it becomes necessary to connect one section of tubing to another. In such situations it is important that the connection be secure so that it will not pull apart and that there be no leakage of fluid at the site of the connection. This is especially critical in applications where the tubing sections are implanted in the human body.
• U.S. Pat. No. 5,405,339, which is incorporated herein by reference, teaches connector for connecting sections of medical tubing and a method for using the connector. The connector has an enlarged middle portion between first and second end portions. The end portions have a smaller diameter than the enlarged middle portion and are adapted to be inserted into the ends of the medical tubing sections. The connector can be grasped at the enlarged middle portion, thus simplifying the process of inserting the end portions into the tubing sections. Additionally, the opposing edges of the enlarged middle portion act as tubing stop surfaces that provide a positive indication that the connector is properly aligned.
• While the invention described in U.S. Pat. No. 5,405,339 has solved numerous difficulties in the manufacture and use of the prior art medical devices, there is still certain areas for further improvement. For example, FIG. 3 of U.S. Pat. No. 5,405,339 teaches an addition of a circumferential suture groove in the surface of the enlarged middle portion that can only be used as a place at which the catheter may be anchored by suturing it to surrounding tissue if the connector is used without a strain relief. Col. 5, lines 37-43.
• It would be desirable to provide a connector that provides a place at which the catheter may be anchored by suturing it to surrounding tissue, while at the same time providing a strain relief. It would also be desirable to provide a connector that provides stronger connections with greater useful life, and which is simple to use.
SUMMARY OF THE INVENTION
• In accordance with the present invention there is disclosed an implantable medical device comprising a connector for connecting sections of medical tubing and a method for using the connector. The connector is shaped in a manner that solves the problems associated with prior art connectors and methods of connecting medical tubing.
• More specifically, the present invention comprises a connector for medical tubing, the connector defining a fluid passageway, the connector having a first end, a first intermediate portion, a middle portion, a second intermediate portion, and a second end. The middle portion located between the first intermediate portion and the second intermediate portion. The end is adapted to fit inside a proximal connector-receiving portion of a proximal medical tube, the second end is adapted to fit inside a distal connector-receiving portion of a distal medical tube. The connector also has a least a first protrusion and a second protrusion projecting from the connector, wherein a first protrusion is located between the first end and the first intermediate portion, and the second protrusion is located between the second intermediate portion and the second end. The connector also includes a first tubular strain relief having an extending first portion that extends past the first end of the connector and is adapted to fit over a proximal connection section of a proximal medical tube, and a second tubular strain relief having an extending second portion that extends past the second end of the connector is and adapted to fit over a distal connection section of a distal medical tube. When the first end of the connector is inserted into the proximal connector-receiving portion a first interlock fit is formed therebetween, and when the second end of the connector is inserted into the distal connector-receiving portion a second interlock fit is formed therebetween. The result is a fluid tight connection between the proximal connector-receiving portion and the distal connector-receiving portion, and wherein at least the middle portion of the connector is exposed. In one embodiment, the first intermediate portion can include a first lip, and the second intermediate portion can include a second lip. Thus, when the first tubular strain relief fits over the first lip of the first intermediate portion, a third interlock fit is formed therebetween. Further, when the second tubular strain relief fits over the second lip of the second intermediate portion, a fourth interlock fit is formed therebetween.
• In one embodiment, the middle portion further comprises a suture receiving portion. The suture receiving portion has a suitable structure that can be anchored by suturing to surrounding tissue or fascia of a patient. For example, but not by way of limitation, the suture receiving structure can have a suture receiving groove or hole. Preferably, the suture receiving portion has at least two locations to receive sutures so as to reduce rotation of the connector.
• In one embodiment, the extending first portion of the first tubular strain relief is more flexible than a remainder of the first tubular strain relief and/or the extending second portion of the second tubular strain relief is more flexible than a remainder of the second tubular strain relief.
• In one embodiment, the extending first portion of the first tubular strain relief tapers to a smaller outside diameter as it extends away from the first end of the connector and/or the extending second portion of the second tubular strain relief tapers to a smaller outside diameter as it extends away from the second end of the connector.
• In one embodiment, at least the first intermediate portion of the connector is exposed and/or at least the second intermediate portion of the connector is exposed. Thus, the first intermediate portion and/or the second intermediate portion of the connector can be used as a convenient place to anchor the catheter to the tissue or fascia of a patient.
• In one embodiment, the connector comprises a metal or metal alloy.
• In one embodiment, the first tubular strain relief fits over the proximal connection section and a proximal fit is formed therebetween.
• In one embodiment, the second tubular strain relief fits over the distal connection section and a distal fit is formed therebetween.
• In one embodiment, the middle portion comprises a suture receiving portion. The suture receiving portion has a suitable structure that can be anchored to the tissue or fascia of a patient. For example, but not by way of limitation, the suture receiving structure can have a suture receiving groove or hole. Preferably, the suture receiving portion has at least two locations to receive sutures so as to reduce rotation of the connector.
• In one embodiment, the present invention includes an implantable medical device comprising a proximal catheter having a proximal connection section, the proximal connection section having a proximal connector-receiving portion, and a distal catheter having a distal connection section, the distal connection section having a distal connector-receiving portion. The implantable medical device also has a connector between the proximal catheter and the distal catheter, the connector defining a fluid passageway, the connector having a first end, a first intermediate portion, a middle portion, a second intermediate portion, and a second end. The middle portion is located between the first intermediate portion and the second intermediate portion. The first end is adapted to fit inside the proximal connector-receiving portion, the second end is adapted to fit inside the distal connector-receiving portion. There is also at least a first protrusion and a second protrusion projecting from the connector, wherein the at least first protrusion is located between the first end and the first intermediate portion, and the second protrusion is located between the second intermediate portion and the second end. The invention further has a first tubular strain relief having an extending first portion that extends past the first end of the connector and fits over the proximal connection section, and a second tubular strain relief having an extending second portion that extends past the second end of the connector and fits over the distal connection section. Thus, when the first end of the connector is inserted into the proximal connector-receiving portion a first interlock fit is formed therebetween, and when the second end of the connector is inserted into the distal connector-receiving portion a second interlock fit is formed therebetween. The result is a fluid tight connection between the proximal catheter and the distal catheter, and wherein at least the middle portion of the connector is exposed. Since the middle portion of the connector is exposed, it can be anchored by suturing to surrounding tissue or fascia of a patient. The connector of this embodiment can have any or all combination of additional features recited in the preceding paragraphs.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a side view of a implantable medical device in accordance with the present invention.
• FIG. 2 is a side view of an alternative embodiment of the implantable medical device of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• FIG. 1 is a side view of a implantable medical device used to connect sections of medical tubing in accordance with a preferred embodiment of the present invention. More specifically, as shown inFIG. 1, an implantablemedical device10 comprises aproximal catheter12 having aproximal connection section14, theproximal connection section14 having a proximal connector-receivingportion34. Implantablemedical device10 also has adistal catheter16 having adistal connection section18, thedistal connection section18 having a distal connector-receivingportion36. Implantablemedical device10 also has aconnector20 between theproximal catheter12 and thedistal catheter16, theconnector20 defining afluid passageway22, theconnector20 having afirst end24, a firstintermediate portion26, amiddle portion28, a secondintermediate portion30, and asecond end32. Themiddle portion28 is located between the firstintermediate portion26 and the secondintermediate portion30. Thefirst end24 is adapted to fit inside the proximal connector-receivingportion34, and thesecond end32 is adapted to fit inside the distal connector-receivingportion36.
• Implantablemedical device10 has at least afirst protrusion38 and asecond protrusion40 projecting from theconnector20, wherein thefirst protrusion38 is located between thefirst end24 and the firstintermediate portion26, and thesecond protrusion40 is located between the secondintermediate portion30 and thesecond end32. Also provided is a firsttubular strain relief42 having an extendingfirst portion44 that extends past thefirst end24 of theconnector20 and fits over theproximal connection section14, and a secondtubular strain relief52 having an extendingsecond portion54 that extends past thesecond end32 of theconnector20 and fits over thedistal connection section18. Thus, when thefirst end24 of theconnector20 is inserted into the proximal connector-receiving portion34 a first interlock fit62 is formed therebetween. Also, when thesecond end32 of theconnector20 is inserted into the distal connector-receiving portion36 a second interlock fit64 is formed therebetween, resulting in a fluid tight connection between theproximal catheter12 and thedistal catheter16. As shown inFIG. 1, this construction results in at least themiddle portion28 ofconnector20 being exposed. Because themiddle portion28 is exposed, themiddle section28 provides a convenient place at which the connector can be anchored by suturing it to surrounding tissue or fascia of a patient. As further shown inFIG. 1, the firstintermediate portion26 can include afirst lip48, and the secondintermediate portion30 can include asecond lip58. Thus, when the firsttubular strain relief42 fits over thefirst lip48 of the firstintermediate portion26, a third interlock fit50 is formed therebetween. Further, when the secondtubular strain relief52 fits over thesecond lip58 of the secondintermediate portion30, a fourth interlock fit60 is formed therebetween.
• Preferably, the extendingfirst portion44 of the firsttubular strain relief42 is more flexible than a remainder of the firsttubular strain relief42, and the extendingsecond portion54 of the secondtubular strain relief52 is more flexible than a remainder of the secondtubular strain relief52. The difference in flexibility can be obtained in any suitable manner, including but not limited to a tapering of the first and second tubular stain reliefs as they extend away from theconnector20. Alternatively, different materials, or slits and/or holes defined in the first and second tubular strain reliefs can provide the desired difference in flexibility as will be recognized by those of skill in the art.
• Preferably, the extendingfirst portion44 of the firsttubular strain relief42 tapers to a smaller outside diameter as it extends away from thefirst end24 of theconnector20, and the extendingsecond portion54 of the secondtubular strain relief52 tapers to a smaller outside diameter as it extends away from thesecond end32 of theconnector20.
• In one embodiment, the firstintermediate portion26 and/or the secondintermediate portion30 have at least one portion that is exposed along with themiddle portion28. Thus,portions26,28 and/or30 can define at least twogrooves68 at which theconnector20 can be anchored by suturing it to the tissue or fascia of a patient. By providing at least two places for suturing,connector20 provides a structure that can be sutured to the tissue or fascia of a patient that will not be a susceptible to rotation as a connector that has only one place to suture it to the tissue or fascia of a patient.
• In a preferred embodiment, theconnector20 comprises a metal or metal alloy. Those of skill in the art will recognize that a metal or metal alloy can be sutured to the tissue or fascia of a patient more securely than a softer material, such as the material used for strain reliefs or for catheter tubing.
• As shown inFIG. 1, when the firsttubular strain relief42 fits over theproximal connection section14, aproximal fit46 is formed therebetween. As also shown inFIG. 1, when the secondtubular strain relief52 fits over thedistal connection section18, adistal fit56 is formed therebetween.
• As shown inFIG. 1, themiddle portion28 further comprises asuture receiving portion66. Thesuture receiving portion66 has a suitable structure that can be anchored to the tissue or fascia of a patient. For example, but not by way of limitation, thesuture receiving portion66 can define asuture receiving groove68 orhole70. Preferably, thesuture receiving portion66 has at least two locations, e.g., at least twosuture receiving grooves68 orholes70 to receive sutures so as to reduce rotation of the connector. As shown inFIG. 1, thesuture receiving portion66 defines twosuture receiving grooves68.
• An alternative embodiment is shown inFIG. 2. InFIG. 2,device100 is the same as thedevice10 shown inFIG. 1, except thatsuture receiving portion66 defines twoholes70 instead of two suture receiving grooves.
• The present invention also provides a method for connecting implantable medical tubing. More specifically, the present invention comprises the step of providing a implantable medical device10 comprising a proximal connection section14, the proximal connection section14 having a proximal connector-receiving portion34; a distal connection section18, the distal connection section18 having a distal connector-receiving portion36; a connector20 between the proximal catheter12 and the distal catheter16, the connector20 defining a fluid passageway22, the connector20 having a first end24, a first intermediate portion26, a middle portion28, a second intermediate portion30, and a second end32, the middle portion28 located between the first intermediate portion26 and the second intermediate portion30, the first end24 adapted to fit inside the proximal connector-receiving portion34, the second end32 adapted to fit inside the distal connector-receiving portion36, and at least a first protrusion38 and a second protrusion40 projecting from the connector20, wherein a first protrusion38 is located between the first end24 and the first intermediate portion26, and the second protrusion40 is located between the second intermediate portion30 and the second end32; a first tubular strain relief42 having an extending first portion44 that extends past the first end24 of the connector20 and fits over the proximal connection section14; and a second tubular strain relief52 having an extending second portion54 that extends past the second end32 of the connector20 and fits over the distal connection section18.
• A preferred method of the present invention further comprises the steps of placing theproximal connection section14 over thefirst end24 of the connector; inserting thefirst end24 of theconnector20 into the proximal connector-receivingportion34 to form a first interlock fit62 therebetween; placing thedistal connection section18 over thesecond end32 of theconnector20; inserting thesecond end32 of theconnector20 into the distal connector-receivingportion36 to form a second interlock fit64 therebetween; thereby forming a fluid tight connection between theproximal connection section14 and thedistal connection section18, and wherein at least themiddle portion28 of theconnector20 is exposed.
• A preferred method further comprises the steps of providing the firstintermediate portion26 with afirst lip48, and the secondintermediate portion30 with asecond lip58. Thus, when the firsttubular strain relief42 is placed over thefirst lip48 of the firstintermediate portion26, a third interlock fit50 is formed therebetween. Further, when the secondtubular strain relief52 is placed over thesecond lip58 of the secondintermediate portion30, a fourth interlock fit60 is formed therebetween.
• A preferred method further comprises the steps of providing at least onesuture receiving portion66 on themiddle portion28 and anchoring theconnector20 by suturing thesuture receiving portion66 to tissue of a patient. In one embodiment, the method further comprises the steps of providing at least twosuture receiving grooves68 on thesuture receiving portion66 and anchoring theconnector20 by suturing thesuture receiving grooves68 to tissue of a patient. In one embodiment, the method further comprises the steps of providing at least two suture receiving holes70 on thesuture receiving portion66 and anchoring theconnector20 by suturing thesuture receiving holes70 to tissue of a patient.
• From the foregoing detailed description of specific embodiments of the invention, it should be apparent that a medical connector and method for its use has been disclosed. Although particular embodiments of the invention have been disclosed herein in detail, this has been done for the purpose of illustration only, and is not intended to be limiting with respect to the scope of the appended claims, which follow. In particular, it is contemplated by the inventors that various substitutions, alterations and modifications may be made to the embodiments of the invention without departing from the spirit and scope of the invention as defined by the claims. Further, although the embodiments disclosed relate primarily to use of the connector for connecting catheter sections, the connector could be used for other applications where it is desirable to connect separate sections of medical tubing together, especially those situations where the tubing is to be implanted in the human body. Such applications include connecting sections of stents, penile implants and sphincter implants.

Claims (24)

1. An implantable medical connection system for medical tubing, the connection system comprising:

an implantable medical connector defining a passageway having first and second ends, the connector including

a central portion defining at least one suture-receiving groove extending annularly around an annular surface of the central portion;

first connection means for connecting an end of a first medical tube in fluid communication with the first end of the passageway; and

second connection means for connecting an end of a second medical tube in fluid communication with the second end of the passageway;

wherein the first and second connection means so connect the first and second medical tube to the implantable medical connector that the suture-receiving groove remains exposed; and

at least one suture placed in and extending along at least a portion of the suture-receiving groove whereby the implantable medical connection system may be anchored to biological tissue.

2. The implantable medical connection system ofclaim 1 wherein:

the central portion has a first end and a second end opposite the first end; and

the first and second connection means each comprise a tubular structure adapted to receive an end of medical tubing thereon, the tubular structure having at least one protrusion adapted for retention of medical tubing thereon, wherein the first connection means extends from the first end of the central portion, and the second connection means extends from the second end of the central portion.

3. The implantable medical connection system ofclaim 2 further comprising:

a first tubular strain relief extending from the first end of the central portion and having a lumen in which the first connection means is housed, the lumen of the first strain relief being adapted to receive the end of the first medical tube therein when the end of the first medical tube is connected to the first connection means; and

a second tubular strain relief extending from the second end of the central portion and having a lumen in which the second connection means is housed, the lumen of the second strain relief being adapted to receive the end of the second medical tube therein when the end of the second medical tube is connected to the second connection means.

4. The combination of the implantable medical connection system ofclaim 3 with a first medical tube having a first end connected to the first connection means and received in the first tubular strain relief and a second medical tube having a first end connected to the second connection means and received in the second tubular strain relief.

5. The combination of an implantable infusion pump with the combination ofclaim 4 wherein the first medical tube has a second end connected in fluid connected to the implantable infusion pump.

6. The implantable medical connection system ofclaim 3, wherein

the first tubular strain relief has a lip at one end that is adapted to fit over the first end of the central portion to form an interlock fit therebetween, and

the second tubular strain relief has a lip at one end that is adapted to fit over the second end of the central portion to form an interlock fit therebetween.

7. The implantable medical connector ofclaim 6, wherein the first tubular strain relief has an extending first portion at an end opposite to the end having the lip of the first tubular strain relief, the extending first portion being more flexible than a remainder of the first tubular strain relief.

8. The implantable medical connector ofclaim 6, wherein the second tubular strain relief has an extending second portion at an end opposite to the end having the lip of the second tubular strain relief, the extending second portion being more flexible than the remainder of the second tubular strain relief.

9. The implantable medical connector ofclaim 6, wherein the first tubular strain relief has an extending first portion at an end opposite to the end of having the lip of the first tubular strain relief, the extending first portion being more flexible than a remainder of the first tubular strain relief, and wherein the second tubular strain relief has an extending second portion at an end opposite the end having the lip of the second tubular strain relief, the extending second portion being more flexible than the remainder of the second tubular strain relief.

10. The implantable medical connector ofclaim 6, wherein the first tubular strain relief has an extending first portion at an end opposite to the end having the lip of the first tubular strain relief, wherein the extending first portion tapers to a smaller outside diameter as it extends in a direction away from the lip.

11. The implantable medical connector ofclaim 6, wherein the second tubular strain relief has an extending second portion at an end opposite to the end having the lip of the second tubular strain relief, wherein the extending second portion tapers to a smaller outside diameter as it extends in a direction away from the lip.

12. The implantable medical connector ofclaim 6, wherein the first tubular strain relief has an extending first portion at an end opposite to the end of having the lip of the first tubular strain relief, wherein the extending first portion tapers to a smaller outside diameter as it extends in a direction away from the lip of the first tubular strain relief, wherein the second tubular strain relief has an extending second portion at an end opposite to the end having the lip of the second tubular strain relief, wherein the extending second portion tapers to a smaller outside diameter as it extends in a direction away from the lip of the second tubular strain relief.

13. An implantable medical connection system for medical tubing, the connection system comprising:

an implantable medical connector defining a passageway having first and second ends, the connector including

a central portion having an outside surface that defines at least one suture-receiving hole;

first connection means for connecting an end of a first medical tube in fluid communication with the first end of the passageway; and

second connection means for connecting an end of a second medical tube in fluid communication with the second end of the passageway;

wherein the first and second connection means so connect the first and second medical tube to the implantable medical connector that the suture-receiving groove remains exposed; and

at least one suture placed in and extending through the suture-receiving hole whereby the implantable medical connection system may be anchored to biological tissue.

14. The implantable medical connection system ofclaim 13 wherein:

the central portion has a first end and a second end opposite the first end; and

the first and second connection means each comprise a tubular structure adapted to receive an end of medical tubing thereon, the tubular structure having at least one protrusion adapted for retention of medical tubing thereon, wherein the first connection means extends from the first end of the central portion, and the second connection means extends from the second end of the central portion.

15. The implantable medical connection system ofclaim 14 further comprising:

a first tubular strain relief extending from the first end of the central portion and having a lumen in which the first connection means is housed, the lumen of the first strain relief being adapted to receive the end of the first medical tube therein when the end of the first medical tube is connected to the first connection means; and

a second tubular strain relief extending from the second end of the central portion and having a lumen in which the second connection means is housed, the lumen of the second strain relief being adapted to receive the end of the second medical tube therein when the end of the second medical tube is connected to the second connection means.

16. The combination of the implantable medical connection system ofclaim 15 with a first medical tube having a first end connected to the first connection means and received in the first tubular strain relief and a second medical tube having a first end connected to the second connection means and received in the second tubular strain relief.

17. The combination of an implantable infusion pump with the combination ofclaim 16 wherein the first medical tube has a second end connected in fluid connected to the implantable infusion pump.

18. The implantable medical connection system ofclaim 15, wherein

the first tubular strain relief has a lip at one end that is adapted to fit over the first end of the central portion to form an interlock fit therebetween, and

the second tubular strain relief has a lip at one end that is adapted to fit over the second end of the central portion to form an interlock fit therebetween.

19. The implantable medical connector ofclaim 18, wherein the first tubular strain relief has an extending first portion at an end opposite to the end having the lip of the first tubular strain relief, the extending first portion being more flexible than a remainder of the first tubular strain relief.

20. The implantable medical connector ofclaim 18, wherein the second tubular strain relief has an extending second portion at an end opposite to the end having the lip of the second tubular strain relief, the extending second portion being more flexible than the remainder of the second tubular strain relief.

21. The implantable medical connector ofclaim 18, wherein the first tubular strain relief has an extending first portion at an end opposite to the end of having the lip of the first tubular strain relief, the extending first portion being more flexible than a remainder of the first tubular strain relief, and wherein the second tubular strain relief has an extending second portion at an end opposite the end having the lip of the second tubular strain relief, the extending second portion being more flexible than the remainder of the second tubular strain relief.

22. The implantable medical connector ofclaim 18, wherein the first tubular strain relief has an extending first portion at an end opposite to the end having the lip of the first tubular strain relief, wherein the extending first portion tapers to a smaller outside diameter as it extends in a direction away from the lip.

23. The implantable medical connector ofclaim 18, wherein the second tubular strain relief has an extending second portion at an end opposite to the end having the lip of the second tubular strain relief, wherein the extending second portion tapers to a smaller outside diameter as it extends in a direction away from the lip.

24. The implantable medical connector ofclaim 18, wherein the first tubular strain relief has an extending first portion at an end opposite to the end of having the lip of the first tubular strain relief, wherein the extending first portion tapers to a smaller outside diameter as it extends in a direction away from the lip of the first tubular strain relief, wherein the second tubular strain relief has an extending second portion at an end opposite to the end having the lip of the second tubular strain relief, wherein the extending second portion tapers to a smaller outside diameter as it extends in a direction away from the lip of the second tubular strain relief.

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