Wound drain catheter

• US 4,398,910 A
• Filed: 02/26/1981
• Issued: 08/16/1983
• Est. Priority Date: 02/26/1981
• Status: Expired due to Term

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated), Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Original Assignee: Duane R. Mason, Ervin R. Harvel, George M. Wright, Larry W. Blake
• Inventors: Blake, Larry W., Mason, Duane R., Wright, George M., Harvel, Ervin R.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US06/238,640
• Time in Patent Office: 901 Days
• Field of Search: 128/348-350 R, 128/347, 604/93, 604/266, 604/280, 604/283
• US Class Current: 604/266
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

The wound drain catheter of the present invention is comprised of a drain portion connected to an outflow tube portion. The drain portion comprises a central core with plural T-shaped members projecting therefrom to form plural lumens having respective longitudinal grooves for fluid communication with the wound. This drain has a uniform cross-sectional area and is preferably made from a silicone elastomer having a durometer shore between 40 and 70 shore A. Such uniform cross-sectional area provides added strength to prevent the drain from breaking during its removal from the patient'"'"'s body, and the silicone elastomer provides sufficient elasticity to permit the cross-sectional area of the drain to decrease by at least 30 percent when a pulling force is applied thereto, thereby reducing the gripping force of tissue surrounding the wound.

Claims

1. A wound drain catheter for draining fluid form, or supplying medication to, a closed, deep wound, comprising:

a drain comprising;

a core portion having a longitudinal axis;

plural strut portions extending outwardly from said core portion; and

plural overhang portions, connected to the outward ends of said strut portions, respectively, said overhang portions cooperating with said strut portions to form plural longitudinal lumens, said overhang portions cooperating with each other to form, on the outer surface of said drain, the segments of a segmented, closed curve, the gaps between said segments providing plural longitudinal grooves for fluid communication between the wound and a respective one of said plural lumens, said grooves sized to inhibit tissue from growing therein and debris from passing therethrough;

said drain formed of a material which, when placed in tension between the gripping wound tissue and a force used to withdraw said drain from said wound, will reduce sufficiently in cross-section to reduce said gripping force to facilitate withdrawal;

said drain having a substantially uniform cross section throughout the portion of its'"'"' length which is placed in tension during such removal to provide means for reducing stress risers and thus preventing breakage;

a flexible outflow tube having a smooth exterior for sealing to surface tissue at the point of exit from a patient'"'"'s body; and

means conforming to said segmented, closed curve, for connecting said outflow tube to said drain.

2. A wound drain catheter, as defined in claim 1, wherein said plural struts combine with respective plural overhang portions to form plural T-shaped members.

4. A wound drain catheter, as defined in claim 1, wherein said connecting means comprises a collar, and wherein the outer surfaces of said overhang portions contact the interior wall of said collar through at least 50 percent of the circumference of said collar.

5. A wound drain catheter, as defined in claim 1, wherein said drain has at least four strut portions extending from said core portion.

6. A wound drain catheter, as defined in claim 1, wherein said plural strut portions project radially from said core portion at equal angles relative to each other.

7. A wound drain catheter, as defined in claim 1, wherein said drain is uniform in cross-section throughout its length.

8. A wound drain catheter, as defined in claim 1, wherein said longitudinal grooves are parallel to said longitudinal axis.

9. A wound drain catheter, as defined in claim 1, wherein said drain is radially symmetrical.

10. A wound drain catheter, as defined in claim 9, wherein said radially symmetrical drain has corresponding portions of said drain on each of equi-angular, plural radii extending from said central axis, and said corresponding portions are equi-distant from said central axis.

11. A wound drain catheter, as defined in claim 1, wherein said drain has diametrical symmetry.

12. A wound drain catheter, as defined in claim 1, wherein said closed curve is a circle.

13. A wound drain catheter, as defined in claim 1, wherein said closed curve is an oval.

3. A wound drain catheter for draining fluid from, or supplying medication to, a closed, deep wound, comprising:

a drain, comprising;

a core portion having a longitudinal axis;

plural strut portions extending outwardly from said core portion; and

plural overhang portions, connected to the outward ends of said strut portions, respectively, said overhang portions cooperating with said strut portions to form plural longitudinal lumens, said overhang portions cooperating with each other to form, on the outer surface of said drain, the segments of a segmented, closed curve, the gaps between said segments providing plural longitudinal grooves for fluid communication between the wound and respective one of said plural lumens, said grooves sized to inhibit tissue from growing therein and debris from passing therethrough;

a flexible outflow tube having a smooth exterior for sealing to surface tissue at the point of exit from a patient'"'"'s body; and

means conforming to said segmented, closed curve, for connecting said outflow tube to said drain;

wherein said outflow tube and said drain are connected end-to-end in abutting relationship, and wherein the connected end of said drain includes a recess in said core portion, said recess providing fluid communication between said lumens and said recess to permit fluid flow between said drain and said tube.

14. A wound drain catheter for draining fluid from, or supplying medication to, a closed, deep wound, comprising:

a flexible silicone drain having plural, external, longitudinal grooves extending along a major portion of the length of said drain, said grooves forming lumens for said drain, said drain having a smooth external surface between said grooves and formed of a material which will reduce sufficiently in cross-section in response to longitudinal tension to permit said drain to contract away from wound tissue as said drain is pulled from said wound, said drain having a substantially uniform cross-section throughout the portion of the length which is placed in tension during removal to provide means for reducing stress risers and thus preventing breakage of said drain;

a flexible outflow tube in fluid communication with said grooves and having a smooth exterior for sealing to surface tissue at the point of exit from a patient'"'"'s body; and

a connector for attaching said drain to said outflow tube securely enough to permit said drain to be withdrawn from said wound by pulling on said outflow tube.

15. A wound drain catheter, as defined in claim 14, wherein said silicone drain has a durometer shore between 40 and 70 shore A.

16. A wound drain catheter, as defined in claim 14, wherein said connector comprises a tube which has a flange which abutts one end of said drain, and said drain comprises a recess for providing a fluid pathway between said drain and said outflow tube.

17. A wound drain catheter, as defined in claim 14, wherein said drain is formed of silicone which is sufficiently elastic to cause said drain to reduce in cross-sectional area by at least 30 percent in response to a tensile force of two pounds to facilitate withdrawal of the drain.

18. A wound drain catheter for draining fluid from, or supplying medication to, a closed, deep wound, comprising:

a drain, made from material having a durometer shore of from 40 to 70 Shore A, to permit said drain to shrink away from the wound during withdrawal, thereby facilitating withdrawal of the drain, comprising;

a core; and

at least three T-shaped members projecting from said core, and cooperating to form (i) at least three lumens, and (ii) at least three grooves for providing fluid communication between the wound and said lumens, said grooves sized to inhibit tissue from growing therein or debris from passing therethrough said core and T-shaped members having a uniform cross section to provide a means for reducing stress risers and thereby prohibit breakage during said withdrawal; and

a flexible outflow tube having a smooth exterior for sealing to surface tissue at a point of exit from a patient'"'"'s body, one end of said outflow tube providing means for connecting said catheter to a suction level, and the other end of said outflow tube providing means for connecting said outflow tube to said drain.

19. A drain, as defined in claim 18, wherein said plural T-shaped members are of equal size and project equi-angularly from said core.

20. A method of drawing or supplying medication to a closed, deep wound, comprising:

providing a drain having plural, external, grooves extending along a major portion of the length of said drain, said grooves forming lumens for said drain, said drain having a smooth external surface between said grooves and having a substantially uniform cross-section substantially free of stress risers, made from a silicone elastomer having a durometer shore of from 40 to 70 shore A, said drain preattached to an outflow tube which is in fluid communication with said grooves;

placing said drain and a portion of said outflow tube in said wound;

closing said wound to seal it from the atmosphere;

connecting said outflow tube to a reservoir; and

removing said drain from said wound by applying a tensile force thereto, said tensile force causing said drain to decrease in cross-sectional area to reduce the gripping force of tissue surrounding the drain, said substantially uniform cross section providing means for preventing breakage of said drain during removal.

21. A method of manufacturing a wound drain catheter for closed, deep wounds, comprising:

constructing a drain by;

selecting a material which responds to a longitudinal tension by reducing in cross-section sufficiently to contract away from wound tissue as said drain is pulled from said wound, thereby facilitating withdrawal of said drain, said drain having a substantially uniform cross-section substantially free of stress risers along the reducing portion of said drain to provide means for prohibiting breakage of said drain;

forming a central core portion and at least three T-shaped members, each projecting from said core portion, cooperating to form at least three lumens, each having a respective longitudinal groove for fluid communication with the wound, said grooves sized to inhibit tissue from growing therein and debris from passing therethrough; and

attaching said drain to a flexible outflow tube having a smooth exterior for sealing to surface tissue at the point of exit from the patient'"'"'s body in a manner which will permit withdrawal of said withdrawal of said drain from deep wounds through application of tensile force on said outflow tube.

22. A method of manufacturing a wound drain catheter, as defined in claim 21, wherein the step of constructing said drain additionally comprises:

forming a recess in the end of said drain most distal from said wound to permit fluid communication between said at least three lumens and said recess.

23. A method of manufacturing a wound drain catheter, as defined in claim 21, wherein said uniform cross-section drain is made from a material having sufficient elasticity to cause said drain to reduce in cross-sectional area by at least 30 percent when a two pound tensile force is applied thereto to reduce the gripping force of the tissue surrounding said drain during removal of said drain from the wound.

24. A method of manufacturing a wound drain catheter, as defined in claim 21, wherein said drain is made from a silicone material having a durometer shore between 40 and 70 shore A.

25. A method of manufacturing a wound drain catheter, as defined in claim 21, wherein said drain has four said T-shaped members.

26. A method of attaching a trocar to a silicone outflow tube, comprising:

coating the connector portion of said trocar with a primer which creates a bonding surface compatible with both stainless steel and silicone;

filling irregularities on the connector portion of said trocar with a silicone adhesive sealant; and

inserting said outflow tube on the connector portion of said trocar.

27. A wound drain catheter for draining fluid from, or supplying medication to, a closed, deep wound in a patient, said catheter comprising:

a drain having plural, external, longitudinal grooves extending along a major portion of the length of said drain, said grooves forming lumens for said drain, said drain having a smooth external surface between said grooves; and

an outflow tube, in fluid communication with said grooves and connected to said drain so that the direction of fluid flow in the drain and the outflow tube is the same, said outflow tube having a smooth exterior surface for sealing to surface tissue at the point of exit from the patient'"'"'s body, said drain having a uniform cross-section along its length and being formed of flexible material so that pulling the drain from the patient causes a reduction in cross-sectional area of the drain to relieve the gripping force of the patient'"'"'s tissue on the drain, said uniform cross section providing means for reducing stress risers and thereby eliminating breakage of said drain due to said pulling.

28. A wound drain catheter, as defined in claim 27, wherein said drain is formed of silicone which is sufficiently elastic to cause said drain to reduce in cross-sectional area by at least 30 percent in response to a tensile pulling force of two pounds.

29. A wound drain catheter, as defined in claim 27, wherein said drain has a durometer shore hardness between 40 and 70 shore A.

30. A wound drain catheter for draining fluid from, or supply medication to, a closed, deep wound, comprising:

a drain formed of a material which will reduce sufficiently in cross-section in response to longitudinal tension to permit said drain to contract away from wound tissue as said drain is pulled from said wound, said drain having a cross-section substantially free of stress risers along the reduced length of said drain, comprising;

a core portion having a longitudinal axis;

plural strut portions extending outwardly from said core portion; and

plural overhang portions, connected to the outward ends of said strut portions, respectively, said overhang portions cooperating with said strut portions to form plural longitudinal lumens, said overhang portions cooperating with each other to form, on the outer surface of said drain, the segments of a segmented, closed curve, the gaps between said segments providing plural longitudinal grooves for fluid communication between the wound and a respective one of said plural lumens, said grooves sized to inhibit tissue from growing therein and debris from passing therethrough;

a flexible outflow tube having a smooth exterior for sealing to surface tissue at the point of exit from a patient'"'"'s body; and

means conforming to said segmented, closed curve, for connecting said outflow tube to said drain.

31. A wound drain catheter for draining fluid from, or supplying medication to, a closed, deep wound, comprising:

a flexible silicone drain having a substantially uniform cross section and formed of material which will reduce sufficiently in cross section during removal of said drain to contract away from wound tissue, said substantially uniform cross section reducing the susceptibility of said drain to breakage, comprising;

a core; and

at least three T-shaped members projecting from said core, and cooperating to form (i) at least three lumens, and (ii) at least three grooves for providing fluid communication between the wound and said lumens, said grooves sized to inhibit tissue from growing therein or debris from passing therethrough;

said lumens cooperating to provide an effective drain even when said drain is kinked or squeezed; and

a flexible outflow tube having a smooth exterior for sealing to surface tissue at a point of exit from a patient'"'"'s body, one end of said outflow tube providing means for connecting said catheter to a suction device, and the other end of said outflow tube providing means for connecting said outflow tube to said drain.

32. A wound drain catheter for draining fluid from, or supplying medication to, a closed, deep wound, comprising:

a flexible silicone drain having plural, external, longitudinal grooves extending along a major portion of the length of said drain, said grooves forming lumens for said drain, said drain having a smooth external surface between said grooves and formed of a material which will reduce sufficiently in cross-section to reduce the gripping force exerted by wound tissue on said drain, when said drain is placed in tension by said gripping force and a force used to withdraw said drain from the wound, said drain having a substantially uniform cross section to provide means for reducing stress risers and thereby preventing breakage during withdrawal;

a flexible outflow tube in fluid communication with said grooves and having a smooth exterior for sealing to surface tissue at the point of exit from a patient'"'"'s body; and

means for attaching said drain to said outflow tube securely enough to permit said drain to be withdrawn from said wound by pulling on said outflow tube.