WO2010115102A1

WO2010115102A1 - Low profile and tension monitoring external peg bolster

Info

Publication number: WO2010115102A1
Application number: PCT/US2010/029779
Authority: WO
Inventors: David G. Quinn
Original assignee: Radius International Limited Partnership
Priority date: 2009-04-02
Filing date: 2010-04-02
Publication date: 2010-10-07

Abstract

The invention is a one-piece external bolster that has a soft silicone body that incorporates a rigid component. The device provides for a non-kinking 90 degree angle at the point of exiting the body for both a wire reinforced and non- wire reinforced PEG. The bolster is easy to apply to the PEG tube, and is easy to adjust proper tension between the internal and external bolster. It incorporates two modes of operation: a tube adjusting mode that allows easy tube movement for tension adjustment and an easy transition to a "locking" mode after adjustment has been made. It incorporates a unique methodology for constantly monitoring the tension between the internal and external bolsters that assures adequate tension for stomach wall/peritoneal wall anastomosis while at the same time monitoring ongoing tension to prevent necrosis of the stomach wall due to excessive pressure.

Description

LOW PROFILE AND TENSION MONITORING EXTERNAL PEG BOLSTER

RELATED APPLICATION

[0001] This application is a PCT (Patent Cooperation Treaty) application based on U.S. Provisional application Serial No. 61/166,072, entitled LOW PROFILE

AND TENSION MONITORING EXTERNAL PEG BOLSTER filed April 2, 2009. The application claims priority from the U.S. PROVISIONAL APPLICATION and hereby incorporates, in its entirety, the disclosure of the PROVSIONAL APPLICATION.

FIELD OF INVENTION

[0002] These inventions relate generally to medical catheters. They relate particularly to catheters used to access the stomach and /or intestine, or the bladder through a stoma or ostomy in the abdominal wall.

BACKGROUND OF THE INVENTIONS [0003] The correct positioning of tubes exiting the body has always created problems. Tubes such as PEG tubes exiting the abdominal wall from the stomach and small intestine have their own particular problems. The initial and continuing adjustment and monitoring of the tension between the internal and external bolster is key. During initial placement correct tension is key. The internal bolster must be "snugged" into contact with the stomach wall so that the stomach is pulled in contact with the abdominal wall. Correct contact allows good blood flow to both components and results in the creation of a working stoma connecting the stomach with the patient's skin, and an anastomosis of the stomach and the abdominal/ peritoneal wall. Too much tension results in necrosis of the stomach, no anastomosis and serious problems for the patient. There has been no easy methodology for adjusting, measuring or monitoring this tension until this invention. The ability to exist the patient at a right angle allows the patient to hide the tube and helps prevent kinking, and resultant stoppage of the instillation of enteral feeding. SUMMARY OF INVENTION

[0004] A primary objective of the invention is to provide a low-profile external bolster that will allow the PEG tube to be bent at a right angle to the patient's body at the point where the tube exits the body without kinking the tube at this 90- degree angle. Forms of the device allow this 90-degree bending for both bending resistant wire reinforced tubes and easily kinkable non-reinforced tubes. [0005] Another primary objective of the device is to provide two functions during the initial PEG tube placement. The first function is to allow easy adjustment of the tube so that the tube can be easily moved within the bolster to adjust its length. It is critical that the correct tension be achieved between the internal and external bolster so that the internal bolster is in contact with the stomach wall without being too loose or too tight. If the bolster is too tight, necrosis of the stomach wall will take place resulting in serious injury to the patient. If the bolster is too loose, anastomosis of the stomach and the abdominal wall may not take place. The second important function during the placement procedure is the ability to be able to "lock" the tube in the bolster to maintain the established correct tube length and resulting correct tension/pressure. The change from the looser adjusting mode and the locking mode must be accomplished easily so that the correct adjustment is not lost. [0006] Another objective is to provide a one-piece bolster to simplify the overall placement procedure. The one-piece design provides easy initial insertion of the PEG tube into the bolster without any special tools or separate parts. [0007] The bolster locking mechanism to easy to lock and unlock, but resists inadvertent unlocking. If there is a need for readjustment because of swelling or weight gain the adjustment process is easily accomplished.

[0008] Another primary, and extremely important objective accomplished by the invention is that it provides a visual means to assess correct pressure and tension between the internal bolster and the external bolster. The invention provides a tension indicator system that allows for tension assessment during the initial placement and for the duration of patient care. The indicator monitoring system is intuitive and easily assessed.

[0009] The tension monitoring system also provides a protective area around the stoma to immediately warn the clinician that tension is not correct. The bolster is not allowed to enter the stoma.

[0010] The design provides good access to the stoma area for cleaning. [0011] The tension/pressure system is part of the one-piece device and is not prone to breakage.

BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 is a side-elevational view of the external bolster invention in the form that it is molded.

[0013] FIG. 2 is a rear perspective view of the external bolster in the form that it is molded.

[0014] FIG. 3 is a bottom/side perspective view of the external bolster in the form that it is molded.

[0015] FIG. 4 is a cross sectional view of the device taken along lines 4-4 of

FIG. 1.

[0016] FIG. 5 is a bottom plan view of the device showing the bottom tube port. [0017] FIG. 6 is a top perspective view of one half of the external bolster injection mold showing both the main molding core pin and the joining pin inserted in the mold.

[0018] FIG. 7 is a top plan view of the joining pin showing the securing hole that ties the joining pin and the bottom leg together during the molding process. [0019] FIG. 8 is a cross sectional view of the joining pin taken along lines 8-8 of FIG. 7.

[0020] FIG. 9 is a side-elevational view of the external bolster as shown in

FIG. 1 with the PEG tube inserted.

[0021] FIG. 10 is a side-elevational view of the bolster with the PEG tube inserted through a cross section of the abdominal wall and the stomach. The upper - A -

leg of the bolster is upwardly extended so that the tube can be moved within the bolster to "snug up" the internal bolster against the stomach wall. [0022] The bolster has not yet been "snugged up" to the stomach wall. [0023] FIG. 1 1 is a side-elevational view of the bolster with the internal PEG bolster now "snugged up" in contact with the stomach wall. The upper leg is being pulled backwardly and stretched so that the joining pin cavity can be secured over the joining pin on the back end of the lower leg. [0024] FIG. 12 is a side-elevational view of the bolster with the PEG tube inserted in its final position and the upper leg of the bolster now secured in its final functioning position with the joining pin inserted into the joining pin cavity.

[0025] FIG. 13 is a top plan view of the bolster also showing the pressure- warning stripes at its front end directly under the pressure-warning arm. [0026] FIG. 14 is a front-elevational view of the bolster showing the pressure- warning arm. [0027] FIG. 15 is a combination side-elevational and top plan view of the main bolster body showing the relationship of the pressure-warning arm and the pressure- warning stripes. The drawing shows the external bolster and interior bolsters positioned and "snugged up" correctly. [0028] FIG. 16 is another combination side-elevational and top plan view of the main bolster body showing the relationship of the pressure-warning arm and the pressure-warning stripes. The drawing shows that the external bolster and interior bolster are too close together. The increased pressure distorts the front pressure-indicator plate and the leading pressure-warning stripe has come into contact with the tip of the pressure- warning arm, indicating the first warning of excessive pressure.

[0029] FIG. 17 is another combination side-elevational and top plan view of the main bolster body showing the relationship of the pressure-warning arm and the pressure-warning stripes. In this case the front pressure- indicator plate has been distorted to the point where the first three pressure-warning stripes are in contact with the pressure-warning arm. The external bolster has been pulled further into the stoma. [0030] FIG. 18 is another combination side-elevational and top elevational view of the main bolster body showing the relationship of the pressure- warning arm and the pressure-warning stripes. In this case the front pressure- indicator plate has been distorted to the point where all of the pressure-warning stripes are in contact with the pressure-warning arm. The external bolster has been pulled yet further into the stoma.

[0031] FIG. 19 is a side-elevational view of a second version of the bolster invention with the upper and lower legs secured together in their final position, but without the PEG tube. Externally it is identical to the version shown in FIG. 12. This version is designed to accommodate PEG tubes that do not employ wire- reinforced tubing.

[0032] FIG. 20 is a longitudinal cross sectional view of the second external bolster version taken along lines 20-20 of the FIG. 19 showing the L-shaped passage for the PEG tube. In this version the part of the passage that forms the bottom tube entry portion leading from the bottom tube port and around the "L" has a larger inside diameter than the remaining straight passage section leading to the rear tube port.

[0033] FIG. 21 is a cross sectional view of FIG. 19 along lines 21 - 21 of FIG. 19. [0034] FIG. 22 is a side elevational view of the second version showing the

PEG tube inserted, and it is externally the same as the first version shown in FIG. 12.

[0035] FIG. 23 is a longitudinal cross sectional view taken along lines 23-23 of FIG. 22 showing the L-shaped passage with the PEG tube, and with another tube surrounding the PEG tube. This second tube fills the expanded passage section described in FIG. 20. This larger tube is wire reinforced. [0036] FIG. 24 is a cross sectional view taken along lines 24-24 of FIG. 22 showing both the PEG tube and the surrounding wire reinforced tube. [0037] FIG. 25 is a side elevational view of the second version of the bolster with the PEG tube inserted through the wire reinforced over-tube with the PEG internal bolster "snugged up." The assembly is ready to be stretched and secured for use.

[0038] FIG. 26 shows the Quinn US Patent No. 5,860,960 prior art bolster secured with the correct tension between the external bolster and internal bolster. [0039] FIG. 27 shows the Quinn prior art bolster with excessive tension between the external and internal bolsters resulting in the bolster being pulled into the tissue forming the stoma.

[0040] FIG. 28 shows a common form of prior art injection molded external bolster that has a tubular section that is part of a flat circular plate that holds the tube at a 90 degree angle to the patients skin.

[0041] FIG. 29 shows a third version of the new invention that incorporates a pressure-warning disk molded over a flat circular plate as shown in FIG. 28. If excessive pressure is exerted on the bottom flat circular plate that is in contact with the skin, contact will be made with the pressure-warning disk. [0042] FIG. 30 shows a common form of a prior art external bolster formed by a section of tubing with a preformed hole that accepts the PEG tube. [0043] FIG. 31 shows a fourth version of the invention a modification of the tube shown in FIG. 30 where the tube is replaced be a molded tubular section that holds the tube at 90 degrees to the patient's skin. The tubular section is molded with two base plates the replace the section of tubing with a hole shown in

FIG. 30. The tubular section also contains two pressure-warning arms that come in contact with the two base plates if excessive pressure is encountered.

REFERENCE NUMERAL SUMMARY OF DRAWTNGS FIG. 1, 2 & 3 [0044] 10 Bolster body

[0045] 1 1 annular collar

[0046] 12 collar tube passage

[0047] 13 front pressure-monitoring plate

[0048] 14 pressure-monitoring pointer [0049] 15 pressure-warning stripes

[0050] 16 bridge

[0051] 17 upper arm

[0052] 21 lower arm

[0053] 22 bottom L-shaped passage port

[0054] 23 base plate

[0055] 24 joining pin

[0056] 25 joining pin-receiving cavity

[0057] 26 base plate

[0058] 27 L-shaped tube passage

[0059] 31 degree of off set

[0060] 32 gripping ridge

FIG. 4-8

[0061] 33. joining cavity portion of mok

[0062] 34. one half of mold

[0063] 35. main mold cavity for bolster

[0064] 36. main core pin

[0065] 37. joining pin securing hole

FIG. 9-10

[0066] 41. wire reinforced PEG tube

[0067] 42. space between internal bolster and stomach wall

[0068] 43. internal bolster

[0069] 44. cross-section of abdominal wall and stomach wall.

FIG. 11-14 FIG. 15-18

[0070] 45. deformation of stoma site and pressure-monitoring plate FIG. 19-23

[0071] 46. expanded section of L-shaped passage

[0072] 47. section of L-shaped passage for PEG tube

[0073] 210. second version of invention - for use with non-wire reinforced tubing.

[0074] 51. non-wire reinforced PEG tube

[0075] 52. wire reinforced over-sleeve tube

[0076] 53. end of gluing area

[0077] 54. molded "O" ring [0078] 55. upper arm

[0079] 56. lower arm

[0080] 57. bridge

[0081] 21 l. Quinn bolster

[0082] 311. common bolster type [0083] 310. third version of invention

[0084] 61. molded tubular section of hold tube 90 degrees from skin

[0085] 62. flat circular plate

[0086] 63. skin

[0087] 64. pressure-warning disk [0088] 41 1. another common form of external bolster

[0089] 65. section of tubing

[0090] 66. preformed hole

[0091] 67. pressure-monitoring pointer

[0092] 68. tabular base plates [0093] 410 fourth version of invention

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0094] FIGS. 1 through 8 describe the construction of the main first embodiment 10 that is the basis for the other three embodiments, 210, 210, 310 and 410. This first embodiment is used with a wire reinforced PEG tube. [0095] FIGS. 9 through 13 describe the application of the bolster 10 into the PEG and the final PEG placement.

[0096] FIGS. 15 through 18 describe the tension monitoring function of embodiment 10. The same basic function applies to the other three embodiments. [0097] FIGS . 19 through 25 describe the second embodiment 210 that addresses the use of the bolster with a common non-reinforced wire PEG tube. [0098] FIGS. 26 & 27 illustrate the problems with another patented PEG tube that shares some of the features of the embodiment 10 and the second embodiment 210. [0099] FIGS. 28 and 29 show an embodiment 310 that utilizes the tension- monitoring feature of the invention on a, commonly used, prior art external bolster design.

[0100] FIGS. 30 and 31 show an embodiment 410 that also utilizes the tension monitoring feature of the invention on another, commonly used, prior art external bolster design.

[0101] FIGS. 1, 2 and 3 show the device as it is molded. This shape is also the shape that is used to insert the PEG tube. The bolster body is seen at 10. The annular collar that accepts and encircles the PEG tube is seen at 1 1 in all three drawings with its port opening at 12. The pressure-monitoring plate 13 is seen in all three drawings. Under the pressure-monitoring plate 13 is the pressure- monitoring pointer 14. Pressure-warning printed stripes 15 are shown in FIG. 2. Upper arm 17 is connected to lower arm 21 by bridge section 16 molded protuberances gripping ridges are seen at 32. [0102] The body 10 is soft silicone rubber. Joining pin 24 is a rigid part and is made from metal such as stainless steel or aluminum, or preferably of a hard plastic such as polycarbonate that can be injection molded in large quantities at a low price. Joining pin 24 is insert molded into main bolster body 10. FIG. 3 shows the bottom port 22 of the L shaped passage shown at 27 in FIG. 2. The base plate of lower arm 21 is shown at 23 in FIG. 3. The joining pin receiving cavity 25 is shown in FIGS. 2 and 3. [0103] In FIG. 1 at 31 the upper arm 17 is molded offset from lower arm 21 at a 33-degree angle.

[0104] The device 10 as shown is meant for use on a commonly used 20FR.

PEGS, which has an outside diameter of 0.263 inches. The overall length of device 10 is 1.830 inches from the leading edge of the front pressuring monitoring plate 13 to the back edge of the annular collar 11. The front pressure-monitoring plate 13 extends 0.594 inches beyond the main body of device 10. This plate is

0.170 inches thick. The pressure-monitoring pointer 14 extends 0.500 inches over the plate 13. The pointer 14 is 0.070 inches thick at its leading end and gradually tapers to 0.120 inches thick at the point where it meets the main body. At the leading edge of pressure-monitoring pointer 14, it is separated from the front pressure-monitoring plate 13 by a space of 0.100 inches.

[0105] FIG. 4 is a cross sectional view of FIG. 1. The collar tube passage is shown at 12. Joining tube-receiving cavity is shown at 25. The cross sectional view of the joining pin 24 is shown in FIG. 4 as well as the hole or joining pin securing hole at 37. The securing hole 37 is filled with silicone during the molding process and traps the Joining pin 24 in the main body 10, thereby providing a one-piece device.

[0106] FIG. 5 is a bottom plan view of the body 10 that shows the bottom L- shaped passage port at 22. This is located approximately midway in the base plate

26 of the bolster 10, or, at the juncture of the front pressure-monitoring plate 13 and the portion of lower arm 21 behind the port 22.

[0107] FIG. 6 shows the main bolster body pin 36 seated in one half of the mold 34. The cavity surrounding the main pin is at 35. The joining pin securing hole is seen at 37 in the joining pin 24 that has been inserted into the tool for final production. The portion 33 of the main pin forms the joining pin security hole 37 in the final molding process.

[0108] FIG. 7 and 8 show the top plan and cross sections of joining pin 24 and joining pin securing hole 37. [0109] FIG. 9 shows the PEG tube 41 inserted into the bolster body 10 as it is molded with the upper arm 17 in its normal 33-degree offset angle from lower arm 21.

[0110] FIG. 10 shows the upper arm extended to straighten PEG 41 for length and bolster tension adjustment. The space 42 between the internal bolster 43 and the wall of the stomach 44 shows that the internal bolster 43 has not yet been "snugged up" in contact with the stomach 44.

[0111] FIG. 11 shows the internal bolster 43 being "snagged up" properly to the stomach and abdominal wall 43. The PEG is now ready to be moved into its "locked" position. The gripping ridges 32 are grasped between thumb and forefinger of both hands. The upper arm 17 is stretched and lengthened and them pulled down to match lower arm 21 where joining pin 24 is aligned with joining pin receiving cavity 25. As grasping ridges 32 are released the pin enters the cavity and the two arms are locked in their final position. [0112] FIG. 12 shows the assembly in its final position with correct tension and the PEG tube locked at a level parallel to the patient's skin. [0113] FIG. 13 is a top plan view of the body 10 showing the pressure- monitoring pointer 14 positioned over the pressure-warning stripes at 15. [0114] FIG. 14 is a front elevational view of the device showing the pressure- monitoring pointer 14 and its relationship to the front pressure-monitoring plate

13.

[0115] FIGS. 15 through 18 show the transition from a correction pressure/ tension placement in FIG. 15 to an increasingly excessive pressure/tension situation in FIGS. 16, 17 and 18. FIG. 15 shows the top plan view of the invention and the side elevational view. The device is placed with correct tension between the external bolster 1 and the internal bolster 43. The front pressure-monitoring plate 13 is not distorted and the pressure-monitoring indicator 14 is not in contact with the pressure-warning stripes 15. In FIG. 16 the front pressure-monitoring plated 13 is distorted. The plated 14 are forced into the tissue and the space 42 between the external and internal bolters is shortened. The first signs of unacceptable pressure are indicated by the contact now made between the first tension-warning stripe 15 and the pressure-monitoring bar 13. As contact is made this touching can be observed be viewing the actual contact from the side and also be seeing the contact from the top when the pointer 14 and the stripe 15 make contact with each other. [0116] FIGS. 17 and 18 show further distortion of the pressure-monitoring plate 13 that results in even more contact between the pointer 14 and the warning stripes 15. The pointer touches the first three stripes in FIG. 17 and all four warning stripes 15 in FIG. 18. [0117] FIGS. 19 through 25 show a second version of the invention at 210. This version functions similarly to the first version 10, but it is designed to be utilized with PEG tubing that is not wire reinforced. Tubing that is not reinforced tends to kink when it is turned though the L-shaped passage 27 at a right angle. FIG. 19 shows the device 210 in its closed position, but without the non-wire reinforced PEG tube 51 inserted. FIG. 20 shows a cross section of the device 210 along lines 20-20 of FIG. 19. This second version varies from version 10 in that it has an expanded section shown at 46. The second version is shown in a side elevational view with the non-wire reinforced PEG tube 51 in place. Note that it appears externally identical to the version 10. [0118] FIG. 23 is a cross-sectional view of FIG. 22 along lines 23-23 of FIG. 22. A wire-reinforced tube 52 is added to the body of 210. It is glued to the body from the bottom 22 of the L-shaped tube passage to the point 53 where the tube is allowed to move freely around the PEG tube 51. Tube 51 cannot not kink at the 90 angles because it is trapped in wire-reinforced tube 52. [0119] FIG. 24 is an additional cross sectional view of FIG. 22 at lines 24-24 of FIG. 22.

[0120] FIG. 25 is a side elevational view showing the non-reinforced tube 51 in the reinforced tube 52. The device has been properly adjusted and is ready to be finally locked in place for use. [0121] FIGS. 26 and 27 show the external bolster 211 described in Quinn US Patent No. 5,860,960. As is the case with the new inventions shown at 10 and

210, the device has an upper arm 17, a bridge 16, an annular collar 11 and a lower arm 21. It is held together with a second part, a molded "O" ring. In figure 26 it is placed correctly and the internal bolster 43 is secured leaving a correct space 42 between the lower arm 21 of bolster 21 1 and the internal bolster 43. There is not deformation 45 of the skin at the front end of the bolster 21 1. FIG. 27 illustrated excessive tension between the internal bolster 43 and the device 21 1. The leading front edge of bolster is pulled into the stoma. This "pulling in" is a good indicator of too much tension. However, the deformation of the stoma at 45 is not desirable. As seen in the new inventions 10 and 210, excess pressure is indicated without allowing bolster to be pulled into the stoma. [0122] FIG. 28 shows another commonly utilized form of an external bolster shown at 31 1 The standard non-reinforced wire PEG tube 51 is threaded through a collar 61 that is molded as an integral part of a flat plate 62. The flat plate for a 20 FR. Tube is approximately 1.5 inches wide and approximately 0.100 inches thick. This external bolster 31 1 allows the PEG to kink when it is bent at a right angle. To instill feeding material into the patient's stomach, the tube must be held at a

90-degree angle to the patient's skin, rather than parallel to the patient's skin as is the case with new inventions 10 and 210. The device does distort when excessive tension occurs, but the degree of tension is difficult to assess by the medical personnel because the degree of tension cannot be easily be determined. [0123] FIG. 29 is the third version of the invention that adapts the tension- monitoring feature of inventions 10 and 210 to the bolster style shown in FIG. 28. In this invention 310 a second plate 64 is molded with a space of 0.100 inches between it and the molded base plate 62. Annular warning stripes are added to the plate 62. When the excessive pressure is encounters at any angle the base plate 62 is distorted and comes in contact with the pressure-warning disk 64. The disk 64 acts in the same manner as the front pressure-monitoring plate 13 and the pressure-monitoring pointer 14 in the first two versions of the inventions, 10 and 210. [0124] FIG. 30 shows another commonly utilized version of an external bolster utilized for PEGs shown at 411. In this device the PEG tube 51 is inserted through a section of tubing 65 that is slightly larger that the PEG tube 51. The tube 65 has a hole 66 punched entirely through. PEG 51 is inserted through hole 66 in tube section 65. The tube 65 becomes the external bolster. Both sides of the tube distort when the excess tension is exerted on the assembly, which provides some indication of excessive pressure. Here again, the assembly does not address the issue of having the PEG lie parallel to the patient's skin without kinking the tube.

[0125] FIG. 31 shows a fourth version of the invention shown at 410. This invention improves another commonly used PEG bolster type that mimics the tube in tube version shown in FIG. 30. Molding two base tabs 68 with a molded collar 61 modifies the tube through a tube version in 31 1. The fourth form of the invention adds pressure-monitoring pointers 67 to the collar 61 at a level 0.100 of an inch above the base tabs 68. Pressure-warning stripes 15 are added to the base tabs 68.

Claims

CLAIM

1. An external bolster for a corporeal access tube assembly including a flexible access tube segment, said external bolster comprising: a) an elongated body formed of resilient plastic material; b) said body having a passage therein extending substantially along the length of said body and adapted to receive said tube segment; c) said elongated body being separated along at least a substantial portion of its length to form two legs which are joined together at corresponding one ends and are separated at corresponding other ends. d) a base surface on one of said legs for seating against a patient; e) a latching element seated in said body and extending out of one of said other leg ends; and f) a receptacle in the other leg end for receiving said latching element, said other leg being resiliently deformable to permit receipt of said element into said receptable.

2. The external bolster of Claim 1 further characterized in that: a) said latching element is molded into said body to form a unitary bolster.

3. The external bolster of Claim 1 further characterized in that: a) an external bolster has a flexible pressure plate; and a pressure measuring and monitoring arm extending over said pressure plate; and b) gauging indicia on said pressure plate indicating the amount of flexure of said plate by the position of said monitoring arm.

4. A system for measuring and monitoring tension between an external bolster and an internal bolster in a corporeal access tube assembly wherein said bolsters are mounted on a percutaneous gastrostomy tube and are separated by a patient's stomach wall, said system comprising: a) an external bolster having a flexible pressure plate adapted to engage the outside of the stomach wall; b) said external bolster having a pressure measuring and monitoring arm extending over said pressure plate; and c) gauging indicia on said pressure plate indicating the amount of flexure of said plate by the position of said monitoring arm.