TUBING CONNECTION SYSTEM FOR NEGATIVE PRESSURE WOUND THERAPY
20200086017 ยท 2020-03-19
Assignee
Inventors
- Vincent Denis Jardret (Powell, TN, US)
- Scott Douglas Barnes (Knoxville, TN, US)
- Walter Cleveland Cowart (Blaine, TN, US)
- Jonathan Matthew Cayce (Knoxville, TN, US)
- Breanna J. Rhyne (Powell, TN, US)
- Andrew Sullivan (Knoxville, TN, US)
- Dhanvin S. Desai (Knoxville, TN, US)
Cpc classification
A61M2205/3344
HUMAN NECESSITIES
A61F13/05
HUMAN NECESSITIES
A61M1/60
HUMAN NECESSITIES
A61M39/105
HUMAN NECESSITIES
A61M39/28
HUMAN NECESSITIES
A61M1/86
HUMAN NECESSITIES
A61M1/98
HUMAN NECESSITIES
A61M1/966
HUMAN NECESSITIES
A61M39/1011
HUMAN NECESSITIES
A61M1/743
HUMAN NECESSITIES
International classification
A61M1/00
HUMAN NECESSITIES
Abstract
A resilient connector for a negative pressure wound therapy system. The connector includes a first lumen having an entrance dimensioned and configured for slidably engaging a projection of a canister adapter to provide fluid communication of the first lumen to a first portion of reduced pressure tubing and an exit dimensioned and configured for slidably engaging a first projection of a dressing adapter to provide fluid communication of the first lumen to a second portion of reduced pressure tubing. The connector further a second lumen having an entrance dimensioned and configured for slidably engaging a second projection of the canister adapter to provide fluid communication of the second lumen to a first portion of secondary pressure tubing and an exit dimensioned and configured for slidably engaging a second projection of the dressing adapter to provide fluid communication of the second lumen to a second portion of the secondary pressure tubing.
Claims
1. A connection system for providing reduced pressure along a first fluid flow path and secondary pressure along a second fluid flow path to a wound site, the connection system comprising a connector formed of a resilient material configured to be fluidly connected to a canister adapter, the canister adapter having a first projection in fluid communication with a first portion of reduced pressure tubing and a second projection in fluid communication with a first portion of secondary pressure tubing, the connector including: a canister connecting end and a dressing connecting end opposite the canister connecting end, a first lumen extending through the connector from the canister connecting end to the dressing connecting end, the first lumen having a first lumen entrance disposed at the canister connecting end and a first lumen exit disposed at the dressing connecting end, the first lumen entrance dimensioned and configured for slidably engaging the first projection of the canister adapter to provide fluid communication of the first lumen to the first portion of reduced pressure tubing along the first fluid flow path, and a second lumen extending through the connector from the canister connecting end to the dressing connecting end, the second lumen being fluidly isolated from the first lumen and having a second lumen entrance disposed at the canister connecting end and a second lumen exit disposed at the dressing connecting end, the second lumen entrance dimensioned and configured for slidably engaging the second projection of the canister adapter to provide fluid communication of the second lumen to the first portion of secondary pressure tubing along the second fluid flow path.
2. The connection system of claim 1 further comprising a multi-lumen tube for providing fluid communication of the first fluid flow path and the second fluid flow path from the connector to the wound site, the multi-lumen tubing including the second portion of reduced pressure tubing and the second portion of secondary pressure tubing.
3. The connection system of claim 1 further comprising a dressing adapter including: a first projection fluidly connected to the first lumen exit of the connector; a reduced pressure lumen in fluid communication with the first projection at a proximal end and a second portion of reduced pressure tubing at a distal end; a second projection connected to the second lumen exit of the connector; and a secondary pressure lumen in fluid communication with the second projection at a proximal end and a second portion of secondary pressure tubing at a distal end.
4. The connection system of claim 3 wherein the dressing adapter includes a third projection and a fourth projection disposed at the distal end of the dressing adapter, the third projection fluidly connecting the reduced pressure lumen of the dressing adapter to the second portion of reduced pressure tubing and the fourth projection fluidly connecting the secondary pressure lumen of the dressing adapter to the second portion of reduced pressure tubing.
5. The connection system of claim 3 wherein the canister connecting end of the connector is configured to be removably connected to the first and second projections of the canister adapter, the dressing connecting end is fluidly sealed to the first and second projections of the dressing adapter, the distal end of the reduced pressure lumen of the dressing adapter is fluidly sealed to a proximal end of the second portion of reduced pressure tubing, the distal end of the secondary pressure lumen of the dressing adapter is fluidly sealed to a proximal end of the second portion of the secondary pressure tubing, and a wound enclosure is fluidly sealed to the distal ends of the second portions of the reduced pressure tubing and the secondary pressure tubing.
6. The connection system of claim 1 wherein the connector further includes a key receiver disposed adjacent to the first lumen entrance and the second lumen entrance that is dimensioned and configured to receive a key of the canister adapter disposed adjacent the first projection and the second projection of the canister adapter, the key receiver for preventing the first projection of the canister adapter from being inserted into the second lumen entrance of the connector and the second projection of the canister adapter from being inserted into the first lumen entrance of the connector.
7. The connection system of claim 1 wherein the first projection of the canister adapter is spaced apart from the second projection and has a greater circumference than the second projection such that the first lumen entrance of the connector is spaced apart from the second lumen entrance and the first lumen entrance has a diameter that is greater than the second lumen entrance for preventing the first projection of the canister adapter from being inserted into the second lumen entrance of the connector and the second projection of the canister adapter from being inserted into the first lumen entrance of the connector.
8. The connection system of claim 1 further comprising a clamp disposed around the connector for preventing fluid flow through the first lumen and the second lumen when the clamp is in a clamped position and permitting fluid flow through the first lumen and the second lumen when the clamp is in an unclamped position.
9. A connection system for providing reduced pressure along a first fluid flow path and secondary pressure along a second fluid flow path to a wound site, the connection system comprising: a collection canister operable to be in fluid communication with a reduced pressure source, the collection canister including: a first nipple for facilitating a flow of reduced pressure along the first fluid flow path from the reduced pressure source to the wound site and receiving exudate collected from the wound site to be deposited in the collection canister, a first portion of reduced pressure tubing having a proximal end fluidly connected to the first nipple, a second nipple for facilitating a flow of fluid along a second fluid flow path from a secondary pressure source to the wound site, and a first portion of secondary pressure tubing having a proximal end fluidly connected to the second nipple; and a canister adapter for providing a removable fluid connection along the first fluid flow path between the first portion of reduced pressure tubing to a second portion of reduced pressure tubing and along the second fluid flow path between the first portion of secondary pressure tubing and a second portion of secondary pressure tubing, the canister adapter including: a base portion, a first set of projections extending from the base portion in a first direction, the first set of projections including a first projection dimensioned and configured to be inserted into a distal end of the first portion of reduced pressure tubing for fluidly connecting the canister adapter to the first fluid flow path and a second projection dimensioned and configured to be inserted into a distal end of the first portion of secondary pressure tubing for fluidly connecting the canister adapter to the second fluid flow path, and a second set of projections extending from the base portion in a second direction, the second set of projections including a third projection in fluid communication with the first projection and a fourth projection in fluid communication with the second projection.
10. The system of claim 9 wherein the proximal end of the first portion of reduced pressure tubing is sealed to the first nipple of the collection canister, the proximal end of the first portion of secondary pressure tubing is sealed to the second nipple of the collection canister, the distal end of the first portion of reduced pressure tubing is sealed to the first projection of the canister adapter, and the distal end of the first portion of secondary pressure tubing is sealed to the second projection of the canister adapter.
11. The connection system of claim 9 further comprising a connector formed of a resilient material, the connector configured to be fluidly connected to the canister adapter and including: a first lumen extending through the connector having a first lumen entrance and a first lumen exit, the first lumen entrance dimensioned and configured for removably engaging the third projection of the canister adapter to fluidly connect the first fluid flow path to the first lumen; a second lumen extending through the connector having a second lumen entrance and a second lumen exit, the second lumen entrance dimensioned for removably engaging the fourth projection of the canister adapter to fluidly connect the second fluid flow path to the second lumen.
12. The connection system of claim 11 wherein the third projection of the canister adapter includes a circumference greater than a circumference of the fourth projection of the canister adapter and the first lumen entrance of the connector includes a diameter that is greater than a diameter of the second lumen entrance for preventing the third projection of the canister adapter from being inserted into the second lumen entrance and the fourth projection of the canister adapter from being inserted into the first lumen entrance.
13. The connection system of claim 11 wherein: the canister adapter further includes a key projection extending from the base portion in the second direction adjacent the third and fourth projections; and the connector further includes a key receiver disposed adjacent to the first lumen entrance and the second lumen entrance dimensioned and configured to receive the key of the canister adapter when the canister adapter correctly engages the connector.
14. The connection system of claim 11 further comprising a clamp disposed around the connector for preventing fluid flow through the first lumen and the second lumen when the clamp is in a clamped position and permitting fluid flow through the first lumen and the second lumen when the clamp is in an unclamped position.
15. The connection system of claim 11 further comprising a multi-lumen tube for providing fluid communication of the first fluid flow path and the second fluid flow path from the connector to the wound site, the multi-lumen tubing including the second portion of reduced pressure tubing and the second portion of secondary pressure tubing.
16. The connection system of claim 11 further comprising a dressing adapter including: a first projection fluidly connected to the first lumen exit of the connector; a reduced pressure lumen in fluid communication with the first projection at a proximal end and a second portion of reduced pressure tubing at a distal end; a second projection connected to the second lumen exit of the connector; and a secondary pressure lumen in fluid communication with the second projection at a proximal end and a second portion of secondary pressure tubing at a distal end.
17. The connection system of claim 16 wherein the dressing adapter includes a third projection and a fourth projection disposed at the distal end of the dressing adapter, the third projection fluidly connecting the reduced pressure lumen of the dressing adapter to the second portion of reduced pressure tubing and the fourth projection fluidly connecting the secondary pressure lumen of the dressing adapter to the second portion of reduced pressure tubing.
18. A connector for a negative pressure wound therapy system, the connector formed of a resilient material and comprising: a canister connecting end and a dressing connecting end opposite the canister connecting end; a first lumen extending through the connector from the canister connecting end to the dressing connecting end, the first lumen having a first lumen entrance disposed at the canister connecting end and a first lumen exit disposed at the dressing connecting end, the first lumen entrance dimensioned and configured for slidably engaging a first projection of a canister adapter to provide fluid communication of the first lumen to a first portion of reduced pressure tubing, and the first lumen exit dimensioned and configured for slidably engaging a first projection of a dressing adapter to provide fluid communication of the first lumen to a second portion of reduced pressure tubing; and a second lumen extending through the connector from the canister connecting end to the dressing connecting end, the second lumen being fluidly isolated from the first lumen and having a second lumen entrance disposed at the canister connecting end and a second lumen exit disposed at the dressing connecting end, the second lumen entrance dimensioned and configured for slidably engaging a second projection of the canister adapter to provide fluid communication of the second lumen to a first portion of secondary pressure tubing, and the second lumen exit dimensioned and configured for slidably engaging a second projection of the dressing adapter to provide fluid communication of the second lumen to a second portion of the secondary pressure tubing.
19. The connector of claim 18 wherein the first lumen entrance has a greater diameter than the second lumen entrance.
20. The connector of claim 18 wherein the connector further includes a key receiver disposed at the canister connecting end adjacent to the first lumen entrance and the second lumen entrance, the key receiver dimensioned and configured to receive a key of the canister adapter disposed adjacent the first projection and the second projection of the canister adapter, the key receiver for preventing the first projection of the canister adapter from being inserted into the second lumen entrance of the connector and the second projection of the canister adapter from being inserted into the first lumen entrance of the connector.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] Other embodiments of the invention will become apparent by reference to the detailed description in conjunction with the figures, wherein elements are not to scale so as to more clearly show the details, wherein like reference numbers indicate like elements throughout the several views, and wherein:
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DETAILED DESCRIPTION
[0046] Referring initially to
[0047] According to the first fluid flow path (indicated by arrow 14), a primary pressure source (not shown) is operable to provide a primary reduced pressure to the wound enclosure 110 such that fluid flows from the wound enclosure 110 to canister 20 through first lumen 12a and first lumen 52a. Thus, the first lumen 12a and first lumen 52a may also be referred to herein as reduced pressure tubing. The primary reduced pressure generated by the primary pressure source serves both to stimulate healing by applying the reduced pressure to the wound site and removing exudate from the wound enclosure 110 to the canister 20.
[0048] According to certain embodiments, the second fluid flow path (indicated by arrow 16) may be used to measure pressure at the wound enclosure 110. In this regard, a pressure measured at one end of a lumen is substantially equal to the pressure at the other end of the lumen so long as very little to no liquid/exudate is present in the lumen and the lumen inside diameter to length ratio is not too small. As result, measuring the pressure of the second fluid flow path of lumens 12b and 52b is able to provide a pressure measurement of the wound enclosure 110 (as compared to a pressure measurement within the reduced pressure tubing), which is helpful to detect leakage and blockage conditions in the first fluid flow path 14.
[0049] As described in more detail in U.S. application Ser. No. 16/235,113, filed Dec. 28, 2018, entitled Negative Pressure Wound Therapy System, the entire contents of which is incorporated herein by reference, the second fluid flow path 16 may also be connected to a secondary pressure source (not shown) to provide a secondary pressure to the wound enclosure 110 through second lumen 12b and second lumen 52b. The secondary pressure provided by the secondary pressure source (when activated) may be used to facilitate flow of the exudate from the wound enclosure 110 to the canister 20 through the first lumen 12a and first lumen 52a. For example, according to certain embodiments, the primary pressure source may be configured to deliver a reduced pressure of 125 mmHg to the wound enclosure 110 via first lumen 12a and 52a while the secondary pressure source delivers a reduced pressure of 80 mmHg to the wound enclosure 110 via the second lumens 12b and 52b. Thus, when both the primary pressure source and secondary pressure source are activated, the second fluid flow path 16 having a pressure of 80 mmHg will converge at the wound enclosure 110 with the first fluid flow path 14 having a pressure of 125 mmHg. The converged fluid flow path in the first lumen 12a and 52a will then have a greater pressure than the 125 mmHG generated by the primary pressure source to facilitate flow of exudate from the wound enclosure 110 to the canister 20 through the first lumens 12a and 52a. Given that the second lumens 12b and 52b will typically have a different pressure than the reduced pressure tubing of the first lumens 12a and 12b whether the second flow path is used to measure pressure at the wound site or to deliver a secondary pressure from a secondary pressure source, second lumens 12b and 52b may also be referred to herein as secondary pressure tubing.
[0050] In certain embodiments, and as depicted in
[0051] In alternate embodiments, an adapter for first and second nipples 22a and 22b could be provided to combine first and second flow paths 14 and 16 within a multi-lumen tube. In other words, using an adapter connected to the canister 20, the first portion of tubing 12 could be a single multi-lumen tube containing both the first lumen 12a and second lumen 12b. However, this results in an additional piece for the canister 20 and yet another connection point within the system 10 in which it must be ensured that the lumens are correctly aligned and fluid leaks are prevented. In yet another alternate embodiment, the second lumen 12b is again a separate tube but it connects to the system somewhere other than at the container (e.g., directly to the pump outlet).
[0052] With continued reference to
[0053] In preferred embodiments, the first projection 34a and second projection 34b are fluidly sealed to the respective distal ends 13a and 13b of the first and second tubes 12a and 12b. As noted above, proximal ends 11a and 11b of the first and second tubes 12a and 12b are preferably fluidly sealed to respective first and second nipples 22a and 22b of the collection canister 20. Thus, in certain embodiments, the canister 20, first and second tubes 12a and 12b, and canister adapter 30 form a canister portion of the connection system 10 that are provided together by the manufacturer in a fluidly sealed arrangement as described above. As described below, the second set of projections 36 of the canister adapter 30 are then able to be used to facilitate a removable fluid connection to a dressing portion of the connection system via connector 80.
[0054] Referring back to
[0055] The first set of projections 64 of the dressing adapter 60 includes a first projection 64a for fluidly connecting to the proximal end 51a of the first tube 52a and a second projection 64b for fluidly connecting to the proximal end 51b of the second tube 52b. To fluidly connect the first and second projections 64a and 64b to the first tubes 52a and 52b, respectively, the projections 64a and 64b are inserted into the corresponding proximal ends 51a and 51b of the tubes. The second set of projections 66 then include a third projection 66a that is in fluid communication with the first projection 64a and a fourth projection 66b that is in fluid communication with the second projection 64b. In other words, the dressing adapter 60 includes a first lumen extending through the first projection 64a, the base portion 62, and the third projection 66a for fluidly connecting to the first fluid flow path 14 and a second lumen extending through the second projection 64b, the base portion 62, and the third projection 66b for fluidly connecting to the second fluid flow path 16. As described further below, the second set of projections 66 are used to facilitate a removable fluid connection to the canister portion of the connection system 10 via connector 80.
[0056] According to another embodiment of the disclosure, the second portion of tubing 52 may be a multi-lumen tube. In other words, the first and second lumens 52a and 52b of the second portion of tubing 52 may be included within the same tube as known in the art of multi-lumen tubing. According to this embodiment, and with reference to
[0057] In preferred embodiments, the dressing adapter 60 (or dressing adapter 70 if connecting to a second portion of tubing 52 in the form of a multi-lumen tube) is fluidly sealed to the proximal ends 51a and 51b of the first and second lumens 52a and 52b. Referring back to
[0058] Referring again to
[0059] With reference to
[0060] Similarly, to connect the connector 80 to the dressing adapter 60 at the dressing connecting end 92, and with reference to
[0061] In preferred embodiments, the connector 80 is formed of a flexible/resilient/elastic material. More specifically, the connector is preferably formed of a soft plastic or elastomeric material such as silicone, PVC, polyurethane, polyethylene, etc. such that the lumen entrances 83a and 83b and lumen exits 85a and 85b expand slightly when receiving a more rigid plastic projection of one of the adapters to provide a friction fit type of engagement. In other words, the adapter projections include a circumference that is slightly larger along at least a portion of the length of the projection than the lumen entrances or exits in which the particular projection is inserted. Thus, the material of the connector is able to slightly expand and closely couple to the projections for preventing fluid leaks. This significantly eases connection for users of the system as compared to prior art luer lock type systems and avoids high levels of dexterity required to twisting and turning to lock connectors together. Further, using a connector formed of a resilient material permits a low-profile connection that is essentially defined by the thickness of the adapters. This low-profile connection, along with the soft material used for the connector 80, avoids unnecessary pressure/discomfort points to the patient if they lay over the connector 80 and accompanying adapters. Further advantages of providing a connection system with adapters having small projections inserted into a resilient connector 80 include the ability to create a simple to use but removable seal via the resilient material of the connector being friction fitted around the adapter projections while having a design that is efficient to manufacture.
[0062] In certain embodiments, either the canister connecting end 82 is fluidly sealed to the canister adapter 30 or the dressing connector end 92 is fluidly sealed to the dressing adapter 60. Thus, when the other components of connection system 10 are fluidly sealed as described above, there will be only one point within the system 10 in which a removable connection is permitted/intended. In preferred embodiments, and with reference to the exploded view
[0063] In certain embodiments, and as shown in the present figures, the connector 80 may include a grip feature 90 (e.g., knurlments, raised ribs, ridges, etc.) at the canister connecting end 82 to both assist the user in locating the removable connection point and to assist the user in gripping the connector 80 at the appropriate location to remove the connector from the canister adapter 30.
[0064] According to another aspect of the disclosure, and as best shown in
[0065] According to another aspect of the disclosure, and as shown best in
[0066] According to another aspect of the disclosure, a clamp 100 may be disposed around the resilient connector 80. In the clamped position fluid flow through the connector 80 along the first and second fluid paths 14 and 16 is prevented while the fluid flow is permitted in the unclamped position. This allows for a dressing change and/or replacing a canister without disconnecting the entire system. Applying the clamp 100 to the resilient connector 80 as opposed to the PVC tubing as known in the art has several advantages. In particular, a lower actuation force is required to move the clamp to the clamped position as a result of the resilient material of the connector 80. Further, the clamp is configurable to be closely coupled to the connector 80 such that the clamp is held in place by the connector during a dressing or canister change even when the tubing is disconnected on one end of the connector (i.e., the clamp 100 is disposed around the connector 80 such that the connector slightly deforms to provide a friction fit engagement between the clamp 100 and the connector 80. In certain embodiments, one end of the clamp 100 may also be disposed around a set of projections of one of the adapters (typically the dressing adapter 60) to further prevent unintended removal of the clamp 100 when tubing is disconnected from one end of the connector 80. Another advantage is that the clamp 100 allows for the user or medical staff to quickly identify/locate the removable connection point of the system 10. Similarly, providing the clamp 100 adjacent the removable connection point will remind the user to clamp the fluid flow paths before disconnection and to unclamp after re-connection. Yet another advantage is that the clamp 100 provides additional gripping surface area to disconnect one end of the resilient connector 80 from the appropriate adapter.
[0067] According to another aspect of the disclosure, canister adapter 30 preferably includes a cap 40 configured to be placed over at least projection 36a when the connector 80 is disconnected from the canister adapter 30 to prevent exudate in tube 12a from leaking out of the adapter 36a. Similarly, in embodiments in which connector 80 is intended to be disconnected from dressing adapter 60, a cap may also be provided for projection 64a.
[0068] According to yet another aspect of the disclosure, and as shown in the figures, certain projections of the adapters may include radially expanded tip portions to help seal the projections to the appropriate tubes or lumens of the connector 80. However, in preferred embodiments, the projections of the removable connection are gently sloped to expand in circumference toward the base portion of the particular adapter (see projections 36a and 36b of
[0069] The foregoing description of preferred embodiments for this invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments are chosen and described in an effort to provide the best illustrations of the principles of the invention and its practical application, and to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.