EP-4739269-A2 - UNIVERSAL ADAPTOR FOR ASSISTED AND MANUAL DELIVERY

Abstract

An adaptor having a connection portion connectable to a fluid container, a first fluid flow path having a first end and a second end, the first end configured to provide fluid communication with the fluid container and the second end having a fluid outlet, at least one valve provided along the first fluid flow path, and a second fluid flow path that is separate from the first fluid flow path, the at least one valve configured to provide selection between assisted fluid delivery and manual fluid delivery. Also described are systems, kits, and methods including an adaptor.

Inventors

• MCGINLEY, Christopher
• KERWELL, Karan
• KRUEGER, JOHN
• MCDONALD, JAMES PATRICK

Assignees

• CAREFUSION 2200, INC

Dates

Publication Date

20260513

Application Date

20240703

Claims (20)

1. 1. An adaptor comprising: a connection portion connectable to a fluid container, a first fluid flow path having a first end and a second end, the first end configured to provide fluid communication with the fluid container and the second end comprising a fluid outlet, at least one valve provided along the first fluid flow path, and a second fluid flow path that is separate from the first fluid flow path, wherein the at least one valve is configured to provide selection between assisted fluid deliver}' and manual fluid delivery.
2. 2. The adaptor according to claim 1, wherein the first end of the first fluid path comprises a spike element.
3. 3. The adaptor according to claim 1, wherein the at least one valve comprises a cross-slit valve.
4. 4. The adaptor according to claim 1, wherein the at least one valve is configured to open in two directions.
5. 5. The adaptor according to claim 1, wherein the adaptor further comprises a vent provided along the second fluid flow path.
6. 6. The adaptor according to claim 5, wherein the vent is irreversibly secured in a vent housing.
7. 7. A system comprising: a fluid container; an adaptor, wherein the adaptor comprises: a connection portion connected to the fluid container, a first fluid flow path having a first end and a second end, the first end configured to provide fluid communication with the fluid container and the second end comprising a fluid outlet, at least at least one valve provided along the first fluid flow path, wherein the valve is configured to provide selection between assisted fluid delivery and manual fluid delivery, and a second fluid flow path that is separate from the first fluid flow path.
8. 8. The system according to claim 7, wherein the first end of the first fluid path comprises a spike element.
9. 9. The system according to claim 7, wherein the at least one valve comprises a cross-slit valve.
10. 10. The system according to claim 7. wherein the at least one valve is configured to open in two directions.
11. 11. The system according to claim 7, wherein the adaptor further comprises a vent provided along the second fluid flow path.
12. 12. The system according to claim 7, wherein the fluid container contains a lavage fluid.
13. 13. A kit comprising: an adaptor, wherein the adaptor comprises: a connection portion connectable to a fluid container, a first fluid flow path having a first end and a second end, the first end configured to provide fluid communication with the fluid container and the second end comprising a fluid outlet, at least one valve provided along the first fluid flow path, wherein the at least one valve is configured to provide selection between assisted fluid delivery and manual fluid delivery, and a second fluid flow path that is separate from the first fluid flow path; and instructions for connecting the adaptor to the fluid container.
14. 14. The kit according to claim 13, wherein the first end of the first fluid path comprises a spike element.
15. 15. The kit according to claim 13, wherein the at least one valve comprises a crossslit valve.
16. 16. The kit according to claim 13, wherein the at least one valve is configured to open in two directions.
17. 17. The kit according to claim 13, wherein the adaptor further comprises a vent provided along the second fluid flow path.
18. 18. The kit according to claim 17, wherein the vent is irreversibly secured in a vent housing.
19. 19. The kit according to claim 13, wherein the kit further comprises the fluid container.
20. 20. The kit according to claim 19, wherein the fluid container contains a lavage fluid.

Description

UNIVERSAL ADAPTOR FOR ASSISTED AND MANUAL DELIVERY TECHNICAL FIELD [001] The present disclosure is directed to an adaptor useable with a fluid container to provide at least two selectable modes of fluid delivery. BACKGROUND [002] Intraoperative incisional wound irrigation is an accepted method to aid in the prevention of surgical site infections (SSIs). For such procedures, irrigation is typically conducted via one of two modes: manually (i.e., direct pour, bulb syringes, etc.) or assisted (i.e., the delivery of solution via an electrically powered lavage device). [003] In assisted delivery methods, solution is ty pically present within a fluid container hung from an IV pole in the non-sterile field while a pulsed lavage device operates in the sterile field. The fluid container is stored outside of the sterile field due primarily to the limited space within the sterile field and in order to reduce clutter in the immediate vicinity' of the surgical cavity. [004] In manual delivery methods, a healthcare practitioner typically applies manual pressure to a compressible fluid container in order to deliver irrigation fluid to a surgical cavity. [005] The selection of manual or assisted delivery' is generally directed by surgeon preference and the specifics of the procedure. While some healthcare practitioners believe that assisted delivery can be detrimental a patient’s health (e.g., by pushing bacteria deeper into the wound or damaging tissue), other surgeons believe that it offers advantages such as higher consistency and a more thorough debridement of the surgical cavity. There are also a significant portion of surgeons who prefer to utilize both manual and assisted delivery in their practice, depending on the specific surgical case. [006] Manual delivery is ty pically accomplished using a device that interfaces with an irrigation fluid container by puncturing the container. These devices generally have a relatively straightforward design, which lack in several areas. For example, after manual compression of a fluid container, the compression force is released and the container is allowed to relax toward its original shape geometry’. During the relaxation phase, air is pulled back into the container, thereby allowing the container to be compressed again to expel more fluid. However, typical devices useable with such containers allow restoration of the container shape with air travelling through the fluid channel, which could potentially introduce contamination into the irrigation fluid itself or into the fluid channel. [007] Assisted delivery is typically performed by puncturing a fluid container with a device to create a fluid pathway. However, such devices cannot be used without the lavage device and thus, fluid cannot be delivered manually once the device has punctured the fluid container. As such, healthcare providers are required to stock both types of devices (i.e., devices designed for manual delivers- and those designed for assisted delivery). Current devices also limit the delivery of fluid from each fluid container to a single deliver}' mode. SUMMARY [008] Disclosed herein is an adaptor having a connection portion connectable to a fluid container, a first fluid flow path having a first end and a second end, the first end configured to provide fluid communication with the fluid container and the second end comprising a fluid outlet, at least one valve provided along the first fluid flow path, and a second fluid flow path that is separate from the first fluid flow path, wherein the at least one valve is configured to provide selection between assisted fluid delivery and manual fluid delivery. Also described herein are kits and systems having the adaptor as described herein. BRIEF DESCRIPTION OF THE DRAWINGS [009] FIG. 1A shows an example adaptor according to aspects of the present disclosure. [0010] FIG. IB shows an example adaptor according to aspects of the present disclosure. [0011] FIG. 1C shows an example vent housing according to aspects of the present disclosure. [0012] FIG. 2 shows an example adaptor having a valve according to aspects of the present disclosure. [0013] FIG. 3 shows an example cross-slit valve according to aspects of the present disclosure. DETAILED DESCRIPTION [0014] The present disclosure is directed to an adaptor that is useable with a fluid container to provide at least two selectable modes of fluid delivery. According to some aspects, the adaptor may be configured to provide both assisted fluid delivery and manual fluid delivery via a single fluid container. The adaptor may include a connection portion, a first fluid flow path, a second fluid flow path, a fluid outlet, and at least one valve provided along the first fluid flow path. The disclosure is also directed to kits and systems having an adaptor and a fluid container as described herein. [0015] The adaptor of the present disclosure is usable with a fluid container. As used herein, the term "‘fluid” refers to a sub