WEARABLE MODULAR EXTRACORPOREAL LIFE SUPPORT DEVICE FOR MOBILE TREATMENT OF SINGLE AND MULTIORGAN FAILURE

Abstract

In one exemplary embodiment, a wearable extracorporeal life support device includes a catheter fluidly connected to a pump and first and second modular extracorporeal life support components. The device may also be configured to be attached to a garment. The pump and the first and second modular extracorporeal life support components may be fluidly connected in series. The pump and the first and second modular extracorporeal life support components may also be fluidly connected in parallel. The first modular extracorporeal life support component may be a lung membrane and the second modular extracorporeal life support component may be a dialysis membrane.

Claims

1.-14. (canceled)

15. A method of providing mobile ambulatory extracorporeal life support comprising: pumping blood of a patient into first and second modular extracorporeal life support components via a pump; wherein the pump and first and second modular extracorporeal life support components are fluidly connected in series; and wherein the pump and first and second modular extracorporeal life support components are configured to be attached to a garment; further comprising a module to scavenge metabolites and/or hemoglobin.

16. A method of providing mobile ambulatory extracorporeal life support comprising: pumping deoxygenated blood of a patient through a first line to a pump; pumping deoxygenated blood to a lung membrane where the blood is oxygenated and carbon dioxide is removed; pumping oxygenated blood from the lung membrane to a dialysis membrane where the blood is filtered; and returning blood to the patient through a second line; further comprising a module to scavenge metabolites and/or hemoglobin.

17. A method of providing anticoagulation in extracorporeal life support comprising: pumping blood of a patient through an extracorporeal circuit; pumping blood to a lung membrane and dialysis membrane in the extracorporeal circuit; infusing an anticoagulant agent into the blood in the extracorporeal circuit; and returning blood to the patient.

18. A method of providing mobile ambulatory extracorporeal life support comprising: pumping blood of a patient through an extracorporeal circuit; pumping blood to first and second modular extracorporeal life support components in the extracorporeal circuit; and returning blood to the patient.

19. The method of claim 18, further comprising administering a fluid through the circuit.

20. The method of claim 18, further comprising administering a medication through the circuit.

21. The method of claim 18, further comprising administering a diagnostic test through the circuit.

22. The method of claim 15, wherein the pump supports blood flow ranging from 50 ml/min to 500 ml/min up to 4 L/min.

23. The method of claim 16, wherein the pump supports blood flow ranging from 50 ml/min to 500 ml/min up to 4 L/min.

24. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane, with the at least one in-line sensor configured to adjust blood flow and sweep gas flow to achieve higher or lower carbon dioxide levels in blood.

25. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane, with the at least one in-line sensor configured to measure a pH of blood passing through the lung membrane or dialysis membrane.

26. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane or dialysis membrane, with the at least one in-line sensor configured to measure and/or adjust a partial pressure of oxygen in blood passing through the lung membrane.

27. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane or dialysis membrane, the at least one in-line sensor configured to measure and/or adjust a partial pressure of carbon dioxide in blood passing through the lung membrane.

28. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane or dialysis membrane, the at least one in-line sensor configured to measure and/or adjust a concentration of potassium in blood passing through the lung membrane or dialysis membrane.

29. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane or dialysis membrane, the at least one in-line sensor configured to measure and/or adjust a concentration of lactate in blood passing through the lung membrane or dialysis membrane.

30. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane or dialysis membrane, the at least one in-line sensor configured to measure and/or adjust a concentration of both potassium and lactate in blood passing through the lung membrane or dialysis membrane.

31. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane or dialysis membrane, the at least one in-line sensor configured to measure and/or reduce a concentration of cytokines in blood passing through the lung membrane or dialysis membrane.

32. The method of claim 16, further comprising embedding at least one in-line sensor into the lung membrane or dialysis membrane, the at least one in-line sensor configured to measure and/or reduce a concentration of pathogens in blood passing through the lung membrane or dialysis membrane.

33. The method of claim 15, wherein the pump and first and second modular extracorporeal life support components are configured to be carried and mounted on a device rather than worn.

34. The method of claim 17, wherein the method promotes anticoagulation that results from modification to a surface of the extracorporeal circuit or by addition of an anticoagulant liquid or gas.

35. The method of claim 15, wherein the pump supports blood flow for pediatric patients.

36. The method of claim 16, wherein the pump supports blood flow for pediatric patients.

37. The method of claim 15, wherein the pump supports blood flow for adult patients.

38. The method of claim 16, wherein the pump supports blood flow for adult patients.

39. The method of claim 15, wherein the pump supports blood flow for tissues, organs, vascular composite allografts, and/or limbs of patients.

40. The method of claim 16, wherein the pump supports blood flow for tissues, organs, vascular composite allografts, and/or limbs of patients.

41. The method of claim 15, wherein the pump and first and second modular extracorporeal life support components are configured to concurrently provide support for a patient body and for tissues, organs, vascular composite allografts, and/or limbs of patients.

42. The method of claim 16, wherein the pump and first and second modular extracorporeal life support components are configured to concurrently provide support for a patient body and for tissues, organs, vascular composite allografts, and/or limbs of patients.

43. The method of claim 15, wherein the pump and first and second modular extracorporeal life support components are powered by a renewable energy source.

44. The method of claim 16, wherein the pump and first and second modular extracorporeal life support components are powered by a renewable energy source.

45. The method of claim 15, wherein the pump operates in a continuous flow or pulsatile flow mode.

46. The method of claim 16, wherein the pump operates in a continuous flow or pulsatile flow mode.

47. The method of claim 15, wherein the first and second modular extracorporeal life support components, the pump, and the garment are connected by tubing to make up a circuitry, the length of the tubing being minimal.

48. The method of claim 16, wherein the pump, the lung membrane, and the dialysis membrane are connected by tubing to make up a circuitry, the length of the tubing being minimal.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0076] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and, together with the description, serve to explain the disclosed embodiments.

[0077] FIG. 1 is a photograph of an exemplary combination device, consistent with at least one of the disclosed embodiments.

[0078] FIG. 2 is an illustration of the components, connections, and fluid flow path of an exemplary combination device in accordance with at least one of the disclosed embodiments.

[0079] FIG. 3 is an illustration of components, connections, and fluid flow path of an exemplary combination device in accordance with at least one of the disclosed embodiments.

[0080] FIG. 4 is an illustration of the components, connections, and fluid flow path of an exemplary combination device in accordance with at least one of the disclosed embodiments.

[0081] FIG. 5 is an illustration of the components, connections, and fluid flow path of an exemplary combination device in accordance with at least one of the disclosed embodiments.

[0082] FIG. 6 is an illustration of the components, connections, and fluid flow path of an exemplary combination device in accordance with at least one of the disclosed embodiments.

[0083] FIG. 7 is an illustration of the components, connections, and fluid flow path of an exemplary combination device in accordance with at least one of the disclosed embodiments.

[0084] Annotations appearing in the figures are exemplary only, and are not restrictive of the invention as claimed.

DETAILED DESCRIPTION

[0085] Reference will now be made in detail to the present embodiments (exemplary embodiments) of the disclosure, examples of which are illustrated in the accompanying drawings.

[0086] FIG. 1 illustrates an exemplary wearable extracorporeal life support device 20 combining extracorporeal membrane oxygenation and extracorporeal continuous renal replacement therapy in accordance with at least some embodiments in accordance with the present disclosures. Identical or similar concepts will apply in case of adding other organ support membranes to the device. In some embodiments, the wearable extracorporeal life support device 20 may be a vest 20. A dual lumen catheter 22 may be inserted into a patient via the right jugular vein (not pictured), for example. The catheter 22 may have two holes to allow draining blood from the superior vena cava and from the inferior vena cava. One lumen (e.g. lumen 24) may allow for deoxygenated blood to be removed from the body, while the other lumen (e.g. lumen 26) may allow for oxygenated blood to return to the body.

[0087] In accordance with at least some embodiments of the present disclosure, the lines from the dual lumen catheter 22 may be attached to the vest 20, for example, in the front of the patient. In accordance at least some embodiments, the lines from the dual lumen catheter 22 may be attached to the vest 20 behind the patient's neck, or on the left or right side of the vest 20. In accordance at least some embodiments, the lines may be attached to the vest 20 at any other placement. In accordance with another embodiment, the lines may not be attached to the vest 20.

[0088] A pump 30 may propel blood by means of suction from one of the ports of the dual lumen catheter 22 and through one of the lines. The pump 30 may be fluidly connected to the inlet of a lung membrane 32. The inlet of the lung membrane 32 may also be fluidly connected to the catheter 22. The lung membrane 32 may remove CO.sub.2 from the blood. The lung membrane 32 may also oxygenate the blood. The design of the lung membrane 32 may also include a heat exchanger to heat the blood by convection if a fluid warmer is available. In some embodiments, the lung membrane 32 may support a minimum of 500 ml/min flow using a ¼ inch tubing size and a 15 French (F) catheter and be also able to accommodate higher flow rates e.g. 1 Liter (L) per minute using an 18 F catheter; through 2 L per minute using a 23 F catheter for up to 4 liters per minute using a 32 F catheter and all using ½ inch tubing.

[0089] In another embodiment, the outlet of the lung membrane 32 may return blood through a second line to the second lumen of the dual-lumen catheter 22 (e.g. a jugular catheter) and may infuse blood into the right atrium.

[0090] In another embodiment, the lung membrane 32 may include an input for sweep gas to remove CO.sub.2 and provide oxygenation. In some embodiments, a sweep gas line 34 may be connected to a small compressor mounted on the device 20 which will generate oxygen and cycle ambient air through the lung membrane 32 for the purposes of gas exchange. In some embodiments, the sweep gas line 34 may input ambient air to the lung membrane 32.

[0091] In another embodiment, a shunt line 36 may be connected to the inlet line, outlet line, in parallel, in series or other combination. The shunt line 36 may lead a side flow of blood from the lung membrane 32 into the inlet of a dialysis membrane 40. The dialysis membrane 40 may remove at least one of metabolites, inflammatory mediators, cytokines, and/or pathogens. This may be accomplished using various commonly established configurations of renal dialysis.

[0092] In another embodiment, the pump 30 may be fluidly connected to the dialysis membrane 40. The outlet of the dialysis membrane 40 may return blood through a second line to the second lumen of the dual-lumen catheter 22 and may infuse blood into the right atrium.

[0093] Although FIG. 1 shows a pump 30 connected to the lung membrane 32 and dialysis membrane 40 in series, various other configurations are contemplated, some of which are illustrated in FIGS. 2 through 7.

[0094] The lung membrane 32, dialysis membrane 40, and pump 30 may be attached to the vest 20 in the front, in the back, on the left, on the right, or in any possible placement on the vest 20.

[0095] In some embodiments. the device 20 may include a power source 42, for example a battery.

[0096] FIGS. 2 through 7 are illustrations of the various configurations of the pump 30, lung membrane 32, and dialysis membrane 40 in accordance with at least some embodiments of the present disclosure. In FIGS. 2 through 7 deoxygenated blood is represented by a dashed line and oxygenated blood is represented by a solid line.

[0097] FIG. 2 illustrates the pump 30, lung membrane 32, and dialysis membrane 40 in series. Deoxygenated blood enters the catheter 22 and enters the first line to the pump 30. Deoxygenated blood is then pumped to the lung membrane 32 where the blood is oxygenated, and carbon dioxide is removed. Oxygenated blood then enters the dialysis membrane 40 where at least one of metabolites, inflammatory mediators, cytokines, and/or pathogens are removed. Then the filtered and oxygenated blood is ultimately returned to the patient through the other line.

[0098] FIG. 3 illustrates the pump 30 in series with the lung membrane 32 and dialysis membrane 40 in parallel. Deoxygenated blood from the patient may enter the pump 30 and may be pumped in parallel to both the lung membrane 32 and dialysis membrane 40. Oxygenated blood from the lung membrane 32 may be joined with filtered, deoxygenated blood from the dialysis membrane 40 and returned to the patient in one line.

[0099] FIG. 4 illustrates the dialysis membrane 40, pump 30, and lung membrane 32 in series. Deoxygenated blood from the patient may enter the dialysis membrane 40. Filtered, deoxygenated blood then enters the pump 30 and is pumped to the lung membrane 32. Oxygenated blood is then returned to the patient. In some embodiments, the series connection may provide direct control of flow through the dialysis membrane. Additionally, the series connection may simplify the tubing and connections of the system.

[0100] FIG. 5 illustrates the pump 30 and dialysis membrane 40 in parallel with the lung membrane 32 in series. Deoxygenated blood from the patient may enter both the pump 30 and dialysis membrane 40 in parallel. Filtered blood from the dialysis membrane 40 may then be joined with blood from the pump 30 and pumped to the lung membrane 32. Oxygenated blood is then returned to the patient. In some embodiments, the parallel arrangement may be advantageous if one of the devices clots, the other device can operate independently or be exchanged for a different device. In some embodiments, blood may flow through one system at a time, e.g. through dialysis membrane 40 or through lung membrane 32. Accordingly, the parallel connection provides a modular design. Additionally, the parallel arrangement may provide lower fluid pressure in the dialysis membrane 40, which may be beneficial for maintenance of blood viability. For example, higher pressure may require turbulent flows and destruction of erythrocytes. In some embodiments, lung support may require higher blood flow than a maximum flow a dialysis membrane 40 may support. The parallel connection may permit independent blood flow regulation and flow through lung membrane 32 can be as high or low as needed, with independent regulation of flow through dialysis membrane 40. For example, the blood flow may range from 50 ml/min to 500 ml/min.

[0101] FIG. 6 illustrates the dialysis membrane 40 in parallel with the pump 30 and lung membrane 32 in series. Deoxygenated blood from the patient may enter both the pump 30 and dialysis membrane 40 in parallel. The blood from the pump 30 is then pumped to the lung membrane 32. Oxygenated blood from the lung membrane 32 may be joined with filtered, deoxygenated blood from the dialysis membrane 40 and returned to the patient in one line.

[0102] FIG. 7 illustrates the dialysis membrane 40 in parallel with the pump 30 and lung membrane 32 in series. Deoxygenated blood from the patient may enter the pump 30 and may be pumped to the lung membrane 32. Oxygenated blood may then separately be returned to the patient and enter the dialysis membrane 40. Filtered blood from the dialysis membrane 40 may be joined with deoxygenated blood from the patient before entering the pump 30.

[0103] Although FIGS. 2 through 7 illustrate exemplary embodiments of the various configurations of the pump 30, lung membrane 32, and dialysis membrane 40, other configurations not illustrated are contemplated. In one embodiment, only the pump 30 and lung membrane 32 are used for patients requiring lung support and not renal support. In another embodiment only the pump 30 and dialysis membrane 40 are used for patients requiring renal support and not lung support.

[0104] Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the steps of the disclosed methods can be modified in any manner, including by reordering steps or inserting or deleting steps. It is intended, therefore, that the specification and examples be considered as example only, with a true scope and spirit being indicated by the following claims and their full scope of equivalents.