Hydrojet Debridement and Wound Bed Preparation

Abstract

A water jet debridement and wound bed preparation system includes a handle (22b) having an integrally molded component, for example, a distal tip (26) that receives liquid from a nozzle (28) is integral with the handle housing to which the nozzle is mounted. In another embodiment where the handle does not include a distal tip, liquid flows from a nozzle having a straight distal region. In another embodiment, the system includes a piston pump having an integrally molded component. In another embodiment, the system includes a double-spiked saline bag assembly.

Description

[0001] This application claims the priority of GB1908251.0 filed on June 10, 2019, which is incorporated herein by reference in its entirety. Background Art

[0002] Smith&Nephew Versajet TM The Hydrosurgery system uses high-pressure saline jets for debridement and wound bed preparation. Versajet TM The components of the Hydrosurgery system are described in U.S. Patent Nos. 9,597,107 and 9,341,184, which are incorporated herein by reference in their entirety. Referring to the prior art Figure 1A-1C , saline flows out of the high-pressure nozzle 11 at the top of the handle, rotates 180° through the end 12 of the nozzle 11, and is ejected from the nozzle 11 into the drain tube 7 at the bottom of the handle. The nozzle 11 is welded to the distal tip 5 defining the treatment window 14.

[0003] The orifice member (nozzle) 6 in the nozzle 11 is a key component that determines the water pressure and debridement effect. In Versajet TM Hydrosurgery system, the orifice member 6 is assembled to the nozzle 11 by a crimping process. The orifice member 6 is placed on the flared end of the nozzle 11, and the end of the nozzle 11 is crimped by bending inward to fix the orifice member 6 in the nozzle 11.

[0004] The orifice member is in the form of a ring configured to form a liquid jet and define a liquid flow channel having a diameter that continuously decreases from a first end to a position near a second end. The drain tube has an opening positioned opposite the orifice member and is configured to receive at least a portion of the liquid jet emitted from the orifice member and convey the liquid flow away from the opening. The pressure nozzle is configured and positioned to convey a liquid stream to the orifice member. The pressure nozzle is mounted on the outer surface of the housing and includes a retainer located at the distal opening of the pressure nozzle. The retainer forms a recess in the distal tip of the pressure nozzle and is configured to fully hold and position the orifice member inside the retainer such that the orifice member is coaxial with the distal end of the pressure nozzle and the liquid flow. The distal end of the opening of the pressure nozzle extends beyond the distal end of the drain tube such that in operation, the liquid flow from the orifice member is directed towards the handle.

[0005] The nozzle assembly is manufactured by fixing a toroidal-shaped orifice member having a flat surface and a curved opposing surface to the retainer or within the retainer. The nozzle assembly is capable of withstanding an internal liquid pressure of at least about 1,000 psig without failure.

[0006] As shown in the prior art Figure 2 in, VersajetTM The hydrosurgery system includes a piston pump implemented as a disposable handpiece. The pump includes a pump housing configured to be removably received by a drive console. The pump housing includes an insertion section, a coupling section, and a handle. The insertion section, the coupling section, and the handle are arranged linearly, wherein the coupling section is between the insertion section and the handle. The insertion section is configured to removably receive a push rod of the drive console. The coupling section includes an external oval flange. A valve assembly located in the pump housing includes an inlet channel, an outlet channel, an inlet ball valve, and an outlet ball valve. The inlet channel and the outlet channel are located side by side in the pump housing and are in fluid communication with a chamber defined in the insertion section. The chamber has an inclined wall axially aligned with the inlet channel and the outlet channel. The piston is slidably received in the chamber and includes a flexible member arranged in the chamber to be acted on by the inclined wall to engage the push rod. The only external force required to couple the piston to the push rod is an axial force acting on the piston in a first direction, and the only external force required to disengage the piston from the push rod is an axial force acting on the piston in a second direction opposite to the first direction.

[0007] As the prior art Figure 3 As shown in the Versajet TM The Hydrosurgery system uses a single spike to connect to a saline bag. Summary of the invention

[0008] Versajet TM The handle of the Hydrosurgery system handpiece consists of multiple parts that require a complex assembly / welding process. In particular, the Versajet TM The distal tip 5 of the hydrosurgery system ( Figure 1A-1C ) has a complex geometry formed by metal injection molding and requires laser welding to the fine nozzle 11.

[0009] Current designs reduce the number of components and subassemblies, for example, integrating several components into a single piece to avoid assembly of components and maintain alignment of components.

[0010] A water jet handpiece for treating tissue includes a handle having an upper housing and a lower housing, a nozzle mounted to the upper housing, and a distal tip receiving liquid from the nozzle and defining a treatment window for treating tissue with a liquid jet. The distal tip is integral with the upper housing.

[0011] Versajet TM The water flow from top to bottom in the hydrosurgery system requires bending the tip of the nozzle tube 11 and welding the nozzle tube 11 to the distal tip 5.

[0012] Certain embodiments of the present design switch the positions of the nozzle and the drain tube, allowing the nozzle to have a straight distal region and eliminating the distal tip.

[0013] A water jet handpiece for treating tissue includes a handle having an upper housing and a lower housing. The lower housing defines a treatment window. The handpiece includes a nozzle mounted to the lower housing. The nozzle has a straight distal region. The treatment window is configured to treat tissue with a liquid jet delivered through the nozzle. The handpiece includes a drain tube mounted to the upper housing.

[0014] Versajet TM The piston pump of the Hydrosurgery system also includes multiple components that require complex assembly.

[0015] The current design reduces the number of components and sub-assemblies. For example, several components are integrated into a single piece to avoid component assembly and maintain component alignment.

[0016] A piston pump of a water jet debridement and wound bed preparation system includes an integrated monolithic piston assembly that includes a fitting retainer, a feed line fitting, and a support screen. Embodiments of this aspect may include two handle halves that are connectable to form a lumen that houses the components of the piston pump including the integrated monolithic piston assembly.

[0017] If the saline bag is empty, in Versajet TM Using a single spike in the Hydrosurgery system can allow air to enter the tube and interlock the saline tube.

[0018] Two spike assemblies of the current design enable air to escape from the open spikes.

[0019] A water jet debridement and wound bed preparation system includes a piston pump and two spikes with tubes that extend from an inlet of the piston pump and are configured to control air entering the system.

[0020] According to one aspect, a water jet handpiece for treating tissue includes a handle housing, a nozzle mounted to the housing, and a distal tip that receives liquid from the nozzle and defines a treatment window for treating tissue with a liquid jet. The distal tip is integral with the housing.

[0021] Embodiments of this aspect may include one or more of the following features.

[0022] The housing includes an upper housing and a lower housing, and the distal tip is integral with the upper housing. The upper housing includes a distal housing and a proximal housing, and the distal tip and the distal housing are an integral unitary member. The water jet head includes a drain tube received by the lower housing. The nozzle includes a 180-degree bent distal end. The water jet head includes an orifice member.

[0023] According to another aspect, a water jet head for treating tissue includes a handle having an upper housing and a lower housing, a nozzle mounted to the lower housing, and a drain tube mounted to the upper housing. The lower housing defines a treatment window. The nozzle has a straight distal region. The treatment window is configured to treat tissue with a liquid jet delivered through the nozzle to the treatment window.

[0024] Embodiments of this aspect may include a lower housing defining a distal inner surface and an upper housing defining a distal inner surface. The distal inner surfaces are configured to direct a liquid jet from the treatment window to the drain tube.

[0025] According to another aspect, a water jet head for treating tissue includes a distal tip defining an internal flow path and a treatment window, a distal tip cap, and an orifice member located between the distal tip and the cap. The head is configured to pass a liquid through the flow path and out the orifice member to the treatment window.

[0026] According to another aspect, a pump for a water jet debridement and wound bed preparation system includes an integrated unitary piston assembly, the piston assembly including a fitting holder, a feed line fitting, and a support screen.

[0027] Embodiments of this aspect may include one or more of the following features: a handle, a piston, a piston cap, a single O-ring, and two valve balls. In the illustrated embodiment, the pump includes two handle halves connectable to form a cavity that houses the integrated unitary piston assembly. The connected handle halves form a piston cap.

[0028] According to another aspect, a water jet debridement and wound bed preparation system includes a piston pump and two spikes with tubing that extends from an inlet of the piston pump and is configured to control air entering the system.

[0029] According to another aspect, a water jet head for treating tissue includes a nozzle, an orifice member received in the distal end of the nozzle, and a spacer received in the distal end of the nozzle on top of the orifice member between the orifice member and the fluid outlet of the nozzle. In the illustrated embodiment, the spacer is welded to the nozzle. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1A-1C Shows a prior art handle of a water jet debridement and wound bed preparation system.

[0031] Figure 2 Shows a prior art piston pump of a water jet debridement and wound bed preparation system.

[0032] Figure 3 Shows a prior art single spike connection to a saline bag in a water jet debridement and wound bed preparation system.

[0033] Figure 4A-4I Includes various views of a handle of a water jet debridement and wound bed preparation system.

[0034] Figure 5 Is a cross-sectional view of an alternative embodiment of a handle of a water jet debridement and wound bed preparation system.

[0035] Figure 6A-6D Includes various views of another alternative embodiment of a handle of a water jet debridement and wound bed preparation system.

[0036] Figure 7A-7F Shows various embodiments of the industrial design of the head.

[0037] Figure 8A-8D Includes various views of a piston pump of a water jet debridement and wound bed preparation system.

[0038] Figure 9A-9D Includes various views of an alternative embodiment of a piston pump of a water jet debridement and wound bed preparation system.

[0039] Figure 10 and 11 Shows a double spike saline bag assembly of a water jet debridement and wound bed preparation system.

[0040] Figure 12 Shows a drip chamber of a water jet debridement and wound bed preparation system.

[0041] Figure 13A-13C Shows a console of a water jet debridement and wound bed preparation system.

[0042] Figure 14A-16B Shows various embodiments of the orifice member assembly process. Detailed Description

[0043] Reference Figure 4A-4H, the handpiece 20 of the water jet debridement and wound bed preparation system includes a top handle housing 22 and a bottom handle housing 24. The top handle housing 22 has a proximal housing 22a and a distal housing 22b with a distal tip 26, which is an integral part of the distal housing 22b. For example, a plastic molded or machined part such that the distal tip 26 and the distal housing 22b are an integral unitary part, and the assembly of the handpiece does not include attaching the distal tip 26 to the distal housing 22b. Received within the distal housing 22b is a nozzle 28 having a liquid outlet orifice member 30. The distal tip 26 of the distal housing 22b defines a treatment window 36 for treating tissue with a liquid jet. Received within the proximal housing 22a is a high-pressure hose 23 through which high-pressure water is fed to the nozzle 28. Integrating the distal tip 26 with the distal housing 22b eliminates the need to weld the nozzle to the distal tip.

[0044] Also refer to Figure 4H and 4I , the bottom handle housing 24 has a proximal housing 24a and a distal housing 24b. When assembled, the proximal housing 24a mates with the proximal housing 22a, and the distal housing 24b mates with the distal housing 22b. Leading from the proximal end 36a of the treatment window 36 to the distal housing 24b is a drain tube 32 that is partially covered by the distal housing 24b. A connecting tube 33 leads from the drain tube 32 to a hose 34 through which the return flow exits the handpiece.

[0045] Compared with the prior art Versajet TM Hydrosurgery system, the high-pressure nozzle 28 is shorter and the drain tube 32 is shorter.

[0046] Refer to Figure 5 , in an alternative embodiment, the handpiece 40 of the water jet debridement and wound bed preparation system includes a nozzle 42 having a liquid outlet orifice member 44. The nozzle 42 is received within the bottom handle housing 46, and a drain tube 48 is received within the top handle housing 50. Compared with Figure 4D the nozzle 28, the nozzle 42 has a straight distal region 52. Additionally, the handpiece 40 does not include a component corresponding to Figure 4D the distal tip 26.

[0047] In use, liquid is ejected from the orifice member 44 of the nozzle 42, passes through the tissue treatment window 54 where the jet is used to debride the wound bed, impinges on the inner surfaces 56, 58 of the bottom and top handle housings 46, 50 respectively, and flows into the drain tube 48.

[0048] Refer to Figure 6A-6D, in an alternative embodiment, the head 200 includes a metal injection molded distal tip 202 and a metal injection molded distal tip cap 204. Captured against the distal tip 202 by the tip cap 204 are a liquid outlet orifice member 206 and an O-ring 203. Liquid is delivered to the distal tip 202 via a high-pressure line 208, and the liquid exits via a drain tube 210. The liquid flows from the high-pressure line 208 through paths 212, 214 in the distal tip 202 out of the orifice member 206, through the treatment window 216, and through the drain tube 210.

[0049] Figure 7A-7D An alternative handle design is shown.

[0050] Figure 7E and 7F An alternative handle design corresponding to the Figure 6A embodiment is shown.

[0051] Referring Figure 8A-8D to, compared with the piston pump Figure 2 , the piston pump 60 has a reduced number of components and sub-assemblies. The piston pump 60 includes an integrated monolithic piston assembly 62, the piston assembly including a fitting retainer 64, feed line fittings 66, 68, and a support screen 70, without the need to assemble the feed line fittings to the fitting retainer with the Figure 2 alignment pins 16 of Figure 2 , and without the need to place the support screen 17 in the

[0052] Instead of the two O-rings 18 of Figure 2 , the piston pump 60 includes a single O-ring 71. The piston pump 60 includes a handle 72 that defines two channels 73 that receive the fittings 66, 68. The piston pump 60 also includes two ball valves 73, a pump body 74, a piston 75, and a piston cap 76.

[0053] Referring Figure 9A-9D to, in another embodiment, the piston pump 80 includes two handle halves 82, 84 that are longer than the handle 19 of Figure 2 and the handle 72 of Figure 8A , and when connected form an inner cavity that houses the components of the piston pump, including the integrated monolithic piston assembly 62. The piston pump 80 includes a valve seat 85 that receives one of the O-ring 71 and the ball valve 73. The valve seat 85 is received within an opening 90 leading to the feed line fitting 68. The handle halves 82, 84 define slots 86 that receive fins 88 of the piston assembly 62. When connected, the handle halves form a piston cap 92. The handle halves 82, 84 facilitate the assembly of the piston pump 80 and do not require Figure 2 and Figure 8AThe fluid channels 15 and 73 in the handle.

[0054] Reference Figure 10 and 11 , the water jet debridement and wound bed preparation system 98 includes two saline tubes 100, 102 extending from the inlet 104 of the piston pump handle 106. The saline tube 100 terminates at a spike 107 connected to a saline bag 108. The saline tube 102 can be open to the atmosphere ( Figure 10 ) or include a spike 109 connected to a second saline bag 110 ( Figure 11 ). In Figure 10 's components, when there is an air lock in the system, air is discharged from the open tube 102 with the clamp 111 in the open position. Figure 10 's tube 102 is shown without a spike, but can optionally include a spike. In Figure 11 's components, two spikes 107, 109 are connected to separate saline bags 108, 110, with corresponding clamps 112, 114 on the tubes 100, 102. In use, one of the clamps (e.g., clamp 112) is closed and the other clamp (e.g., clamp 114) is open. First, the saline in the bag 110 with the open clamp is used. When the saline bag 110 is empty, air will enter the tube 102 and the pump, which will cause a system air lock. To prime the pump and remove the air lock, open clamp 112, allowing saline to flow down the tube 100 from the bag 108, through the pump chamber, and back up the tube 102 towards the empty bag 110, thus flushing out the air trapped in the system. Once no more air is seen leaving the pump, clamp 114 is closed and the pump is now primed and will draw fluid from the bag 108.

[0055] Reference Figure 12 , in an alternative embodiment, a drip chamber 120 is used in the saline line, which allows air to rise from the liquid so that it does not flow downstream. The drip chamber should be kept approximately half full to prevent air from entering the saline tube, which could block the tube and stop the procedure. Compared with Figure 10 and 11 's embodiments, if there is already air in the pipeline, priming will stop. Figure 10 and 11 's embodiments allow air to rise, even if air is already in the saline pipeline, so that the procedure is not affected.

[0056] Reference Figure 13A-13C , the console 250 of the water jet debridement and wound bed preparation system includes an LCD screen 252 for displaying device status information such as power level, program run time, outpatient / operating room mode, and service reminder. The console includes an interface 254 for receiving the piston pump 256, as well as an RFID reader 258 and an antenna 260 for identifying the RFID tag 262 installed in the piston pump head.

[0057] Figure 14A-16B Shows various embodiments of the orifice member assembly process.

[0058] Referring Figure 14A and 14B , to provide additional fixation of the orifice member 308 to the nozzle 306, a metal spacer 302, such as a washer or bushing, is added to the assembly. During the assembly process, the end 304 of the nozzle 306 is opened and the orifice member 308 is placed inside the end of the nozzle. Then a metal washer or metal bushing 302 is placed on top of the orifice member 308 between the orifice member 308 and the fluid outlet at the end 304 of the nozzle. The end 304 of the nozzle 306 is crimped to press the washer or bushing 302 against the orifice member 308 and to press the washer or bushing together with the orifice member onto the nozzle. The addition of the washer or bushing ensures that the orifice member has less room for movement during the assembly process, thereby increasing the consistency of the crimping process and improving the yield.

[0059] Referring Figure 15 , the orifice member 308 can be directly laser welded into the end of the nozzle 306. The orifice member is placed in the flared end of the nozzle and then laser welded. The weld block secures the orifice member in place.

[0060] Referring Figure 16A and 16B , a washer or bushing 302 located Figure 14A and 14B above the orifice member 308 can be combined with laser welding. The orifice member 308 is placed in the end of the flared nozzle 306, and then a metal washer or bushing is placed on top of the orifice member. Laser welding is performed around the top of the metal washer or bushing. The metal washer or bushing ensures that the orifice member has less room for movement during the assembly process. The advantage of laser welding on the metal washer is that it avoids direct heat on the orifice member from the laser welding, which may change the material properties or weaken the orifice member. Laser welding has high consistency and repeatability, thus ensuring a higher yield during the manufacturing process.

[0061] In an alternative embodiment, the orifice can be directly fabricated on the nozzle by micro-machining or EDM techniques.

[0062] Other embodiments are within the scope of the following claims.

Claims

1. A water jet head for treating tissue, comprising: A handle including a housing; A nozzle for delivering a liquid jet, wherein the nozzle is mounted to the housing, the nozzle has a 180-degree bent distal end, and the distal end of the nozzle has a fluid outlet; and Wherein the housing includes an integral distal tip, wherein the distal tip defines a treatment window for treating tissue with a liquid jet, and wherein the treatment window is positioned relative to the fluid outlet such that in use the treatment window receives the liquid jet from the fluid outlet; Wherein the water jet head further includes a drain tube received in the housing.

2. The water jet head according to claim 1, wherein the housing includes an upper housing and a lower housing, and the distal tip is integral only with the upper housing of the housing.

3. The water jet head according to claim 2, wherein the upper housing includes a distal housing and a proximal housing, and the distal tip and the distal housing are an integral unitary component.

4. The water jet head according to claim 2, wherein, The drain tube is received in the lower housing.

5. The water jet head according to claim 1, further comprising a liquid outlet orifice member received in the distal end of the nozzle.

Images