阅读说明：本技术 水射流清创和伤口床准备 (Water jet debridement and wound bed preparation ) 是由 郑威金 徐小东 蓝丽 陈腾腾 潘志成 于 2020-06-10 设计创作，主要内容包括：一种水射流清创和伤口床准备系统包括具有集成模制部件的手柄(22b),例如,接收来自喷管(28)的液体的远侧尖端(26)与手柄壳体成一体,喷管安装到所述手柄壳体。在手柄不包括远侧尖端的另一实施例中,液体从具有直远端区域的喷管流动。在另一实施例中,系统包括具有集成模制部件的活塞泵。在另一实施例中,系统包括双尖刺盐水袋组件。(A water jet debridement and wound bed preparation system includes a handle (22b) having an integrally molded component, e.g., a distal tip (26) that receives liquid from a spout (28) integral with a handle housing to which the spout is mounted. In another embodiment where the handle does not include a distal tip, the liquid flows from a spout 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 dual spike saline bag assembly.)

1. A waterjet handpiece for treating tissue, comprising:

A handle including a housing;

a spout mounted to the housing; and

a distal tip receiving liquid from the nozzle and defining a treatment window for treating tissue with a jet of liquid, the distal tip integral with the housing.

2. The waterjet handpiece of claim 1, wherein the housing comprises an upper housing and a lower housing, the distal tip being integral with the upper housing.

3. The water jet handpiece of claim 2, wherein the upper housing includes a distal housing and a proximal housing, the distal tip and the distal housing being an integral, unitary component.

4. The waterjet handpiece of claim 2, further comprising an evacuation tube received by the lower housing.

5. The waterjet handpiece of claim 1, wherein the nozzle includes a 180 degree curved distal end.

6. The waterjet handpiece of claim 1, further comprising an orifice member.

7. A waterjet handpiece for treating tissue, comprising:

a handle comprising an upper housing and a lower housing, the lower housing defining a treatment window;

a nozzle mounted to the lower housing, the nozzle having a straight distal region, the treatment window configured to treat tissue with a liquid jet delivered to the treatment window via the nozzle; and

An evacuation tube mounted to the upper housing.

8. The water jet handpiece of claim 7, wherein the lower housing defines a distal inner surface and the upper housing defines a distal inner surface configured to direct a jet of liquid from the treatment window to the evacuation tube.

9. A waterjet handpiece for treating tissue, comprising:

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;

wherein the handpiece is configured to flow liquid through the flow path and out of the orifice member to the treatment window.

10. A pump for a water jet debridement and wound bed preparation system, comprising:

an integrated monobloc piston assembly including a fitting holder, a feed line fitting, and a support screen.

11. The pump of claim 10, further comprising a handle.

12. The pump of claim 10, further comprising a piston.

13. The pump of claim 12, further comprising a piston cap.

14. The pump of claim 10, comprising a single O-ring.

15. The pump of claim 10, further comprising two valve balls.

16. The pump of claim 10, further comprising two handle halves connectable to form an internal cavity, the internal cavity housing the integrated, unitary piston assembly.

17. The pump of claim 16, wherein the connected handle halves form a piston cap.

18. A water jet debridement and wound bed preparation system comprising:

a piston pump; and

two spikes with tubing extending from the inlet of the piston pump and configured to control the entry of air into the system.

19. A waterjet handpiece for treating tissue, comprising:

a nozzle;

an orifice member received in the distal end of the spout; and

a spacer received in the distal end of the spout on top of the orifice member between the orifice member and the fluid outlet of the spout.

20. The waterjet handpiece of claim 19, wherein the spacer is welded to the nozzle.

Background

Smith&Nephew Versajet^TMThe Hydrosurgery system uses high pressure saline jets for debridement and wound bed preparation. Versajet^TMThe components of the Hydrosurgery system are described in U.S. Pat. Nos. 9,597,107 and 9,341,184, which are hereby incorporated by reference in their entireties. Referring to prior art fig. 1A-1C, saline flows from a high pressure spout 11 at the top of the handle, is rotated 180 ° through the end 12 of the spout 11, and is sprayed from the spout 11 to an evacuated tube 7 at the bottom of the handle. The nozzle 11 is welded to the distal tip 5 defining the treatment window 14.

The orifice member (nozzle) 6 in the nozzle 11 is a key component that determines the water pressure and debridement effect. In Versajet^TMIn the Hydrosurgery system, orifice member 6 is assembled to spout 11 by a crimping process. Orifice member 6 is placed over the flared end of spout 11 and the end of spout 11 is crimped by bending inwardly to secure orifice member 6 in spout 11.

The orifice member is in the form of a ring configured to form a liquid jet and defining a liquid flow channel having a diameter that continuously decreases from a first end to a location proximate a second end. The evacuation 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 stream away from the opening. The pressure nozzle is configured and positioned to deliver a liquid stream to the orifice member. The pressure lance is mounted on an outer surface of the housing and includes a retainer at a distal opening of the pressure lance. The retainer forms a well in the distal tip of the pressure nozzle and is configured to retain and position the orifice member completely inside the retainer such that the orifice member is coaxial with the distal end of the pressure nozzle and the liquid flow. The open distal end of the pressure spout extends beyond the distal end of the evacuation tube such that, in operation, a flow of liquid from the orifice member is directed toward the handle.

The nozzle assembly is manufactured by fixing a ring-shaped orifice member having a flat surface and a curved opposite surface into a holder or a retainer. The nozzle assembly is capable of withstanding internal liquid pressures of at least about 1,000psig without failure.

As shown in prior art FIG. 2, Versajet^TMThe Hydrosurgery system includes a piston pump implemented as a single-use handpiece. The pump includes a pump housing configured to be removably received by the 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, with the coupling section between the insertion section and the handle. The insertion section is configured to removably receive a push rod of a drive console. The articulated section comprises an outer oval flange. The valve assembly located in the pump housing includes an inlet passage, an outlet passage, an inlet ball valve and an outlet ball valve. The inlet and outlet passages are located side-by-side in the pump housing and are in fluid communication with a chamber defined in the insert section. The chamber has an inclined wall axially aligned with the inlet and outlet passages. The piston is slidably received within the chamber and includes a flexible member disposed within the chamber to be acted upon by the sloped 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 decouple the piston from the push rod is an axial force acting on the piston in a second direction opposite the first direction.

As shown in prior art FIG. 3, Versajet^TMThe Hydrosurgery system uses a single spike (spike) to connect to the saline bag.

Disclosure of Invention

Versajet^TMHydrosThe handle of the urgery system handpiece includes multiple components that require a complex assembly/welding process. In particular, Versajet^TMThe distal tip 5 of the Hydrosurgery system (FIGS. 1A-1C) has a complex geometry formed by metal injection molding and requires laser welding to the thin spout 11.

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

A waterjet 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 that receives liquid from the nozzle and defines a treatment window for treating tissue with a jet of liquid. The distal tip is integral with the upper housing.

Versajet^TMThe flow of water from top to bottom in the Hydrosurgery system requires bending the tip of the lance 11 and welding the lance 11 to the distal tip 5.

Particular embodiments of the current design switch the position of the spout tube and the evacuation tube, allowing the spout tube to have a straight distal region and eliminating the distal tip.

A waterjet handpiece for treating tissue includes a handle including an upper housing and a lower housing. The lower housing defines a treatment window. The head includes a spout mounted to the lower housing. The nozzle has a straight distal region. The treatment window is configured to treat tissue with a jet of liquid delivered to the treatment window via the spout. The handpiece includes an evacuation tube mounted to the upper housing.

Versajet^TMThe piston pump of the Hydrosurgery system also includes multiple components that require complex assembly.

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

A piston pump of a water jet debridement and wound bed preparation system includes an integrated monolithic piston assembly including a fitting holder, a feed line fitting, and a support screen. Embodiments of this aspect may include two handle halves connectable to form an internal cavity that houses components of a piston pump including an integrated, unitary piston assembly.

If the saline bag is empty, in Versajet^TMThe use of a single spike in the Hydrosurgery system may allow air to enter the tube and interlock the saline tube.

Two spike assemblies of the current design enable air to be expelled from the open spike.

A water jet debridement and wound bed preparation system includes a piston pump and two spikes with tubing extending from an inlet of the piston pump and configured to control air entering the system.

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 jet of liquid. The distal tip is integral with the housing.

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

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 component. The water jet handpiece includes an evacuated tube received by the lower housing. The spout includes a 180 degree curved distal end. The water jet handpiece includes an orifice member.

According to another aspect, a waterjet handpiece for treating tissue includes a handle having an upper housing and a lower housing, a nozzle mounted to the lower housing, and an evacuation 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 jet of liquid delivered to the treatment window via the spout.

Embodiments of this aspect may include a lower shell defining a distal inner surface and an upper shell defining a distal inner surface. The distal inner surface is configured to direct a jet of liquid from the treatment window to the evacuation tube.

According to another aspect, a waterjet handpiece for treating tissue includes a distal tip defining an internal flow path and a treatment window, a distal tip cap, and an orifice member between the distal tip and the cap. The handpiece is configured to flow liquid through the flow path and out of the orifice member to the treatment window.

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

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

According to another aspect, a water jet debridement and wound bed preparation system includes a piston pump, and two spikes with a conduit extending from an inlet of the piston pump and configured to control air entering the system.

According to another aspect, a waterjet handpiece for treating tissue includes a nozzle, an orifice member received in a distal end of the nozzle, and a spacer received in the distal end of the nozzle on a top of the orifice member between the orifice member and a fluid outlet of the nozzle. In the illustrated embodiment, the spacers are welded to the spout.

Drawings

Figures 1A-1C illustrate a prior art handle of a water jet debridement and wound bed preparation system.

Figure 2 shows a prior art piston pump of a water jet debridement and wound bed preparation system.

Figure 3 shows a prior art single point stab connection with a saline bag in a water jet debridement and wound bed preparation system.

Figures 4A-4I include various views of the handle of the water jet debridement and wound bed preparation system.

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

Figures 6A-6D include various views of another alternative embodiment of a handle of a water jet debridement and wound bed preparation system.

Fig. 7A-7F illustrate various embodiments of industrial designs for a handpiece.

Figures 8A-8D include various views of a piston pump of a water jet debridement and wound bed preparation system.

Figures 9A-9D include various views of an alternative embodiment of a piston pump of a water jet debridement and wound bed preparation system.

Figures 10 and 11 show the dual spike saline bag assembly of the water jet debridement and wound bed preparation system.

Figure 12 shows the drip chamber of the water jet debridement and wound bed preparation system.

Figures 13A-13C illustrate a console of a water jet debridement and wound bed preparation system.

Fig. 14A-16B illustrate various embodiments of an orifice member assembly process.

Detailed Description

Referring to fig. 4A-4H, handpiece 20 of the water jet debridement and wound bed preparation system includes a handle top housing 22 and a handle bottom housing 24. The handle top housing 22 has a proximal housing 22a and a distal housing 22b with a distal tip 26 that is an integral part of the distal housing 22b, e.g., one plastic molded or machined part, such that the distal tip 26 and the distal housing 22b are an integral, unitary part, and assembly of the handpiece does not include attaching the distal tip 26 to the distal housing 22 b. Received within distal housing 22b is a spout 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 the liquid jet. Received within the proximal housing 22a is a high pressure hose 23 through which high pressure water is fed to a jet tube 28. Integrating distal tip 26 with distal housing 22b eliminates the need to weld the nozzle tube to the distal tip.

Referring also to fig. 4H and 4I, the handle base housing 24 has a proximal housing 24a and a distal housing 24 b. When assembled, proximal housing 24a mates with proximal housing 22a, and distal housing 24b mates with distal housing 22 b. Leading from the proximal end 36a of the treatment window 36 to the distal housing 24b is an evacuation tube 32 partially covered by the distal housing 24 b. A connecting tube 33 leads from the evacuation tube 32 to a hose 34 through which the return flow leaves the handpiece.

With Versajet of the prior art^TMThe Hydrosurgery system is shorter with the high pressure nozzle 28 and shorter with the evacuation tube 32.

Referring to fig. 5, in an alternative embodiment, a handpiece 40 of a water jet debridement and wound bed preparation system includes a nozzle 42 having a liquid outlet orifice member 44. The spout 42 is received in the handle bottom housing 46 and the drain tube 48 is received in the handle top housing 50. In contrast to the nozzle 28 of fig. 4D, the nozzle 42 has a straight distal region 52. In addition, the handpiece 40 does not include components corresponding to the distal tip 26 of fig. 4D.

In use, liquid is ejected from the orifice member 44 of the spout 42, through the tissue treatment window 54 where the jet stream is used to debride the wound bed, impinges against the inner surfaces 56, 58 of the handle bottom and top housings 46, 50, respectively, and flows into the evacuation tube 48.

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

Fig. 7A-7D illustrate alternative handle designs.

Fig. 7E and 7F show an alternative handle design corresponding to the embodiment of fig. 6A.

Referring to fig. 8A-8D, the piston pump 60 has a reduced number of components and subassemblies as compared to the piston pump of fig. 2. The piston pump 60 includes an integrated, unitary piston assembly 62 that includes a fitting retainer 64, feed line fittings 66, 68, and a support screen 70, without requiring the feed line fittings to be assembled to the fitting retainer with the locating pins 16 of fig. 2, and without requiring the support screen 17 to be placed in the assembly of fig. 2. The integrated piston assembly 62 may be manufactured by, for example, metal injection molding, machining, and/or ceramic injection molding.

Instead of the two O-rings 18 of fig. 2, the piston pump 60 comprises a single O-ring 71. The piston pump 60 includes a handle 72 defining two channels 73 that receive the fittings 66, 68. The piston pump 60 further comprises two ball valves 73, a pump body 74, a piston 75 and a piston cap 76.

Referring to fig. 9A-9D, in another embodiment, the piston pump 80 includes two handle halves 82, 84 that are longer than the handle 19 of fig. 2 and the handle 72 of fig. 8A and when connected form an internal cavity that houses the components of the piston pump, including the integrated, unitary 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 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 assembly of the piston pump 80 and eliminate the need for the fluid passages 15 and 73 in the handle of fig. 2 and 8A.

Referring to fig. 10 and 11, the water jet debridement and wound bed preparation system 98 includes two saline tubes 100, 102 extending from an inlet 104 of a piston pump handle 106. The saline tube 100 terminates in a spike 107 connected to a saline bag 108. The saline tube 102 may be open to the atmosphere (fig. 10) or include a spike 109 (fig. 11) connected to a second saline bag 110. In the assembly of fig. 10, when there is an airlock in the system, air is vented from the open tube 102 with the clamp 111 in the open position. The tube 102 of fig. 10 is shown without spikes, but may alternatively include spikes. In the assembly of fig. 11, two spikes 107, 109 are connected to separate saline bags 108, 110 with respective clamps 112, 114 on the conduits 100, 102. In use, one of the clamps (e.g., clamp 112) is closed and the other clamp (e.g., clamp 114) is open. The saline in bag 110 is first opened using a clamp. When the saline bag 110 is empty, air will enter the tube 102 and the pump, which will cause the system to become airlocked. To reactivate the pump and remove the airlock, clamp 112 is opened, allowing saline to flow down tube 100 from bag 108, through the pump chamber, and back down tube 102 toward empty bag 110, thereby flushing air locked in the system. Once air is no longer seen exiting the pump, the clamp 114 is closed and the pump is now primed and will draw fluid from the bag 108.

Referring to fig. 12, in an alternative embodiment, a drip chamber 120 is used in the saline line that allows air to rise up 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 clog the tube and stop the procedure. In contrast to the embodiment of fig. 10 and 11, priming will stop if there is already air in the duct. The embodiment of fig. 10 and 11 allows air to rise even if the air is already in the brine line, so that the procedure is not affected.

Referring to fig. 13A-13C, a console 250 of the waterjet debridement and wound bed preparation system includes an LCD screen 252 for displaying device status information, such as power levels, procedure run times, outpatient/operating room modes, and service reminders. The console includes an interface 254 for receiving a piston pump 256, and an RFID reader 258 and antenna 260 for identifying an RFID tag 262 mounted in the piston pump handpiece.

Fig. 14A-16B illustrate various embodiments of an orifice member assembly process.

Referring to fig. 14A and 14B, to provide additional securement 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 assembly, end 304 of nozzle 306 is flared and orifice member 308 is placed within the end of the nozzle. A metal washer or metal bushing 302 is then placed on top of the orifice member 308 between the orifice member 308 and the fluid outlet at the nozzle end 304. The end 304 of the spout 306 is crimped to compress the washer or bushing 302 against the orifice member 308 and to crimp the washer or bushing to the spout with the orifice member. The addition of the washer or bushing ensures that the orifice member has less room to move during the assembly process, thereby increasing the uniformity of the crimping process and improving yield.

Referring to fig. 15, orifice member 308 may be laser welded directly into the end of spout 306. The orifice member is placed in the flared end of the nozzle and subsequently laser welded. The weld nuggets secure the orifice member in place.

Referring to fig. 16A and 16B, a washer or bushing 302 over the orifice member 308 of fig. 14A and 14B may be combined with laser welding. An orifice member 308 is placed in the end of the flared spout 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 to move during the assembly process. The advantage of laser welding on metal gaskets is that direct heat of the laser welding to the orifice member is avoided, which may alter material properties or weaken the orifice member. Laser welding has high consistency and repeatability, thereby ensuring higher yields during the manufacturing process.

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

Other embodiments are within the scope of the following claims.