METHOD OF PRE-TREATING MEDICAL INSTRUMENTS
20170252125 · 2017-09-07
Assignee
Inventors
Cpc classification
A61B90/70
HUMAN NECESSITIES
A61B50/39
HUMAN NECESSITIES
Y10T29/49826
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
B08B3/10
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A method of pre-treating a contaminated medical instrument that is to undergo decontamination involves inserting a distal tip of the instrument into a distal tip protector. The distal tip of the instrument is inserted through a rupturable resilient seal into an internal cavity of the protector that contains a fluid. The distal tip protector thereby maintains a fluid around the distal tip of the instrument until the distal tip protector is removed to allow reprocessing of the instrument to take place, facilitating decontamination of the instrument.
Claims
1. A method of pre-treating a contaminated medical instrument that is to undergo reprocessing, the method comprising; applying a rigid distal tip protector to a distal tip of the instrument; using the distal tip protector to maintain a fluid around the distal tip of the instrument while the distal tip is located within the distal tip protector; wherein the distal tip protector comprises a seal through which the instrument extends when the distal tip of the instrument is located in the distal tip protector, the seal being arranged to conform to a contour of the instrument to inhibit the leakage of fluid from the interior of the distal tip protector, wherein the step of applying the distal tip protector to the distal tip of the instrument comprises inserting the distal tip of the instrument though the seal into the distal tip protector; and rupturing the seal to insert the distal tip of the instrument into the distal tip protector, wherein the distal tip protector is pre-filled with the fluid before the seal is ruptured and the distal tip protector is applied to the distal tip of an instrument, the distal tip protector having a sealed chamber of the fluid into which the distal tip of the instrument is inserted.
2. The method of claim 1, wherein the seal is located at a proximal end of the distal tip protector.
3. The method of claim 1, wherein the seal is a resilient seal.
4. The method of claim 1, further comprising: removing the distal tip protector from the instrument; and subjecting the instrument to one or more reprocessing steps, wherein the one or more reprocessing steps comprise one or more decontamination steps.
5. The method of claim 4, wherein the one or more reprocessing steps are automated reprocessing steps.
6. The method of claim 4, wherein the step of subjecting the instrument to one or more automated reprocessing steps comprises locating the instrument in an automated decontaminating apparatus, and subjecting the instrument to an automated decontaminating cycle of the apparatus, and/or wherein the decontaminating steps are cleaning steps, comprising one or more of; deluge decontamination, ultrasonic decontamination, soaking and internal flushing steps.
7. The method of claim 1, wherein the distal tip protector is applied to the distal tip of the instrument at a first location, wherein the first location is a location of use of the instrument, and wherein the distal tip protector is left applied to the distal tip of the instrument maintaining the fluid around the distal tip until the instrument reaches a different, second location, being a reprocessing facility location.
8. The method of claim 1, wherein the distal tip protector does not include a sponge material.
9. The method of claim 1, wherein the distal tip protector is closed at the distal end thereof to prevent the passage of the fluid therethrough, the distal tip protector comprising no fluid inlet at the distal end thereof.
10. The method of claim 1, wherein the distal tip protector is tubular in shape.
11. The method of claim 1, wherein the distal tip protector has a length of at least 50 mm and/or the distal tip protector has a length of no greater than 300 mm.
12. The method of claim 1, wherein the distal tip protector has a diameter of at least 5 mm and/or the distal tip protector has a diameter of no greater than 25 mm.
13. The method of claim 1, wherein the medical instrument is a surgical instrument.
14. The method of claim 1, wherein the fluid comprises one or more decontaminating agents.
15. A method comprising: pre-treating a contaminated medical instrument that is to undergo reprocessing including decontamination such as ultrasonic decontamination by maintaining a fluid around a distal tip of the instrument prior to any reprocessing of the instrument as a pre-treatment for the decontamination, the pre-treating including: applying a rigid distal tip protector to the distal tip of the instrument, the distal tip protector having a proximal end and a distal end; using the distal tip protector to maintain the fluid around the distal tip of the instrument while the distal tip of the instrument is located within the distal tip protector, wherein the distal tip protector comprises a seal through which the instrument extends when the distal tip of the instrument is located in the tip protector, the seal being arranged to conform to a contour of the instrument to inhibit the leakage of the fluid from the interior of the distal tip protector; wherein the distal tip protector is closed at the distal end thereof to prevent the passage of the fluid therethrough, the distal tip protector comprising no fluid inlet at the distal end thereof; and removing the distal tip protector from the distal tip of the instrument and only then subjecting the instrument to one or more automated reprocessing steps, wherein the one or more reprocessing steps comprise one or more decontamination steps.
16. The method of claim 15, wherein the distal tip protector does not include a sponge material.
17. The method of claim 15, wherein the step of subjecting the instrument to one or more automated reprocessing steps comprises locating the instrument in an automated decontaminating apparatus, and subjecting the instrument to an automated decontaminating cycle of the apparatus.
18. The method of claim 15, wherein the decontamination steps are cleaning steps, comprising one or more of; deluge decontamination, ultrasonic decontamination, soaking and internal flushing steps.
19. The method of claim 15, wherein the distal tip protector is applied to the distal tip of the instrument at a first location, wherein the first location is a location of use of the instrument, and wherein the distal tip protector is left applied to the distal tip of the instrument maintaining fluid around the distal tip until the instrument reaches a different, second location, being a reprocessing facility location.
20. The method of claim 15, wherein the seal is located at a proximal end of the distal tip protector.
21. The method of claim 15, wherein the step of applying the distal tip protector to the distal tip of the instrument comprises inserting the distal tip through the seal into the distal tip protector.
22. The method of claim 15, wherein the medical instrument is a surgical instrument.
23. The method of claim 15, wherein the seal is a resilient seal.
24. The method of claim 15, further comprising a step of supplying the fluid to the distal tip protector before application of the distal tip protector to the distal tip of the instrument.
25. The method of claim 15, comprising applying the distal tip protector to the distal tip of the instrument and using the distal tip protector to maintain the fluid around the distal tip after use of the instrument and before the instrument undergoes reprocessing.
26. The method of claim 15, wherein the distal tip protector is tubular in shape.
27. The method of claim 15, wherein the distal tip protector has a length of at least 50 mm and/or wherein the distal tip protector has a length of no greater than 300 mm.
28. The method of claim 15, wherein the distal tip protector has a diameter of at least 5 mm and/or the distal tip protector has a diameter of no greater than 25 mm.
29. The method of claim 15, wherein the fluid comprises one or more decontaminating agents.
30. A method of pre-treating a contaminated medical instrument that is to undergo reprocessing, the method comprising; applying a distal tip protector to a distal tip of the instrument; and using the distal tip protector to maintain fluid around the distal tip of the instrument while the distal tip is located within the distal tip protector, wherein the distal tip protector comprises a resilient seal through which the instrument extends when the distal tip of the instrument is located in the tip protector, the resilient seal being arranged to conform to a contour of the instrument to inhibit leakage of the fluid from the interior of the distal tip protector.
31. The method of claim 30, wherein the distal tip protector is closed at the distal end thereof to prevent the passage of the fluid therethrough, the distal tip protector comprising no fluid inlet at the distal end thereof.
32. The method of claim 30, wherein the distal tip protector is rigid.
33. The method of claim 30, wherein the distal tip protector is rigid and wherein the distal tip protector does not include a sponge material.
34. The method of claim 33, wherein the method comprises rupturing the resilient seal to insert the distal tip of the instrument into the distal tip protector.
35. The method of claim 34, wherein the distal tip protector is pre-filled with the fluid before the protector is applied to the distal tip of an instrument, wherein the protector comprises a sealed chamber of the fluid into which the distal tip of the instrument is inserted.
36. The method of claim 30, wherein the distal tip protector comprises an internal cavity in which the distal tip is located when the distal tip protector is applied to the instrument, wherein the method comprises using the internal cavity to maintain the fluid around the distal tip of the instrument.
37. The method of claim 36, wherein the step of applying the distal tip protector to the distal tip of the instrument comprises inserting the distal tip of the instrument into the internal cavity, wherein the resilient seal is located at an entrance to the internal cavity.
38. The method of claim 36, wherein the distal tip protector comprises a hollow main body having an interior space, the internal cavity being defined at least in part by the interior space of the main body.
39. The method of claim 30, further comprising a step of supplying the fluid to the distal tip protector before or after application of the distal tip protector to the distal tip of the instrument.
40. The method of claim 30, wherein the distal tip protector further comprises heat generating means for heating the fluid around the distal tip when activated, the method further comprising activating the heat generating means to heat the fluid around the distal tip.
41. The method of claim 30, comprising applying the distal tip protector to the distal tip of the instrument and using the distal tip protector to maintain fluid around the distal tip after use of the instrument and before the instrument undergoes reprocessing.
42. The method of claim 30, further comprising removing the distal tip protector from the instrument and subjecting the instrument to one or more reprocessing steps, wherein the one or more reprocessing steps comprise one or more decontamination steps.
43. The method of claim 30, wherein the distal tip protector comprises multiple longitudinal sections that are connected together, the method further comprising a user assembling the sections together to provide the distal tip protector.
44. The method of claim 30, wherein the distal tip protector is tubular in shape.
45. The method of claim 30, wherein the distal tip protector has a length of at least 50 mm, or wherein the distal tip protector has a length of no greater than 300 mm.
46. The method of claim 30, wherein the distal tip protector has a diameter of at least 5 mm or wherein the distal tip protector has a diameter of no greater than 25 mm.
47. The method of claim 30, wherein the medical instrument has a working portion at the distal tip thereof.
48. The method of claim 30, wherein the medical instrument is a surgical instrument.
49. The method of claim 30, wherein the fluid comprises one or more decontaminating agents.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0113] Some preferred embodiments of the invention will now be described by way of example only and by reference of the accompanying drawing of which;
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DETAILED DESCRIPTION OF THE INVENTION
[0124] Referring to
[0125] The main body 3 defines a longitudinal side wall and a distal end wall, which are integrally formed with one another. The main body defines an interior space which provides an interior cavity 11 which is filled by a fluid. The fluid is a decontaminating fluid in the form of a liquid, and may be water, or may additionally include one or more decontaminating agents. The seal 9 seals the proximal end of this cavity to provide a fluid tight container.
[0126] The distal tip protector further comprises an end cap 13 which is used to protect the seal 9 before use of the distal tip protector.
[0127] The distal tip protector has a length L and a diameter d.
[0128]
[0129] As in the embodiment of
[0130] Again, the seal 18 is shown in an exploded view, and will be connected to the proximal end of the section 14 to seal the end of an internal cavity 13 defined by the main body of the protector and provide a fluid container, this time with the main body being defined by the sections 12 and 14 when connected together. A fluid is present in this internal cavity 13 in the use of the protector. The interior spaces of the two sections 12 and 14 define a continuous internal cavity of the main body. The seal is attached to the proximal end of the proximal end section 14 before the end section is supplied to a user.
[0131]
[0132] In embodiments of the type shown in
[0133]
[0134] Once again a proximal end of the proximal end section 22 is sealed by a ruptureable seal 28, which is shown in an exploded view in
[0135] When the sections 22 and 24 are assembled to one another, the sections provide a main body that defines an interior space providing an internal cavity 23 which contains a fluid during use of the protector. The proximal end of the cavity 23 is sealed by the seal 28 to provide a fluid holding container.
[0136] The embodiment of
[0137] Although not shown in
[0138] In this embodiment the protector may be filled with fluid before or after connection of the distal and proximal end sections to one another.
[0139] In
[0140] When the sections 32,36 and 34 are assembled together, they provide a main body defining a continuous interior space that provides an internal cavity 33 which holds fluid in use. At the proximal end of the proximal section 36, a rupturable seal 40 is provided which is located over the open end to close the proximal end of the internal cavity 33 to define a fluid holding container. An end cap 42 is provided for protecting the seal 40.
[0141] The protector of the
[0142] The embodiments of
[0143] The use of the distal tip protector in accordance of the embodiment of
[0144] The method will be described by reference to the pre-treatment of a contaminated surgical instrument 50 having a distal tip 52. The distal tip 52 includes a working portion which is connected to a shaft 54 of the instrument via a wrist 53. The working portion is the part of the surgical instrument which interacts with the body, and includes various moving parts whose surfaces may become contaminated e.g. with tissue or blood during use. The method is a method of pre-cleaning of the surgical instrument before the instrument undergoes full reprocessing step e.g. decontamination such as may include deluge cleaning, ultra-sonic cleaning, sterilisation, disinfection or any other cleaning processes, whether carried out manually or automatically to render the instrument suitable for reuse. The instrument is one which has been used in a surgical procedure. The method of pre-cleaning may be carried out in the operating theatre.
[0145] A user removes the end cap 13 from the proximal end of the main body 3 of the protector 1. This exposes the ruptureable seal 9 which closes the proximal end of the main body, and co-operates with the internal cavity 11 of the main body to hold a decontaminating fluid.
[0146] The user of the surgical instrument and pushes the distal tip 52 through the ruptureable seal 9 into the internal cavity 11, thereby bringing it into contact with the decontaminating fluid therein. Once the surgical instrument has been inserted in the protector, it will be as shown in
[0147] The resilient seal 9 cooperates with the shaft of the instrument 54 to grip the shaft and retain the distal tip in the protector, and also to provide a barrier to the passage of fluid out of the cavity 11 around the instrument. This enables the protector to remain attached to the instrument, and maintain fluid around the distal tip thereof, until it is removed by a user e.g. to allow the instrument to undergo decontamination. The resilient seal is formed of a material which allows it to conform to the contours of an instrument inserted therethrough in use to provide a fluid resistant seal therearound.
[0148] The distal tip protector is kept in position located over the distal end of the instrument until it undergoes reprocessing. This may be during storage or transport of the instrument e.g. from a site of use to a reprocessing facility. In this way, the working end of the instrument is kept moist by the fluid surrounding it, facilitating subsequent decontamination thereof, avoiding contaminants becoming coalesced and dried to the surfaces of the instrument.
[0149] Once a distal tip protector of the type shown in
[0150]
[0151] Of course the distal tip protector may be used in conjunction with numerous types of instrument, and those shown in
[0152] In the embodiments of
[0153] As mentioned above, in other embodiments a user may fill the protector i.e. the internal cavity thereof themselves, rather than the protector being supplied in a pre-filled form. This may be achieved by filling the internal cavity via a fluid inlet where provided, for example at a distal end in a manner shown in
[0154] Operation of the embodiment shown in
[0155] The embodiment of
[0156] The embodiment of
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[0160] Although the embodiments described use a rupturable resilient seal at the proximal end of the protector, it is envisaged that an apertured resilient seal could be used. Such a seal may still co-operate with an instrument when inserted therethrough in use to provide a suitable barrier to the passage of fluid out of the proximal end of the protector. In such arrangements, filling of the fluid holding chamber would need to occur after insertion of the medical instrument therein.
[0161] Although not shown in the illustrated Figures, heat generating means may be associated with the distal tip protector to provide heating of a fluid located in the internal cavity in use. This may enhance the effects of the fluid, particularly where it comprises enzyme containing decontaminating agents. Heat generating means may generate the heat via an exothermic reaction. Suitable components for generating heat via an exothermic reaction when mixed may be located e.g. to the exterior of a distal end of the distal tip protector, and may be activated to bring the components into contact with one another by a user. This might be via a simple manual action such as a squeezing action or similar, as used with heat packs. In other arrangements, exothermic heat generating means might be arranged to be activated when an instrument is inserted into the protector.
[0162] The distal tip protector in accordance with the invention of any of its embodiments may be of any suitable length. The total length may range from around 50 mm to 300 mm. In preferred embodiments the length of the protector is from 100 mm to 240 mm. The length of the main body of the protector is marked “L” in
[0163] Rather than using seals of the type shown in
[0164] The invention is particularly applicable to more complex instruments such as those used in key-hole surgery, minimally invasive procedures, laparoscopic procedures, robotic surgery, incisionless surgery or NOTES surgery, but may be applied to other types of instrument.
[0165] Although the present invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the scope of the invention as set forth in the accompanying claims.