disposable blade holder set

专利摘要:
DISPOSABLE BLADE SUPPORT ASSEMBLY A rotary knife operated with energy having a reusable handle assembly and a disposable blade support assembly including a head portion and a blade support portion extending from the head portion, with the end of a debridement operation on a donor, the used blade holder assembly is removed from the cable assembly and discarded, the cable assembly is autoclaved / sterilized and a new, sterile blade holder assembly is attached to the cable assembly before subsequent use. The knife includes a connection assembly to reliably connect the disposable blade support assembly to the handle assembly and a retainer structure positioned in an annular groove formed on a lower surface of the blade housing portion, the retainer structure leaning against a rotary annular knife blade and the blade housing portion for permanently retaining an annular body section of the annular groove blade.
公开号:BR112012026351B1
申请号:R112012026351-0
申请日:2011-04-05
公开日:2021-03-09
发明作者:Jeffrey Alan Whited；David Curtis Ross；Dennis R. Seguin Jr.；Geoffrey D. Rapp
申请人:Bettcher Industries, Inc；
IPC主号:

专利说明:

Technical field
[001] The present disclosure relates to a method and apparatus for using a rotary knife operated with energy to debride tissue from bones recovered from a human donor and, more specifically, with a rotating knife operated with energy having a set of reusable cable and disposable blade support set, with the end of a tissue debridement operation in the bones recovered from a donor, the used blade support set is removed from the cable set and discarded, the cable set is sterilized / autoclaved and a new, sterile blade support assembly is attached to the cable assembly prior to subsequent use. Background of the invention
[002] Power operated rotary knives are widely used in meat processing facilities for meat cutting and cutting operations. Such energy operated rotary knives typically include a handle assembly including a head member extending from the handle assembly, an annular blade housing coupled to the head member via a clamp assembly, and an annular rotary blade supported for rotation by the blade housing. The annular rotating blade of a rotary knife operated with conventional energy is rotated by a drive mechanism including a flexible driving shaft that extends through an opening in the handle assembly and contacts a pinion gear supported in a distal portion of the head member of the cable assembly. The flexible drive shaft includes a stationary outer cover and a rotating inner drive shaft that is driven by a pneumatic or electric motor. The pinion gear teeth mesh with matching gear teeth formed on an upper surface of the annular rotating blade. With the pinion rotating through the flexible driving shaft, the annular rotating blade rotates inside the blade housing at a high RPM, in the order of 1,500-2,000 RPMs. Conventional powered rotary knives are disclosed in US patents 6,354,949 for Baris and others, 6,751,872 for Whited and others, 6,769,184 for Whited, and 6,978,548 for Whited and others, all of which are assigned to the assignee of this invention and all of which are incorporated herein in their respective totalities by reference.
[003] Due to advances in biomedical technology, tissue engineering and the ability to safely sterilize musculoskeletal tissue, there is a growing demand for more donated human tissue. Musculoskeletal, cardiovascular, ocular and skin / dermis are tissues commonly recovered for transplantation. Tissue processing agencies typically receive tissue after legal authorization is obtained under the Uniform Anatomical Donation Act (UAGA) and have adopted state reviews from the procurement agencies approved by the Food and Drug Administration (FDA) and the American Food Association. Tissue Banks (AATB). After a comprehensive selection process, the tissue can be used for purposes of transplantation, medical research and / or medical education. Long bones of the human body, eg, femurs are especially valuable due to their thicker cortical walls and therefore their ability to be manufactured in weight-bearing vertebral constructions. In some cases, bone marrow can also be extracted to create bone products infused from stem cells which promote incorporation and healing. In many cases, the soft tissues of the lower extremities can also be recovered for transplant purposes such as gracilis, semitendinosus, Achilles and knee tendons. The requirements for successfully recovering bones from human donors are stringent, both in terms of the very limited period of time after death in which bones can be successfully recovered after the donor dies (typically, within 24 hours after death) and in terms of the sterility conditions required during the bone harvesting process. The sterility required to harvest human donor body parts is similar to the sterility required during human surgery.
[004] Under AATB guidelines, human bone must be recovered within 24 hours of the documented hour of death if the body is refrigerated and within 15 hours of the documented death time if the body is not refrigerated. Under the established rules, if a death occurs in a hospital, the descendants must be referred for evaluation of organ / tissue donation to the designated organ procurement organization (OPO) of the hospital. OPO may have its own tissue recovery team or may choose to refer to a contracted tissue and eye recovery agency for assessing medical suitability. If the donor is medically released for donation, the tissue is recovered by trained technicians in a clean environment using sterile disposable sheets and instrumentation. The tissue is usually recovered in a "zone" or, at the donor site, cultured and individually placed in individual bags on wet ice in shipping containers validated prior to dispatch to a tissue processor.
[005] Once the shipping container is received at a musculoskeletal tissue processing facility, the tissue is monitored for temperature and inventoried. Typically, the tissue is cultured, repackaged and stored in freezers until the results of serological, microbiological and fungal tests are completed. In addition, a complete medical registered examination, to include the donor's medical / social history and post-mortem examination, if applied, are examined by a medical doctor before the tissue is released for processing. With the release, the tissue is thawed and moved to technicians who are involved in bone debridement. Debridement is the process that involves removing tissue such as muscle, ligaments, tendons, adipose and other tissues from the recovered bone. After debridging the bones, the recovered, debrided bones are placed in a container having a low temperature interior region to preserve the recovered bones placed in the container. Generally, no coarse debridement with energy driven tools is performed by field recovery teams. Processors prefer block leg recovery to prevent recovery team technicians from damaging tendons and menisci. Coarse debridement is performed by a separate technical team in a controlled environment at the musculoskeletal tissue processing facility, eg, AlloSource, Regeneration Technologies, Incl., Or Musculoskeletal Transplant Foundation.
[006] Regarding the recovery of skin or full-thickness dermis, removal of the upper dermal layer and fat is required prior to processing. This is also referred to as a debridement tissue. Such an upper layer of skin tissue from the donor's abdomen and buttocks area can be used as, for example, a cap or cover for severely burned areas of a burned patient.
[007] Typical instruments used to remove or debride tissue from recovered bones include scalpels, stainless steel medical chisels, and energy operated tools having disposable stainless steel brushes, where brush bristles remove tissue from the bone surface by rubbing recovered. In addition, a liquid can be applied to a recovered bone to soften attached tissue before debridement. Unfortunately, the use of electrically operated scalpels, chisels and brushes is slow, time-consuming and tedious. The debridement process can include multiple steps: first, the larger pieces of tissue attached to a recovered bone can be removed with a chisel; the remaining smaller pieces of fabric can be cut off with a chisel; finally, the remaining tissue can be removed by scrubbing with an energy-operated brush.
[008] Additionally, since ensuring sterility in the recovery process and avoiding the possibility of cross contamination between donors is of paramount importance, the instruments used for tissue debridement must be sterilized before use and one or the other: 1) disposable with the end of the harvesting process for a given donor; or 2) capable of autoclaving, that is, being sterilized after use.
[009] Using rotary knives operated with energy seems to have potential for use in the removal of various tissues and / or tissue recovery operations, including, for example, debridging bones, debridling full-thickness skin, recovery of tendons and ligaments, among others . However, the sterility requirements of the human donor recovery process raise concerns and create problems that have effectively prevented the use of conventional energy-operated rotary knives in the recovery of human donors. The number of individual components of a rotary knife operated with conventional energy is large and the assembly / disassembly process takes time. Therefore, the time and cost to disassemble and sterilize all components of a rotary knife operated with conventional energy and then reassemble the knife under sterile conditions before using it in a new donor would be problematic. Additionally, the disposability of, for example, the annular rotating blade is not economically feasible, that is, the annular rotating blade of a rotary knife operated with conventional energy is simply too expensive to be discarded after using the blade for a relatively short time. in a single donor. When used in meat processing facilities, a typical annular rotary blade is re-sharpened numerous times and, when properly maintained, can be used for an extended period of time in the range of 50-100 hours or more, before being discarded.
[0010] What is needed is an energy-operated rotary knife that can be effectively used for tissue removal or tissue debridement in the recovery of human donor body parts, including, but not limited to bone debridement, skin debridement full thickness, and / or tendon / ligament recovery operations / processes. What is also needed is an energy-operated rotary knife that is cost-effective for use in the recovery of donor human body parts, including but not limited to, the removal or debridement of tissue such as bone debridement, skin debridement full thickness, tendon / ligament harvesting operations / processes. What is also needed is a rotary knife operated with energy that provides a reduced number of components, ease of sterilization of reusable components, and / or disposable components / assemblies. What is also needed is an energy-operated rotary knife that is easy to assemble and disassemble for purposes of sterilization and / or replacing disposable components / assemblies.
[0011] It should also be recognized, of course, that the former is also applicable to non-human donors. For example, certain animals, such as pigs, have parts of the body that can be useful to human patients and are therefore recovered for medical purposes. Therefore, to the extent that tissue recovery operations such as bone debridement, skin debridement, tendon / ligament collection operations / processes are performed on non-human donors, the method and apparatus of this disclosure are equally applicable and are intended to cover such non-human donors and associated recovery / collection operations / processes. Summary of the invention
[0012] The present disclosure relates to a method and apparatus for using an energy-operated rotary knife for the removal or debridement of tissue in connection with tissue recovery operations such as, but not limited to, bone debridement, debridement full thickness skin, tendon / ligament recovery operations / processes from a donor's body and, more specifically, to an energy-operated rotary knife having a reusable handle assembly and disposable blade support assembly, with the end of a tissue removal or debridement operation, the used blade support assembly is removed from the cable assembly and discarded, the cable assembly is autoclaved / sterilized and a new sterile blade support assembly is attached to the before a subsequent use of the energy-operated rotary knife in a subsequent donor.
[0013] An exemplary configuration of the present disclosure includes a disposable blade holder assembly for an energy operated rotary knife including a handle assembly including an elongated handle defining a longitudinal through hole and an interface element at a distal end of the handle assembly along a longitudinal geometric axis of the cable assembly. The disposable blade support set features: a head portion; a blade housing portion extending from a distal end of the head portion, the blade housing portion including an annular ring and defining an annular groove on a lower surface of the annular ring; a rotary annular knife blade permanently supported for rotation within the annular groove of the blade housing portion, the blade having first and second ends spaced axially from each other and an annular body extending between them, the annular body including a body support section annular adjacent the first end, the annular body support section defining a plurality of gear teeth at the first end, the annular body additionally including an annular blade section adjacent to the second end, the annular blade section defining a cutting edge at the second edge; a driving gear mechanism rotatably supported within the head portion and including a plurality of gear teeth which engage with the plurality of gear teeth of the annular body support section for rotating the blade; and a retainer structure including a retainer holding and rotatingly supporting the annular body support section of the knife blade within the annular groove, the retainer permanently attached within the annular groove. In an exemplary configuration, the disposable blade holder assembly includes an interface structure disposed at a proximal end of the blade holder assembly, the interface structure contacting the cable assembly interface element to reliably connect the blade holder assembly to the assembly cable.
[0014] Another exemplary configuration of the present disclosure includes an energy-operated rotary knife featuring: a handle assembly including an elongated handle defining a longitudinal through hole; a disposable blade support assembly including a head portion, a blade housing portion extending from the head portion, and an annular rotary knife blade permanently supported for rotation within the blade housing portion, the blade having first and second ends axially spaced apart and an annular body extending between them, the annular body including an annular body support section adjacent the first end, the annular body support section defining a plurality of gear teeth on the first end, the body annular blade additionally including an annular blade section adjacent the second end, the annular blade section defining a cutting edge at the second edge, the blade support assembly additionally including a driving gear mechanism rotatably supported within the head portion and including a plurality of gear teeth that mesh with the plurality of gear teeth gear of the annular body support section to rotate the blade; and a connection assembly for releasably connecting the blade support assembly to the cable assembly, the connection assembly including: an interface element at a distal end of the cable assembly along a longitudinal geometric axis of the cable assembly; an interface structure disposed at a proximal end of the blade support assembly, and a retainer for reliably connecting the blade support assembly to the cable assembly by coupling the interface element and the interface structure.
[0015] Another exemplary configuration of the present disclosure includes a connection set for reliably connecting a blade support assembly to a handle assembly of an energetically operated rotary knife. The connection assembly features: an interface element arranged at a distal end of the cable assembly along a longitudinal geometric axis of the cable assembly; an interface structure disposed at a proximal end of the blade support assembly, the socket defining an opening receiving the cable assembly interface projection when the blade support assembly is connected to the cable assembly, one of the interface element and the interface structure comprising an interface projection and the other of the interface element and the interface structure comprising a socket; and a retainer for reliably connecting the blade support assembly to the cable assembly, one of the socket and the interface projection including a retainer receiver receiving a retainer and the other of the socket and the interface projection including a support surface of retainer to support against the retainer to prevent detachment of the blade support assembly and the cable assembly.
[0016] Another exemplary configuration of the present disclosure includes a retainer structure for permanently retaining and supporting an annular rotary knife blade from an energetically operated rotary knife with an annular groove formed on a lower surface of a blade housing portion of the blade support assembly of an energetically operated rotary knife, the retainer structure having a retainer permanently fixed within the annular groove, the retainer including: an upper wall; a first plurality of tongues; and a second plurality of tongues; the first plurality of tabs extending radially outward and downward from the upper wall and are sized to have an interference fit with a radially external wall of the annular groove to permanently secure the retainer within the annular groove; and additionally where the second plurality of tongues extend radially outward and downward from the upper wall, each of the second plurality of tongues having a first and second portion forming a radially inward support track generally shaped from L to rotatingly support a support section of the annular blade body.
[0017] Another embodiment of the present disclosure includes an energy-operated rotary knife featuring: a handle assembly including an elongated handle defining a longitudinal through hole; a disposable blade support assembly including a head portion and a blade housing portion extending from the head portion, the blade housing portion including an annular groove on a lower surface of the blade housing portion, the groove annular generally has a rectangular cross section and is defined by an upper wall and first and second opposite side walls, the first side wall being radially outwardly from the second side wall; a rotary annular knife blade permanently supported for rotation within the blade housing portion, the blade having a body section and an annular blade section extending angularly axially downward from a lower surface of the body section, a surface upper section of the body defining a plurality of gear teeth; a driving gear mechanism supported within the nose section and including a plurality of gear teeth that engage with the plurality of gear teeth at the second end of the blade to rotate the blade; a connection assembly for reliably connecting the disposable blade holder assembly to the cable assembly; and a retainer structure permanently attached within the annular groove and providing at least two supporting surfaces to rotatively support the blade body section within the annular groove.
[0018] In one aspect, the present disclosure includes a method for debridging tissue using a rotary knife operated with energy, the steps of the method featuring: a) providing a rotary knife operated with energy including: a cable assembly including an elongated cable defining a longitudinal through hole, a disposable blade holder assembly including a blade housing portion, a head portion, a rotary annular knife blade permanently supported for rotation within the housing portion, the blade having first and second ends spaced axially to the part, the first end including an annular blade section and the second end defining a plurality of gear teeth, and a driving gear mechanism rotatably supported within the head portion and including a plurality of gear teeth engaging with the plurality of gear teeth on the second end of the blade to rotate the blade, and a set connection point for reliably connecting the blade holder assembly to the cable assembly; b) use the energy-operated rotary knife to cut a layer of fabric; and c) removing the cut layer of fabric. Brief description of the drawings
[0019] The foregoing and other characteristics and advantages of the present disclosure will become apparent to someone experienced in the technique to which the present disclosure relates by considering the following description of the invention with reference to the accompanying drawings, where equal reference numerals , unless otherwise described, refer to identical parts across all drawings and in which:
[0020] Figure 1 is a schematic perspective view of an exemplary configuration of a rotary knife operated with energy of the present disclosure including a first exemplary configuration of cable connection structure to reliably couple a disposable blade holder assembly to a set of reusable cable;
[0021] Figure 2 is a schematic view in exploded perspective of the rotary knife operated with energy of Figure 1;
[0022] Figure 3 is a schematic side elevation view of the rotary knife operated with energy of figure 1;
[0023] Figure 4 is a schematic top plan view of the rotary knife operated with energy of Figure 1;
[0024] Figure 5 is a schematic view in longitudinal section of the rotary knife operated with energy of figure 1;
[0025] Figure 6 is a schematic perspective view of the energy-operated rotary knife of Figure 1 with the reusable handle assembly detached from the disposable blade holder assembly to show the first handle link structure configuration;
[0026] Figure 7 is a schematic longitudinal sectional view of a portion of the rotary knife operated with energy of Figure 1 showing the first configuration of the cable connection structure;
[0027] Figure 8 is a schematic side elevation view of the energy operated rotary knife of Figure 1 with the reusable cable assembly detached from the disposable blade holder assembly to show the first cable connection structure configuration;
[0028] Figure 9 is a schematic perspective view of another exemplary configuration of a rotary knife operated with energy of the present disclosure including a second exemplary configuration of cable connection structure for reliably coupling a disposable blade holder assembly to an assembly reusable cable assembly cable;
[0029] Figure 10 is a schematic longitudinal view, partly in section and partly in side elevation, of a portion of the rotary knife operated with power of Figure 9 showing the second configuration of the cable connection structure;
[0030] Figure 11 is a schematic perspective view of another exemplary configuration of a rotary knife operated with energy of the present disclosure including a third exemplary configuration of cable connection structure for reliably coupling a blade support assembly to a set of reusable cable assembly cable;
[0031] Figure 12 is a schematic perspective view of a portion of the rotary knife operated with energy of Figure 10 showing a disposable blade holder assembly and a first exemplary configuration of blade retainer structure for retaining an annular rotary knife blade in the disposable blade holder assembly, the blade retainer structure including a one-piece flap retainer;
[0032] Figure 13 is a schematic perspective view of the annular rotary knife blade and the tabbed blade retainer structure of figure 12;
[0033] Figure 14 is a schematic top plan view of the annular rotary knife blade and the tabbed blade retainer structure of figure 12;
[0034] Figure 15 is a schematic plan view below the disposable blade holder assembly of figure 12 with the annular rotary knife blade and the blade structure with flaps removed to show the retaining notches in the blade housing portion. to accept the tabbed blade retainer structure;
[0035] Figure 16 is a schematic plan view below the disposable blade holder assembly of figure 12 with the annular rotary knife blade and blade retainer structure supported within the blade holder assembly;
[0036] Figure 17 is a schematic, enlarged, bottom plan view of a portion of the blade support assembly, the annular rotary knife blade, and the tabbed blade retainer structure of figure 16;
[0037] Figure 18 is a schematic view in axial section of the annular rotary knife blade, the blade retainer structure with flaps and the disposable blade support assembly, as seen from a plane indicated by line 18-18 in figure 17;
[0038] Figure 19 is a schematic view in axial section of the annular rotary knife blade, the blade retainer structure with flaps and the disposable blade support assembly, as seen from a plane indicated by line 19-19 in figure 17;
[0039] Figure 20 is a schematic axial sectional view of the annular rotary knife blade, the flanged blade retainer structure and the disposable blade support assembly, as seen from a plane indicated by line 20-20 in figure 17;
[0040] Figure 21 is a schematic perspective view of a portion of the energy-operated rotary knife of Figure 1 showing a disposable blade holder assembly and a second exemplary retainer structure configuration for retaining an annular rotary knife blade in the assembly disposable blade holder, the blade retainer structure including a one-piece annular retainer assembly;
[0041] Figure 22 is a schematic sectional view of the blade holder assembly, the annular rotary knife blade, and the one-piece blade retainer structure of figure 21;
[0042] Figure 23 is a schematic enlarged sectional view of a portion of the blade holder assembly, annular rotary knife blade, and the one-piece blade retainer structure of figure 22;
[0043] Figure 24 is a schematic perspective view of a portion of the energy-operated rotary knife of Figure 1 showing a disposable blade holder assembly and a third exemplary retainer structure configuration for retaining an annular rotary knife blade in the assembly disposable blade holder, the blade retainer structure including a two-piece retainer;
[0044] Figure 25 is a schematic sectional view of the blade holder assembly, the annular rotary knife blade, and the two-piece blade retainer structure of figure 23;
[0045] Figure 26 is a schematic enlarged cross-sectional view of a portion of the blade holder assembly, annular rotary knife blade, and the two-piece blade retainer structure of figure 25;
[0046] Figure 27 is a schematic top plan view of an alternative exemplary configuration of an energy-operated rotary knife of the present disclosure including a second exemplary configuration driving gear and drive mechanism that includes a flexible driving shaft that extends through a longitudinal opening through the handle assembly to drive an alternative exemplary configuration of an annular rotary knife blade;
[0047] Figure 28 is a schematic view in longitudinal section of the rotary knife operated with energy of figure 27, as seen from a plane indicated by line 28-28 in figure 27;
[0048] Figure 29 is an exploded perspective view of the disposable blade holder assembly of the energy operated rotating knife of figure 27; and
[0049] Figures 30-33 are schematic representations of an energy operated knife of the present disclosure used in a method to debride or remove tissue from a bone. Detailed Description
[0050] The present disclosure relates to a method and apparatus for using an energy-operated rotary knife to remove and / or recover tissue from a donor in connection with tissue recovery operations, including, but not limited to, bone debridement , full-thickness skin debridement, and / or tendon / ligament recovery operations / processes (all such tissue removal / recovery operations will generally be referred to here as “removing tissue”, “recovering tissue”, debriding tissue ”or“ debridement of tissue ”). More specifically, the present disclosure relates to a rotary knife operated with energy having a set of reusable handle and set of disposable blade support, and with the end of operations of removal / recovery / debridement of tissue in a donor, the set of support of the used blade is removed from the cable assembly and discarded, the cable assembly is autoclaved / sterilized and a new, sterile blade support assembly is attached to the cable assembly before using the knife for a subsequent collection operation and a new donor. Advantageously, the cable assembly is configured to be easy to assemble and disassemble and is made of materials that are durable and able to withstand repeated autoclave / sterilization cycles. Also, advantageously, the main body of the blade support assembly, in an exemplary configuration, is made of PPS (poly (phenylene sulfide resin)), a plastic material that is light, strong, resistant to chemicals, suitable for molding injection and is relatively inexpensive.
[0051] An exemplary configuration of a rotary knife operated with energy of the present disclosure is generally shown at 10 in figures 1-6. The energy operated rotary knife 10 includes a reusable handle assembly 20, a disposable blade holder assembly 60, a connection assembly 100 to releasably connect the handle assembly 20 to the blade holder assembly 60 and a blade retainer structure 150 for attaching an annular rotary knife blade 200 for rotation to a blade housing portion 62 of the blade holder assembly 60. The blade holder assembly 60 includes an integral molded main body 61 that includes the blade housing portion 62 and a head portion 80. In an exemplary configuration, the one-piece main body 61 is made of PPS or other material known to have comparable properties. Head portion 80, among other things, supports a driving gear mechanism 92 which rotates blade 200 within blade housing portion 62.
[0052] The blade 200 is supported by the blade housing portion 61 for rotation on a central geometric axis of rotation AC (figures 3 and 4). The central axis of rotation AC of the blade 200 is substantially congruent with a central axis of the blade housing portion 62. The cable assembly 20 extends away from the blade support assembly 60 along an axis of HA cable. (Figure 1) which is substantially orthogonal to the central geometric axis of the AC blade, allowing a knife operator 10 to handle the knife with one hand. As used here, axial, upper and lower should mean movement or a dimension in a direction generally along or parallel to an extension of the central AC axis. Forward or distal should mean in a direction generally along a direction labeled F in Figure 1, the direction F being generally parallel to or along the HA cable geometric axis. Backward or close should generally mean in a direction opposite to the F direction.
[0053] Advantageously, the present disclosure contemplates a number of exemplary configurations of the connection set 100 and a number of exemplary configurations of the blade retainer structure 150, each of the configurations of connection set capable of being interchangeably combined with each of the blade retainer frame configurations to provide maximum flexibility for the rotary knife design of the present disclosure. In addition, the present disclosure contemplates at least two different driving sets, an air motor configuration and a flexible driving shaft configuration to provide driving power to rotate the blade 200 within the disposable blade holder set 60. Handle set 20
[0054] As can be better seen in figure 5, the cable assembly 20 includes an elongated cable 21 extending along the geometric axis of the HA cable. The handle 21 includes an inner cable assembly sleeve 22 and an outer hand grip 23. The outer hand grip 23 is made of a resilient waterproof material and is contoured for easy gripping. In an exemplary configuration, the inner sleeve 22 is made of stainless steel and the outer hand grip 23 is thermal, softer plastic rubber that is overmolded over the sleeve. Alternatively, the inner sleeve 22 and the hand cuff 23 can be manufactured as a high temperature plastic member, in one piece. The inner cable assembly sleeve 22 defines a longitudinal through hole 24. Supported in the longitudinal through hole 24 is a driving assembly 25 including a vane or pneumatic air motor 26 and a planetary gear reduction unit 27. The motor 26 includes a rotor 28 eccentrically mounted within a bore defined by a motor body 29. The rotor 28 is supported for rotation by a pair of ball bearings 30 within the motor body 29.
[0055] A plurality of vanes 31 are supported for inward and outward radial movement in respective slits 32 formed on the external surface of the rotor 28. High pressure air is communicated via an air hose (not shown) coupled to a proximal end 33 of the cable assembly 20 and directed into the motor body 29 through an air inlet 34. Air is routed through the main body 29 and directed against the plurality of vanes 31 to rotate the rotor 28 as is conventional in engines air vane type. The exhaust air leaves the main body 29 via an air outlet 35 surrounding the air inlet 34. The rotor includes an outlet shaft 36 coupled to the planetary gear reduction unit 27. The torque on the rotor outlet shaft 36 it is a product of air pressure, an exposed vane area between an external surface of the rotor and the motor body bore, and a vane moment arm.
[0056] The planetary gear reduction unit 27 serves to convert the high rotational speed of the rotor shaft 36 to a drive coupling 37 that rotates at a lower speed but at a torque output higher than the rotor shaft. The planetary gear reduction unit 27 and air motor 26 are secured inside the through hole 24 of the inner cable assembly sleeve 22 by a retaining nut 38 that rests against the motor body 29. The drive coupling 37 of the unit planetary gear reduction unit 27 receives a proximal end portion 96 of a driving shaft 94 of the driving gear mechanism 92 which, in an exemplary configuration, is a pinion assembly 93. The driving gear mechanism 92 is part of the blade support assembly disposable 60.
[0057] As can be better seen in figures 3 and 4, the cylindrical proximal end 39 of the inner cable assembly sleeve 22 includes a groove 40 on an outer surface of the sleeve. The groove accepts a rotating bayonet lock on an air hose (not shown) that supplies air to the air motor 25. A foot pedal valve is coupled to the air hose to provide the operator with the ability to activate the knife 10, that is, supplying air to the motor 26 thereby making the annular rotary knife blade 200 rotate at a high rotational speed (of the order of 1,500 to 2,000 RPM) within the blade housing portion 62 of the disposable blade holder assembly 60. Alternatively, an actuating valve (not shown) can be mounted at the proximal end 39 in which case knife 10 is actuated by a lever (not shown) hingedly attached to the cable assembly 20. Motor 26 is actuated when the hand grip 23 is grabbed by the operator and the lever is pivoted towards the handgrip and is switched off when the lever is released by the operator.
[0058] As can be better seen in figure 7, the cable assembly 20 also includes a connection structure 110 supported within a front or distal end portion 41 of the cable assembly. Although the cable assembly connection structure 110 is part of the cable assembly 20, it is also a component of the connection assembly 100. The cable assembly connection assembly 110 engages a connection structure 130 of the head portion 80 of the disposable blade holder assembly 60 to reliably connect blade holder assembly 60 to cable assembly 20. Connection assembly 100, including cable assembly connection structure 110 and head portion connection structure 130, facilitates the removal and disposal of the disposable blade support assembly 60 from the reusable cable assembly 20, for example, subsequent to the end of tissue debridement of a given donor. The blade support set used advantageously is replaced by a new sterile blade support set prior to a subsequent tissue debridement session in a new donor. In the meantime, the cable assembly 20 is configured to be easily disassembled and sterile, such that it is sterilized before connecting a new sterile blade holder assembly. In an exemplary configuration, the cable assembly connection structure 110 is plugged and the proximal end 33 of the cable assembly 20 is covered with a cover to protect the air motor 20 from damage during the sterilization process.
[0059] The cable assembly connection structure 110 includes a coupling 111 attached to the internal cable assembly sleeve 22, a cylindrical collar 112 that includes an interface element such as an interface projection 113 that protrudes distally (in a direction F) from a front wall 42 defined by cable assembly 22, and a threaded retainer 114 that secures collar 112 against coupling 111. The collar interface projection 113 engages the assembly head portion connection structure blade holder 130. In an exemplary configuration, the head portion connecting structure 130 includes a proximal / backward cylindrical interface region 131 in the form of a socket 132. Socket 132 defines a generally cylindrical opening 133. The projection of interface 113 combined contacts and mounts within the cylindrical opening 133 of socket 132.
[0060] As can be better seen in figure 7, coupling 111 includes internal threads 115 that receive external threads combining 116 from threaded retainer 114. Threaded retainer 114 includes a distal extreme portion radially outwardly 117 which, when retainer 114 is threaded into coupling 111, rests against an internal shoulder 118 of collar 112. As threaded retainer 114 is threaded into coupling 111, the extreme portion of retainer 117 contacts and rests against the internal collar shoulder 118 to force a staggered rear end portion 119 of collar 112 against a corresponding staggered front end 120 of coupling 111 to rigidly secure collar 112 with respect to cable assembly 20. Advantageously, retainer 114 includes a central opening with hexagonal shape 121 at a front end 122 of retainer 114 to allow easy assembly / disassembly of retainer 114 and collar 112 from the head assembly o 20 using a conventional hexagonal drive tool. Blade holder set 60
[0061] The blade support assembly 60 includes the blade housing portion 62 and a head portion 80 that are part of a unitary main body 61. The blade housing portion 62 supports the annular rotary knife blade 200 for rotation , while the head portion 80 supports the drive gear mechanism 92. The drive gear mechanism 92 is driven by the drive assembly 25 of the handle assembly 20 and in turn rotates the rotary knife blade 200 as it is supported within the blade housing portion 62. The head portion 80 also includes the connecting structure 130. Although the head portion connecting structure 130 is part of the head portion 80, it is also a component of the connection 100. The head portion connection structure 130 engages the cable assembly connection structure 110 to reliably connect the blade holder assembly 60 to the cable assembly 20. Head portion 80
[0062] The head portion 80 of the blade support assembly 60 includes the connecting structure 130 formed in the generally cylindrical interface region 131 at a back / proximal end 81 of the head portion 80. The interface region 131 includes the socket 132 which defines the cylindrical opening 133 (figure 7) which extends substantially along the central geometric axis HA and receives the interface projection 113 of the cable assembly connection structure 110. The rear end 81 of the cable portion includes a wall proximal or staggered rear 82. As best seen in figure 7, when the cable assembly 20 and the blade holder assembly 60 are correctly and completely engaged, the staggered rear wall 82 of the head portion interface region 131 entests the front wall 42 of the cable assembly.
[0063] The blade support assembly 60 additionally includes the drive gear mechanism 92 rotatably supported within the head portion 80. The drive gear mechanism 92 includes a pinion 97 and an integral driven shaft 94. In an exemplary configuration, the pinion 97 is comprised of a temperature-resistant plastic material such as poly (ether-ether-ketone) (PEEK) or some other suitable material, while the driven shaft 94 is comprised of metal or some other suitable material. Pinion 97 includes a plurality of gear teeth 98 that mesh with a plurality of gear teeth 214 of the rotary knife blade 200 to rotate the blade 200. The rear end portion 96 of the driven shaft 94 is coupled to and rotatably driven by the coupling of drive 37 of the planetary gear reduction unit 27. This causes the pinion 97 to rotate and, in turn, rotates the blade 200.
[0064] Pinion 97 is supported for rotation in a cylindrical cavity 84 defined within a body region 85 of the head portion 80. Cavity 84 is longitudinally aligned with the cylindrical opening 133 of the interface region 131, that is, aligned along the HA cable geometric axis and slightly smaller in diameter than the cylindrical opening of interface region 133. The cavity 84 is defined by a cylindrical wall 84a and is positioned in the head portion body region 85 such that a front portion 99 (figure 5) of the gear teeth 98 of the pinion 97 engage and activate the corresponding gear teeth 214 of the annular rotary knife blade 200.
[0065] A retainer ring 86 is inserted into a distal end of the cylindrical opening 133, adjacent to the cavity 84. The retainer ring 86 includes six resiliently deflectable tabs 87 (figure 2) projecting radially outwardly from an annular body 88 As can best be seen in figure 7, when retaining ring 86 is inserted into cylindrical opening 133. Retaining ring 86 is slightly oversized compared to the diameter of cylindrical opening 133 such that the tabs 87 of retaining ring 86 are slightly deform against a wall 133a defining the cylindrical opening 133 to hold it firmly in place within the cylindrical opening 133, adjacent to the cavity 84. When in place in the cylindrical opening 133 adjacent to the cavity 84, the annular body 88 of the retaining ring 86 is it rests against a rear wall 97a of pinion 97 to hold the pinion in place within cavity 84.
[0066] A lower portion of the body region 85 of the head portion 80 includes a radially inwardly tilted portion 89 and a finger guard extending radially downward 90 to reduce the chances of an operator's fingers slipping forward on the wrist 23 and contact the rotating blade 200. As can be seen in figure 15, in front of the finger guard 90 is a pinion opening 91 in the body region 85 in communication with the pinion cavity 84. How can it be more well seen in figures 5 and 15, the opening 91 provides clearance for engaging the front portion 99 of the plurality of gear teeth 98 of the pinion 97 with the plurality of gear teeth 214 of the rotary knife blade 200. As the pinion 97 is rotated on its axis of rotation, which is congruent with that of the driven axis 94, the blade 200 is rotated on its central axis AC and is supported for rotation within a rotational plane RP (figures 3, 5, and 19 ) defined by the blade housing portion 62 and the blade retainer structure 150. Blade housing portion 62
[0067] The blade housing portion 62 comprises a generally annular shaped ring 63 that extends forward (in the F direction) from the head portion 80. As can best be seen in figures 5 and 18, the ring annular 63 includes an upper or upper wall 64, a lower wall 65, an inner wall 66 and an outer wall 67. In regions extending away from the head portion 80, the annular ring 63 generally has a rectangular cross section. The lower wall 65 of the annular ring 63 includes an annular groove or opening 68. The rectangular cross section of the annular ring 63 provides strength and stiffness to absorb the significant torque that is generated by an operator when, for example, forming a distal tip T ( figures 3 and 5) of blade 200 against a bone when debriding bone tissue. As can be seen better in figure 15, the groove 68 forms a complete circle, that is, subtends an angle of 360 °, and extends axially upwards from the lower wall 65 of the ring 63. As can be better seen in figures 16-20, the groove 68, when viewed in cross section, is generally inverted U-shape and is defined by a radially internal wall 69, an outer wall spaced radially to part 70, and an upper wall 71. exemplary configuration, a radial distance from the central axis AC of the blade 200 and the blade housing portion 62 of the disposable blade holder assembly 60 to the outer wall 70 is approximately 25.40 mm (one inch). In the exemplary configuration illustrated in figures 16-20, the radial distance from the central geometric axis AC of the blade 200 and the blade housing portion 62 of the disposable blade holder assembly 60 to the outer wall 70 is approximately 26.39 mm ( 1.039 inch) and a radial distance through the annular groove is approximately 2.84 mm (0.112 inch).
[0068] The annular groove 68 is dimensioned to receive both an annular body support section 204 of the blade 200 and the blade retainer structure 150 that works to permanently retain the blade in the groove and serves as a support structure for the blade to the as the blade rotates inside the blade holder assembly. In the region of the head portion 80, the upper wall 64 and the outer wall 67 make the transition or slope gently into the major main body region 85 of the head portion 80. The groove 68 defined by the lower wall 65 and the structure of the blade retainer 150 defines the horizontal rotational plane RP of the knife blade 200, the rotational plane RP being substantially orthogonal to the central geometric axis AC of the blade. The inner wall 66 of the blade housing portion 62 also defines a central opening extending axially CO 'such that material, such as fabric, which is cut by the cutting edge 208 of the blade 200 flows in an upward direction U (figures 1 and 3) upwards through a central opening CO of the blade and also through the central opening CO 'of the blade housing where it exits the rotating knife 10. Blade 200
[0069] As can be better seen in figure 20, the blade 200 includes a first upper axial end 201 and a second lower axial end 202, spaced axially apart by an annular body 203. The rotatable annular body 203 includes the support section with annular body 204 extending downwardly from the upper axial end 201 and having a generally cylindrical configuration, that is, having a generally rectangular cross section. The annular body 203 also includes a lower blade section 205 that extends downward and slightly radially inward from a radially lower outer portion 206 of the annular body support section 204. A lower portion 207 of the blade section 205 adjacent the axial end 202 defines the cutting edge 208 of the blade 200.
[0070] Extending between the upper and lower axial ends 201, 202, respectively, the annular body 23 of the blade 200 is defined by an inner wall 210 and a radially separate outer wall 211. An upper portion 212 of the body support section annular 204 defines a driving gear section 213 including a plurality of gear teeth spaced apart 214. The plurality of gear teeth 214 extend downwardly from the upper axial end 201 and additionally extend between and through the outer wall 211 and the inner wall 210. The outer wall 211 in the region of the annular body support section 204 defines the outermost radial surface of the blade 200. The plurality of gear teeth spaced apart 214 mesh with gear teeth combining 98 of a pinion 97 of the pinion assembly 93 to rotate the blade 200 in the blade housing portion 62.
[0071] A central axis of the rotatable annular body 203 is congruent with and the same as the central axis of CA and, for simplicity, both the central blade axis and the central axis of the annular body must be referred to here as CA . The upper axial end 201 includes an upper surface of the plurality of gear teeth 214, while the lower axial end 202 includes a lower surface of the cutting edge 208 of the blade. As can be seen in Figures 5 and 18, the upper axial end 201 defines a generally flat surface UAEP and the lower axial end 202 defines a generally flat surface LAEP. The UAEP, LAEP planes are substantially parallel, substantially orthogonal to the central blade axis / annular body AC, and substantially parallel to the plane of rotation RP of the blade 200. The inner wall 210 of the blade 200 defines the central opening CO of the blade and is angled such that material that is cut by the cutting edge 208 of the blade flows upwards and out of the blade. In an exemplary configuration of the present disclosure, the diameter of the central opening CO at the lower axial end 202 of the blade 200 is approximately 50.72 mm (1.997 inches), the diameter of the central opening CO at its largest diameter near the upper axial end 201 is approximately 47.54 mm (1.872 inches), while the outer diameter of the blade at its largest diameter, which is close to the upper axial end 201, is approximately 51.56 mm (2.030 inches). In an exemplary configuration, an axial height of the blade 200 measured from the axial upper end 201 to the axial lower end 202 is approximately 8.63 mm (0.340 inches). The blade 200 can be manufactured from a hardenable grade of alloy steel or a hardenable grade of stainless steel, or other material known to have comparable properties. Connection set 100
[0072] The connection assembly 100 provides a secure connection between the blade support assembly 60 and the cable assembly 20 when the connection assembly is engaged. Link assembly 100 also provides quick and easy detachment of blade support assembly 60 from cable assembly 20 such that blade support assembly 60 can be removed and discarded after, for example, the end of a tissue debridement session in a donor. After the cable assembly 20 is sterilized, the connection structure 100 provides for the quick and easy connection of a new sterile blade support assembly 60 to the sterile cable assembly 20.
[0073] The connection assembly 100 includes socket 132 of the head portion connection structure 130 and collar 112 of the cable assembly connection structure 110. The interface or projection element 113 of the collar 112, which extends to front from the front wall 42 of the cable assembly mounts within the cylindrical opening 133 of the socket. As can best be seen in figures 7 and 8, when the blade support assembly 60 is correctly connected to the cable assembly 20, the stepped rear wall 82 of the head portion 80 rests against and combined contacts the corresponding stepped portion of the wall front 42 of the cable assembly 20.
[0074] In an exemplary configuration, the connection set 100 uses a retaining clip generally U-shaped 101 to secure the blade support assembly 60 to the cable assembly 20. As is best seen in figure 6, the clip includes a central portion 101a and two arms 101b extending from the central portion 101a. Each of the two arms 101b includes an intermediate portion 101c that curves inwardly together forming a narrow waist region 101d. The intermediate arm portions 101c defining a narrow waist region 101d are sized to fit tightly within flush portions 126 (one of which can be seen in figures 6 and 8) formed on opposite sides of the interface projection 113 of the cable assembly 20 .
[0075] An outer surface 131a of the cylindrical interface region 131 defining socket 132 includes an annular groove 138. As can be better seen in figure 8, annular groove 138 extends most of the way, but not entirely around the peripheral outer surface 131a of the cylindrical interface region 131. The annular groove 138 does not extend around a small lower portion 131b (figure 8) of the outer surface 131a of the interface region 131. In opposite side regions of the annular groove 138, the groove extends completely through the wall of socket 132 thus forming a pair of separate slit-shaped openings 140 (one of which can be seen in figures 6 and 8). Slit-shaped openings 140 are aligned with flush portions 126 of interface region 113 when blade holder assembly 60 is attached to cable assembly 20. An angled region 141 adjacent annular groove 138 near the top of outer surface 131a the cylindrical interface region 131 is provided to facilitate the insertion of a tool tip, such as the tip of a screwdriver to remove the retaining clip 101 when detachment from the blade holder assembly 60 is desired.
[0076] When the interface projection 113 of the cable assembly 20 is longitudinally aligned with the cylindrical opening 133 defined by socket 132 and the blade support assembly 60 is moved against the cable assembly 20, the interface projection 113 fits in. the opening 133 of the socket 132 and the slot-shaped openings 140 of the annular groove 138 are aligned with the respective recessed portions 126 of the interface projection 113. The retaining clip 101 is then aligned with the annular groove 138 and pushed down until that the intermediate portion 101a is firmly seated in the groove 138. When the retaining clip 101 is fully inserted, the intermediate portions 101c of the arms 101b pass through the slot-shaped openings 140 of the annular groove 148 and fit within the respective recessed portions 126 from interface projection 113 to secure blade holder assembly 60 to cable assembly 20.
[0077] The retaining clip 101, which fits snugly into the annular groove 138, rests against the forward facing surfaces 126a limiting the recessed portions 126 of the interface projection 113 to prevent detachment of the blade support assembly 60 from the assembly cable 20. In this configuration, the retaining clip 101 is a retainer that connects the blade holder assembly 60 and the cord assembly 20. The annular groove 138 of socket 132 is a retainer receiver that receives the retainer (retainer clip 101) . The forward facing surfaces 126a of the interface projection 114 limiting the embedded portions 126 define support surfaces that rest against the retainer (retaining clip 101) to prevent detachment of the cable assembly 20 and the blade holder assembly 60.
[0078] For the removal of the disposable blade support assembly 60 from the cable assembly 20, the operator inserts a suitable tool, such as the tip of a screwdriver, into the angled region 141 and intrudes up and out of the annular groove 138. Once the retainer clip 101 is removed, the operator then pulls the blade holder assembly 60 in the forward direction F with one hand while holding the cable assembly 20 with his other hand until the interface projection 113 disengaged from socket 132. Second exemplary connection set configuration 400
[0079] Figures 9 and 10 schematically represent a rotating knife 300 of the present disclosure including a second exemplary configuration of a connection assembly 400 for detaching a disposable blade support assembly 360 to a reusable cable assembly 320. For simplicity, only the differences from the previous configuration will be described here, it being understood that the overall configuration and operation of the rotary knife 300 of the present configuration are substantially the same as those of the rotary knife 10 of the first configuration.
[0080] In this configuration, the rotary knife 300 includes the reusable handle assembly 320 and the disposable blade holder assembly 360. The connector assembly 400 provides the secure connection between the blade holder assembly 360 and the handle assembly 320 when the the connection assembly is engaged, while at the same time providing quick and easy detachment of the blade support assembly 360 from the cable assembly 320 when the connection assembly is disengaged.
[0081] In the present configuration, instead of using a retaining clip 101, as was the case in the first configuration, in this configuration the connection set 400 uses an O-ring 401 to fix the blade support set 360 to the set of cable 320. The interface projection 413 of the cable assembly 320 includes four radial projections or protrusions 424 extending from an outer surface 425 of the interface projection. A cylindrical interface region 431 defining a socket 432 includes an annular groove 438 on an external surface 439 of the cylindrical interface region and four axially extending passages 440 (two of which can be seen in figure 9) extending between the stepped rear wall 382 of the head portion 380 and the annular groove 438. O-ring 401 is sized to fit tightly within annular groove 438. The cylindrical socket 432 additionally includes four recesses 441 (two of which can be seen in figure 10) just ahead of the annular groove 438, the four recesses 441 are dimensioned to receive and seat the four projections 424.
[0082] Before connection, the O-ring 401 is stretched and positioned in the head portion socket 432 just ahead or distally from the annular groove 438. The blade support assembly 360 and the cable assembly 320 are aligned such that the projection interface 413 of the cable assembly 320 is longitudinally aligned with the cylindrical opening 433 defined by socket 432. As the blade support assembly 360 is moved towards the cable assembly 320, the projections 424 of the interface projection 413 pass through respective passages of the four passages 440 of the interface region socket 432 and are seated in respective recesses of the four recesses 441.
[0083] The connection set 400 is engaged by sliding the stretched O-ring 401 from its position on the head portion 380 into the annular groove 438. The O-ring 401, which is sized to fit tightly into the annular groove 438, rests against rear-facing surfaces 424a of the protrusions 424 to prevent detachment of the blade support assembly 360 from the cable assembly 320. In this configuration, O-ring 401 is a retainer that connects the blade support assembly 360 and the cable assembly 320. Socket 432 annular groove 438 is a retainer receiver that receives the retainer (O-ring 401). The rear-facing surface 424a of the projections 424 of the interface projection 413 defines support surfaces that rest against the retainer (O-ring 401) to prevent detachment of the cable assembly 320 and the blade holder assembly 360.
[0084] For disengaging the connection set 400, that is, removing the disposable blade support assembly 360 from the cable set 320, the operator cuts the O-ring 401 with a suitable cutting tool, such as a knife. Once the O-ring 401 has been removed, the operator then pulls the blade holder assembly 360 in the forward direction F with one hand while holding the stationary cable assembly 320 with his other hand until interface projection 413 is disengaged. of socket 432. Third exemplary configuration of connection set 600
[0085] Figure 11 schematically represents a rotating knife 500 of the present disclosure including a third exemplary configuration of a connection assembly 600 for detaching a disposable blade holder assembly 560 to a reusable cable assembly 520. For simplicity, only the differences from the previous configurations will be described here, it being understood that the overall configuration and operation of the rotary knife 500 of the present configuration are substantially the same as that of the rotary knife 10 of the first configuration.
[0086] In this configuration, the rotary knife 500 includes the reusable handle assembly 520 and the disposable blade holder assembly 560. The connector assembly 600 provides the secure connection between the blade holder assembly 560 and the handle assembly 520 when the the connection assembly is engaged, while at the same time providing quick and easy detachment of the blade support assembly 560 from the cable assembly 520 when the connection assembly is disengaged.
[0087] In the present configuration, instead of using a retaining clip fastener 101, as was the case in the first configuration, a threaded fastener 601 such as a threaded screw 601 is used to freely engage the blade support assembly 560 and the cable assembly 520. Threaded screw 601 includes a threaded rod 602 and an enlarged head with slot 603. An interface region 631 of the head portion 580 of the blade support assembly 560 defines a socket 632. The interface region 631 also includes a longitudinally extending slit opening 634 and a countersunk area 635 formed on an outer surface 621a of the interface region and centered on a front end portion 636 of the slit opening 634. The interface projection 613 of the cable assembly connection structure 610 includes a threaded opening 623 which is aligned with the extreme front or distal portion 636 of the slit opening 634 of the interface region 631. When the blade support assembly 560 is properly connected to the cable assembly 520, the front end portion 636 of the slot opening 634 of socket 634 is aligned with the threaded opening 623 of the interface projection 613.
[0088] To engage connection set 600, a two-step process is used. First, the interface projection 613 of the cable assembly 520 is longitudinally aligned with the cylindrical opening 633 of socket 632 of the blade holder assembly 560, that is, along the geometric axis of the HA cable, and the two parts are joined such that the threaded opening 623 of the interface projection 613 is aligned radially with the front end portion 636 of the slit opening 634 (the alignment shown in figure 11) and the front wall 542 of the cable assembly 520 enters the rear wall 631b of the cylindrical interface region 631.
[0089] Second, after the cable assembly 520 and the blade holder assembly 560 are correctly and completely engaged, the threaded fastener 601 is used to secure the blade holder assembly 560 in the connected position with respect to the cable assembly 520. A threaded rod 602 of the threaded fastener 601 passes through the front end portion 636 of the slot opening 634 and threads into the threaded opening 623 of the interface projection 613. When the fastener 601 is threaded into the opening 623, the enlarged head 603 of the threaded fastener is tightly received within the countersunk region 635 and rests against the portions of socket 632 forming the countersunk region 635. Particularly, the rear shoulder portions 637 of socket 632 that form a side wall of countersunk region 635 adjacent to the crack opening 634 are supported against the enlarged fixator head 603 to prevent the relative movement of the blade support assembly 560 in a forward direction with respect to the ca bo 520 when fastener 600 is threaded into threaded opening 623 of interface projection 613. When cable assembly 520 and blade holder assembly 560 are correctly and completely engaged and fastener 601 is threaded into threaded opening 623 of the projection interface, the connection assembly 600 is engaged, that is, the disposable blade support assembly 560 is attached to the cable assembly 520.
[0090] In essence, threaded fastener 601 is a retainer that connects blade holder assembly 560 and cable assembly 520 and threaded opening 623 of interface projection 613 is a retainer receiver that receives the retainer (threaded fastener 601 ). The rear shoulder portions 637 of socket 632 defining the side wall of the countersunk region 635 adjacent to the slit opening 634 define support surfaces to rest against the retainer (threaded fastener 601) to prevent detachment of the cable assembly 520 and the support assembly of blade 560.
[0091] To disengage the connection assembly 600, that is, to remove the blade holder assembly 560 from the cable assembly 520, the operator simply uses a screwdriver to remove the threaded fastener 601 from the threaded opening 623 of the interface projection 613. Once the threaded fastener 601 is removed, the operator then pulls the blade holder assembly 560 in the forward direction F with one hand while holding the stationary cable assembly 520 with his other hand until the interface projection 613 is disengaged from socket 632. This two-step process completes the detachment of the blade support assembly 560 from the cable assembly 520, that is, the connection assembly is disengaged. Blade retainer structure 150
[0092] Figures 12-20 schematically represent the rotating knife 10 of the present disclosure and, more specifically, schematically represent a first exemplary configuration of the blade retainer structure 150 of the present disclosure. The rotary knife 10 shown in figures 12-20 actually includes the first connection assembly 100 discussed above. However, as mentioned earlier, any of the connection sets 100, 400, 600 can be used interchangeably. As the focus in this section is on the blade retainer structure 150, not the specifics of the connection set, for simplicity, the rotating knife and components will be referred to in terms of the reference numbers used in connection with the first configuration discussed earlier.
[0093] The blade retainer structure 150 retains and allows rotation of the annular rotary knife blade 200 within the annular groove 68 of the blade housing portion 62 of the disposable blade holder assembly 60. The retainer structure 150, in the first exemplary configuration, includes a one-piece retainer 152. Retainer 152 can be made of a resilient material, such as, for example, stainless steel spring material. Retainer 152 works both to secure the blade annular body support section 204 in the annular blade housing groove 68 and to provide a support surface for the rotation of the blade 200 on the central axis of the AC blade and along the rotational plane of RP blade. As can best be seen in figures 13 and 14, retainer 152 does not form a complete circle or tubular ring. Instead, retainer 152 even defines a cutout region 154 between the extreme portions 156, 158. The cutout region 154 of retainer 152 provides clearance for teeth 98 of pinion 97, pinion 97 being supported for rotation at pinion opening 91 of main body region 85 of the head portion 80.
[0094] Retainer 152 includes an upper wall 160 that extends horizontally and is substantially flat. As can be seen in figures 18-20, there is a small gap between the upper retainer wall 160 and the upper wall 71 of the annular groove 68. The clearance region allows some travel of the retainer 152 when it is inserted into the groove 68 and to compensate for any limited non-uniformity or pucker of the upper retainer wall 160 when the retainer is inserted into the groove. Retainer 152 additionally includes a plurality of downwardly extending short tongues 162 (figure 18), a plurality of angled locator / support tongues 164 (figure 20), and a plurality of L-shaped support legs 166 (figure 19) , all extending from a radially outer peripheral region 168 of the upper retainer wall 160. Retainer 152 is first attached to blade 200, then blade and retainer assembly 250 is inserted into annular groove 68 and, when correctly seated in the annular groove, the blade and retainer assembly 250 is permanently attached to the blade housing portion 62.
[0095] The L 166-shaped support legs of retainer 152 secure blade 200 and provide a support surface for rotation of blade 200 with respect to retainer 152 and the blade housing portion 62. How can it be better seen in figure 19, an inner surface 166a of a vertical portion 166b of the legs 166 extends along and provides a supporting surface for a vertical portion 215 of the outer wall 211 of the annular body support section 204 of the blade 200. Additionally, a upper surface 166c of a short horizontal portion 166d of the legs 166 extends along and provides a supporting surface for a radially external horizontal portion 216 (figure 17) of the outer wall 211 of the annular body support section 204 of the blade 200. Thus, the L 166-shaped support legs of retainer 152 provide both vertical and horizontal support surfaces for the body support section 204 of the blade 200. In an exemplary configuration, as can be seen in the figure 14, there are fourteen L 166 shaped support legs.
[0096] A lower surface 160a of upper wall 160 of retainer 152 also serves as a horizontal support surface, leaning against the first upper axial end 201 of blade 200. The radial inner wall 69 defining annular groove 68 also serves as a vertical support surface, leaning against a vertical portion 217 of the inner wall 210 of the annular body support section 204 of the blade 200.
[0097] It should be appreciated that not all the matching support surfaces of the blade 200, retainer 152 and the radial inner wall 69 of the annular groove 68, as described above, are in contact at any given time because there are necessarily current clearances between the blade, retainer and annular groove that allow the blade to rotate relatively freely within a region defined by retainer 152 and the inner wall 69 of the annular blade housing groove 68. These current clearances make the blade 200 act somewhat similar to a seesaw within the blade housing retainer 152 and annular groove 68, that is, as a region of the blade is hinged or moved upward within the retainer and annular groove during a cutting or cutting operation in a debridement process of bone, the diametrically opposite portion of the blade (180 ° apart) is pivoted or moved down into the retainer and annular groove. Consequently, the supporting surfaces combining in contact at a specific location on the blade-retainer-annular groove interface will change and, at any given time, will be determined by the forces applied during the use of the rotary knife.
[0098] The blade retainer structure 150 also includes a plurality of recesses or notches of location 72 formed on the outer wall 70 of annular groove 68. As can be better seen in figure 15, in an exemplary configuration, there are eight notches of location 72 spaced separately radially along the outer wall 70. In one configuration, the notches 72 have a radial length of approximately 3.175 mm (0.125 inch). In the retainer 152, the number of locating / support tabs 164 matches the number of locating notches 72. The locating tabs / support 164 are angled downwards at an angle of approximately 15-30 ° with respect to the horizontal flat top wall 160 of retainer 152.
[0099] When the blade and retainer assembly 250 (figure 13) is inserted into the annular groove 68, the eight horizontally extending locating / support tabs 164 extend into each of the locating notches 69 thereby orienting the blade and retainer such that pinion gap 154 of retainer 152 is correctly aligned with pinion opening 91 at the bottom of head portion 80 that provides clearance for the blade pinion-gear interface. In addition, the radial distance of the upper retainer wall 160 and a length and angle of the locator / support tabs 164 are selected such that when the blade and retainer assembly 250 is inserted into annular groove 68, the locator / support tabs 64 are forced to flex radially inward. As best seen in Figure 20, the distal ends 164a of each of the locating / support tongues 165 rest against and bite within portions of the outer wall 70 defining the locating grooves 72 thereby providing an interference fit between the retainer 152 and the blade housing portion 62 of the blade holder assembly 60.
[00100] Additionally, due to the interference fit between the locating / support tabs 164 of the retainer 152 and the outer wall 70 defining a portion of the annular groove 68 of the blade housing portion 62, a radially inner peripheral region 169 of the upper wall 160 is forced against the inner wall 69 defining the annular groove 68. Remember that the blade support assembly 60, in a preferred configuration, is manufactured via molding of a plastic material, therefore, the retainer 152 being spring steel, is a relatively stiffer material than the blade support assembly 60. Consequently, the distal ends 164a of the tabs 164 bite or bury within the softer material of the outer wall 70 generating an interference fit. In addition, the interference fit is permanent because attempting to remove retainer 152 from annular groove 68 is likely to distort and bend the retainer to a condition where it will no longer be usable as a support for blade 200. The combination of upper wall tension retainer 160 against the inner wall 69 and the locating / support tabs 164 leaning against and / or biting between the portions of the outer wall 60 defining the location notches 72, the blade and retainer assembly 250 are permanently locked in place and are prevented from exiting the annular groove 68. The retainer 152 is stationary with respect to the annular groove 68 and the blade housing portion 62, while the blade 200 is supported for rotation within the annular groove 68.
[00101] The plurality of short interconnecting tabs or tabs extending downward 162 (figure 18) from retainer 152 support against the outer wall 70 defining annular groove 68 and provide additional stability and rigidity to the retainer and contribute to maintaining the blade and retainer assembly 250 correctly seated in annular groove 68. In a preferred configuration, as can be seen in figure 14, the number of short tabs extending downward 162 is seven. Second exemplary configuration of 850 blade retainer structure
[00102] Figures 21-23 schematically represent a rotating knife 700 of the present disclosure including a second exemplary configuration of a blade retainer structure 850 that retains and allows rotation of an annular rotating knife blade 900 within an annular groove 768 of the blade housing portion 762 of the disposable blade holder assembly 760. For simplicity, only the differences from the previous configuration will be described here, it being understood that the overall configuration and operation of the rotating knife 700 of the present configuration is substantially the same as that of rotary knife 10 of the first configuration.
[00103] In this configuration, the rotary knife 700 includes the reusable handle assembly 720 and the disposable blade support assembly 760. The blade retainer structure 850, in the second exemplary configuration, includes a single piece retainer 870. The retainer 870 it can be manufactured from a resilient material, such as, for example, a durable plastic material such as PPS, discussed above. Retainer 870 works both to secure the blade annular body support section 904 in the annular blade housing groove 768 and to provide a supporting surface for blade rotation 900 over the central axis of the AC blade and along the rotational plane of blade RP.
[00104] As can be better seen in figure 23, when seen in cross section, the retainer is basically an inverted T shape and includes a horizontal base 872 and a vertical base 874 extending vertically from a central portion of the base 872. Looking at figure 21, base 872 of retainer 870 forms a complete circle or, more specifically, a tubular ring. The vertical base 874 is also continuous and forms a complete circle, but it includes a cutout region 876 (figure 21) which, with the insertion of the blade and retainer assembly 950 into the annular groove 768 of the blade housing portion 762, is aligned with the pinion gap opening 791 of the main body region 785 of the head portion 780.
[00105] The blade and retainer assembly 950 is permanently attached to the annular groove of the blade housing portion 768. First, blade 900 is placed or positioned over (but not attached to) the blade retainer structure 850, nominally, the retainer 870. Specifically, as best seen in figure 23, a portion of an inner wall 878 of the vertical base 874 is in contact with a vertical portion 915 of an outer wall 911 of the annular body support section 904 of the blade 900 and a portion of an inner upper surface 880 of the base 872 is in contact with a radially outer horizontal portion 916 of the outer wall 911 of the annular body support section 904 of the blade.
[00106] After the blade 900 is placed in the retainer 870 as described above, the set 950 is then inserted and seated within the annular groove 768 of the blade housing portion 762 of the disposable blade holder set 760. As best seen in the figure 23, when the blade and retainer assembly 950 is inserted and seated within the annular groove 768, an outer wall 882 of the vertical base 874 of the retainer 870 is in contact with an outer wall 767 defining the annular groove 768, an upper surface 884 of the vertical base 874 is in contact with an upper wall 771 defining the annular groove 768, and an outer upper surface 886 of the base 872 is in contact with a portion 888 of the lower wall 765 of the annular ring 763 of the blade housing portion 762. At at least part of the contact portions of the retainer 870 and the blade housing portion 762 are then permanently attached via adhesive or fusion. In an exemplary configuration, adhesive is applied to the outer wall 882 of the vertical base 874 of the retainer 870. When the blade and retainer assembly 950 is inserted and seated within the annular groove 768 of the blade housing portion 762, the outer wall 882 is attached to the outer wall 767 of the housing portion 762. Part of the adhesive flows downwards and connects the upper surface 886 to the portion 888 of the lower wall 765 of the annular ring 762. In an exemplary configuration, both the retainer 870 and the blade support assembly 760 are manufactured from PPS, so a suitable adhesive would be a cyanoacrylate adhesive such as the Apollo H7 single component cyanoacrylate adhesive sold by Cyberbond LLC, 401 North Raddant Road, Batavia, IL 60510. Another exemplary method for attaching the retainer 870 to the blade housing portion 762 would be to fuse them together via ultrasonic welding. Consequently, because the retainer 870 is permanently attached to the blade housing portion 762 of the disposable blade holder assembly 760, the blade 900 is permanently supported for rotation within the annular groove 768, while the retainer 870 is permanently attached to the housing portion. blade 762 and is stationary with respect to rotating blade 900. Otherwise recorded, because retainer 8790 is permanently attached to the blade housing portion 762, the blade and retainer assembly 950 becomes permanently attached to the housing portion of blade 762 of the disposable blade holder set 760.
[00107] The inner wall 878 of the vertical base 874 and the inner upper surface 880 of the base 872 form an L-shaped support surface 889 providing the rotation of the blade 900 with respect to the retainer 870 and the blade housing portion 762. The L-shaped support surface 889 of the retainer 870 provides both vertical and horizontal support surfaces for the body support section 904 of the blade 900. The upper wall 771 defining the annular groove 768 also serves as a horizontal support surface for the body support section 904 of the blade 900, while the inner wall 769 defining the annular groove 768 also serves as a vertical support surface for the body support section 904 of the blade.
[00108] It should be appreciated that not all the matching support surfaces of the blade 900, the retainer 870, the radial inner wall 769 of the annular groove 768, and the upper wall 771 of the annular groove 768, as described above, are in contact with any given instant because there are necessarily current clearances between the blade and the retainer which allows the blade to rotate relatively freely within a region defined by the retainer 870 and the annular blade housing groove 768. As explained above, these current clearances make the blade 900 act somewhat similar to a seesaw within the blade housing retainer 870 and the annular groove 768, that is, as a region of the blade is pivoted or moved upward within the retainer and annular groove during a cutting operation or cutting in a bone debridement process, the diametrically opposite portion of the blade (180 ° apart) is pivoted or moved down into the retainer and annular groove. Consequently, the supporting surfaces in contact in contact at a specific location on the annular blade-retainer groove interface will change and, at any given time, will be determined by the forces applied during the use of the rotary knife. Third exemplary configuration of the 1150 blade retainer structure
[00109] Figures 24-26 schematically represent a rotary knife 1000 of the present disclosure including a third exemplary configuration of a blade retainer structure 1150 that retains and allows rotation of an annular rotary knife blade 1200 within an annular groove 1068 of the blade housing portion 1062 of the disposable blade holder assembly 1060. For simplicity, only the differences from the previous configuration will be described here, it being understood that the overall configuration and operation of the rotary knife 1000 of the present configuration is substantially the same as that of rotary knife 10 of the first configuration.
[00110] In this configuration, the rotary knife 1000 includes the reusable handle set 1020 and the disposable blade holder set 1060. The blade retainer structure 1150, in the third exemplary configuration, is identical to the blade retainer of the second configuration, that is ie, the blade retainer structure 850, including the blade retainer 870, with the addition of an extra component, nominally, a washer 1190 which is inserted between an upper axial surface 1201 of the blade 1200 and the upper wall 1071 defining the groove annular 1068. Thus, the blade retainer structure 1150 includes a retainer 1170, equal to retainer 850 of the second blade retainer configuration, and washer 1190.
[00111] Washer 1190 is preferably manufactured from a durable low-friction material such as steel or other metal / alloy. The purpose of washer 1190 is to minimize the wear that would otherwise occur between the upper axial surface 1201 which is defined by an upper surface of the plurality of gear teeth 1214 formed in the upper portion of the annular body support section 1204 of the blade 1200 as measured. that the blade 1200 is rotating in the annular groove 1068 of the blade housing portion 1062. As can be better seen in figure 24, washer 1190 is not a complete tubular ring. In contrast, washer 1190 includes a cutout region 1192 that provides clearance for pinion gap opening 1191 of main body region 1185 of head portion 1180.
[00112] Unlike retainer 1170, washer 1190 is not connected to the blade housing portion 1062. Instead, washer 1190 is inserted into annular groove 1068 and is held in position axially within the groove by retainer 1170 when the assembly retainer and blade 1250 is inserted into the groove and retainer 1170 is attached to the blade housing portion 1062, as described above. Specifically, as can be seen in figure 26, when retainer 1170 is attached to the blade housing portion 1062, an upper surface 1184 of the vertical base 1174 is in contact with and rests against washer 1190 preventing it from moving axially. inside the annular groove of blade housing portion 1068. Additionally, washer 1190 is prevented from moving radially within annular groove 1068 by downwardly extending stops (not shown) formed on the upper wall 1071 of annular groove 1068. The stops are arranged within the cut-out region of washer 1192 adjacent to the ends 1193, 1194 of the washer. The stops prevent washer 1190 from rotating in the direction of blade rotation within groove 1068.
[00113] The inner wall 1178 of the vertical base 1174 and the inner upper surface 1180 of the base 1172 form an L-shaped support surface 1189 providing the rotation of the blade 1200 with respect to the retainer 1170 and the blade housing portion 1062. The L-shaped support surface 1189 of retainer 1170 provides both vertical and horizontal support surfaces for the body support section 1204 of the blade 1200. The bottom surface 1196 of washer 1190 also serves as a horizontal support surface for the support section body 1204 of blade 1200, while inner wall 1069 defining annular groove 1068 also serves as a vertical support surface for body support section 1204 of blade 1200.
[00114] It should be appreciated that not all matching support surfaces of blade 1200, retainer 1170, washer 1190, and radial inner wall 1069 of annular groove 1068, as described above, are in contact at any given time because there are necessarily running clearances between the blade and retainer that allow the blade to rotate relatively freely within a region defined by retainer 1170, washer 1190 and the annular blade housing groove 1068. As explained above, these current clearances make blade 1200 act a somewhat similar to a seesaw within the blade housing retainer 1170, washer 1190, and annular groove 1068, that is, as a region of the blade is pivoted or moved upward within the retainer and annular groove during an operation cut or cut in a bone debridement process, the diametrically opposite portion of the blade (180 ° apart) is pivoted or moved down into the retainer and the groove cancels r. Consequently, the supporting surfaces in contact at a specific location on the blade-retainer-washer-annular groove interface will change and, at any given time, will be determined by the forces applied during the use of the rotary knife. Second exemplary configuration of blade support set 1560 and driving set 1525
[00115] In the previously described configurations of the energy operated rotary knife of the present disclosure, the reusable handle assembly 20 included a driving assembly 25 in which driving energy for turning the annular blade 200 was provided by an air motor 26 disposed in the through hole longitudinal handle 24 of the inner handle sleeve 22. In previously described configurations of the energy operated knife of the present disclosure, the disposable blade support assembly 60 included a drive gear mechanism 92 in which pinion 97 was supported for rotation within an opening or cylindrical cavity 84 and the pinion was held in place within the head portion cavity 84 by a retaining ring 86 with a plurality of flexible tabs 87 which flexed and contacted the cylindrical wall 133a defining the socket opening 133.
[00116] In an exemplary alternative configuration shown in figures 27-30, a rotary knife operated with energy 1500 of the present disclosure includes a reusable handle assembly 1520 that uses a driving assembly 1525 that includes a flexible driving shaft assembly 1526 through a longitudinal through hole 1524 of an elongated cable 1521, in place of the air motor 26 of the previous configurations. The 1521 cable, in the exemplary configuration illustrated, is a one-piece plastic member, capable of being sterilized at high temperatures, as opposed to the two-piece structure of the previous configurations. Alternatively, cable 1521 may be a one-piece metal member, also capable of withstanding the high temperatures required by sterilization methods. The flexible drive shaft assembly 1525 includes a stationary outer sleeve 1528 and an internal rotatable drive shaft 1527. In an exemplary configuration, the extreme portions of the driving shaft 1527 have substantially square cross sections. The opposite extreme portions of the driving shaft assembly 1525 include couplings 1530, 1532. The proximal end coupling 1532 engages an outboard motor 1534 (shown schematically in dashed line in figures 27 and 28), such as an AC electric motor to rotate the shaft motive 1527.
[00117] The disposable blade support set 1560 is shown in figure 29 and includes a drive gear mechanism 1592 which is modified from drive gear mechanism 92 of the first configuration. The drive gear mechanism 1592 includes a pinion assembly 1593 including a pinion 1597 and a driven shaft 1594 extending backwards from a longitudinal geometry axis of pinion 1597 which is substantially congruent with the HA cable geometric axis. However, unlike the previous configurations, pinion 1597 is not supported for rotation by a cylindrical cavity in the head portion with the cavity wall acting as a support, instead the driven shaft 1594 and pinion 1597 are supported for rotation by a 1586 ring-shaped bushing that inserts a rear or proximal rear wall 1597a of the pinion. As can be seen better in figure 29, the chuck 1586 includes a central opening 1587 that allows the chuck to slide over the driven shaft 1594. Compared to the previous configurations, pinion 1597 is reduced or shortened in the longitudinal extension to allow space for the 1586 bushing.
[00118] The size of the cylindrical pinion cavity 1584 formed in the head portion 1580 is large enough to provide clearance such that pinion 1597 does not mount on the wall 1584a defining the cavity, as in the previous configurations. On the contrary, the cavity 1584 has built-in clearance and the pinion is supported for rotation by the driven shaft 1594 and the sleeve 1586. The sleeve 1586 is pressed inside and supported inside a cylindrical opening of slightly larger diameter 1633 defined by socket 1632 of the region of cylindrical interface 1631. In an exemplary configuration, the 1586 bushing is comprised of a temperature-resistant plastic material such as (poly (ether-ether-ketone) (PEEK) or some other suitable material. Wall 1633a defining the cylindrical opening 1633 includes a a plurality of inwardly extending ribs that rest against the outer surface of bushing 1586 to hold the bushing and pinion 1597 in. The ribs in wall 1633a alleviate the need to maintain a tight tolerance in the cylindrical opening 1633.
[00119] As best seen in figure 28, the transmission of rotational energy from a distal end 1527a of the driving shaft of the flexible shaft assembly 1527 to the driven shaft 1594 of the pinion assembly 1593 is provided by a tubular coupling 1537 supported for rotation with the longitudinal cable through hole 1524. The tubular coupling 1537 includes a cylindrical outer surface for rotation within the cable through hole 1524 and a central square opening to receive a proximal end 1596 of the driven shaft 1594 and a distal end 1527a of the shaft drive 1527. A housing extending distally 1530a from the distal coupling 1530 of the driving shaft assembly 1525 holds the tubular coupling 1527 in place against a stepped inward portion 1524a of the through hole 1524. The housing 1530a and therefore the distal coupling 1530 of the drive assembly drive shaft 1526 are held in place with respect to cable 1521 by a screw 1521a. When the screw 1521a is threaded through a threaded radial opening in the cable 1521, a rounded distal end 1521b extends inward and rests against a groove 1530b formed in an outer wall of the housing 1530a to secure the housing and distal coupling 1530 to the place. When the screw 1521a is removed, the coupling 1537 can be removed from the cable 1521 and the tubular coupling 1537 will fall out of the through hole 1524 to facilitate sterilization of the cable assembly 1520. In this configuration of the cable assembly 1520, the ends of the cable 1521 do not need to be plugged or capped before sterilization. On the contrary, the entire cable 1521 can be subjected to sterilization without protection.
[00120] It should be understood that depending on the debridement task to be performed, different types and sizes of annular knife blades can be used. As can be better seen in figure 28, the 1700 annular knife blade is of a different configuration from the knife blade 200 of the previous configurations in which the blade section 1705 is "hooked" and extends radially inward against the central geometric axis AC of the blade when moving towards the cutting edge 1708.
[00121] Although a given rotating knife of the present disclosure, as explained above, has a specific annular blade permanently installed in the disposable blade holder assembly, the lowest cost of the disposable blade holder of the present disclosure provided by the plastic main body portion, unit, will facilitate the purchase of several different models having different section configurations and different blade diameters.
[00122] For example, looking at the rotary knife blade 900 shown in figure 22, the blade includes a blade section 905 that is angled slightly outward away from the blade's central AC axis. Such a blade that is referred to as a straight blade is particularly useful when making deep cuts or blows in fabric. In contrast, the blade shown in figures 27-29 includes a radially inwardly curved blade section 1705, generally referred to as a hook blade. Such a type of hook blade is particularly suitable for producing layers of tissue cut while cutting in a sweeping motion.
[00123] If it is desired to be able to efficiently cut relatively thin, but wider layers of fabric, selecting a blade with a larger blade diameter will generally be advantageous. On the other hand, if it is desired to be able to produce deeper and narrower cuts, selecting a blade with a smaller blade diameter will generally be advantageous. Ring blade diameters typically range from approximately 38.1 mm to more than 127 mm (1.5 to more than 5 inches). The present disclosure contemplates annular blades with various blade section configurations and blade diameters, the configuration and diameter to be combined with the type of cut or cut in connection that the rotary knife is expected to be predominantly used. Method for debridement of tissue using the energy operated rotary knife 10
[00124] A method for debridging tissue using any of the energy operated rotary knives of the present disclosure, for example, the energy operated rotary knife 10, is schematically shown generally in 2000 in figures 30-33. A bone from a donor body (human or other) is usually shown in 2001. Bone 2001 can be connected to other bones 202 in the donor via connective tissue. A ball and socket arrangement is shown schematically between the bones 2001, 2002. A layer of tissue 2003 must be removed from an upper outer surface 2004 of bone 2001. The tissue can comprise, skin, muscle, fat, connective tissue, etc. 2003 tissue may be tissue that is desired, in and of itself, for recovery and future use, or 2003 tissue may be tissue that is not desired for recovery but is being removed only for purposes of debridement / cleaning of bone tissue 2001 such that the bone can be recovered for future use.
[00125] The thickness of the tissue layer 2003 to be removed may require multiple layers to be cut from the bone 2001 to remove all or enough of the tissue 2003 from the outer surface of bone 2004 such that subsequent processing of the debrided bone can begin. In the illustrative example shown in figures 30-33, due to the thickness of the tissue layer 2003, two layers L1, L2 of tissue 2003 must be cut or trimmed from bone 2001 to remove substantially all tissue 2003 from the outer surface of bone 2004. One cut line or trim C1 schematically represents a path path of the blade cutting edge 208 to remove the layer of tissue L1 from bone 2001, while cut line or trim C2, which is adjacent to the outer surface of bone 2004, represents schematically a path of the blade cutting edge 208 to remove the L2 tissue layer from the bone 2001. That is, the global TO tissue debridement operation will include a first TO1 cutting operation to remove the L1 tissue layer from the bone 2001 (figures 30 and 31) and a second TO2 cutting operation to remove the L2 tissue layer from the bone 2001 (figures 32 and 33). The rotary knife 10 is moved from left to right in the figures, that is, in a cutting direction CD in the figures to cut the fabric layers L1 and L2.
[00126] As can be seen in figure 30, the cutting of the first layer of fabric L1 is initiated at a starting point SP1. The blade cutting edge 208 is brought to rest against the outer or skin layer 2006 of the fabric layer 2003 and knife 10 is manipulated to cut within the skin layer 2006 and continue cutting along the cut line C1 (figure 31). This results in a cut layer CL1 corresponding to layer 1. In this case, the starting point SP1 may be in an extreme upper portion 2005 of bone 2001, where it is closest to an outer or skin 2006 layer of the tissue. 2003. This is convenient because where the tissue layer 2003 is relatively thin through the 2005 extreme portion of a 2001 bone, the extreme bone portion can be readily identified by the operator. However, it is not necessary for the SP1 starting point to be at or near an extreme portion 2005 of bone 2001. Depending on the position of the operator with respect to knife 10 and bone 2001, the length of the operator's arms, the amount and the configuration of the fabric 2003 to be removed, etc., the operator can select another starting point.
[00127] As can be seen in figure 31, for the first cutting operation TO1, knife 10 is moved in the CD direction and the blade cutting edge 208 follows a path along a cutting path C1 to remove the L1 tissue layer. The cutting portion CL1 of the first layer L1 moves through the central openings CO, CO 'of the blade 200 and the blade housing portion 62, respectively as the blade cutting edge 208 moves along the cutting path. C1. The first cutting portion CL1 in the vicinity of the starting point SP1 is generally wedge-shaped at the distal end SPCP1 of the cutting portion CL1. This is because as the cut is initiated at the starting point SP1, the cutting edge 208 will move simultaneously downward against the bone 2001 and forward in the direction of cutting CD and will contact and move along the upper surface 2004 of the bone 2001 as it moves along the C1 cutting path. Thus the SPCP1 end of the cutting portion C1 will generally be wedge shaped.
[00128] The cutting path C1 ends at a termination point TP1 (figure 31) typically, the termination point TP1 can be at or near the opposite end portion 2007 of bone 2001 being debrided. If bone 2001 is not usually short or not usually long the end point may not coincide with the extreme portion of the bone since the operator can make a longer or shorter cut given his arm length, knife position 10 with with respect to the operator, the resistance of the L1 layer to be cut, etc. After the termination point TP1 is reached the first TO1 cut is complete and the cut layer L1 of tissue is removed from the debridement region (ie bone 2001) such that a second cutting operation can be started without interference from the first cut layer L1 that is detached from bone 2001 and the remaining tissue.
[00129] As can be seen in figures 32 and 33, the TO tissue debridement process includes repeating the cutting operation for a second TO2 cutting to cut the L2 tissue layer of the bone 2001. Here, in the second cutting operation TO2 , the cutting path C2 is along the surface 2004 of bone 2001, that is, the blade cutting edge 208 generally follows the outer surface 2004 of bone 2001. After the second TO2 cut is complete, the surface 2004 of bone 2001 it is substantially free of tissue and the debrided bone is ready for further processing. In some cases, further processing of the debrided bone may include, for example, removing residual tissue after cutting is completed by immersing the 2001 bone in a chemical bath or washing the bone with chemicals to remove some or all of the residual tissue. Generally, tissue debridement steps include: 1) cutting a layer of tissue from the bone; and 2) removing the cut layer of tissue are repeated as many times as necessary such that the desired tissue is obtained, e.g., bone 2001 is sufficiently debrided or has sufficient tissue removed for further processing or storage of the debridled bone.
[00130] It should be recognized that the schematic representations of the first and second cutting operations TO1, TO2 are shown in two dimensions. In fact, the 2001 bone is three-dimensional. Therefore, the clean or debrided area of the external bone surface 2004 resulting from the first and second cutting operations TO1, TO2 when viewed in three dimensions should look somewhat like a long clean rectangular area on the external surface of bone 2001 extending in a direction along a longitudinal geometric axis LAB of the bone 2001. To clean or debride the entire external surface 2004 of the bone 2001, the TO cut operation would have to be repeated numerous times around the external peripheral three-dimensional surface of the bone 2004 2001.
[00131] As seen in figure 32, the starting point SP2 for the second layer of cutting L2 will typically be close to but slightly offset from the first starting point of cutting SP1. This is because when the first TO1 cut is initiated, part of the tissue along the outer surface 2004 of bone 2001 will be removed thereby leaving the outer surface of bone 2001 bare or clean in the vicinity of SP1 and there is no point in trying to cut a portion of bone 2001 that is already clean or debrided. Therefore, as can be seen in figures 32 and 33, the second starting point SP2 is slightly beyond (in the CD direction) the first starting point. From the second starting point SP2, knife 10 is moved in the CD direction to remove the second cut layer TO2.
[00132] Similarly, the termination point TP2 of the second cut will be close to but slightly offset from the first termination point TP1 because the outer surface 2004 of bone 2001 is likely to be clean in the vicinity of TP1. Therefore, the second endpoint TP2 will fall somewhat close to the first endpoint TP1 with respect to the second extreme 2007 portion of bone 2001.
[00133] As used here, the terms of guidance such as upper, lower, inward, outward, forward, backward, proximal, distal, etc., are provided for purposes of convenience and generally relate to the orientation shown in the figures. Such guidance terms are not intended to limit the scope of this disclosure or the claims attached hereto.
[00134] What has been described above are examples of the present invention. It is not possible, of course, to describe every conceivable combination of components or methodologies for the purpose of describing the present invention, but one of ordinary skill in the art will recognize that many additional combinations and permutations of the present invention are possible. Consequently, the present invention is intended to cover all such changes, modifications and variations that fall within the spirit and scope of the appended claims.

权利要求:
Claims (9)
[0001]
1. Disposable blade support set, for an energy-operated rotary knife (10), including a handle set (20) including an elongated handle (21) defining a longitudinal through hole (24) and an interface element (110) at a distal end (41) of the cable assembly (20) along a longitudinal geometric axis (HA) of the cable assembly (20), the disposable blade support assembly (60) being characterized by the fact that it comprises: a) a head portion (80); b) a blade housing portion (62) extending from a distal end of the head portion (80), the blade housing portion (62) including an annular ring (63) and defining an annular groove (68 ) on a lower surface (65) of the annular ring (63); c) an annular rotary knife blade (200) permanently supported for rotation within the annular groove (68) of the blade housing portion (62), the blade (200) having first and second axially separated ends (201, 202) and an annular body (203) extending between them, the annular body (203) including an annular body support section (204) adjacent to the first end (201), the annular body support section (204) defining a plurality of teeth gear (214) at the first end (201), the annular body (203) additionally including an annular blade section (205) adjacent to the second end (202), the annular blade section (205) defining a cutting edge (208 ) at the second end (202); d) a driving gear mechanism (92) rotatably supported within the head portion (80) and including a plurality of gear teeth (98) which engage with the plurality of gear teeth (214) of the annular body support section ( 204) to rotate the blade (200); and e) a retainer structure (150) including a retainer (152) rotatably securing and supporting the annular body support section (204) of the knife blade (200) within the annular groove (68) of the blade housing portion (62 ), the retainer (152) contacting a wall (70) of the annular groove (68) to permanently fix the retainer (152) within the annular groove (68) and to rotatively support the annular body support section (204) of the rotating knife (200) into the annular groove (68).
[0002]
2. Disposable blade support assembly, according to claim 1, characterized in that the retainer (152) includes: a) an upper wall (160); b) a first plurality of tongues (164); and c) a second plurality of tongues (166); d) the first plurality of tongues (164) extending radially outward and downward from the upper wall (160) and being sized to have an interference fit with a radially external wall (70) of the annular groove (68) ) to permanently fix the retainer (152) inside the annular groove (68); and e) furthermore, the second plurality of tongues (166) extending radially outward and downward from the upper wall (160), each of the second plurality of tongues (166) having first and second portions (166b, 166d) forming a support track turned radially inward with an L shape to rotatively support the annular body support section (204) of the blade (200).
[0003]
Disposable blade support assembly according to claim 2, characterized in that for each of the second plurality of tongues (166), the first portion (166b) extends axially downwards along a radially external surface ( 215) of the annular body support section (204) of the blade (200) and the second portion (166d) extending radially inward along a lower surface (216) of the annular body support section (204) of the blade (200 ).
[0004]
Disposable blade support assembly according to claim 1, characterized in that the head portion (80) and the blade housing portion (62) form part of a main body in a single unitary piece.
[0005]
5. Disposable blade support assembly according to claim 1, characterized in that it also includes a connection structure (130) disposed at the proximal end of the blade support assembly (60), the connection structure (130) engaging the interface element (110) of the cable assembly (20) to releasably secure the blade support assembly (60) to the cable assembly (20).
[0006]
6. Disposable blade support assembly according to claim 5, characterized in that the connection structure (130) includes a socket (130) disposed at a proximal end of the blade support assembly (60), the socket (130) releasably receiving the interface element (110) of the cable assembly (20) to releasably secure the blade support assembly (60) to the cable assembly (20).
[0007]
7. Disposable blade support assembly according to claim 1, characterized in that the driving gear mechanism (92) includes a cylindrical pinion gear (97) supported for rotation in an internal region (85) in the head portion (80), the plurality of gear teeth (98) of the driving gear mechanism (92) comprising axially extending teeth (98) defined at a first end of the pinion gear (97).
[0008]
Disposable blade support assembly according to claim 7, characterized in that the drive mechanism (92) further includes a retaining ring (86) adjacent to a second end of the pinion gear (97), the retaining ring (86) including a plurality of outwardly extending radial tongues (87) that rest against an inner wall of the head portion (80) defining the inner region of the head portion (85) for securing the pinion gear (97 ) within the inner region (85).
[0009]
9. Disposable blade support assembly according to claim 7, characterized in that the driving mechanism (92, 1592) also includes a driven shaft (94, 1594) that extends proximally from the pinion gear (97 , 1597) in addition to the proximal end of the disposable blade support assembly (60, 1560) and also including a ring-shaped bushing (1586) including a central opening (1587) sized to receive the driven shaft (94, 1594) and rotatingly supporting the aciodo shaft (94, 1594) and the pinion gear (97, 1597) for rotation within the head portion (80, 1580).

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公开号 | 公开日

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EP2557935A4|2013-09-25|

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EP2557935B1|2016-06-08|

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JP2013531509A|2013-08-08|

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AU2011240903B2|2014-06-05|

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US20140298965A1|2014-10-09|

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WO2011130057A1|2011-10-20|

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US20110247220A1|2011-10-13|

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BR112012026351A2|2015-09-15|

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CA2796222A1|2011-10-20|

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US9089980B2|2015-07-28|

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US8756819B2|2014-06-24|

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EP2557935A1|2013-02-20|

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CA2796222C|2015-10-27|

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AU2011240903A1|2012-11-08|

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ZA201207657B|2015-06-24|

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JP5675960B2|2015-02-25|

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法律状态:
2018-04-10| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-08-04| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2021-02-02| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-03-09| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/04/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US32334610P| true| 2010-04-12|2010-04-12|

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US61/323,346|2010-04-12|

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US13/073,207|2011-03-28|

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US13/073,207|US8756819B2|2010-04-12|2011-03-28|Power operated rotary knife with disposable blade support assembly|

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PCT/US2011/031196|WO2011130057A1|2010-04-12|2011-04-05|Power operated rotary knife with disposable blade support assembly|

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