Injection molded heavy duty assembly with strain gauge

Abstract

This invention relates to injection-molded reassembly assemblies with strain gauges, and provides a surgical suturing apparatus comprising a reassembly assembly including a housing, a staple cartridge, a plurality of staples received within the staple cartridge, a staple ejector for ejecting the plurality of staples from the staple cartridge, and a cutting tool for cutting tissue. The housing supports strain gauges that can be molded into the housing.

Description

Technical Field

[0001] This disclosure generally relates to surgical suturing devices, and more specifically, to surgical suturing devices comprising a reloading assembly having strain gauges for measuring various parameters related to suturing and / or cutting of tissue. Background Technology

[0002] The electric surgical suturing device includes a handle assembly, an adapter assembly supported on a distal portion of the handle assembly, and a tool assembly supported on the distal portion of the adapter assembly. The suturing device may also include strain gauges for measuring characteristics of the sutured tissue and / or parameters related to staple formation or tissue cutting, such as tissue thickness, tissue compression, etc., and parameters such as cutting force, impact force, etc. Typically, the strain gauges are supported within the adapter assembly and are formed of electronics that can be sterilized or reprocessed to facilitate the reuse of the adapter assembly. Such electronics are expensive. Summary of the Invention

[0003] The technology disclosed herein generally relates to surgical suturing devices, and more specifically, to circular suturing devices for performing end-to-end anastomosis and similar suturing procedures.

[0004] One aspect of this disclosure relates to a reloading assembly comprising a housing, a staple cartridge, a plurality of staples, a staple pusher, a tool holder, and a cutting tool. The housing supports a strain gauge and includes a distal portion, a proximal portion, and a housing portion defining a cavity. The staple cartridge is supported on the distal portion of the housing, and the plurality of staples are received within the cartridge. The staple pusher is supported within the cavity defined by the housing and defines a through-hole. The tool holder is supported within the through-hole of the staple pusher and is movable between a retracted and an advanced position. The cutting tool is supported on the tool holder and is movable together with the tool holder between a retracted and an advanced position.

[0005] Another aspect of this disclosure relates to a suturing apparatus comprising a handle assembly, an adapter assembly, and a reloading assembly. The adapter assembly has a proximal portion and a distal portion supported on the handle assembly. The reloading assembly includes a housing, a staple cartridge, a plurality of staples, a staple pusher, a tool holder, and a tool. The housing supports a strain gauge and includes a distal portion, a proximal portion, and a housing portion defining a cavity. The staple cartridge is supported on the distal portion of the housing, and the plurality of staples are received within the staple cartridge. The staple pusher is supported within the cavity defined by the housing and defines a through-hole. The tool holder is supported within the through-hole of the staple pusher and is movable between a retracted and an advanced position. The tool is supported on the tool holder and is movable together with the tool holder between a retracted and an advanced position.

[0006] In various aspects of this disclosure, the housing portion has a tubular extension, and the strain gauge is supported on the tubular extension.

[0007] In some aspects of this disclosure, the strain gauge is molded into a tubular extension of the housing.

[0008] In some aspects of this disclosure, the staple cartridge and the cutting tool have a ring configuration.

[0009] In various aspects of this disclosure, the coupling mechanism is supported around the tubular extension of the housing and is used to secure the reassembly assembly to the surgical suture device.

[0010] In some aspects of this disclosure, the reloading assembly includes a nail actuator positioned within a cavity defined by the housing and adjacent to a nail pusher member, wherein the nail actuator is movable from a retracted position to an advanced position to move the nail pusher member from its retracted position to its advanced position.

[0011] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the reloading components described herein will become apparent from the description, drawings, and claims. Attached Figure Description

[0012] Various aspects and features of this disclosure are described with reference to the accompanying drawings, wherein similar reference numerals designate the same or corresponding elements in each of the several views, and:

[0013] Figure 1 It is a side perspective view of a surgical suturing device including tool components, in which the reloading components of various aspects of the present disclosure are in an unclamped position;

[0014] Figure 2 yes Figure 2 The exploded side perspective view of the housing assembly of the tool component shown in the figure;

[0015] Figure 3 yes Figure 1 A magnified view of the indicated area;

[0016] Figure 4 It is in an unclamped position. Figure 1 The tool assembly shown is a side perspective view, with the connecting mechanism of the reinstalled assembly removed.

[0017] Figure 5 yes Figure 2 A magnified view of the indicated area shown;

[0018] Figure 6 It is along Figure 5 The cross-sectional view taken from section line 6-6;

[0019] Figure 7 It is along Figure 5 The cross-sectional view taken from section line 7-7; and

[0020] Figure 8 yes Figure 1 The tool assembly shown is in a side cross-sectional view, with the tool assembly in the clamping and firing position. Detailed Implementation

[0021] In this specification, the term "proximal" generally refers to the portion of the device closer to the clinician, while the term "distal" generally refers to the portion of the device farther from the clinician. Furthermore, the term "clinician" generally refers to healthcare personnel, including doctors, nurses, and support staff.

[0022] Figure 1 The description includes a circular stitching device 10, generally shown as a reloading assembly 100, according to exemplary aspects of this disclosure. The circular stitching device 10 includes a handle assembly 12, an elongated body or adapter assembly 14, a reloading assembly 100, and an anvil assembly 18, which supports the anvil assembly 18 in an open position relative to the reloading assembly 100. Figure 1 ) and clamping position ( Figure 8 The reloading assembly 100 includes a proximal portion 102 that can be releasably coupled to the distal portion 14a of the adapter assembly 14, and the adapter assembly 14 includes a proximal portion 14b that can be releasably coupled to the handle assembly 12. The handle assembly 12 includes a fixed handle 22 that supports an actuation button 24 for controlling the operation of various functions of the circular suture device 10, including approaching the reloading assembly 100 and the anvil assembly 18, firing staples from the reloading assembly 100, and tissue cutting or coring, as described in further detail below.

[0023] The circular suture device 10 is shown as an electrically powered suture device including an electric handle assembly 12, which may support one or more batteries (not shown). An adapter assembly 14 transfers power from the handle assembly 12 to the reloading assembly 100 and the anvil assembly 18, respectively, for suturing and cutting tissue. Examples of electrically powered suture devices can be found in U.S. Patents Nos. 9,055,943 and 9,023,014, and U.S. Publications Nos. 2018 / 0125495 and 2017 / 0340351. Alternatively, it is contemplated that aspects of the reloading assembly disclosed herein may also be incorporated into, for example, a manual suture device disclosed in U.S. Patent No. 7,303,106 ('106 patent) or a suture device disclosed, for example, in U.S. Patent No. 9,962,159, configured for use with a robotic system and not including a handle assembly.

[0024] Figure 2 The exploded view illustrates the reassembly assembly 100, which includes a housing 110, a nail actuator 112, a nail pusher 112a, a blade holder 114, a ring blade 116 supported on the blade holder 114, a nail magazine 118, and a plurality of nails 120 supported within the nail magazine 118. The housing 110 includes an outer shell portion 120 and an inner shell portion 122. Figure 8 They are spaced apart from each other to define an annular cavity 124 positioned between the outer shell portion 120 and the inner shell portion 122. Figure 8 The inner housing portion 122 supports a bushing 122a that provides stability to the outer housing 110. The nail actuator 112 and the nail pusher 112a can move from a retracted position to an advanced position within the annular cavity 124 of the outer housing 110 to eject the nail 120 from the nail cartridge 118, as described in further detail below.

[0025] The staple cartridge 118 is annular and defines the staple recess 126. Figure 8 A ring array of pins. Each pin recess 126 supports one pin 120. The pin actuator 112 and the pin pusher member 112a together define a longitudinal through hole 128 of the receiving tool holder 114. Figure 8 The nail actuator 112 has a distal portion that abuts against a proximal portion of the nail pusher 112a, such that distal movement of the nail actuator 112 within the housing 110 causes distal movement of the nail pusher 112a within the housing 110. The nail pusher 112a of the reloading assembly 100 has a plurality of fingers 130. Each of the plurality of fingers 130 is received in a corresponding nail recess 126 of the nail cartridge 118 and is movable through the corresponding nail recess 126 such that when the nail pusher 112a moves from a retracted position to an advanced position within the housing 110, the sew nail 120 is ejected from the nail recess 126.

[0026] The tool holder 114 is received within the longitudinal through-hole 128 of the nail actuator 112 and includes a distal body portion 140 and a plurality of spaced-apart longitudinally extending proximal body portions 142. The distal body portion 140 and the proximal body portions 142 define a stepped central hole having proximal portions 144a and distal portions 144b. Figure 8 The proximal portion 144a of the stepped center bore of the tool holder 114 is received around the inner housing portion 122 of the outer housing 110, such that the tool holder 114 can be in both a retracted position and an advanced position within the nail actuator 112 around the inner housing portion 122 of the outer housing 110. Figure 8The tool holder 114 has a distal body portion 140 that includes a plurality of longitudinal extensions 146. The proximal body portion 142 of the tool holder 114 defines a slot 148 that receives a guide portion (not shown) of the housing 110 to limit the tool holder 114 to longitudinal movement within the housing 110.

[0027] The housing 110 includes a support connection mechanism 152. Figure 3 The proximal portion 150 of the suture device 10. The coupling mechanism 152 can be used to releasably couple the reloading assembly 100 to the suture device 10. Figure 1 The adapter assembly 14 facilitates the replacement of the reinstallation assembly 100 and the reuse of the stitching device 10. The coupling mechanism 152 includes a retaining member 154 and a coupling member 156. The coupling member 156 is received around the proximal portion 158 of the housing 110 and configured to engage the adapter assembly 14. Figure 1 The distal portion of the adapter assembly 14 is used to connect the adapter assembly 14 to the reassembly assembly 100. It is contemplated that other types of connection mechanisms can be used to secure the reassembly assembly 100 to the distal portion of the adapter assembly 14.

[0028] The remounting assembly 100 may include an e-prom holder 160 supported on the housing 110 to support the e-prom (not shown). Figure 2 As is known in the art, the e-prom communicates with the adapter assembly 14 to provide information related to the characteristics of the reloading assembly 10 to the adapter assembly 14 and the handle assembly 12.

[0029] In some aspects of this disclosure, the reloading assembly 110 of the suture device 10 is designed to be disposable, and the handle assembly 12 and adapter assembly 14 are designed to be reprocessable, re-sterilized, and reused. Thus, the reloading assembly 100 and the components forming the reloading assembly 100 are formed of materials such as plastic, which are less expensive than, but less durable than, materials such as stainless steel used to form the handle assembly 12 and adapter assembly 14.

[0030] Figures 2 to 7 This describes the proximal portion 158 of the housing 110 of the reassembly assembly 100. The housing 110 of the reassembly assembly 100 is molded from plastic materials such as polycarbonate, polyethylene, and nylon. The proximal portion 158 of the housing 110 includes a tubular extension 158a of the outer housing portion 120 of the housing 110. The tubular extension 158a defines dimensions that are configured to be the distal portion 14a of the receiver adapter assembly 14. Figure 1 The cylindrical cavity 164. The coupling mechanism 152 is supported around the tubular extension 158a of the proximal portion 158 of the housing 110 and can be used to secure the remount assembly 100 to the adapter assembly 14.

[0031] The housing 110 of the reloading assembly 100 supports the strain gauge 170. In one aspect of this disclosure, the strain gauge 170 includes one or more components molded into the housing 110 of the reloading assembly 100 and is available for placement after the reloading assembly 100 is fired. In some aspects of this disclosure, the strain gauge 170 is molded into a tubular extension 158a of the proximal portion 158 of the housing 110. However, it is contemplated that the strain gauge 170 may be molded or supported on or within the housing 110 or other portions of the reloading assembly 100.

[0032] like Figure 8 As described above, strain gauge 170 is connected via wire 180 to the handle assembly 12 ( Figure 1 The processor (not shown) is located within the housing 100. When the reloading assembly 100 is in the clamped position and is fired, the firing and clamping forces are transferred through the housing 100 and via strain gauge 170, thereby altering the circuitry defined by strain gauge 170 and wire 180. The processor interprets this alteration to identify specific parameters related to the structural characteristics and / or clamping and firing conditions. As described above, the strain gauge is formed of an inexpensive material for easy disposal of the reloading assembly 100 after use.

[0033] Those skilled in the art will understand that the apparatuses and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is contemplated that elements and features illustrated or described in connection with one exemplary embodiment may be combined with elements and features of another exemplary embodiment without departing from the scope of this disclosure. Furthermore, those skilled in the art will understand other features and advantages of this disclosure based on the embodiments described above. Therefore, this disclosure is not limited to what has been specifically shown and described, except as indicated by the appended claims.

Claims

1. A reassembly component, comprising: A housing includes an outer housing portion defining a cavity and having a proximal portion and a distal portion, the housing portion having a proximal portion forming the proximal portion of the housing portion and a tubular extension configured as a distal portion of a receiving adapter assembly, the proximal portion of the housing portion having a diameter smaller than the diameter of the distal portion of the housing portion; A strain gauge, which is molded into the tubular extension of the housing; The staple cartridge is supported on the distal portion of the outer casing and has a ring-shaped configuration; Multiple nails are received within the nail magazine; A push pin member supported within the cavity defined by the outer shell, the push pin member defining a through hole; A tool holder, which is supported in the through hole of the push pin member, is movable between a retracted position and an advanced position; A cutting tool, supported on the tool holder, is movable together with the tool holder between the retracted and forward positions and has a ring configuration; as well as A coupling mechanism extending around the tubular extension of the housing, the coupling mechanism being used to secure the remount assembly to the stitching device, the remount assembly being detachable from the adapter assembly such that the remount assembly including the strain gauge is disposable; The strain gauge is positioned such that when the reloading assembly is clamped and fired, the firing and clamping forces are transferred through the housing and via the strain gauge.

2. The reassembly assembly of claim 1, further comprising a nail actuator positioned within the cavity defined by the housing and adjacent to the pusher member, the nail actuator being movable from a retracted position to an advanced position to move the pusher member from its retracted position to its advanced position.

3. The reloading assembly of claim 1, wherein the staple cartridge defines a circular array of staple recesses, and the staple pusher includes a plurality of fingers received within the circular array of staple recesses, each of the plurality of staples being received within one of the circular array of staple recesses, such that movement of the staple pusher from its retracted position to its forward position can eject the plurality of staples from the staple cartridge.

4. A suturing device comprising: Handle assembly; An adapter assembly having a proximal portion and a distal portion, the proximal portion being supported on the handle assembly; as well as A remounting assembly releasably coupled to the distal portion of the adapter assembly, the remounting assembly including a housing, a staple cartridge, a plurality of staples, a staple pusher, a tool holder, a tool, and a coupling mechanism, the housing including an outer housing portion defining a cavity and having a proximal portion and a distal portion, the housing portion including a proximal portion forming the proximal portion of the housing portion and receiving a tubular extension of the distal portion of the adapter assembly, the coupling mechanism extending around the tubular extension of the housing and releasably securing the remounting assembly to the adapter assembly, the proximal portion of the housing portion having a diameter smaller than the diameter of the distal portion of the housing portion, and a strain gauge molded to the tubular extension. In this assembly, the staple cartridge is supported on the distal portion of the housing and has an annular configuration; the plurality of staples are received within the staple cartridge; the staple pusher is supported within the cavity defined by the housing and defines a through-hole; the tool holder is supported within the through-hole of the staple pusher and is movable between a retracted and an advanced position; the tool is supported on the tool holder and is movable together with the tool holder between the retracted and advanced positions; the tool has an annular configuration; and the strain gauge is positioned such that when the reloading assembly is clamped and fired, the firing and clamping forces are transferred through the housing and through the strain gauge; the reloading assembly is detachable from the adapter assembly such that the reloading assembly including the strain gauge is disposable.

5. The suturing apparatus of claim 4, further comprising a staple actuator positioned within the cavity defined by the housing and adjacent to the staple pusher member, the staple actuator being movable from a retracted position to an advanced position to move the staple pusher member from its retracted position to its advanced position.

6. The suture apparatus of claim 4, wherein the staple cartridge defines a circular array of staple recesses, and the staple pusher includes a plurality of fingers received within the circular array of staple recesses, each of the plurality of staples being received within one of the circular array of staple recesses, such that movement of the staple pusher from its retracted position to its forward position can eject the plurality of staples from the staple cartridge.

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