Expandable Compression Rings for Improved Anastomotic Joining of Tissues

Abstract

The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections so as to improve tissue viability, prevent tissue infection, and to prevent leakage. The present invention further relates to an expandable compression device for application to anastomotically joined tubular tissues, comprising: an upper ring-shaped or disk-shaped flange at a distal end of said device connected to a lower ring-shaped inflatable flange at a proximal end of said device via a hollow cylindrical tubular body, with an opening forming an axial passage through said upper flange, lower flange, and tubular body.

Claims

1. A circular stapling instrument comprising: a. An anvil b. A stapling head assembly c. A moveable shaft connecting the anvil and staple head assembly; d. A longitudinal shaft from which the moveable shaft extends; e. A compression device removeably affixed to the anvil and having an upper ring-shaped or disk-shaped flange at a distal end of said device connected to a lower ring-shaped expandable flange at a proximal end of said device via a hollow cylindrical tubular body and an opening forming an axial passage through said upper flange, lower flange, and tubular body.

2. The compression device of claim 1, wherein said device is generally barbell-shaped.

3. The compression device of claim 1, wherein said upper flange is ring-shaped and expandable.

4. The compression device of claim 1 further comprising an inflation cannula in fluid communication with said lower expandable flange.

5. The compression device of claim 1, wherein at least a portion of said compression device is erodible in a mammalian gastrointestinal tract over a period ranging from 1 to 4 weeks.

6. The compression device of claim 1, wherein said compression device is at least partially coated or impregnated with a releasable anti-bacterial, anti-microbial, anti-infective agent, or combinations thereof.

7. The compression device of claim 6, wherein at least 50% of said agent is released over the first 1 to 2 weeks after implantation of said compression device in a joined tubular tissue section.

8. A circular anastomosis stapler kit comprising: a) A compression device having an upper ring-shaped or disk-shaped flange at a distal end of said device connected to a lower ring-shaped expandable flange at a proximal end of said device via a hollow cylindrical tubular body and an opening forming an axial passage through said upper flange, lower flange, and tubular body; and b) an anastomotic stapler comprising a stapling head and an anvil moveable longitudinally relative to the stapling head and mounted on an axially extending moveable shaft, wherein said compression device can be releasably attachable to said anvil.

9. A method of establishing an anastomotic joint between tubular tissue lumens with an anastomotic stapler, the stapler having a stapling head connectable to an opposing anvil and the stapling head containing a plurality of deployable staples, the method comprising the steps of: a. Axially positioning on the anvil a compression device having an upper ring-shaped or disk-shaped flange at a distal end of said device connected to a lower ring-shaped expandable flange at a proximal end of said device via a hollow cylindrical tubular body and an opening forming an axial passage through said upper flange, lower flange, and tubular body; b. Axially inserting the anvil into a first tubular tissue; c. Axially inserting the anastomotic stapler into a second tubular tissue; d. Connecting the anvil to the stapling head via an anvil shaft; e. Approximating the anvil and the stapling head and compressing said first and second tubular tissues between the stapling head and the anvil; f. Firing the anastomotic stapler and establishing the anastomotic joint between said first and second tubular tissues; g. Partially withdrawing the anastomotic stapler thus positioning said compression device with said upper flange above stapled areas of said first and second tubular tissues and said lower flange below the stapled areas of said first and second tubular tissues; h. Expanding said upper flange; i. Expanding said lower flange, thus compressing the stapled areas of said first and second tubular tissues between the upper flange and the lower flange; j. Removing the anastomotic stapler from the tubular tissues; k. Separating the anastomotic stapler from the compression device; and l. Leaving the compression device within said first and second tubular tissues with the upper flange above the stapled areas and the lower flange below the stapled areas.

10. The method of claim 9 further comprising the step of releasing antimicrobial agents from the compression device after removing the anastomotic stapler from the tubular tissues.

11. The method of claim 9 wherein said step h) is performed by inflating said upper flange and said step i) is performed by inflating said lower flange.

12. The compression device of claim 1, wherein said lower flange is inflatable.

13. The compression device of claim 3, wherein said upper flange is inflatable.

14. The compression device of claim 1, wherein said compression device is affixed to said anvil at said lower flange.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0019] FIG. 1 shows a perspective view of a typical circular surgical stapling instrument

[0020] FIG. 2 shows a perspective view of an embodiment of the compression device of the present invention

[0021] FIG. 3 shows an exploded view of an embodiment of the compression device of the present invention

[0022] FIG. 4 shows a perspective view of an embodiment of the compression device of the present invention

[0023] FIG. 5 shows a perspective view of an embodiment of the compression device of the present invention

[0024] FIG. 6 shows an exploded view of an embodiment of the compression device of the present invention

[0025] FIG. 7 shows a perspective view of an embodiment of the compression device of the present invention

[0026] FIGS. 8, 9 and 10 show a schematic side cross-sectional view of a portion of a circular stapler and of the compression device of the present invention in operation.

[0027] FIGS. 11, 12, 13, 14 and 15 show a schematic side cross-sectional view of an embodiment of the compression device of the present invention

[0028] FIGS. 16 and 17 show a perspective view of an embodiment of the compression device of the present invention

DETAILED DESCRIPTION OF THE INVENTION

[0029] Surgery often involves joining of two or more layers of tissue together with optional simultaneous sectioning of a portion of the tissue along the staple line. For example, colorectal surgery in many cases involves the resection of a segment of the colon and rectum. Following a colorectal resection, the colon and rectum are drawn together with a circular stapler and an end-to-end anastomosis is performed. Post- op leakage of the anastomosis has been shown to lead to morbidity and mortality.

[0030] Typical surgical stapling instruments have a staple-containing component and an opposing anvil component, between which at least two tissue layers to be joined are compressed prior to delivery of staples from the staple-containing component, whereby staples are piercing both tissue layers and are bent, deformed, or closed against the opposing anvil component.

[0031] Referring now to FIG. 1, a generic surgical anastomosis stapling instrument or stapling device for performing a circular anastomosis stapling operation is shown, with the figure taken from the U.S. Pat. No. 5,271,544 “Surgical anastomosis stapling instrument”, assigned to Ethicon, Inc., Somerville, N.J., and incorporated herein by reference in its entirety for all purposes. Various modifications and iterations of the shown stapling device are known in the art, having similar features. The circular anastomosis surgical stapling instrument 500 includes a distal stapling head assembly 600 connected by a longitudinally curved support shaft assembly 700 to a proximal actuator handle assembly 800. The stapling instrument includes an anvil assembly or anvil 1000 which is slidable longitudinally relative to the stapling head assembly 600 and mounted on an axially extending moveable shaft 1040. An optional rotatable adjusting knob 820 is provided at the proximal end of the actuator handle assembly 800 for adjusting the spacing between the stapling head assembly 600 and the anvil assembly 1000. Other approximating means to compress adjacent sections of tissue are known to skilled artisans and can be used. An optional movable indicator 840 is visible through an optional window 850 on top of the handle assembly 800 to indicate the staple height and/or gap between the stapling head assembly 600 and anvil 1000 selected by rotation of the adjusting knob 820. The indicator 840 is movable indicating that the anvil gap is within a desired operating range of the stapling instrument 500. The position of the indicator 840 also indicates whether the selected staple height is large or small.

[0032] A staple actuating lever 860 is pivotally mounted on the actuator handle assembly 800 for driving the surgical staples from the stapling head assembly 600 when the anvil assembly 1000 is closed to provide the desired staple height. A pivotal latching member 880 is mounted on the handle assembly 800 for locking the staple actuating lever 860 against movement to preclude actuation of the stapling head assembly 600 when the anvil gap is outside of a predetermined range. The stapling head assembly 600 includes a tubular casing 610 as well as a hollow tubular connector 640 at the proximal end of the casing 610 which receives the distal end of the support shaft 700. A ferrule or sleeve 720 overlaps the joint between the tubular connector 640 and the distal end of the support shaft 700. The proximal end of the support shaft 700 is received by a tubular extension 740 at the distal end of the actuator handle assembly 800. A ferrule or sleeve 760 overlaps the joint between the proximal end of the support shaft 700 and the distal end of the tubular extension 740. The movable indicator 840 is visible through a window 850 on top of the handle assembly 800 to indicate the staple height selected by rotation of the adjusting knob 820.

[0033] Other versions and modifications of the circular surgical stapler are known to a skilled artisan. There are typically at least two and frequently more concentric stapling lines or concentric circular rows of staples-containing slots surrounding shaft 1040, with staples in each row typically staggered or offset relative to the staples in the adjacent row, to improve the sealing and prevent leakage along the stapling line.

[0034] Clinical evidence shows the formation of a full wall intestinal defect at or near the anastomotic site may occur as soon as 1-2 days post-op, with typical time period when the clinical symptoms of leaks occur being from 1 to 5 days post-op. See, for example, K. Jonsson, H. Jiborn, B. Zederfeldt, “Breaking strength of small intestinal anastomoses”, The American Journal of Surgery, v. 145, pp. 800-803, 1983; Y.-H. Ho, M.A.T. Ashour, “Techniques for colorectal anastomosis”, World Journal of Gastroenterology, 16(13), pp. 1610-1621, 2010.

[0035] According to the present invention, after the staples from a circular anastomotic stapler are deployed and an anastomotic joint is established connecting two parts of a tissue lumen, the circular anastomotic stapler is withdrawn and an inflatable barbell-shaped hollow compression device is installed over the stapled area within the tissue lumen, providing additional reinforcement and particularly isolating the just stapled and just resected areas from contaminations and potential infection. Optionally, a medicant is released from the compression device, such medicant being an anti-bacterial or anti-infective agent.

[0036] Referring now to FIG. 2, a schematic perspective view of generally barbell-shaped hollow compression device 10 is shown, with device 10 comprising an upper ring-shaped or toroid-shaped expandable flange 20, such as in one embodiment, inflatable flange 20 connected to a lower ring-shaped or toroid-shaped expandable flange 30, such as in one embodiment, inflatable flange 30 via a hollow cylindrically shaped tubular body 40, with an opening 50 forming an axial passage through all three interconnected components of device 10, i.e. through upper flange 20, tubular body 40, and lower flange 30. FIG. 3 shows an exploded view of device 10 with upper flange 20, tubular body 40, and lower flange 30 shown separately but axially aligned with opening 50 visible in all three components. FIG. 2 shows upper flange 20 and lower flange 30 in the inflated configuration, filled with a fluid such as water, saline, air, nitrogen, or the like. FIG. 4 shows device 10 with upper flange 20 and lower flange 30 in a deflated configuration.

[0037] Referring now to FIG. 5, a schematic perspective view of an alternative embodiment of compression device of the present invention is shown, with generally barbell-shaped hollow compression device 11 comprising an upper disk-shaped non-inflatable flange 21 connected to a lower ring-shaped or toroid-shaped inflatable flange 30 via a hollow cylindrically shaped tubular body 40, with an opening 50 forming an axial passage through all three interconnected components of device 10, i.e. through upper flange 21, tubular body 40, and lower flange 30. FIG. 6 shows an exploded view of device 11 with upper flange 21, tubular body 40, and lower flange 30 shown separately but axially aligned with opening 50 visible in all three components. FIG. 5 shows lower flange 30 in the inflated configuration, filled with a fluid such as water, saline, air, nitrogen, or the like. FIG. 7 shows device 11 with lower flange 30 in a deflated configuration.

[0038] The ring-shaped or disk-shaped flanges are understood to have any shapes suitable for functioning in a manner described in this invention.

[0039] Gap G between upper flange 20 or 21 and lower flange 30 is shown in FIGS. 2 and 5, when upper flange 20 and lower flange 30 are inflated.

[0040] Referring now to FIG. 8, a schematic cross-sectional partial view of a portion of circular stapler 500 performing anastomotic joining of tubular tissues T1 and T2 is presented. Anvil 1000 is shown disposed within tubular tissue T1 and connected to stapling head 600 via moveable shaft 1040. Anvil 1000 can be of any suitable shape or form, such as of generally widely used conical form as shown in FIG. 1, or of generally flat cylinder or disk form, as schematically shown in FIGS. 8-10 or any other form such as a trapezoidal, toroidal or the like. Stapling head assembly 600 is shown disposed within tubular tissue T2 and supported on support shaft assembly 700. For simplification, the mechanism of staples 110 deployment and mechanism of deploying tissue cutting concentric knife 112 are not shown. FIG. 8 shows anvil 1000 and stapling head 600 approximated, compressing tissue T1 and T2 between them, with staples 110 fired thus establishing a stapled joint between tissues T1 and T2 with staples 110 concentrically arranged in one or more concentric rows around tissue donut or cut-out 120.

[0041] Compression device 10 is shown disposed within tubular tissue T1 and removably attached onto anvil 1000 via means of attachment, such as via snug fit of pin 55 into opening 50 within tubular body 40. Pin 55 is positioned attached to or machined on top of anvil 1000. Upper inflatable flange 20 is shown at least partially expanded or inflated, whereby lower inflatable flange 30 is in unexpanded, deflated configuration.

[0042] As shown in FIG. 9, after deploying staples and cutting out tissue cutout 120, circular stapler 500 is being withdrawn in the direction of arrow A, with anvil 1000 moving past staples 110, pulling device 10 lower inflatable flange 30 also past staples 110. Upper inflatable flange 20 is at least partially or preferably fully expanded or inflated prior to circular stapler withdrawal and thus upper inflatable flange is not brought past staples 110, positioning device 10 with upper flange 20 above staples 110 and within tubular tissue T1 and lower flange 30 below staples 110 and within tubular tissue T2.

[0043] As shown in FIG. 10, once device 10 is positioned with upper flange 20 above staples 110 and lower flange 30 below staples 110, upper flange is optionally additionally inflated if needed to achieve full inflation. Lower flange 30 is also fully inflated thus immobilizing device 10 around staples 110 compressing staples 110 lines from above and below and isolating areas of tubular tissues T1 and T2 that were cut and stapled tissue. Circular stapler 500 is then fully withdrawn severing anvil 1000 connection to device 10 via pin 55. Device 10 is positioned with upper flange 20 above staples 110 and within tubular tissue T1 and lower flange 30 below staples 110 and within tubular tissue T2.

[0044] As shown in FIG. 11, after removal of circular stapler 500, device 10 remains within tubular tissues T1 and T2 which are joined by staples 110, with device 10 immobilized around staples 110 and compressing staple lines from above and below and isolating areas of cut and stapled tissue.

[0045] As shown in FIG. 12, compression device 11 which is an alternative embodiment of compression device 10 of the present invention, is installed in a similar fashion, with the upper disk-shaped non-inflatable flange 21 positioned within tissue T1 above staples 110 and lower flange 30 positioned in fully inflated state below staples 110 and within tubular tissue T2.

[0046] Referring now to FIGS. 13 and 14, embodiments for the inflation means for inflating upper flange 20 and lower flange 30 are shown. Flexible cannula 26 is shown connected to channel 27 in tubular body 40, thus providing fluid communication from cannula 26 inlet 28 to upper flange 20.

[0047] Flexible cannula 36 is shown connected to channel 37 in tubular body 40, thus providing fluid communication from cannula 36 inlet 38 to lower flange 30. Inflating is performed by connecting a source of pressurized fluid, such as a syringe containing saline or air, to cannulas 26, 36 inlets 28, 38 and delivering fluid into upper flange 20 and lower flange 30. An optional one way valve (not shown) can be provided in cannulas 26, 36 or in channels 27, 37, or within upper flange 20 and lower flange 30, to prevent deflation. A single cannula (not shown) such as cannula 26, can also be used to connect to both channels 27 and 37 and simultaneously inflate upper flange 20 and lower flange 30 with the means to assure upper flange 20 is inflated to a greater extent or size, said means exemplified by a check valve or an orifice of a larger diameter.

[0048] In certain embodiments compression devices 10 or 11 are made of non-resorbable polymers and metals or composites, preferably from polymeric and elastomeric materials. In one embodiment, inflatable flanges are non-compliant balloons whereby they are made of materials with low elasticity, low elastomeric properties materials, such as PET, whereby upon reaching the expanded state, increase of inflating pressure does not result in appreciable increase in size of the balloon. They are excreted as the stapled areas of tissues T1 and T2 eventually undergo necrotic transformation and die off.

[0049] In certain embodiments compression devices 10 and 11 are made of resorbable or erodible/soluble materials which are known to a skilled artisan. In certain embodiments only upper flange 20 and 21 and lower flange 30 are erodible/soluble, with time to at least partially dissolve from about 3 days to about 30 days in the gastro-intestinal (GI) tract, such as 1 week, 2 weeks, 3 weeks, or 4 weeks, most preferably 2-4 weeks. Partial dissolution is defined as dissolution sufficient enough to result in deflation.

[0050] In certain embodiments inflatable flanges 20 and 30 are not per se rapidly soluble or erodible in the GI tract, however inflatable flanges 20 and 30 have at least one deflation plug which is soluble or erodible in the GI environment and such plug defines the rate of deflating of flanges 20 and 30. Upon dissolution of the plug, flanges 20 and 30 deflate releasing compression devices 10 or 11 resulting in devices 10 or 11 excretion. For the deflation plug the time to at least partially dissolve is from about 3 days to about 30 days in the gastro-intestinal (GI) tract, such as 1 week, 2 weeks, 3 weeks, or 4 weeks, most preferably 2-4 weeks. Partial dissolution is defined as dissolution sufficient enough to result in deflation.

[0051] FIG. 15 shows embodiments of device 10 having soluble/erodible deflation plugs 29a and 29b installed to deflate upper flange 20 and soluble/erodible deflation plugs 39a and 39b installed to deflate lower flange 30.

[0052] According to one embodiment of the present invention, the sequence of using the inflatable compression device of the present invention for establishing an anastomotic joint is as follows: [0053] a) Axially positioning the inflatable compression device on the anvil [0054] b) Axially inserting the anvil into the tubular tissue T1 [0055] c) Axially inserting the anastomotic stapler into tubular tissue T2 [0056] d) Connecting the anvil to the stapling head via the anvil shaft [0057] e) Approximating the anvil and the stapling head and compressing tubular tissues T1 and T2 between the stapling head and the anvil [0058] f) Firing the anastomotic stapler and establishing stapled anastomotic joint between tissues T1 and T2 [0059] g) Partially withdrawing the anastomotic stapler thus positioning the inflatable compression device with the upper flange above the stapled areas of tissues T1 and T2 and the lower flange below the stapled areas of tissues T1 and T2 [0060] h) Expanding the upper flange e.g. by inflating it prior to step f), immediately after step f), or immediately after step g), if the inflatable compression device has inflatable upper flange [0061] i) Expanding the lower flange, e.g. by inflating it, thus compressing the stapled areas of tissues T1 and T2 between the upper flange and the lower flange [0062] j) Removing the anastomotic stapler from the tubular tissue T2, separating the anastomotic stapler from the inflatable compression device and leaving the inflatable compression device within tubular tissues T1 and T2 with the upper flange above the stapled areas of tissues T1 and T2 and the lower flange below the stapled areas of tissues T1 and T2 [0063] Additional steps after the inflatable compression device installation include: [0064] Optionally releasing antimicrobial agents from the inflatable compression device [0065] Deflating the inflatable compression device and allowing the inflatable compression device to pass through the GI tract out of the body

[0066] Complete steps of anastomotic surgical procedures, e.g. application of purse string sutures are not listed above, but will be known to skilled artisans.

[0067] According to the present invention, compression devices 10 or 11 are optionally at least partially coated or impregnated with releasable antimicrobial agents. All portions of devices 10 and 11 can be treated with such agents, or specific outside portions of devices 10 and 11 which are in contact with areas of tissues T1 and T2 which are stapled or cut, are preferably coated or impregnated with releasable antimicrobial agents. Referring to FIGS. 16, 17, one or more of the following areas are preferably coated or impregnated with releasable antimicrobial agents: Area A on the lower side of upper flange 20 or 21; area B on the upper side of lower flange 30; area C on the external surface of tubular body 40 between upper flange 20 or 21 and lower flange 30.

[0068] Advantageously, compression devices 10 or 11 isolate areas of stapled and cut tissue from the GI environment and establish a concentration of anti-microbial agents in the immediate vicinity of these areas of tissue. Such treatment is thought to minimize formation of tissue ulcerations and other defects and decrease the occurrence of anastomotic leaks.

[0069] The diameter of disk-shaped upper flange 21 and inflated upper flange 20 and inflated lower flange 30 is conforming generally to the diameter of stapling head 600 and anvil 1000 and to the geometry/inner diameter of tubular tissue T1 and T2. In some embodiments, diameter of upper flange 21 and inflated upper flange 20 and inflated lower flange 30 is from about 15 mm to about 30 mm, such as 20 mm, 22 mm, 25 mm. The diameter of non-inflated upper flange 20 and lower flange 30 is at least 25% smaller vs. the inflated diameter, such as 25%, 30% or 50% smaller.

[0070] The diameter of the opening forming an axial passage through upper flange 20, lower flange 30, and tubular body 40 is from about 10 mm to about 20 mm. The wall thickness of the tubular body 40 is from about 0.5 mm to about 5 mm, such as 1, 2, 3 mm.

[0071] The height of the disk-shaped upper flange 21 is about 0.5 mm to about 5 mm, such as 1, 2, or 3 mm. The height of inflated upper flange 20 and inflated lower flange 30 is from about 2 mm to about 10 mm, more preferably 3 to 8 mm, such as 3, 4, or 6 mm,

[0072] Gap G between upper flange 20 or 21 and lower flange 30 in inflated position is from 0 mm (i.e. upon inflation in absence of tissue T1 and T2 present in the gap G, upper flange 20 or 21 touches lower flange 30) to about 0.5 to 2 mm, such as 0.5 mm or 1 mm. When device 10 is installed on stapled tissue, Gap G corresponds to thickness of compressed tissues T1 and T2 between upper flange 20 or 21 and lower flange 30.

[0073] While the invention has been described above with reference to specific embodiments thereof, it is apparent that many changes, modifications, and variations can be made without departing from the inventive concept disclosed herein. Accordingly, it is intended to embrace all such changes, modifications, and variations that fall within the spirit and broad scope of the appended claims.