WO2024129949A1 - Introducteurs luminaux et procédés associés - Google Patents

Introducteurs luminaux et procédés associés Download PDF

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Publication number
WO2024129949A1
WO2024129949A1 PCT/US2023/083983 US2023083983W WO2024129949A1 WO 2024129949 A1 WO2024129949 A1 WO 2024129949A1 US 2023083983 W US2023083983 W US 2023083983W WO 2024129949 A1 WO2024129949 A1 WO 2024129949A1
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WO
WIPO (PCT)
Prior art keywords
introducer
sheath
distal end
surgical
surgical instrument
Prior art date
Application number
PCT/US2023/083983
Other languages
English (en)
Inventor
SR. James S. Franklin
Original Assignee
Franklin Institute of Innovation, LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Franklin Institute of Innovation, LLC filed Critical Franklin Institute of Innovation, LLC
Publication of WO2024129949A1 publication Critical patent/WO2024129949A1/fr

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Definitions

  • the present disclosure relates generally to surgical instruments and methods, and more particularly to surgical introducers and related methods of using such introducers to introduce devices into a body cavity.
  • a surgical stapler may be introduced into the bowel to join or attach tissue segments, e g., an anastomosis.
  • tissue segments e g., an anastomosis.
  • a head assembly and a portion of a shaft of the stapler may be inserted into the bowel of the patient and advanced to a surgical site, while the handle remains outside of the patient to allow the clinician to control positioning and operation of the stapler.
  • the head assembly generally may be relatively large in order to accommodate the various components for staple formation and for cutting the inner portions of the colon segments being joined.
  • distal end face of the head assembly may be flat or relatively flat in order to cooperate with the mating portion of the anvil head, resulting in an abrupt edge along the outer circumference of the head assembly.
  • Other surgical instruments may also include components that may be relatively large or include edges, comers, points, or transitions.
  • Various surfaces of a surgical instrument may contact internal tissue and surrounding anatomy as the surgical instrument is introduced and advanced into a body cavity.
  • the introducer includes a sheath extending between a proximal end and a distal end, where the sheath is configured to receive and cover a distal tip of the elongated surgical device.
  • the introducer also includes an inflatable segment coupled to the sheath and configured to move between a collapsed configuration and an inflated configuration, where the inflatable segment is configured to inflate about the distal tip of the elongated surgical device to facilitate insertion and advancement of the elongated surgical device.
  • the distal end of the sheath defines a distal opening. The distal opening may be configured to facilitate removal of the introducer from the elongate surgical device while the elongate surgical device is disposed within a body cavity of the patient.
  • a distal portion defining the distal end of the sheath has a narrower diameter than a proximal portion of the sheath.
  • the distal portion may have a wall thickness greater than that of a proximal portion of the sheath.
  • the inflatable segment is coupled to the distal end of the sheath within an interior of the sheath.
  • the inflatable segment may surround an internal lumen of the sheath, or may be defined with a wall of the sheath.
  • the introducer also includes an inflation fluid container coupled to the inflatable segment by a supply tube. The inflation fluid container is configured to supply an inflation fluid to the inflatable segment, via the supply tube, to inflate the inflatable segment.
  • the inflation fluid container is a syringe.
  • the inflation fluid is sterile water or saline.
  • the introducer is also configured to remove the inflation fluid from the inflatable segment, via the supply tube, to deflate the inflatable segment.
  • the sheath is formed of a material that is one or more of elastomeric, flexible, or stretchable. The material may comprise an elastomer, such as silicone or polyurethane.
  • an introducer for a colorectal stapler includes a sheath extending between a proximal end and a distal end, the sheath being configured to receive and cover a distal tip of the colorectal surgical stapler, and an inflatable segment coupled to the sheath and configured to move between a collapsed configuration and an inflated configuration.
  • the inflatable segment may be configured to inflate about the distal tip of the colorectal surgical stapler to form a smooth contoured shape, which facilitates insertion and advancement of the distal tip of the colorectal surgical stapler into a patient.
  • the sheath is formed of a polymeric elastomer, such as silicone or polyurethane.
  • an assembly in a further aspect, includes a surgical instrument and an introducer.
  • the surgical instrument may include a tubular shaft having a proximal end and a distal end, a handle extending from the proximal end of the tubular shaft, and a head assembly extending from the distal end of the tubular shaft.
  • the introducer may be coupled to the head assembly of the surgical instrument, wherein the introducer is configured to facilitate insertion and advancement of the distal end of the surgical instrument into a patient.
  • the surgical instrument is a surgical stapler.
  • the introducer includes a sheath extending between a proximal end and a distal end, the sheath being configured to receive and cover at least the head assembly of the distal end of the surgical device, an inflatable portion coupled to the sheath and configured to move between a collapsed configuration and an inflated configuration, and an inflation fluid container coupled to the inflatable portion by a supply tube.
  • the inflatable portion may be configured to inflate about the distal end of the surgical instrument to form a smooth contoured shape.
  • a method of introducing a surgical instrument into a patient includes covering at least a head assembly of the surgical instrument with an introducer, inserting the surgical instrument covered with the introducer into a body cavity of the patient, and advancing the surgical instrument covered with the introducer to a location in the body.
  • the method also includes inflating the inflatable segment before, during, or after advancing the surgical instrument.
  • the sheath may have a smooth contoured shape effective to facilitate insertion and advancement of the surgical instrument.
  • the method also includes the steps of deflating the inflatable segment after advancing the surgical instrument, and proximally withdrawing the sheath over the distal portion of the surgical stapler to expose the head assembly.
  • FIG. 1 A is a perspective view of an introducer for a surgical instrument having a sheath and an inflatable segment, according to one or more embodiments of the present disclosure.
  • FIG. IB is a side view of the introducer of FIG. 1A. according to one or more embodiments of the present disclosure.
  • FIG. 2 is a side view of a prior art surgical stapler, which may be used with the introducer of FIGS. 1 A-1B, according to one or more embodiments of the present disclosure.
  • FIG. 3A-3B illustrates a sequence of attaching an introducer to a surgical instrument, according to one or more embodiments of the present disclosure.
  • FIGS. 4A-4C illustrates a method of inflating an introducer, according to one or more embodiments of the present disclosure.
  • FIGS. 5A-5D illustrates a method of deflating and removing an introducer from a distal portion of a surgical instrument, according to one or more embodiments of the present disclosure.
  • FIG. 6 illustrates an introducer with a retrieval strap to facilitate proximal displacement of the introducer from the distal portion of a surgical instrument, according to one or more embodiments of the present disclosure.
  • Introducers have been developed for covering at least a distal portion of a surgical instrument, to protect internal tissue and anatomical features during insertion or advancement of the surgical instrument in a body cavity.
  • the introducer is used to cover a distal portion of a conventional surgical stapler designed to be introduced into a body cavity and advanced to a predetermined site substantially atraumatically.
  • the stapler may be introduced through a patient’s anus to reach a desired region of the colon.
  • Such introducers advantageously may ease insertion and advancement of a distal portion of the surgical instrument, for example, a head assembly of a stapler to a desired location for performing a procedure, while reducing incidence of injury to the surrounding anatomy and corresponding complications for the patient.
  • the introducers described herein may include a sheath and an inflatable segment that is configured to be positioned about a distal portion of the surgical instrument.
  • the inflatable segment may be inflated prior to, during, or after introduction of the surgical instrument into the patient. While in the inflated configuration, the inflatable segment may cover a distal portion of the surgical instrument, for example, the head assembly, thereby inhibiting the distal portion from engaging the surrounding anatomy as the head assembly is advanced toward a desired location within a tissue segment.
  • FIGS. 1 A-1B depict an introducer 100 for use with a surgical instrument, such as the instrument 200 shown in FIG. 2, which is the distal end portion of a surgical stapler.
  • the introducer 100 includes a sheath 102 extending between a proximal portion 104 and a distal portion 106.
  • the proximal portion 104 includes a proximal end 108 defining a proximal opening 110 therein through which the surgical instrument 200 may be introduced into the sheath 102.
  • the distal portion 106 may include a distal end 112 defining a distal opening 114.
  • the distal opening 114 is configured to facilitate removal of the introducer 100 from the surgical instrument 200 so that the instrument 200 may be used for its intended purpose during a surgical procedure.
  • the sheath 102 may be configured to receive and cover at least a distal end portion of the surgical instrument 200.
  • a head assembly 202 of the surgical instrument 200 disposed at the distal end 204 of a tubular shaft 206 of the instrument 100. may be inserted into the introducer 100 via the proximal opening 110 thereof.
  • the distal end 204 of the instrument 100 may be passed through the sheath 102 until the head assembly 202 abuts the distal end 112 and is in contact with the distal opening 114 of the sheath 102.
  • the surgical instrument 200 is a surgical stapler, including a stapler configured to be introduced into/through channels of the anus, rectum, and/or colon.
  • the sheath may include, consist of, or consist essentially, of a stretchable material. That material may be a polymer, or copolymer, or polymeric blend. For instance, the material may include, consist of, or consist essentially of, an elastomer, such as a silicone or a polyurethane, e.g.. a biocompatible thermoplastic polyurethane, or TPU, as known in the art.
  • an elastomer such as a silicone or a polyurethane, e.g.. a biocompatible thermoplastic polyurethane, or TPU, as known in the art.
  • the distal portion 106 of the sheath 102 has a narrow er diameter than the proximal portion 104 of the sheath 102.
  • the distal portion 106 of the sheath 102 has a wider diameter than the proximal portion 104 of the sheath 102. In some embodiments, the distal portion 106 of the sheath 102 has a greater thickness than the proximal portion 104 of the sheath 102. In other embodiments, the distal portion 106 of the sheath 102 has a lesser thickness than the proximal portion 104 of the sheath 102.
  • the introducer 100 includes an inflatable portion 116 coupled to the sheath 102, where the inflatable portion 116 is configured to move between a collapsed configuration and an inflated configuration.
  • the inflatable portion 1 16 of the sheath 102 may be configured to inflate about the distal tip 204 of the surgical instrument 200 to form a smooth contoured shape, w hich may facilitate insertion of the distal tip 204 of the instrument 200 into a patient.
  • the inflatable portion 116 is a balloon.
  • the inflatable portion 116 may be discrete or integrated with the sheath 102.
  • a portion of the sheath 102 may define the inflatable segment 110, for example, including the balloon. That is, the inflatable portion 116 may be defined within the sheath 102.
  • the sheath 102 may include a double-walled portion defining the inflatable portion 116 therein.
  • the inflatable portion 116 is coupled to an interior surface of the distal portion 106 of the sheath 102.
  • the inflatable portion 116 may be filled with an inflation fluid before or after the introducer 100 has been stretched over the surgical instrument 200.
  • the inflatable portion 116 may be attached to a supply tube 118 through which an inflation fluid is passed to inflate the inflatable portion 116.
  • the inflation fluid may be water, a saline solution, air, or the like.
  • the supply tube 112 includes a port 120, as shown in FIG. 4 A, to which an inflation fluid container 122 may be coupled in order to supply the inflation fluid to the supply tube 118 and the inflatable portion 116.
  • the inflation fluid container 116 is a syringe.
  • the supply tube 118 may be fluidly connected to the inflatable portion 116 via a connector 124 disposed within the sheath 102, for example, as shown in FIGS. 4A-4C.
  • the proximal end 108 of the sheath 102 may include an opening 126 configured to receive the supply line 118.
  • the supply line 118 may then be provided to the connector 124 and the inflatable portion 116 of the sheath 102.
  • the supply line 118 may be used to inflate the inflatable portion 116.
  • FIGS. 3A-3B a sequence (300) of attaching the introducer 100 to the surgical instrument 200 is shown.
  • the introducer 100 is pulled over the distal portion 204 of the instrument 200. More specifically, as shown in FIG. 3 A, the proximal opening 110 of the introducer 100 sheath 102 is aligned (302) with the head assembly 200 at the distal end 204 of the instrument 200 so that the introducer 100 may be secured to the instrument 200. Once the instrument 200 and the introducer 100 are aligned, the introducer 100 is advanced (304) in a proximal direction to cover the head assembly 202 of the instrument 200, as show n in FIG. 3B. The introducer 100, or at least a portion thereof, is secured to the instrument 200 by frictional engagement with the lateral surface of the distal portion 204 of the instrument 200. After the introducer 100 is secured about the instrument 200, the inflatable portion 116 of the introducer 100 may be inflated for use.
  • the inflatable portion 116 is disposed within an interior wall 128 of the sheath 102, surrounding an internal lumen 130 thereof.
  • the inflatable portion 116 may therefore expand at least partially into the internal lumen 130 of the sheath 102.
  • FIG. 4A depicts the introducer 100 in the non-inflated position prior to use (402).
  • the fluid supply container 122 is attached to the fluid supply line 118 via the port 120.
  • the inflatable portion 116 is in the non-inflated state, the internal wall 128 does not protrude into the internal lumen 130 of the sheath 102.
  • the fluid supply container 122 is used to transfer fluid (404), via the supply line 118, to the inflatable portion 116, the inflatable portion begins to expand.
  • the inflatable portion 116 may expand such that the internal wall 128 may begin to protrude into the internal lumen 130 of the sheath 130 at least at the distal end 112 of the sheath 102. Inflation of the inflatable portion 116 may also cause the overall profile of the introducer 100 to expand. In such embodiments, the distal portion 106 of the introducer 100 may have a larger diameter than the proximal portion 104 of the introducer 100 when the inflatable portion 116 is partially or fully inflated. Once the inflatable portion 116 is fully inflated (406). as shown in FIG. 4C, the introducer 100 and the surgical instrument may be inserted into a body cavity of the patient.
  • the inflatable segment 116 may be deflated to facilitate removal of the introducer 100 from the surgical instrument 200.
  • the inflatable portion 116 may be deflated, and the introducer 100 may be retracted circumferentially off of the distal end 204 of the surgical instrument 200, which may be effective to allow the surgical instrument 200 to be used as intended w ithin the patient without interference from the introducer 100.
  • the surgical instrument 200 is a stapler, for example, proximal retraction of the introducer 100 may enable use of the stapler to safely and effectively complete a surgical procedure such as an anastomosis following a bowel resection.
  • FIGS. 5A-5D An exemplary method (500) of deflating and removing the introducer 100 is shown in FIGS. 5A-5D. Insertion of the surgical instrument 200 is accomplished with the introducer in the fully inflated state (502), as shown in FIG. 5A. Following insertion, the inflatable portion 116 may be partially or fully deflated (504) by withdrawing the inflation fluid from the inflatable portion. For example, the inflation fluid may be removed from the inflatable portion 116 via the supply tube 118. In some embodiments where the fluid supply container 122 is a syringe, for example, the syringe may draw fluid back in from the inflatable portion 116 through the supply line.
  • the fluid supply container 122 is a syringe
  • the syringe may draw fluid back in from the inflatable portion 116 through the supply line.
  • Deflation of the inflatable portion 116 may reduce the profile of at least the distal portion 106 of the introducer 100 sheath 102.
  • the extent to which the internal wall 128 protrudes into the internal lumen 130 defined by the sheath 102 may also be reduced, thereby enabling movement of the sheath 102 with respect to the distal end 204 and head assembly 202 of the surgical instrument 200.
  • the sheath 102 may be retracted (506) in a proximal direction to expose the head assembly 202 of the instrument 200, as shown in FIG. 5C.
  • the introducer 100 may include one or more tethers 132 (e.g., retrieval straps) attached to the proximal end 108 of the sheath 102 and extending out of the patient to enable a surgeon to grasp the one or more tethers and pull the introducer in a proximal direction to facilitate removal of the introducer from at least the distal end face of the head assembly of the instrument 200, as shown in FIG. 5C.
  • the supply line may be used to facilitate removal of the introducer from at least the distal end of the head assembly of the instrument, either alone or in conjunction with the one or more retrieval straps 132.
  • the introducer 100 may be fully removed (508) from the distal end 204 of the surgical instrument 200 to prepare the instrument 200 for use.
  • the sheath 102 is only partially removed from the instrument 200, and remains disposed around the proximal base 208 and/or handle 210 of the instrument 200 until the procedure is complete.
  • the entire instrument 200 and the attached but separated or withdrawn introducer 100 may then be removed.
  • the stapler may be retracted with the introducer remaining attached to the stapler, or otherwise be withdrawn together with the introducer.
  • the introducer 100 may be fully removed from the surgical instrument 200 prior to proceeding with the surgical procedure.
  • Embodiment 1 An introducer for an elongated surgical device, the introducer comprising a sheath extending between a proximal end and a distal end, the sheath being configured to receive and cover a distal tip of the elongated surgical device, and an inflatable segment coupled to the sheath and configured to move betw een a collapsed configuration and an inflated configuration, wherein the inflatable segment is configured to inflate about the distal tip of the elongated surgical device to facilitate insertion and advancement of the elongated surgical device.
  • Embodiment 2 The introducer of Embodiment 1, wherein the distal end of the sheath defines a distal opening.
  • Embodiment 3 The introducer of Embodiment 2, wherein the distal opening is configured to facilitate removal of the introducer from the elongate surgical device while the elongate surgical device is disposed within a body cavity of a patient.
  • Embodiment 4 The introducer of any one of Embodiments 1 to 3, wherein a distal portion defining the distal end of the sheath has a narrower diameter than a proximal portion of the sheath.
  • Embodiment 5 The introducer of any one of Embodiments 1 to 3, wherein the distal portion has a wall thickness greater than that of a proximal portion of the sheath.
  • Embodiment 6 The introducer of any one of Embodiments 1 to 5, wherein the inflatable segment is coupled to the distal end of the sheath within an interior of the sheath.
  • Embodiment 7. The introducer of any one of Embodiments 1 to 6, wherein the inflatable segment surrounds an internal lumen of the sheath.
  • Embodiment 8 The introducer of any one of Embodiments 1 to 7, wherein the inflatable segment is defined within a wall of the sheath.
  • Embodiment 9 The introducer of any one of Embodiments 1 to 8, further comprising an inflation fluid container coupled to the inflatable segment by a supply tube.
  • Embodiment 10 The introducer of Embodiment 9, wherein the inflation fluid container is configured to supply an inflation fluid to the inflatable segment, via the supply tube, to inflate the inflatable segment.
  • Embodiment 11 The introducer of Embodiment 10, wherein the inflation fluid container comprises a syringe.
  • Embodiment 12 The introducer of Embodiment 10 or 11, wherein the inflation fluid is sterile water or saline.
  • Embodiment 13 The introducer of any one of Embodiments 10 to 12. wherein the introducer is also configured to remove the inflation fluid from the inflatable segment, via the supply tube, to deflate the inflatable segment.
  • Embodiment 14 The introducer of any one of Embodiments 1 to 13, wherein the sheath comprises a polymeric material, such as an elastomeric material.
  • Embodiment 15 The introducer of Embodiment 14, wherein the elastomeric material comprises silicone, polyurethane (e.g., a TPU), or a combination thereof.
  • the elastomeric material comprises silicone, polyurethane (e.g., a TPU), or a combination thereof.
  • Embodiment 16 An introducer for a colorectal surgical stapler, the introducer comprising a sheath extending between a proximal end and a distal end, the sheath being configured to receive and cover a distal tip of the colorectal surgical stapler, and an inflatable segment coupled to the sheath and configured to move between a collapsed configuration and an inflated configuration, wherein the inflatable segment is configured to inflate about the distal tip of the colorectal surgical stapler to form a smooth contoured shape, which facilitates insertion and advancement of the distal tip of the colorectal surgical stapler into a patient.
  • Embodiment 17 The introducer of Embodiment 16, wherein the sheath comprises an elastomer, such as silicone, polyurethane (e.g., a TPU) or a combination thereof.
  • Embodiment 18 An assembly comprising (i) a surgical instrument comprising a tubular shaft having a proximal end and a distal end, a handle extending from the proximal end of the tubular shaft, and a head assembly extending from the distal end of the tubular shaft, and (ii) an introducer coupled to the head assembly of the surgical instrument, wherein the introducer is configured to facilitate insertion and advancement of the distal end of the surgical instrument into a patient.
  • Embodiment 19 The assembly of Embodiment 18, wherein the surgical instrument is a surgical stapler.
  • Embodiment 20 The assembly of Embodiment 18 or 19, wherein the introducer comprises a sheath extending between a proximal end and a distal end, the sheath being configured to receive and cover at least the head assembly of the distal end of the surgical device, an inflatable portion coupled to the sheath and configured to move between a collapsed configuration and an inflated configuration, and an inflation fluid container coupled to the inflatable portion by a supply tube.
  • the introducer comprises a sheath extending between a proximal end and a distal end, the sheath being configured to receive and cover at least the head assembly of the distal end of the surgical device, an inflatable portion coupled to the sheath and configured to move between a collapsed configuration and an inflated configuration, and an inflation fluid container coupled to the inflatable portion by a supply tube.
  • Embodiment 21 The assembly of Embodiment 20, wherein the inflatable portion is configured to inflate about the distal end of the surgical instrument to form a smooth contoured shape.
  • Embodiment 22 A method of introducing a surgical instrument into a patient, the method comprising covering at least a head assembly of the surgical instrument with the introducer of any one of Embodiments 1 to 15, inserting the surgical instrument covered with the introducer into a body cavity' of the patient, and advancing the surgical instrument covered with the introducer to a location in the body.
  • Embodiment 23 The method of Embodiment 22, further comprising inflating the inflatable segment before, during, or after advancing the surgical instrument.
  • Embodiment 24 The method of Embodiment 23, wherein the inflatable segment is inflated before advancement of the surgical instrument such that the sheath has a smooth contoured shape effective to facilitate insertion and advancement of the surgical instrument.
  • Embodiment 25 The method of any one of Embodiments 22 to 24, further comprising deflating the inflatable segment after advancing the surgical instrument, and proximally withdraw ing the sheath over the distal portion of the surgical stapler to expose the head assembly.

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Abstract

L'invention concerne un introducteur servant à faciliter l'insertion d'un dispositif chirurgical allongé, comprenant une gaine et un segment gonflable couplé à celle-ci, la gaine recouvrant une extrémité distale du dispositif chirurgical allongé et prenant une forme profilée lisse sur celle-ci afin de faciliter l'insertion et l'avancement dudit dispositif chirurgical allongé dans un patient.
PCT/US2023/083983 2022-12-14 2023-12-14 Introducteurs luminaux et procédés associés WO2024129949A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263387417P 2022-12-14 2022-12-14
US63/387,417 2022-12-14

Publications (1)

Publication Number Publication Date
WO2024129949A1 true WO2024129949A1 (fr) 2024-06-20

Family

ID=91485916

Family Applications (1)

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PCT/US2023/083983 WO2024129949A1 (fr) 2022-12-14 2023-12-14 Introducteurs luminaux et procédés associés

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WO (1) WO2024129949A1 (fr)

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